Acetaminophen (Lexi-Drugs)

ALERT: US Boxed Warning
  Risk of medication errors and hepatotoxicity (injection):
Pronunciation

(a seet a MIN oh fen)

Brand Names: US

Acephen [OTC]; Aspirin Free Anacin Extra Strength [OTC]; Cetafen Extra [OTC]; Cetafen [OTC]; FeverAll Adult [OTC]; FeverAll Children’s [OTC]; FeverAll Infants’ [OTC]; FeverAll Junior Strength [OTC]; Little Fevers [OTC]; Mapap Arthritis Pain [OTC]; Mapap Children’s [OTC]; Mapap Extra Strength [OTC]; Mapap [OTC]; Midol Long Lasting Relief [OTC]; Non-Aspirin Pain Reliever [OTC]; Nortemp Children’s [OTC]; Ofirmev; Pain & Fever Children’s [OTC]; Pain Eze [OTC]; Pain Relief Extra Strength [OTC]; Pharbetol Extra Strength [OTC]; Pharbetol [OTC]; Q-Pap Children’s [OTC] [DSC]; Q-Pap Extra Strength [OTC] [DSC]; Q-Pap Infants’ [OTC] [DSC]; Q-Pap [OTC] [DSC]; Silapap Children’s [OTC]; Silapap Infants’ [OTC] [DSC]; Triaminic Children’s Fever Reducer Pain Reliever [OTC]; Tylenol 8 HR Arthritis Pain [OTC]; Tylenol 8 HR [OTC] [DSC]; Tylenol Children’s [OTC]; Tylenol Extra Strength [OTC]; Tylenol Infants’ [OTC]; Tylenol [OTC]; Valorin Extra [OTC]; Valorin [OTC]

Brand Names: Canada

Abenol; Apo-Acetaminophen; Atasol; Novo-Gesic; Pediatrix; Tempra; Tylenol

Pharmacologic Category

Analgesic, Nonopioid

Dosing: Adult

Note: In 2011, McNeil Consumer Healthcare reduced the maximum doses and increased the dosing interval on the labeling of some of their acetaminophen OTC products used in older pediatric patients (usually children ≥ 12 years and adolescents) and adults in an attempt to protect consumers from inadvertent overdoses. For example, the maximum daily dose of Tylenol Extra Strength and Tylenol Regular Strength was decreased and the dosing interval for Tylenol Extra Strength was increased. Health care professionals may still prescribe or recommend the 4 g daily maximum to patients (but are advised to use their own discretion and clinical judgment) (McNeil Consumer Healthcare, 2014).

Pain or fever:

Oral: Note: OTC dosing recommendations may vary by product and/or manufacturer. When calculating the maximum daily dose, consider all sources of acetaminophen (prescription and OTC) and all routes of administration. Do not exceed the maximum recommended daily dose. No dose adjustment required when converting between different acetaminophen formulations.

Immediate-release:

Regular strength: 650 mg every 4 to 6 hours; maximum daily dose: 3250 mg daily unless directed by health care provider; under health care provider supervision, daily doses ≤4 g may be used

Extra strength: 1000 mg every 6 hours; maximum daily dose: 3000 mg daily unless directed by a health care provider; under health care provider supervision, daily doses ≤4 g may be used

Extended-release: 1300 mg every 8 hours; maximum daily dose: 3900 mg daily

Rectal: 650 mg every 4 to 6 hours; maximum daily dose: 3900 mg daily

IV:

<50 kg: 12.5 mg/kg every 4 hours or 15 mg/kg every 6 hours; maximum single dose: 15 mg/kg/dose (≤750 mg/dose); maximum daily dose: 75 mg/kg/day (≤3.75 g/day)

≥50 kg: 650 mg every 4 hours or 1,000 mg every 6 hours; maximum single dose: 1,000 mg/dose; maximum daily dose: 4 g/day

Dosing: Geriatric

Pain (acute) or fever: Oral, IV: Refer to adult dosing.

Persistent pain (off-label): Adults ≥75 years: Oral:

Initial: 325 to 500 mg every 4 hours or 500 to 1,000 mg every 6 hours

Maximum: ≤4,000 mg/day. In older adults with hepatic impairment or history of alcohol abuse being treated for persistent pain, do not exceed a maximum of 2,000 to 3,000 mg/day (AGS 2009)

Dosing: Renal Impairment: Adult

Oral (Aronoff 2007):

GFR ≥50 mL/minute: No dosage adjustment necessary.

GFR 10 to 50 mL/minute: Administer every 6 hours.

GFR <10 mL/minute: Administer every 8 hours.

CRRT: Administer every 6 hours.

IV:

CrCl >30 mL/minute: There are no dosage adjustments provided in the manufacturer’s labeling.

CrCl ≤30 mL/minute: There are no dosage adjustments provided in the manufacturer’s labeling. Use with caution; consider decreasing daily dose and extending dosing interval.

Dosing: Hepatic Impairment: Adult

Oral: Use with extreme caution. Although limited data exist, low-dose (≤2 to 3 g/day) therapy is usually well tolerated in hepatic disease/cirrhosis; however, factors such as alcohol use, nutritional status, and renal function must also be taken into consideration (Bosilkovska 2012; Chandok 2010; Dwyer 2014; Hayward 2015, Imani 2014). In patients with hepatic impairment/cirrhosis and active alcohol use, most experts recommend avoiding use as much as possible, and if used, limiting therapy to short-term use only at doses ≤2 g/day (Bosilkovska 2012; Chandok 2010).

IV:

Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer’s labeling. Use with caution; a reduced total daily dosage may be warranted.

Severe impairment: Use is contraindicated.

Dosing: Pediatric

Note: In 2011, McNeil Consumer Healthcare reduced the maximum daily doses and increased the dosing interval on the labeling of some of their acetaminophen OTC products used in older pediatric patients (usually children ≥12 years and adolescents) and adults in an attempt to protect consumers from inadvertent overdoses. For example, the maximum daily dose of Extra Strength Tylenol OTC and Regular Strength Tylenol OTC were decreased to 3,000 mg/day and 3,250 mg/day respectively, and the dosing interval for Extra Strength Tylenol OTC was increased. Health care professionals may still prescribe or recommend the 4 g adult daily maximum to patients ≥12 years of age (but are advised to use their own discretion and clinical judgment) (McNeil Consumer Healthcare 2014).

Note: Oral liquids are available in multiple concentrations (eg, 160 mg/5 mL, 500 mg/5 mL and 500 mg/15 mL); precautions should be taken to verify and avoid confusion between the different concentrations; dose should be clearly presented as “mg”

Pain (mild to moderate) or fever: Note: Limit acetaminophen dose from all sources (prescription and OTC); maximum daily dose of acetaminophen should be limited to ≤75 mg/kg/day in ≤5 divided doses and not to exceed 4,000 mg/day for most products although some formulations suggest lower maximum daily dosing (see dosing information for further detail):

Oral: Note: With OTC use, should not exceed recommended treatment duration unless directed by health care provider; for fever: 3 days (all ages); pain (excluding sore throat): Children ≥12 years and Adolescents: 10 days, children: 5 days, or infants: 3 days; sore throat in children: 2 days

Weight-directed dosing: Infants, Children, and Adolescents: 10 to 15 mg/kg/dose every 4 to 6 hours as needed (American Pain Society 2008; Kliegman 2011; Sullivan 2011); do not exceed 5 doses in 24 hours; maximum daily dose: 75 mg/kg/day not to exceed 4,000 mg/day

Fixed dosing:

Oral suspension, chewable tablets: Infants and Children <12 years: Consult specific product formulations for appropriate age groups. See table; use of weight to select dose is preferred; if weight is not available, then use age; doses may be repeated every 4 hours; maximum: 5 doses/day

Acetaminophen Dosing (Oral)
Weight (preferred)A Age Dosage

(mg)

kg lbs
AManufacturer’s recommendations are based on weight in pounds (OTC labeling); weight in kg listed here is derived from pounds and rounded; kg weight listed also is adjusted to allow for continuous weight ranges in kg. OTC labeling instructs consumer to consult with physician for dosing instructions in infants and children under 2 years of age.
2.7 to 5.3 6 to 11 0 to 3 mo 40
5.4 to 8.1 12 to 17 4 to 11 mo 80
8.2 to 10.8 18 to 23 1 to 2 y 120
10.9 to 16.3 24 to 35 2 to 3 y 160
16.4 to 21.7 36 to 47 4 to 5 y 240
21.8 to 27.2 48 to 59 6 to 8 y 320
27.3 to 32.6 60 to 71 9 to 10 y 400
32.7 to 43.2 72 to 95 11 y 480

Immediate release solid dosage formulations: Note: Actual OTC dosing recommendations may vary by product and/or manufacturer:

Children 6 to 11 years: 325 mg every 4 to 6 hours; maximum daily dose: 1,625 mg/dayNote: Do not use more than 5 days unless directed by a physician

Children ≥12 years and Adolescents:

Regular strength: 650 mg every 4 to 6 hours; maximum daily dose: 3,250 mg/day unless directed by a physician; under physician supervision daily doses ≤4,000 mg may be used

Extra strength: 1,000 mg every 6 hours; maximum daily dose: 3,000 mg/day unless directed by a physician; under physician supervision daily doses ≤4,000 mg may be used

Extended release: Children ≥12 years and Adolescents: 1,300 mg every 8 hours; maximum daily dose: 3,900 mg/day

IV:

Infants and Children <2 years:

Manufacturer’s labeling: Fever: 15 mg/kg/dose every 6 hours; maximum daily dose: 60 mg/kg/day

Alternate dosing: Limited data available: Pain and fever: 7.5 to 15 mg/kg/dose every 6 hours; maximum daily dose: 60 mg/kg/day (Wilson-Smith 2009)

Children ≥2 years and Adolescents:

<50 kg: 15 mg/kg/dose every 6 hours or 12.5 mg/kg/dose every 4 hours; maximum single dose: 15 mg/kg up to 750 mg; maximum daily dose: 75 mg/kg/day not to exceed 3,750 mg/day

≥50 kg: 1,000 mg every 6 hours or 650 mg every 4 hours; maximum single dose: 1,000 mg; maximum daily dose: 4,000 mg/day

Rectal:

Weight-directed dosing: Limited data available: Infants and Children <12 years: 10 to 20 mg/kg/dose every 4 to 6 hours as needed; do not exceed 5 doses in 24 hours(Kliegman 2011; Vernon 1979); maximum daily dose: 75 mg/kg/day

Fixed dosing:

Infants 6 to 11 months: 80 mg every 6 hours; maximum daily dose: 320 mg/day

Infants and Children 12 to 36 months: 80 mg every 4 to 6 hours; maximum daily dose: 400 mg/day

Children >3 to 6 years: 120 mg every 4 to 6 hours; maximum daily dose: 600 mg/day

Children >6 up to 12 years: 325 mg every 4 to 6 hours; maximum daily dose: 1,625 mg/day

Children ≥12 years and Adolescents: 650 mg every 4 to 6 hours; maximum daily dose: 3,900 mg/day

Pain; peri-/postoperative management; adjunct to opioid therapy:

IV:

Infants and Children <2 years: Limited data available: 7.5 to 15 mg/kg/dose every 6 hours; maximum daily dose: 60 mg/kg/day (Wilson-Smith, 2009)

Children ≥2 years and Adolescents:

<50 kg: 15 mg/kg/dose every 6 hours or 12.5 mg/kg/dose every 4 hours; maximum single dose: 15 mg/kg up to 750 mg; maximum daily dose: 75 mg/kg/day not to exceed 3,750 mg/day

≥50 kg: 1,000 mg every 6 hours or 650 mg every 4 hours; maximum single dose: 1,000 mg; maximum daily dose: 4,000 mg/day

Rectal: Limited data available: Children and Adolescents:

Loading dose: 40 mg/kg for 1 dose, in most trials, the dose was administered postoperatively (Birmingham 2001; Capici 2008; Hahn 2000; Mireskandari 2011; Prins 2008; Riad 2007; Viitanen 2003); a maximum dose of 1,000 mg was most frequently reported. However, in one trial evaluating 24 older pediatric patients (all patients ≥25 kg; mean age: ~13 years), the data suggested that a dose of 1,000 mg does not produce therapeutic serum concentrations (target for study: >10 mcg/mL) compared to a 40 mg/kg dose (up to~ 2,000 mg); the resultant Cmax was: 7.8 mcg/mL (1,000 mg dose group) vs 15.9 mcg/mL (40 mg/kg dose group). Note: Therapeutic serum concentrations for analgesia have not been well-established (Howell 2003).

