Ferrous Sulfate (Lexi-Drugs)

Pronunciation

(FER us SUL fate)

Brand Names: US

BProtected Pedia Iron [OTC]; Fer-In-Sol [OTC]; Fer-Iron [OTC] [DSC]; FeroSul [OTC]; Ferro-Bob [OTC] [DSC]; FerrouSul [OTC]; Iron Supplement Childrens [OTC]; Iron Supplement [OTC]; Slow Fe [OTC]; Slow Iron [OTC]

Brand Names: Canada

PMS-Ferrous Sulfate

Pharmacologic Category

Iron Salt

Dosing: Adult

Note: Multiple concentrations of ferrous sulfate oral liquid exist; close attention must be paid to the concentration when ordering and administering ferrous sulfate; incorrect selection or substitution of one ferrous sulfate liquid for another without proper dosage volume adjustment may result in serious over- or underdosing. Immediate release oral iron products are preferred for treatment of iron deficiency anemia; enteric coated and slow/sustained release preparations are not desired due to poor absorption (Hershko 2014; Liu 2012). Doses are expressed in terms of elemental iron; ferrous sulfate contains ~20% elemental iron; ferrous sulfate exsiccated (dried) contains ~30% elemental iron.

Iron-deficiency anemia, prevention (in areas where anemia prevalence is ≥40%) (off-label): Oral: Menstruating women (non-pregnant females of reproductive potential): 30 to 60 mg daily for 3 consecutive months in a year (WHO 2016a)

Iron-deficiency anemia, treatment: Oral: 65 to 200 mg/day (Liu 2012; Schrier 2019; Stoltzfus 1998; WHO 2001); may administer in up to 3 divided doses (depending on formulation). Note: Alternate-day dosing (eg, every other day or Monday, Wednesday, Friday) has been shown to result in greater absorption of iron; some experts recommend this dosing schedule in patients who can maintain adherence (Schrier 2019; Stoffel 2017).

Restless legs syndrome (off-label use): Oral: 65 mg (325 mg ferrous sulfate) twice daily in combination with vitamin C in patients with a ferritin level ≤75 mcg/L (AAN [Winkelman 2016])

Dosing: Geriatric

Lower doses (15 to 50 mg elemental iron/day) may have similar efficacy and less GI adverse events (eg, nausea, constipation) as compared to higher doses (eg, 150 mg elemental iron/day) (Rimon 2005).

Dosing: Pediatric

Note: Multiple concentrations of ferrous sulfate oral liquid exist; close attention must be paid to the concentration when ordering and administering ferrous sulfate; incorrect selection or substitution of one ferrous sulfate liquid for another without proper dosage volume adjustment may result in serious over- or underdosing.

Note: Doses expressed in terms of elemental iron; Ferrous sulfate contains ~20% elemental iron; ferrous sulfate exsiccated (dried) contains ~30% elemental iron

Iron deficiency anemia; prevention: Oral:

Infants ≥4 months (receiving human milk as only nutritional source or >50% as source of nutrition without iron fortified food): 1 mg iron/kg/day (Baker 2010); Note: In healthy, term infants, AAP does not recommend routine additional supplementation of iron be considered until at least 4 to 6 months of age if breastfed (full or partial) (Baker 2010; Schanler 2011)

Infants ≥6 months and Children <2 years in areas where anemia prevalence is >40%: 10 to 12.5 mg daily for 3 consecutive months in a year (WHO 2016b)

Children 2 years to <5 years in areas where anemia prevalence is >40%: 30 mg daily for 3 consecutive months in a year (WHO 2016b)

Children ≥5 to 12 years in areas where anemia prevalence is >40%: 30 to 60 mg daily for 3 consecutive months in a year (WHO 2016b)

Adolescent menstruating females (nonpregnant females of reproductive potential) in areas where anemia prevalence is >40%: 30 to 60 mg daily for 3 consecutive months in a year (WHO 2016a)

Treatment of iron deficiency: Infants, Children, and Adolescents: 3 to 6 mg/kg/day in 3 divided doses; suggested maximum daily dose: 200 mg/day (ASPEN Pediatric Nutrition Support Core Curriculum [Corkins 2015]; Kliegman 2016)

Use: Labeled Indications

 Iron-deficiency anemia: Prevention and treatment of iron-deficiency anemias

Use: Off-Label: Adult

  Restless legs syndromeLevel of Evidence [C, G]

Iron supplementation has been proposed as therapy for patients with restless legs syndrome (RLS) associated with low ferritin levels and is likely ineffective for other forms of RLS. Results are inconsistent among various forms of iron. Small controlled trials with oral ferrous sulfate have demonstrated varying effects.Ref American Academy of Sleep Medicine guidelines give iron supplementation an option strength recommendation for use in adults with RLS associated with low ferritin levels based on very low-level supportive evidence; American Academy of Neurology guidelines also recommend that ferrous sulfate be considered in patients with low ferritin levels.Ref European Federation of Neurological Societies/European Neurological Society/European Sleep Research Society guidelines consider ferrous sulfate probably effective for the short-term treatment of primary RLS based on limited data.Ref Access Full Off-Label Monograph

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Iron Supplementation:

WHO, “Guideline: Daily Iron Supplementation in Adult Women and Adolescent Girls,” 2016

WHO, “Guideline: Daily Iron Supplementation in Infants and Children,” 2016

Restless Legs Syndrome:

American Academy of Neurology, “Treatment of Restless Legs Syndrome in Adults,” 2016

American Academy of Sleep Medicine, “The treatment of restless legs syndrome and periodic limb movement disorder in adults – An update for 2012: Practice parameters with an evidence-based systematic review and meta-analysis,” 2012

European Federation of Neurological Societies, the European Neurological Society and the European Sleep Research Society, “European guidelines on management of restless legs syndrome: Report of a joint task force by the European Federation of Neurological Societies, the European Neurological Society and the European Sleep Research Society,” November 2012

International Restless Legs Syndrome Study Group (IRLSSG), European Restless Legs Syndrome Study Group (ERLSSG), and Restless Legs Syndrome Foundation, “Guidelines for the first-line treatment of restless legs syndrome/Willis-Ekbom disease, prevention and treatment of dopaminergic augmentation: A combined task force