Maintenance dose: 20 to 25 mg/kg/dose every 6 hours as needed for 2 to 3 days has been suggested if further pain control is needed postoperatively; maximum daily dose: 100 mg/kg/day; therapy longer than 5 days has not been evaluated (Birmingham 2001; Hahn 2000; Prins 2008).

Note: In the majority of trials, suppositories were not divided due to unequal distribution of drug within suppository; doses were rounded to the nearest mg amount using 1 or 2 suppositories of available product strengths.

Dosing: Renal Impairment: Pediatric

IV: Children ≥2 years and Adolescents: CrCl ≤30 mL/minute: Use with caution; consider decreasing daily dose and extending dosing interval

Oral (Aronoff 2007):

Infants, Children, and Adolescents:

GFR ≥10 mL/minute/1.73 m2: No adjustment required

GFR <10 mL/minute/1.73 m2: Administer every 8 hours

Intermittent hemodialysis or peritoneal dialysis: Administer every 8 hours

CRRT: No adjustments necessary

Dosing: Hepatic Impairment: Pediatric

Use with caution. Limited, low-dose therapy is usually well-tolerated in hepatic disease/cirrhosis; however, cases of hepatotoxicity at daily acetaminophen dosages <4,000 mg/day have been reported. Avoid chronic use in hepatic impairment.

Use: Labeled Indications

Pain:

Injection: Management of mild to moderate pain in patients ≥2 years of age; management of moderate to severe pain when combined with opioid analgesia in patients ≥2 years

Oral, Rectal: Temporary relief of minor aches, pains, and headache

Fever: Temporary reduction of fever

Use: Unsupported: Adult
Prevention of adverse reactions with diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine (children)

Prophylactic use of acetaminophen to reduce fever and discomfort associated with diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccination is not recommended in the Advisory Committee on Immunization Practices (ACIP) General Recommendations on Immunization. Although prophylactic acetaminophen has been shown to significantly reduce incidence of postvaccination fever and other adverse effects in some children, it also has been shown to significantly reduce antibodies to vaccine serotypes. This negative immunogenic effect, which occurs after prophylactic acetaminophen is given during the primary series, can persist after the booster doses. Although acetaminophen should not be used before or at the time of vaccination to prevent fever, use after vaccination to treat fever and local discomfort is endorsed by current ACIP recommendations. Access Full Off-Label Monograph

Prevention of febrile seizure with diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccine (children)

Prophylactic use of acetaminophen to reduce fever and discomfort associated with diphtheria and tetanus toxoids and acellular pertussis (DTaP) vaccination is not recommended in the Advisory Committee on Immunization Practices (ACIP) General Recommendations on Immunization. Although prophylactic acetaminophen has been shown to significantly reduce incidence of postvaccination fever and other adverse effects in some children, it also has been shown to significantly reduce antibodies to vaccine serotypes. This negative immunogenic effect, which occurs after prophylactic acetaminophen is given during the primary series, can persist after the booster doses. Although acetaminophen should not be used before or at the time of vaccination to prevent fever, use after vaccination to treat fever and local discomfort is endorsed by current ACIP recommendations. Access Full Off-Label Monograph

Clinical Practice Guidelines

Critical Care:

SCCM, “Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU,” September 2018

SCCM, “Clinical Practice Guidelines for the Management of Pain, Agitation, and Delirium in Adult Patients in the Intensive Care Unit,” January 2013

Drug-Induced Liver Injury:

American College of Gastroenterology (ACG), “2014 ACG Guideline for Idiosyncratic Drug-induced Liver Injury,” July 2014

Fever:

AAP, Fever and Antipyretic Use in Children, March 2011

Osteoarthritis:

American College of Rheumatology, “Recommendations for the Use of Nonpharmacologic and Pharmacologic Therapies in Osteoarthritis of the Hand, Hip, and Knee,” 2012

Administration: IV

Injection: For IV infusion only. Administer undiluted over 15 minutes.

For doses <1,000 mg (<50 kg): Withdraw appropriate dose and place into separate empty, sterile container (eg, glass bottle, plastic IV container, syringe) for administration.

For 1,000 mg doses (≥50 kg): Insert a vented IV set through vial stopper or a non-vented IV set through the administration spike port of the bag.

Administration: Injectable Detail

pH: 5.5

Administration: Oral

May administer without regards to food; may administer with food to decrease possible GI upset; do not crush or chew extended release products.

Administration: Rectal

Remove wrapper; insert suppository well up into the rectum.

Administration: Pediatric

Oral: Administer with food to decrease GI upset; shake drops and suspension well before use; do not crush or chew extended release products

Parenteral: For IV infusion only. May administer undiluted over 15 minutes. Use within 6 hours of opening vial or transferring to another container. Discard any unused portion; single-use vials only.

Rectal: Remove wrapper; insert suppository well up into the rectum.

Dietary Considerations

Some products may contain phenylalanine and/or sodium.

Storage/Stability

Injection: Store intact vials and bags at 20°C to 25°C (68°F to 77°F); do not refrigerate or freeze. Use within 6 hours of penetrating vial/bag or transferring to another container. Discard any unused portion.

Oral formulations: Store at 20°C to 25°C (68°F to 77°F); avoid excessive heat (40°C [104°F]). Avoid high humidity (chewable tablets).

Suppositories: Store at 2°C to 27°C (25°F to 80°F); do not freeze.

Preparation for Administration: Adult

Injectable solution may be administered without further dilution.

Doses <1,000 mg (<50 kg): Withdraw appropriate dose and transfer to a separate sterile container (eg, glass bottle, plastic IV container, syringe) for administration.

Doses of 1,000 mg (≥50 kg): Insert a vented IV set through vial stopper or a non-vented IV set through the administration spike port of the bag.

Preparation for Administration: Pediatric

Parenteral: Injectable solution may be administered directly from the vial without further dilution. Use within 6 hours of opening vial or transferring to another container. Discard any unused portion; single-use vials only.

Doses <1,000 mg (<50 kg): Withdraw appropriate dose from vial and transfer to a separate sterile container (eg, glass bottle, plastic IV container, syringe) for administration. Small volume pediatric doses (up to 600 mg [60 mL]) may be placed in a syringe.

Doses of 1,000 mg (≥50 kg): Insert vented IV set through vial stopper.

Compatibility

See Trissel’s IV Compatibility Database

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea, vomiting, or insomnia. Have patient report immediately to prescriber signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), urinary retention, change in amount of urine passed, or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
  Other safety concerns:
  International issues:
Contraindications

Injection: Hypersensitivity to acetaminophen or any component of the formulation; severe hepatic impairment or severe active liver disease

OTC labeling: When used for self-medication, do not use with other drug products containing acetaminophen or if allergic to acetaminophen or any of the inactive ingredients

Warnings/Precautions

Concerns related to adverse effects:

• Hepatotoxicity: Injection: [US Boxed Warning]. Acetaminophen has been associated with acute liver failure, at times resulting in liver transplant and death. Hepatotoxicity is usually associated with excessive acetaminophen intake and often involves more than one product that contains acetaminophen. Do not exceed the maximum recommended daily dose (>4 g daily in adults). In addition, chronic daily dosing may also result in liver damage in some patients.

• Hypersensitivity/anaphylactic reactions: Hypersensitivity and anaphylactic reactions have been reported; discontinue immediately if symptoms of allergic or hypersensitivity reactions occur.

• Skin reactions: Serious and potentially fatal skin reactions, including acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have occurred rarely with acetaminophen use. Discontinue therapy at the first appearance of skin rash.

Disease-related concerns:

• Ethanol use: Use with caution in patients with alcoholic liver disease; consuming ≥3 alcoholic drinks/day may increase the risk of liver damage.

• G6PD deficiency: Use with caution in patients with known G6PD deficiency.

• Hepatic impairment: Use with caution in patients with hepatic impairment or active liver disease; use of the IV formulation is contraindicated in patients with severe hepatic impairment or severe active liver disease.

• Hypovolemia: Use the IV formulation with caution in patients with severe hypovolemia (eg, due to dehydration or blood loss).

• Malnutrition: Use with caution in patients with chronic malnutrition.

• Renal impairment: Use with caution in patients with severe renal impairment; consider dosing adjustments.

Dosage form specific issues:

• Aspartame: Some products may contain aspartame, which is metabolized to phenylalanine and must be avoided (or used with caution) in patients with phenylketonuria.

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol and/or sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP [“Inactive” 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol and/or benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

• Injection: [US Boxed Warning]: Take care to avoid dosing errors; ensure that the dose in mg is not confused with mL, dosing in patients <50 kg is based on body weight, infusion pumps are properly programmed, and total daily dose of acetaminophen from all sources does not exceed the maximum daily limits.

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson, 2002; Lucente 2000; Shelley, 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade, 1986; CDC, 1984). See manufacturer’s labeling.

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP [“Inactive” 1997]; Zar, 2007).

Other warnings/precautions:

• Dosage limit: Limit acetaminophen dose from all sources (prescription, OTC, combination products) and all routes of administration (IV, oral, rectal) to <4 g/day (adults).

• Self-medication (OTC use): When used for self-medication, patients should be instructed to contact health care provider if symptoms get worse or new symptoms appear, redness or swelling is present in the painful area, fever lasts >3 days (all ages), or pain (excluding sore throat) lasts longer than: Adults: 10 days, Children and Adolescents: 5 days, Infants: 3 days. When treating children with sore throat, if sore throat is severe, persists for >2 days, or is followed by fever, rash, headache, nausea, or vomiting, consult health care provider immediately.

Geriatric Considerations

Given its relative safety when compared to NSAIDs, acetaminophen remains the mainstay of pain relief for mild pain in the older adult (AGS 2009). Total daily doses of acetaminophen should be no more than 4 grams. While single-dose acetaminophen studies support a decreased clearance of acetaminophen in those who are frail or of advanced age (Bannworth 2003; Butler 2008; Liukas 2011; McLachlan 2011; Wynne 1990), the clinical significance of this has not been proven. Professional opinions suggest lowering total daily doses of acetaminophen (Fitzcharles 2010; Makris 2014; Rastogi 2013), however, there is little research to support their recommended doses.

An American Geriatrics Society pain guideline supports a maximum daily dose of 4 grams daily for the older adult without hepatic disease (AGS 2009). An FDA workgroup convened in 2011 to evaluate risk mitigation strategies for avoidance of acetaminophen overdose limited the maximum amount of acetaminophen allowed in oral prescription products to 325 mg per dosage form unit, but also supported a continued daily maximum of 4 grams (FDA 2011). McNeil Consumer Healthcare, a manufacturer of acetaminophen, however, voluntarily changed daily maximums on some of their OTC product labeling to anywhere between 3,000 mg and 3,900 mg, depending on the product.

Warnings: Additional Pediatric Considerations

Prophylactic use of acetaminophen to reduce fever and discomfort associated vaccination is not recommended by the Advisory Committee on Immunization Practices (ACIP). Additionally, the ACIP does not recommend prophylactic acetaminophen to reduce risk of febrile seizure in infants and children with or without a history of febrile seizures. Antipyretics have not been shown to prevent febrile seizures (NCIRD/ACIP 2011). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination decreased the immune response of some vaccines; in the trial evaluating 459 infants (including 226 who received acetaminophen), antibody geometric mean concentrations (GMCs) for targeted vaccine immune response markers were lower in significantly more infants in the acetaminophen group compared with control. Before the booster dose, children who received prophylactic acetaminophen had lower antibody GMCs for all vaccine serotypes than children in the control group; this effect persisted after boosting even in the absence of additional acetaminophen doses. The clinical significance of this reduction in immune response has not been established (Prymula 2009). Antipyretics may be used to treat fever or discomfort following vaccination (NCIRD/ACIP 2011).

Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP, 1997; Shehab, 2009).

Pregnancy Considerations

Acetaminophen crosses the placenta and can be detected in cord blood, newborn serum, and urine immediately after delivery (Levy 1975; Naga Rani 1989; Wang 1997). An increased risk of teratogenic effects has not been observed following maternal use of acetaminophen during pregnancy. Prenatal constriction of the ductus arteriosus has been noted in case reports following maternal use during the third trimester (Suhag 2008; Wood 2005). The use of acetaminophen in normal doses during pregnancy is not associated with an increased risk of miscarriage or still birth; however, an increase in fetal death or spontaneous abortion may be seen following maternal overdose if treatment is delayed (Li 2003; Rebordosa 2009; Riggs 1989). Frequent maternal use of acetaminophen during pregnancy may be associated with wheezing and asthma in early childhood (Perzanowki 2010).

Breast-Feeding Considerations

Acetaminophen is excreted in breast milk (Notarianni 1987).

The relative infant dose (RID) of acetaminophen is 3.98% when calculated using the highest breast milk concentration located and compared to an infant therapeutic dose of 60 mg/kg/day. In general, breastfeeding is considered acceptable when the RID is <10%; when an RID is >25% breastfeeding should generally be avoided (Anderson 2016; Ito 2000). Using the highest milk concentration (15.9 mcg/mL), the estimated daily infant dose via breast milk is 2.385 mg/kg/day. This milk concentration was obtained following a single maternal dose of oral acetaminophen 1,000 mg (Hurden 1980).

Following a single oral maternal dose of acetaminophen 650 mg, the half-life of acetaminophen is 1.35 to 3.5 hours in breast milk (Berlin 1980). Acetaminophen can be detected in the urine of nursing infants (Notarianni 1987). Except for a single case report of a rash (Matheson 1985), adverse reactions have generally not been observed in nursing infants (Ito 1993).

Current guidelines note that nonopioid analgesics are preferred for the treatment of pain in breastfeeding women and acetaminophen is one of the preferred nonopioid agents (Montgomery 2012; Sachs 2013). Acetaminophen is considered compatible with breast-feeding when used in usual recommended doses (WHO 2002).

Lexicomp Pregnancy & Lactation, In-Depth
Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

Oral, Rectal: Frequency not defined:

Dermatologic: Skin rash

Endocrine & metabolic: Decreased serum bicarbonate, decreased serum calcium, decreased serum sodium, hyperchloremia, hyperuricemia, increased serum glucose

Genitourinary: Nephrotoxicity (with chronic overdose)

Hematologic & oncologic: Anemia, leukopenia, neutropenia, pancytopenia

Hepatic: Increased serum alkaline phosphatase, increased serum bilirubin

Hypersensitivity: Hypersensitivity reaction (rare)

Renal: Hyperammonemia, renal disease (analgesic)

IV:

>10%: Gastrointestinal: Nausea (adults: 34%; neonates, infants, children, and adolescents: ≥5%), vomiting (adults: 15%; neonates, infants, children, and adolescents: ≥5%)

1% to 10%:

Cardiovascular: Hypertension (≥1%), hypotension (≥1%), peripheral edema (adults: ≥1%), tachycardia

Central nervous system: Headache (adults: 10%; neonates, infants, children, and adolescents: ≥1%), insomnia (adults: 7%), agitation (neonates, infants, children, and adolescents: ≥1%), anxiety (adults: ≥1%), fatigue (adults: ≥1%), trismus (adults: ≥1%)

Dermatologic: Pruritus (neonates, infants, children, and adolescents: ≥5%), skin rash

Endocrine & metabolic: Hypoalbuminemia (neonates, infants, children, and adolescents: ≥1%), hypokalemia (≥1%), hypomagnesemia (neonates, infants, children, and adolescents: ≥1%), hypophosphatemia (neonates, infants, children, and adolescents: ≥1%), hypervolemia

Gastrointestinal: Constipation (neonates, infants, children, and adolescents: ≥5%), diarrhea (neonates, infants, children, and adolescents: ≥1%), abdominal pain

Genitourinary: Oliguria (neonates, infants, children, and adolescents: ≥1%)

Hematologic & oncologic: Anemia (≥1%)

Hepatic: Increased serum transaminases

Local: Pain at injection site (≥1%)

Neuromuscular & skeletal: Limb pain, muscle spasm (≥1%)

Ophthalmic: Periorbital edema

Respiratory: Abnormal breath sounds (adults: ≥1%), atelectasis (neonates, infants, children, and adolescents: ≥1%), dyspnea (adults: ≥1%), hypoxia, pleural effusion (neonates, infants, children, and adolescents: ≥1%), pulmonary edema (neonates, infants, children, and adolescents: ≥1%), stridor (adults: ≥1%), wheezing (adults: ≥1%)

Miscellaneous: Fever (neonates, infants, children, and adolescents: ≥1%)

All formulations: <1%, postmarketing, and/or case reports: Anaphylaxis, hypersensitivity reaction

Allergy and Idiosyncratic Reactions
Toxicology
Metabolism/Transport Effects

Substrate of CYP1A2 (minor), CYP2A6 (minor), CYP2C9 (minor), CYP2D6 (minor), CYP2E1 (minor), CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions 

Alcohol (Ethyl): May enhance the hepatotoxic effect of Acetaminophen. Risk C: Monitor therapy

Barbiturates: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Exceptions: Amobarbital; Butabarbital; Butalbital; Methohexital; PENTobarbital; Secobarbital; Thiopental. Risk C: Monitor therapy

Busulfan: Acetaminophen may increase the serum concentration of Busulfan. Risk C: Monitor therapy

CarBAMazepine: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy

Dapsone (Topical): May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Risk C: Monitor therapy

Dasatinib: Acetaminophen may enhance the hepatotoxic effect of Dasatinib. Dasatinib may increase the serum concentration of Acetaminophen. Risk D: Consider therapy modification

Flucloxacillin: May enhance the adverse/toxic effect of Acetaminophen. Specifically, the risk for high anion gap metabolic acidosis may be increased. Risk C: Monitor therapy

Fosphenytoin-Phenytoin: May decrease the serum concentration of Acetaminophen. Specifically, serum concentrations of acetaminophen may be decreased (leading to decreased efficacy), but the formation of the toxic N-acetyl-p-benzoquinone imine (NAPQI) metabolite may be increased (leading to increased hepatotoxicity). Risk C: Monitor therapy

Imatinib: Acetaminophen may enhance the hepatotoxic effect of Imatinib. Risk C: Monitor therapy

Isoniazid: May enhance the adverse/toxic effect of Acetaminophen. Risk C: Monitor therapy

LamoTRIgine: Acetaminophen may decrease the serum concentration of LamoTRIgine. Risk C: Monitor therapy

Local Anesthetics: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased.Risk C: Monitor therapy

MetyraPONE: May increase the serum concentration of Acetaminophen. More importantly, by inhibiting the conjugative metabolism of acetaminophen, metyrapone may shift the metabolism towards the oxidative route that produces a hepatotoxic metabolite. Risk C: Monitor therapy

Mipomersen: Acetaminophen may enhance the hepatotoxic effect of Mipomersen. Risk C: Monitor therapy

Nitric Oxide: May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when nitric oxide is used in combination with other agents associated with development of methemoglobinemia. Avoid lidocaine/prilocaine. Risk C: Monitor therapy

Phenylephrine (Systemic): Acetaminophen may increase the serum concentration of Phenylephrine (Systemic). Risk C: Monitor therapy

Prilocaine: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Prilocaine. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when prilocaine is used in combination with other agents associated with development of methemoglobinemia. Avoid lidocaine/prilocaine in infants receiving such agents. Risk C: Monitor therapy

Probenecid: May increase the serum concentration of Acetaminophen. Probenecid may also limit the formation of at least one major non-toxic metabolite, possibly increasing the potential for formation of the toxic NAPQI metabolite. Risk D: Consider therapy modification

Sodium Nitrite: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Sodium Nitrite. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor therapy

SORAfenib: Acetaminophen may enhance the hepatotoxic effect of SORAfenib. SORAfenib may increase the serum concentration of Acetaminophen. Risk D: Consider therapy modification

Vitamin K Antagonists (eg, warfarin): Acetaminophen may enhance the anticoagulant effect of Vitamin K Antagonists. This appears most likely with daily acetaminophen doses exceeding 1.3 or 2 g/day for multiple consecutive days. Risk C: Monitor therapy

Food Interactions

Rate of absorption may be decreased when given with food. Management: Administer without regard to food.

Test Interactions

Acetaminophen may cause false-positive urinary 5-hydroxyindoleacetic acid.

Monitoring Parameters

 Serum acetaminophen levels: Where acute overdose suspected and with long-term use in patients with hepatic disease; relief of pain or fever

Advanced Practitioners Physical Assessment/Monitoring

Assess patient for history of liver disease or ethanol abuse (acetaminophen and any ethanol may have adverse liver effects). Ensure adult patients keep daily dose to ≤4 g/day.

Nursing Physical Assessment/Monitoring

Assess patient for history of liver disease or ethanol abuse (acetaminophen and any ethanol may have adverse liver effects). Ensure adult patients keep daily dose to ≤4 g/day.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Caplet, oral: 500 mg

Cetafen Extra: 500 mg

Mapap Extra Strength: 500 mg

Mapap Extra Strength: 500 mg [scored]

Pain Eze: 650 mg

Tylenol: 325 mg

Tylenol Extra Strength: 500 mg

Caplet, extended release, oral:

Mapap Arthritis Pain: 650 mg

Midol Long Lasting Relief: 650 mg

Tylenol 8 HR Arthritis Pain: 650 mg

Capsule, oral:

Mapap Extra Strength: 500 mg

Tylenol: 325 mg

Tylenol Extra Strength: 500 mg

Injection, solution [preservative free]:

Ofirmev: 10 mg/mL (100 mL)

Liquid, oral: 160 mg/5 mL (120 mL, 473 mL)

Q-Pap Children’s: 160 mg/5 mL (118 mL [DSC], 473 mL [DSC]) [ethanol free; contains propylene glycol, sodium 2 mg/5 mL, sodium benzoate; cherry flavor, grape flavor]

Silapap Children’s: 160 mg/5 mL (118 mL, 237 mL, 473 mL) [ethanol free, sugar free; contains propylene glycol, sodium benzoate; cherry flavor]

Solution, oral: 160 mg/5 mL (5 mL, 10 mL, 20 mL); 325 mg/10.15 mL (10.15 mL); 650 mg/20.3 mL (20.3 mL)

Pain & Fever Children’s: 160 mg/5 mL (118 mL, 473 mL) [ethanol free, sugar free; contains propylene glycol, sodium 1 mg/5 mL, sodium benzoate; cherry flavor]

Solution, oral [drops]: 80 mg/0.8 mL (15 mL [DSC])

Little Fevers: 80 mg/mL (30 mL [DSC]) [dye free, ethanol free, gluten free; contains propylene glycol, sodium benzoate; berry flavor]

Q-Pap Infants’: 80 mg/0.8 mL (15 mL [DSC]) [ethanol free; contains propylene glycol; fruit flavor]

Silapap Infants’: 80 mg/0.8 mL (15 mL [DSC], 30 mL [DSC]) [ethanol free; contains propylene glycol, sodium benzoate; cherry flavor]

Suppository, rectal: 120 mg (12s); 325 mg (12s); 650 mg (12s)

Acephen: 120 mg (12s, 50s, 100s); 325 mg (6s, 12s, 50s, 100s); 650 mg (12s, 50s, 100s)

FeverAll Adults: 650 mg (50s)

FeverAll Children’s: 120 mg (6s, 50s)

FeverAll Infants’: 80 mg (6s, 50s)

FeverAll Junior Strength: 325 mg (6s, 50s)

Suspension, oral: 160 mg/5 mL (5 mL, 10.15 mL, 20.3 mL)

Mapap Children’s: 160 mg/5 mL (118 mL) [ethanol free; contains propylene glycol, sodium benzoate; cherry flavor]

Nortemp Children’s: 160 mg/5 mL (118 mL) [ethanol free; contains propylene glycol, sodium benzoate; cotton candy flavor]

Pain & Fever Children’s: 160 mg/5 mL (60 mL) [ethanol free; contains propylene glycol, sodium benzoate; cherry flavor]

Q-Pap Children’s: 160 mg/5 mL (118 mL [DSC]) [ethanol free; contains sodium 2 mg/5 mL, sodium benzoate; bubblegum flavor, cherry flavor, grape flavor]

Tylenol Children’s: 160 mg/5 mL (120 mL) [dye free, ethanol free; contains propylene glycol, sodium benzoate; cherry flavor]

Tylenol Children’s: 160 mg/5 mL (120 mL) [ethanol free; contains propylene glycol, sodium 2 mg/5 mL, sodium benzoate; bubblegum flavor]

Tylenol Children’s: 160 mg/5 mL (60 mL, 120 mL) [ethanol free; contains propylene glycol, sodium 2 mg/5 mL, sodium benzoate; cherry flavor]

Tylenol Children’s: 160 mg/5 mL (120 mL) [ethanol free; contains propylene glycol, sodium 2 mg/5 mL, sodium benzoate; grape flavor]

Tylenol Children’s: 160 mg/5 mL (120 mL) [ethanol free; contains propylene glycol, sodium 2 mg/5 mL, sodium benzoate; strawberry flavor]

Tylenol Infants’: 160 mg/5 mL (60 mL) [ethanol free; contains propylene glycol, sodium benzoate; grape flavor]

Syrup, oral:

Triaminic Children’s Fever Reducer Pain Reliever: 160 mg/5 mL (118 mL) [contains benzoic acid, sodium 6 mg/5 mL; bubblegum flavor]

Triaminic Children’s Fever Reducer Pain Reliever: 160 mg/5 mL (118 mL) [contains sodium 5 mg/5 mL, sodium benzoate; grape flavor]

Tablet, oral: 325 mg, 500 mg

Aspirin Free Anacin Extra Strength: 500 mg

Cetafen: 325 mg

Mapap: 325 mg

Mapap Extra Strength: 500 mg

Non-Aspirin Pain Reliever: 325 mg

Pain Relief Extra Strength: 500 mg

Pharbetol: 325 mg

Pharbetol Extra Strength: 500 mg

Q-Pap: 325 mg [scored] [DSC]

Q-Pap Extra Strength: 500 mg [scored] [DSC]

Tylenol: 325 mg

Tylenol Extra Strength: 500 mg

Valorin: 325 mg [sugar free]

Valorin Extra: 500 mg [sugar free]

Tablet, chewable, oral: 80 mg

Mapap Children’s: 80 mg [fruit flavor]

Tablet, dispersible, oral: 80 mg, 160 mg

Mapap Children’s: 80 mg [bubblegum flavor] [DSC]

Mapap Children’s: 80 mg [grape flavor]

Anatomic Therapeutic Chemical (ATC) Classification
  • N02BE01
Generic Available (US)

Yes: Excludes extended release products; injectable formulation

Pricing: US

Capsules (Tylenol Oral)

325 mg (per each): $0.18

Chewable (Mapap Childrens Oral)

160 mg (per each): $0.09

Chewable (Tylenol Childrens Chewables Oral)

160 mg (per each): $0.26

Gel (ElixSure Fever/Pain Oral)

160 mg/5 mL (per mL): $0.04

Liquid (Acetaminophen Oral)

160 mg/5 mL (per mL): $0.02

Liquid (Mapap Acetaminophen Extra Str Oral)

500 mg/15 mL (per mL): $0.02

Solution (Acetaminophen Oral)

160 mg/5 mL (per mL): $0.16 – $0.45

Solution (Ofirmev Intravenous)

10 mg/mL (per mL): $0.52

Suppository (Acephen Rectal)

120 mg (per each): $0.61

325 mg (per each): $0.66

650 mg (per each): $0.71

Suppository (FeverAll Adults Rectal)

650 mg (per each): $0.66

Suppository (FeverAll Childrens Rectal)

120 mg (per each): $0.80

Suppository (FeverAll Infants Rectal)

80 mg (per each): $0.80

Suppository (FeverAll Junior Strength Rectal)

325 mg (per each): $0.80

Suspension (Nortemp Oral)

160 mg/5 mL (per mL): $0.05

Suspension (Tylenol Childrens Oral)

160 mg/5 mL (per mL): $0.05

Suspension (Tylenol Infants Oral)

160 mg/5 mL (per mL): $0.15

Suspension (Tylenol Infants Pain+Fever Oral)

160 mg/5 mL (per mL): $0.18

Syrup (Triaminic Fever Reducer Oral)

160 mg/5 mL (per mL): $0.08

Tablet, controlled release (Tylenol 8 Hour Arthritis Pain Oral)

650 mg (per each): $0.12

Tablet, controlled release (Tylenol 8 Hour Oral)

650 mg (per each): $0.12

Tablet, orally-disintegrating (Mapap Childrens Oral)

80 mg (per each): $0.10

Tablets (Acetaminophen Oral)

325 mg (per each): $0.01 – $0.06

500 mg (per each): $0.01 – $0.08

Tablets (Healthy Mama Shake That Ache Oral)

500 mg (per each): $0.06

Tablets (Pharbetol Extra Strength Oral)

500 mg (per each): $0.03

Tablets (Pharbetol Oral)

325 mg (per each): $0.02

Tablets (Tylenol Extra Strength Oral)

500 mg (per each): $0.11

Tablets (Tylenol Oral)

325 mg (per each): $0.05

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Although not fully elucidated, the analgesic effects are believed to be due to activation of descending serotonergic inhibitory pathways in the CNS. Interactions with other nociceptive systems may be involved as well (Smith 2009). Antipyresis is produced from inhibition of the hypothalamic heat-regulating center.

Pharmacodynamics/Kinetics

Note: With the exception of half-life, the pharmacokinetic profile in pediatric patients (0-18 years) is similar to adult patients.

Onset of action:

Oral: <1 hour

IV: Analgesia: 5 to 10 minutes; Antipyretic: Within 30 minutes

Peak effect: IV: Analgesic: 1 hour

Duration:

IV, Oral: Analgesia: 4 to 6 hours

IV: Antipyretic: ≥6 hours

Absorption: Primarily absorbed in small intestine (rate of absorption dependent upon gastric emptying); minimal absorption from stomach; varies by dosage form

Distribution: ~1 L/kg at therapeutic doses

Protein binding: 10% to 25% at therapeutic concentrations; 8% to 43% at toxic concentrations

Metabolism: At normal therapeutic dosages, primarily hepatic metabolism to sulfate and glucuronide conjugates, while a small amount is metabolized by CYP2E1 to a highly reactive intermediate, N-acetyl-p-benzoquinone imine (NAPQI), which is conjugated rapidly with glutathione and inactivated to nontoxic cysteine and mercapturic acid conjugates. At toxic doses (as little as 4 g daily) glutathione conjugation becomes insufficient to meet the metabolic demand causing an increase in NAPQI concentrations, which may cause hepatic cell necrosis. Oral administration is subject to first pass metabolism.

Half-life elimination: Prolonged following toxic doses

Neonates: 7 hours (range: 4 to 10 hours)

Infants: ~4 hours (range: 1 to 7 hours)

Children: 3 hours (range: 2 to 5 hours)

Adolescents: ~3 hours (range: 2 to 4 hours)

Adults: ~2 hours (range: 2 to 3 hours); may be slightly prolonged in severe renal insufficiency (CrCl<30 mL/minute): 2 to 5.3 hours

Time to peak, serum: Oral: Immediate release: 10 to 60 minutes (may be delayed in acute overdoses); IV: 15 minutes

Excretion: Urine (<5% unchanged; 60% to 80% as glucuronide metabolites; 20% to 30% as sulphate metabolites; ~8% cysteine and mercapturic acid metabolites)

Pharmacodynamics/Kinetics: Additional Considerations

Hepatic function impairment: The half-life may increase 2-fold or more in patients with liver disease.

Dental Use

Treatment of postoperative pain

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Dental Health Professional Considerations

Although the OTC product labeling for acetaminophen products state to limit the maximum dose to 3,000 mg daily (for extra strength) or 3,250 mg (for regular strength) (see this site for details: http://www.tylenolprofessional.com/products-and-dosages.html), it is still appropriate for patients to take up to 4,000 mg daily “under the direction of a health care provider” (http://www.tylenolprofessional.com/dosage.html).

The acetaminophen component requires use with caution in patients who use alcohol, with preexisting liver disease, and those receiving more than one source of acetaminophen-containing medication.

Hepatotoxicity caused by acetaminophen is potentiated by chronic alcohol consumption. People who are taking acetaminophen, even at therapeutic doses, and consume alcohol are at risk of developing hepatotoxicity.

Acetaminophen may increase the levels and enhance the anticoagulant effects of vitamin K antagonists acenocoumarol and warfarin (Coumadin). Studies have reported that acetaminophen has increased the INR in warfarin-treated patients with daily acetaminophen doses as low as 2 g, particularly when taking acetaminophen for >1 week (Gebauer 2003; Hylek 1998). In addition, case reports of bleeding as a result of increased INR have been published (Bagheri 1999). There is no known mechanism of the interaction; furthermore, some studies have failed to demonstrate this interaction (Gadisseur 2003; Kwan 1995; van den Bemt 2002). In terms of risk, the data suggest that acetaminophen and warfarin could interact in some clinically significant manner but that the benefits of concomitant use of acetaminophen for pain control in dental patients taking warfarin usually outweigh the risks. An appropriate monitoring plan should be in place to identify potential negative effects and dosage adjustments may be necessary in a minority of patients. The interaction may be more likely to occur with daily acetaminophen doses of >1.3 g for >1 week. In a review of seven random controlled trials comparing acetaminophen versus placebo in warfarin-treated patients (Caldeira 2015), acetaminophen was associated with a mean 0.62 INR increase compared to placebo. Specifically, there was 0.17 mean increase of the INR per each daily gram of acetaminophen. Statistically, this was significant; however, the clinical relevance was questionable since the reviewed studies did not report any major bleeding event.

There are no reports of acetaminophen interacting with antiplatelet drugs such as aspirin, clopidogrel (Plavix), ticagrelor (Brilinta), or prasugrel (Effient). Also, there are no reports of acetaminophen in combination with hydrocodone, codeine, or oxycodone interacting with warfarin (Coumadin).

Effects on Dental Treatment

No significant effects or complications reported (see Dental Health Professional Considerations)

Effects on Bleeding

As a single agent, acetaminophen does not appear to affect bleeding or platelet aggregation. Acetaminophen may prolong the INR and increase bleeding in patients taking warfarin (Coumadin). For patients taking warfarin, single acetaminophen doses or acetaminophen therapy of short duration should be safe, but if large (>1.3 g/day) doses are administered for longer than 10 to 14 days, then the INR should be monitored (see Dental Health Professional Considerations).

Dental Usual Dosing

Postoperative pain: Oral, rectal:

Children <12 years: 10 to 15 mg/kg/dose every 4 to 6 hours as needed; do not exceed 5 doses (2.6 g) in 24 hours

Adults: 325 to 650 mg every 4 to 6 hours or 1000 mg 3 to 4 times/day; do not exceed 4 g/day

Index Terms

APAP (abbreviation is not recommended); N-Acetyl-P-Aminophenol; Paracetamol

References

Acephen (acetaminophen suppositories) [prescribing information]. South Plainfield, NJ: G&W Laboratories; April 2014.

Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319.[PubMed 11487763]

Alade SL, Brown RE, Paquet A. Polysorbate 80 and E-Ferol toxicity. Pediatrics. 1986;77(4):593-597.[PubMed 3960626]

American Academy of Pediatrics Committee on Drugs, “Acetaminophen Toxicity in Children,” Pediatrics, 2001, 108(4):1020-4.[PubMed 11581462]

American Geriatrics Society Panel on Pharmacological Management of Persistent Pain in Older Persons. Pharmacological management of persistent pain in older persons. J Am Geriatr Soc. 2009;57(8):1331-1346.[PubMed 19573219]

American Pain Society, 2008: Principles of Analgesic Use in the Treatment of Acute Pain and Cancer Pain. 6th ed, Glenview, IL: American Pain Society, 2008.

Anand KJ, Chair, International Evidence-Based Group for Neonatal Pain, personal correspondence, April 2002.

Anand KJ, International Evidence-Based Group for Neonatal Pain. Consensus statement for the prevention and management of pain in the newborn. Arch Pediatr Adolesc Med. 2001;155(2):173-180.

Anderson PO, Sauberan JB. Modeling drug passage into human milk. Clin Pharmacol Ther. 2016;100(1):42-52.[PubMed 27060684]

Anderson PO, Sauberan JB, Lane JR, et al, “Hydrocodone Excretion Into Breast Milk: The First Two Reported Cases,” Breastfeed Med, 2007, 2(1):10-4.[PubMed 17661614]

Aronoff GR, Bennett WM, Berns JS, et al, Drug Prescribing in Renal Failure: Dosing Guidelines for Adults and Children, 5th ed. Philadelphia, PA: American College of Physicians; 2007.

Bagheri H, Bernhard NB, and Montastruc JL, “Potentiation of the Acenocoumarol Anticoagulant Effect by Acetaminophen,” Ann Pharmacother, 1999, 33(4):506.[PubMed 10332548]

Bannwarth B, Péhourcq F. Pharmacological rationale for the clinical use of paracetamol: pharmacokinetic and pharmacodynamic issues. Drugs. 2003;63(2):5-13.[PubMed 14758786]

Barker JD Jr, de Carle DJ, and Anuras S, “Chronic Excessive Acetaminophen Use in Liver Damage,” Ann Intern Med, 1977, 87(3):299-301.[PubMed 900673]

Barr J, Fraser GL, Puntillo K, et al, “Clinical Practice Guidelines for the Management of Pain, Agitation, and Delirium in Adult Patients in the Intensive Care Unit,” Crit Care Med, 2013, 41(1):263-306.[PubMed 23269131]

Berlin CM Jr, Yaffe SJ, Ragni M. Disposition of acetaminophen in milk, saliva, and plasma of lactating women. Pediatr Pharmacol (New York). 1980;1(2):135-141.[PubMed 7202185]

Birmingham PK, Tobin MJ, Fisher DM, et al, “Initial and Subsequent Dosing of Rectal Acetaminophen in Children: A 24-Hour Pharmacokinetic Study of New Dose Recommendations,” Anesthesiology, 2001, 94(3):385-9.[PubMed 11374595]

Bosilkovska M, Walder B, Besson M, Daali Y, Desmeules J. Analgesics in patients with hepatic impairment: pharmacology and clinical implications. Drugs. 2012;72(12):1645-1669.[PubMed 22867045]

Brackett CC and Bloch JD, “Phenytoin as a Possible Cause of Acetaminophen Hepatotoxicity: Case Report and Review of the Literature,” Pharmacotherapy, 2000, 20(2):229-33.[PubMed 10678302]

Bradley JD, Brandt KD, Katz BP, et al, “Comparison of an Antiinflammatory Dose of Ibuprofen, an Analgesic Dose of Ibuprofen, and Acetaminophen in the Treatment of Patients With Osteoarthritis of the Knee,” N Engl J Med, 1991, 325(2):87-91.[PubMed 2052056]

Buck ML, “Perioperative Use of High-Dose Rectal Acetaminophen,” Pediatr Pharmacol (New York), 2001, 7(9). Available at http://www.medscape.com/viewarticle/415082_2

Burkhart KK, Janco N, Kulig KW, et al, “Cimetidine as Adjunctive Treatment for Acetaminophen Overdose,” Hum Exp Toxicol, 1995, 14(3):299-304.[PubMed 7779462]

Butler JM, Begg EJ. Free drug metabolic clearance in elderly people. Clin Pharmacokinet. 2008;47(5):297-321.[PubMed 18399712]

Caldeira D, Costa J, Barra M, Pinto FJ, Ferreira JJ. How safe is acetaminophen use in patients treated with vitamin K antagonists? A systematic review and meta-analysis. Thromb Res.2015; 135(1):58-61.[PubMed 25456003]

Centers for Disease Control (CDC). Neonatal deaths associated with use of benzyl alcohol—United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291. http://www.cdc.gov/mmwr/preview/mmwrhtml/00001109.htm[PubMed 6810084]

Centers for Disease Control (CDC). Unusual syndrome with fatalities among premature infants: association with a new intravenous vitamin E product. MMWR Morb Mortal Wkly Rep. 1984;33(14):198-199. http://www.cdc.gov/mmwr/preview/mmwrhtml/00000319.htm[PubMed 6423951]

Chandok N, Watt KD. Pain management in the cirrhotic patient: the clinical challenge. Mayo Clin Proc. 2010;85(5):451-458.[PubMed 20357277]

Clissold SP, “Paracetamol and Phenacetin,” Drugs, 1986, 32(Suppl 4):46-59.[PubMed 3552585]

Dart RC and Rumack BH, “Intravenous Acetaminophen in the United States: Iatrogenic Dosing Errors,” Pediatrics, 2012, 129(2):349-53.[PubMed 22271694]

Dionne RA, Campbell RA, Cooper SA, et al, “Suppression of Postoperative Pain by Preoperative Administration of Ibuprofen in Comparison to Placebo, Acetaminophen, and Acetaminophen Plus Codeine,” J Clin Pharmacol, 1983, 23(1):37-43.[PubMed 6341415]

“Drugs for Pain,” Med Lett Drugs Ther, 2000, 42(1085):73-8.[PubMed 10951654]

Duggan ST and Scott LJ, “Intravenous Paracetamol (Acetaminophen),” Drugs, 2009, 69(1):101-13.[PubMed 19192939]

Dwyer JP, Jayasekera C, Nicoll A. Analgesia for the cirrhotic patient: a literature review and recommendations. J Gastroenterol Hepatol. 2014;29(7):1356-1360.[PubMed 24548074]

FDA Drug Safety Communication: Prescription acetaminophen products to be limited to 325 mg per dosage unit; boxed warning will highlight potential for severe liver failure. From: https://www.fda.gov/Drugs/DrugSafety/ucm239821.htm. Accessed: 9/29/17.

Feverall (acetaminophen) [prescribing information]. Cranford, NJ: Actavis; received August 2015.

Feverall Children’s (acetaminophen) [prescribing information]. Cranford, NJ: Actavis; received August 2015.

Feverall Infant’s (acetaminophen) [prescribing information]. Cranford, NJ: Actavis; received August 2015.

Feverall Junior Strength (acetaminophen) [prescribing information]. Cranford, NJ: Actavis; received August 2015.

Fitzcharles MA, Lussier D, Shir Y. Management of chronic arthritis pain in the elderly. Drugs Aging. 2010;27(6):471-490.[PubMed 20524707]

Gadisseur AP, Van Der Meer FJ, and Rosendaal FR, “Sustained Intake of Paracetamol (Acetaminophen) During Oral Anticoagulant Therapy With Coumarins Does Not Cause Clinically Important INR Changes: A Randomized Double-Blind Clinical Trial,” J Thromb Haemost, 2003, 1(4):714-7.[PubMed 12871405]

Gebauer MG, Nyfort-Hansen K, Henschke PJ, et al, “Warfarin and Acetaminophen Interaction,” Pharmacotherapy, 2003, 23(1):109-12.[PubMed 12523469]

Harrison PM, Keays R, Bray GP, et al, “Improved Outcome of Paracetamol-Induced Fulminant Hepatic Failure by Late Administration of Acetylcysteine,” Lancet, 1990, 335(8705):1572-3.[PubMed 1972496]

Hayward KL, Powell EE, Irvine KM, Martin JH. Can paracetamol (acetaminophen) be administered to patients with liver impairment? Br J Clin Pharmacol. 2016;81(2):210-222.[PubMed 26460177]

Hochberg MC, Altman RD, April KT, et al, “American College of Rheumatology 2012 Recommendations for the Use of Nonpharmacologic and Pharmacologic Therapies in Osteoarthritis of the Hand, Hip, and Knee,” Arthritis Care Res (Hoboken), 2012, 64(4):465-74.[PubMed 22563589]

Hurden EL, Harvey DL, Lewis PJ. Excretion of paracetamol in human breast milk, Neonatal Society Meeting Held on 4 July 1980 in Southampton. Arch Dis Child. 1980; 55(12):969-972.[PubMed 21032602]

Hylek EM, Heiman H, Skates SJ, et al, “Acetaminophen and Other Risk Factors for Excessive Warfarin Anticoagulation,” JAMA, 1998, 279(9):657-62.[PubMed 9496982]

Imani F, Motavaf M, Safari S, Alavian SM. The therapeutic use of analgesics in patients with liver cirrhosis: a literature review and evidence-based recommendations. Hepat Mon. 2014;14(10):e23539.[PubMed 25477978]

“Inactive” ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics (AAP) Committee on Drugs. Pediatrics. 1997;99(2):268-278.[PubMed 9024461]

Isaksson M, Jansson L. Contact allergy to Tween 80 in an inhalation suspension. Contact Dermatitis. 2002;47(5):312-313.[PubMed 12534540]

Institute for Safe Medication Practices (ISMP), “IV Acetaminophen and Overdoses in Kids,” ISMP Medication Safety Alert, April 19, 2012. Available at http://ismp.org/Newsletters/acutecare/issue.asp?dt=20120419

Ito S, Blajchman A, Stephenson M, Eliopoulos C, Koren G. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993;168(5):1393-1399.[PubMed 8498418]

Ito S. Drug therapy for breast-feeding women. N Engl J Med. 2000;343(2):118-126.[PubMed 10891521]

Katzir Z, Baruch O, Hochman B, et al, “Spontaneous Remission of Paracetamol Induced Acute Renal Failure,” Clin Nephrol, 1995, 43(5):346.[PubMed 7634553]

Kliegman RM, Stanton BF, St. Gemell JW, et al, eds. Nelson Textbook of Pediatrics. 19th ed. Philadelphia, PA: Saunders Elsevier; 2011.

Knoop KJ, Snook CP, Stephan M, et al, “Failure of N-Acetylcysteine (NAC) to Prevent Acetaminophen-Induced Renal Failure,” Vet Hum Toxicol, 1993, 35:336.

Kwan D, Bartle WR, and Walker SE, “The Effects of Acetaminophen on Pharmacokinetics and Pharmacodynamics of Warfarin,” J Clin Pharmacol, 1999, 39(1):68-75.[PubMed 9987702 ]

Kwan D, Bartle WR, and Walker SE, “The Effects of Acute and Chronic Acetaminophen Dosing on the Pharmacodynamics and Pharmacokinetics of (R)- and (S)-Warfarin,” Clin Pharmacol Ther, 1995, 57:212.

Lee WM, “Drug-Induced Hepatotoxicity,” N Engl J Med, 1995, 333(17):1118-27.[PubMed 7565951]

Levy G, Garrettson LK, and Soda DM, Letter: evidence of placental transfer of acetaminophen. Pediatrics. 1975, 55(6):895.[PubMed 1134892]

Li DK, Liu L, Odouli R. “Exposure to non-steroidal anti-inflammatory drugs during pregnancy and risk of miscarriage: population based cohort study. BMJ. 2003, 327(7411):368.[PubMed 12919986]

Licht H, Seeff LB, and Zimmerman HJ, “Apparent Potentiation of Acetaminophen Hepatotoxicity by Alcohol,” Ann Intern Med, 1980, 92(4):511.

Liukas A, Kuusniemi K, Aantaa R, et al. Pharmacokinetics of intravenous paracetamol in elderly patients. Clin Pharmacokinet. 2011;50(2):121-129.[PubMed 21241071]

Lucente P, Iorizzo M, Pazzaglia M. Contact sensitivity to Tween 80 in a child. Contact Dermatitis. 2000;43(3):172.[PubMed 10985636]

Makris UE, Abrams RC, Gurland B, Reid MC. Management of persistent pain in the older patient: a clinical review. JAMA. 2014;312(8):825-836.[PubMed 25157726]

Mapap Children’s (acetaminophen) [prescribing information]. Livonia, MI: Major Pharmaceuticals; October 2015.

Matheson I, Lunde PK, Notarianni L. Infant rash caused by paracetamol in breast milk? Pediatrics. 1985, 76(4):651-652.[PubMed 2931668]

Mayoral CE, Marino RV, Rosenfeld W, et al, “Alternating Antipyretics: Is This an Alternative?” Pediatrics, 2000, 105(5):1009-12.[PubMed 10790455]

McClain CJ, Kromhout JP, Peterson FJ, et al, “Potentiation of Acetaminophen Hepatotoxicity by Alcohol,” JAMA, 1980, 244(3):251-3.[PubMed 7382090]

McLachlan AJ, Bath S, Naganathan V, et al. Clinical pharmacology of analgesic medicines in older people: impact of frailty and cognitive impairment. Br J Clin Pharmacol. 2011;71(3):351-364.

McNeil Consumer Healthcare website. Frequently Asked Questions About New Dosing for Extra Strength Tylenol Products. http://www.tylenolprofessional.com/assets/v4/faqs-new-dosing.pdf. Published 2011. Accessed May 6, 2014.

Mehlisch DR, Aspley S, Daniels SE, et al, “Comparison of the Analgesic Efficacy of Concurrent Ibuprofen and Paracetamol With Ibuprofen or Paracetamol Alone in the Management of Moderate to Severe Acute Postoperative Dental Pain in Adolescents and Adults: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Single-Dose, Two-Center, Modified Factorial Study,” Clin Ther, 2010, 32(5):882-95.[PubMed 20685496]

Montgomery A, Hale TW, Academy Of Breastfeeding Medicine. ABM clinical protocol #15: analgesia and anesthesia for the breastfeeding mother, revised 2012. Breastfeed Med. 2012;7(6):547-553.[PubMed 23215911]

Naga Rani MA, Joseph T, Narayanan R. Placental transfer of paracetamol. J Indian Med Assoc. 1989, 87(8):182-183.[PubMed 2621359]

Notarianni LJ, Oldham HG, Bennett PN. Passage of paracetamol into breast milk and its subsequent metabolism by the neonate. Br J Clin Pharmacol. 1987, 24(1):63-67.[PubMed 3620287]

Ofirmev (acetaminophen) [prescribing information]. Hazelwood, MO: Mallinckrodt; March 2018.

Perzanowski MS, Miller RL, Tang D, et al. Prenatal acetaminophen exposure and risk of wheeze at age 5 years in an urban low-income cohort. Thorax. 2010, 65(2):118-23.[PubMed 19850963]

“Principles of Analgesic Use in the Treatment of Acute Pain and Cancer Pain,” 6th ed, Glenview, IL: American Pain Society, 2008.

Rastogi R, Meek BD. Management of chronic pain in elderly, frail patients: finding a suitable, personalized method of control. Clin Interv Aging. 2013;8:37-46.[PubMed 23355774]

Rathmell JP, Viscomi CM, and Ashburn MA, “Management of Nonobstetric Pain During Pregnancy and Lactation,” Anesth Analg, 1997, 85(5):1074-87.[PubMed 9356103]

Rebordosa C, Kogevinas M, Bech BH, et al. Use of acetaminophen during pregnancy and risk of adverse pregnancy outcomes. Int J Epidemiol. 2009, 38(3):706-14.[PubMed 19332503]

Riggs BS, Bronstein AC, Kulig K, et al. Acute acetaminophen overdose during pregnancy. Obstet Gynecol. 1989, 74(2):247-53.[PubMed 2748061]

Rose SR, “Subtleties of Managing Acetaminophen Poisoning,” Am J Hosp Pharm, 1994, 51(24):3065-8.[PubMed 7856628]

Sachs HC, Committee On Drugs. The transfer of drugs and therapeutics into human breast milk: an update on selected topics. Pediatrics. 2013;132(3):e796-809.[PubMed 23979084]

Shehab N, Lewis CL, Streetman DD, Donn SM. Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates. Pediatr Crit Care Med. 2009;10(2):256-259.[PubMed 19188870]

Shek KL, Chan LN, and Nutescu E, “Warfarin-Acetaminophen Drug Interaction Revisited,” Pharmacotherapy, 1999, 19(10):1153-8.[PubMed 10512064 ]

Shelley WB, Talanin N, Shelley ED. Polysorbate 80 hypersensitivity. Lancet. 1995;345(8980):1312-1313.[PubMed 7746084]

Singer AJ, Carracio TR, and Mofenson HC, “The Temporal Profile of Increased Transaminase Levels in Patients With Acetaminophen-Induced Liver Dysfunction,” Ann Emerg Med, 1995, 26(1):49-53.[PubMed 7793720]

Smilkstein MJ, Knapp GL, Kulig KW, et al, “Efficacy of Oral N-Acetylcysteine in the Treatment of Acetaminophen Overdose. Analysis of the National Multicenter Study (1976 to 1985),” N Engl J Med, 1988, 319(24):1557-62.[PubMed 3059186]

Smith HS. Potential analgesic mechanisms of acetaminophen. Pain Physician. 2009;12(1):269-280.[PubMed 19165309]

Stork CM, Rees S, Howland MA, et al, “Pharmacokinetics of Extended Relief vs Regular Release Tylenol in a Simulated Human Overdose,” J Toxicol Clin Toxicol, 1996, 34(2):157-62.[PubMed 8618248]

Suhag A, Wood DC, Bisulli G, et al. Abstracts of the 18th World Congress on Ultrasound in Obstetrics and Gynecology. August 24-28, 2008. Chicago, Illinois, USA. Ultrasound Obstet Gynecol. 2008, 32(3):243-466.[PubMed 18696803]

Sullivan JE, Farrar HC. Fever and antipyretic use in children. Pediatrics. 2011; 127(3): 580-587.[PubMed 21357332]

Tanaka E, Yamazaki K, and Misawa S, “Update: The Clinical Importance of Acetaminophen Hepatotoxicity in Nonalcoholic and Alcoholic Subjects,” J Clin Pharm Ther, 2000, 25(5):325-32.[PubMed 11123483 ]

Tylenol 8 Hour Arthritis Pain (acetaminophen) [prescribing information]. Ft. Washington, PA: McNeil Consumer Healthcare Division; received February 2019.

Tylenol Children’s (acetaminophen) [prescribing information]. Ft. Washington, PA: McNeil Consumer; received July 2018.

Tylenol Infant’s Drops (acetaminophen) [prescribing information]. Ft. Washington, PA: McNeil Consumer Healthcare Division; received January 2019.

van den Bemt PM, Geven LM, Kuitert NA, et al, “The Potential Interaction Between Oral Anticoagulants and Acetaminophen in Everyday Practice,” Pharm World Sci, 2002, 24(5):201-4.[PubMed 12426965]

van der Steeg J, Akhtar J, Burkhart K, et al, “Initial Prothrombin Time as a Predictor of Acetaminophen-Induced Hepatotoxicity,” Clin Toxicol, 1995, 33(5):508-9.

Wang PH, Yang MJ, Lee WL, et al. Acetaminophen poisoning in late pregnancy. A case report. J Reprod Med. 1997, 42(6):367-371.[PubMed 9219126]

Watkins PB, Kaplowitz N, Slattery JT, et al, “Aminotransferase Elevations in Healthy Adults Receiving 4 Grams of Acetaminophen Daily: A Randomized Controlled Trial,” JAMA, 2006, 296(1):87-93.[PubMed 16820551]

Whitcomb DC and Block GD, “Association of Acetaminophen Hepatotoxicity With Fasting and Ethanol Use,” JAMA, 1994, 272(23):1845-50.[PubMed 7990219]

Williams HJ, Ward JR, Egger MJ, et al, “Comparison of Naproxen and Acetaminophen in a Two-Year Study of Treatment of Osteoarthritis of the Knee,” Arthritis Rheum, 1993, 36(9):1196-206.[PubMed 8216413]

Wood D, Shah S, Broth RE, et al. Abstracts of the 15th World Congress on Ultrasound in Obstetrics and Gynecology, 25-29 September 2005, Vancouver, Canada. Ultrasound Obstet Gynecol. 2005, 26(4):309-471.[PubMed 16152007]

Woo OF, Anderson IB, Kim SY, et al, “Shorter Duration of N-Acetylcysteine (NAC) for Acute Acetaminophen Poisoning,” Clin Toxicol, 1995, 33(5):508.

World Health Organization (WHO). Breastfeeding and maternal medication, recommendations for drugs in the eleventh WHO model list of essential drugs. 2002. Available at http://www.who.int/maternal_child_adolescent/documents/55732/en/

Wynne HA, Cope LH, Herd B, Rawlins MD, James OF, Woodhouse KW. The association of age and frailty with paracetamol conjugation in man. Age Ageing. 1990;19:419-424.[PubMed 2285011]

Yerman B, Tseng J, and Caravati EM, “Pediatric Acetaminophen Ingestion: A Prospective Study of Referral Criteria,” Clin Toxicol, 1995, 33(5):530.

Zar T, Graeber C, Perazella MA. Recognition, treatment, and prevention of propylene glycol toxicity. Semin Dial. 2007;20(3):217-219.[PubMed 17555487]

Zenger F, Russmann S, Junker E, et al, “Decreased Glutathione in Patients With Anorexia Nervosa. Risk Factor for Toxic Liver Injury?” Eur J Clin Nutr, 2004, 58(2):238-43.[PubMed 14749742]

Zimmerman HJ and Maddrey WC. Acetaminophen (paracetamol) hepatotoxicity with regular intake of alcohol: analysis of instances of therapeutic misadventure. Hepatology.1995;22(3):767-763.[PubMed 7657281]

Brand Names: International

A-Mol (TH); Acamol (CL, IL, LI); Acamol To-Go (IL); Acamoli Baby (IL); Acamoli Forte suppositories for Kids (IL); Accelio (JP); Acemol (VN); ACET suppositories (SG); Acetab (VN); Acetalgan (EG); Acetalgin (CH); Acetamol (IT); Acicur-P (PY); Adinol (CR, DO, GT, HN, MX, NI, SV); Adol (BH, EG, ET, JO, KW, LB, QA, SA); Adolin (PA); Adorem (CO); Afebrin (HK); Afebryl (LU); Agap Fast (PL); Agomol (TZ); Alcocin (IN); Alginox (EC); Alvedon (SE); Amadol (AU); Ametrex (CO); Amol (AE, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Analgiser (AE, BH, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Analphen (MX); Angela (TH); Antalgic (ZW); Antamol (JO); Apacet (LI); Apap (LI); Apimol (ZW); Aptamol (IN); Arfen (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, MY, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW); Atamel (PE); Avadol (MY); Axcel (MY); Ben-U-Ron (CH, PT); ben-u-ron (HU); Benuron (JP); Betamol (ZW); Biogesic (SG); Biogesic Suspension (HK); Biopain (PH); Biragan Kids (VN); Blimol (UA); Calapol (ID); Calonal (JP); Calpol (AE, BF, BJ, CI, CY, EG, ET, GH, GM, GN, IE, IQ, IR, JO, JP, KE, KW, LB, LK, LR, LY, MA, ML, MR, MT, MU, MW, NE, NG, OM, PR, QA, SA, SC, SD, SI, SL, SN, SY, TN, TZ, UG, YE, ZM, ZW); Causalon (AR); Cemol (TH); Cetal (ET); Cetapain (ID); Cetapyrin (LK); Cetta (TH); Champ Syrup (KR); Children’s Bufferin (CN); Children’s S Tylenol (KR); Christamol (HK); Claradol (MA); Cotemp (TH); Croix Blanche (LU); Curpol (LU); Dafalgan (BE, LU); Dafalgan odis (LU); Dailyal (LV); Daleron (HR, SI); Demneq (NL); Den-U-Ron (CN); Denamol (TH); Depon (TR); Dirox (AR); Dismifen (MX); Dol-Stop (LU); Dolan Infantil (GT, HN, NI, SV); Dolex (UY); Dolgesic (ES); Doliprane (FR, IN, LB, MA); Dolitabs (FR); Dolomol (AE, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Dolorol (ZA); Dolprone (LU); Doluvital (MX); Dolviran (MX); Dumin (LK); Efermol (PY); Efferalgan (HR, HU, LT, LU, LV, UA); Efferalgan 500 (CR, DO, EE, GT, HN, NI, PA, SV); Efferalganodis (FR); Elgan (UA); Eneffa (BH); Enelfa (LU); Eterfix (ID); Europain (HK); Fast (BD); Fbridol (ET); Febridol (AU); Febrile Free (PH); Fervex (BR); Fevadol (BH, QA); Fibralgin (HR); Filanc (MX); Fortolin (CN, HK); Gelocatil (ES); Geluprane 500 (FR); Hedex (IE); Hoemal (MY); Influgan (UA); Kelvin (ET, LK); Lekadol (HR); Lemgrip (BE, LU); Lonarid mono (LU); Lotemp (TH); Lupocet (HR); Maccabimol (IL); Mafidol (PE); Medipyrin (SK); Mejoralito Junior (MX); Mejoralito Pediátrico (MX); Meldol (ZW); Metagesic (PH); Mexalen (AT, CZ, HU); Minopan (KR); Momentum (LU); Mypara (TH); Napafen (EC); Napamol (ZA); Napaton (TW); Napran (PH); Naprex (ID); NEBS (JP); Neuridon (LU); Nordinet Infantil (MX); Normotemp (EC); Novadol (ZW); Nufadol (ID); Omnipap (PL); Omol (QA); Pacemol (KR); Padolieve (IE); Pamol (DK, JO, NZ); Pamol 650 (SG); Panadol (AE, AU, BE, BF, BG, BJ, CH, CI, CL, CN, CY, CZ, EE, EG, ES, ET, FI, FR, GB, GH, GM, GN, GR, HK, HU, ID, IE, IL, IQ, IR, IT, JO, KE, KR, KW, LB, LK, LR, LU, LV, LY, MA, ML, MR, MT, MU, MW, NE, NG, NL, NZ, OM, PE, PK, PL, PT, QA, RO, RU, SA, SC, SD, SG, SK, SL, SN, SY, TH, TN, TW, TZ, UA, UG, YE, ZM, ZW); Panadol Actifast (MY, SG); Panadol Extend (SG); Panadol for Children (SG); Panadon (HR); Panadrex (BH, ET); Panamax (AU); Panodil (DK, NO, SE); Para-IV (PH); Paracet (IS, NO, ZW); Paracetamol (HR); Paracetamol Pharmavit (HU); Paracetamol-ratiopharm (LU); Paracetol (LK); Paracil (MY); Paracip (LV); Paragin (TH); Paralgin (AU); Paralief (IE); Paramol (IL, LB, RO, TW); Paramol Kat Drops (IL); Parapaed (DE); Parapaed Junior (NZ); Parapaed Six Plus (NZ); Parapane (AU); Paratabs (IS); Parcemol (HK); Parcemol Forte (HK); Parmol (HK); Paromon (HK); Parvid (PH); Paximol (SG); Pe-Tam (LU); Pedipan (KR); Penral-Night (KR); Perdolan Mono (LU); Perfalgan (AE, AT, BG, BH, CH, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, HR, IE, IL, IN, IS, IT, JO, KR, KW, LB, LT, MT, NZ, PL, PT, QA, RO, RU, SA, SE, SI, SK, TR, VN, ZA); Pharmacen-M (MX); Pinex (NO); Pireta (ID); Plicet (HR); Poro (ID, MY, PH, SG, TH); Portem (CR, DO, GT, HN, NI, PA, SV); Prest (NL); Progesic (HK); Raperon (KR); Rapidene (LK); Rapidol (CL); Reliv (SE); Remedol (MT, PR, TR); Revanin (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW); Rhinapen elixir (KR); Rubophen (HU); Salzone (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW); Sanmol (PH); Sanmol Infusion (ID); Saridon (CO); Sedalito (MX); Sedalmerck (CR, DO, GT, HN, NI, PA, SV); Selegesic (PH); Sensamol (IL); Setamol (HK); Setopain (KR); Setopain ER (KR); Sinebriv (PL); Sinedol (DO, MX); Strimol (ZW); Supadol mono (LU); Suspen ER (KR); Tafirol (PE); Tamin (TZ); Tamoliv (ID); Tasmen (KR); Tempol (MY); Tempra (ID, JP, LU, MX); Tempte (TW); Teramol (PH); Teramol Forte (PH); Tipol (IE); Toniker (TW); Turpan (ID); Tylenol (BR, CH, DE, JP, KR, MX, NL, PH, PT, QA, TH, VE); Tylenol 8-hour (TH); Tylenol Acetaminophen Extended Relief (CN); Tylenol ER (KR); Tylenol Extra Fuerte (PY); Tylenol Forte (AE, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Tylex (BB, BM, BS, BZ, CR, DO, GT, GY, HN, JM, MX, NI, PA, SR, SV, TT); Umbral (EC); Winadol (CO, VE); Xcel (BD); Xebramol (TH); XL-Dol Infantil (MX); Z-Mol (PY)

Acetaminophen (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(a seet a MIN oh fen)

Brand Names: US

Acephen [OTC]; Aspirin Free Anacin Extra Strength [OTC]; Cetafen Extra [OTC]; Cetafen [OTC]; FeverAll Adult [OTC]; FeverAll Children’s [OTC]; FeverAll Infants’ [OTC]; FeverAll Junior Strength [OTC]; Little Fevers [OTC]; Mapap Arthritis Pain [OTC]; Mapap Children’s [OTC]; Mapap Extra Strength [OTC]; Mapap [OTC]; Midol Long Lasting Relief [OTC]; Non-Aspirin Pain Reliever [OTC]; Nortemp Children’s [OTC]; Ofirmev; Pain & Fever Children’s [OTC]; Pain Eze [OTC]; Pain Relief Extra Strength [OTC]; Pharbetol Extra Strength [OTC]; Pharbetol [OTC]; Q-Pap Children’s [OTC] [DSC]; Q-Pap Extra Strength [OTC] [DSC]; Q-Pap Infants’ [OTC] [DSC]; Q-Pap [OTC] [DSC]; Silapap Children’s [OTC]; Silapap Infants’ [OTC] [DSC]; Triaminic Children’s Fever Reducer Pain Reliever [OTC]; Tylenol 8 HR Arthritis Pain [OTC]; Tylenol 8 HR [OTC] [DSC]; Tylenol Children’s [OTC]; Tylenol Extra Strength [OTC]; Tylenol Infants’ [OTC]; Tylenol [OTC]; Valorin Extra [OTC]; Valorin [OTC]

Brand Names: Canada

Abenol; Apo-Acetaminophen; Atasol; Novo-Gesic; Pediatrix; Tempra; Tylenol

Warning
  • Liver problems have happened with the use of acetaminophen. Sometimes, this has led to a liver transplant or death. Most of the time, liver problems happened in people taking more than 4,000 mg (milligrams) of acetaminophen in a day. People were also often taking more than 1 drug that had acetaminophen in it. If you have questions, talk with your doctor.
What is this drug used for?
  • It is used to ease pain and fever.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to acetaminophen or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have liver disease.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • All products:
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid taking other products that have acetaminophen in them. Check labels closely. Too much acetaminophen may cause liver problems.
  • Follow the directions exactly. Do not take more acetaminophen in a day than directed. If you do not know how much acetaminophen you can take in a day, ask your doctor or pharmacist. Some people may take up to 4,000 mg (milligrams) in a day if told to do so by the doctor. Some people (like people with liver problems and children) should take less acetaminophen. Call your doctor right away if you have taken too much acetaminophen in a day, even if you feel well.
  • Talk with your doctor before you drink alcohol.
  • If you are taking warfarin, talk with your doctor. You may need to have your blood work checked more closely while you are taking it with this drug.
  • This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug.
  • Allergic reactions have happened with this drug. Rarely, some reactions can be very bad or life-threatening. Talk with the doctor.
  • Different brands of this drug may have different doses for children. Talk with the doctor before giving this drug to a child.
  • Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.
  • Chewable tablet:
  • If you have phenylketonuria (PKU), talk with your doctor. Some products have phenylalanine.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Not able to pass urine or change in how much urine is passed.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Upset stomach or throwing up.
  • Trouble sleeping.
  • Headache.
  • Constipation.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • All oral products:
  • Take with or without food.
  • Chewable tablet:
  • Chew well before swallowing.
  • Oral-disintegrating tablet:
  • Place on the tongue and let dissolve.
  • Extended-release tablets:
  • Swallow whole. Do not chew, break, or crush.
  • Take with a full glass of water.
  • Liquid (drops):
  • Measure liquid doses carefully. Use the measuring device that comes with this drug.
  • All other liquid products:
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
  • Liquid (suspension):
  • Shake well before use.
  • Suppository:
  • Use suppository rectally.
  • Wash your hands before and after use.
  • If suppository is soft, chill in a refrigerator or run cold water over it.
  • To use suppository, take off foil wrapper.
  • Wet suppository before putting in rectum.
  • Put suppository into the rectum with gentle pressure, pointed end first. Do not handle too much.
  • Injection:
  • It is given into a vein for a period of time.
What do I do if I miss a dose?
  • Oral products and suppository:
  • If you take this drug on a regular basis, take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Many times this drug is taken on an as needed basis. Do not take more often than told by the doctor.
  • Injection:
  • Call your doctor to find out what to do.
How do I store and/or throw out this drug?
  • All oral products:
  • Store at room temperature. Do not refrigerate or freeze.
  • Store in original container.
  • Keep lid tightly closed.
  • Suppository:
  • Store at room temperature. Do not freeze.
  • Some brands may be stored in the refrigerator. Ask your pharmacist or check the package label.
  • Oral products and suppository:
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Injection:
  • If you need to store this drug at home, talk with your doctor, nurse, or pharmacist about how to store it.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Acetaminophen (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(a seet a MIN oh fen)

Brand Names: US

Acephen [OTC]; Aspirin Free Anacin Extra Strength [OTC]; Cetafen Extra [OTC]; Cetafen [OTC]; FeverAll Adult [OTC]; FeverAll Children’s [OTC]; FeverAll Infants’ [OTC]; FeverAll Junior Strength [OTC]; Little Fevers [OTC]; Mapap Arthritis Pain [OTC]; Mapap Children’s [OTC]; Mapap Extra Strength [OTC]; Mapap [OTC]; Midol Long Lasting Relief [OTC]; Non-Aspirin Pain Reliever [OTC]; Nortemp Children’s [OTC]; Ofirmev; Pain & Fever Children’s [OTC]; Pain Eze [OTC]; Pain Relief Extra Strength [OTC]; Pharbetol Extra Strength [OTC]; Pharbetol [OTC]; Q-Pap Children’s [OTC] [DSC]; Q-Pap Extra Strength [OTC] [DSC]; Q-Pap Infants’ [OTC] [DSC]; Q-Pap [OTC] [DSC]; Silapap Children’s [OTC]; Silapap Infants’ [OTC] [DSC]; Triaminic Children’s Fever Reducer Pain Reliever [OTC]; Tylenol 8 HR Arthritis Pain [OTC]; Tylenol 8 HR [OTC] [DSC]; Tylenol Children’s [OTC]; Tylenol Extra Strength [OTC]; Tylenol Infants’ [OTC]; Tylenol [OTC]; Valorin Extra [OTC]; Valorin [OTC]

Brand Names: Canada

Abenol; Apo-Acetaminophen; Atasol; Novo-Gesic; Pediatrix; Tempra; Tylenol

Warning
  • This drug has acetaminophen in it. Liver problems have happened with the use of acetaminophen. Sometimes, this has led to a liver transplant or death. Most of the time, liver problems happened in people taking too much acetaminophen in a day. People were also often taking more than 1 drug that had acetaminophen in it. If you have questions, talk with your child’s doctor.
What is this drug used for?
  • It is used to ease pain and fever.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child has liver disease.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • All products:
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Avoid giving your child other products that have acetaminophen in them. Check labels closely. Too much acetaminophen may cause liver problems.
  • Follow the directions exactly. Do not give your child more acetaminophen in a day than directed. If you do not know how much acetaminophen you can give to your child in a day, ask your child’s doctor or pharmacist. Call your child’s doctor right away if you have given your child too much acetaminophen in a day, even if your child feels well.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • If your child is taking warfarin, talk with the doctor. Your child may need to have blood work checked more closely while taking it with this drug.
  • This drug may affect certain lab tests. Tell all of your child’s health care providers and lab workers that your child takes this drug.
  • Allergic reactions have happened with this drug. Rarely, some reactions can be very bad or life-threatening. Talk with the doctor.
  • Different brands of this drug may have different doses for children. Talk with the doctor before giving this drug to a child.
  • If your child is pregnant or breast-feeding a baby:
  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.
  • Chewable tablet:
  • If your child has phenylketonuria (PKU), talk with your child’s doctor. Some products have phenylalanine.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Not able to pass urine or change in how much urine is passed.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if your child has signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in the mouth, throat, nose, or eyes.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Upset stomach or throwing up.
  • Trouble sleeping.
  • Headache.
  • Constipation.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • All oral products:
  • Give this drug with or without food.
  • Chewable tablet:
  • Have your child chew all the way up before swallowing.
  • Oral-disintegrating tablet:
  • Place on the tongue and let dissolve.
  • Extended-release tablets:
  • Have your child swallow whole. Do not let your child chew, break, or crush.
  • Give this drug with a full glass of water.
  • Liquid (drops):
  • Measure liquid doses carefully. Use the measuring device that comes with this drug.
  • All other liquid products:
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
  • Liquid (suspension):
  • Shake well before use.
  • Suppository:
  • Suppositories are for rectal use only.
  • Wash your hands before and after use.
  • If suppository is soft, chill in a refrigerator or run cold water over it.
  • To use suppository, take off foil wrapper.
  • Wet suppository before putting in rectum.
  • Put suppository into the rectum with gentle pressure, pointed end first. Do not handle too much.
  • Injection:
  • It is given into a vein for a period of time.
What do I do if my child misses a dose?
  • Oral products and suppository:
  • If your child takes this drug on a regular basis, give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
  • Many times this drug is given on an as needed basis. Do not give to your child more often than told by the doctor.
  • Injection:
  • Call your child’s doctor to find out what to do.
How do I store and/or throw out this drug?
  • All oral products:
  • Store at room temperature. Do not refrigerate or freeze.
  • Store in original container.
  • Keep lid tightly closed.
  • Suppository:
  • Store at room temperature. Do not freeze.
  • Some brands may be stored in the refrigerator. Ask your pharmacist or check the package label.
  • Oral products and suppository:
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Injection:
  • If you need to store this drug at home, talk with your child’s doctor, nurse, or pharmacist about how to store it.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.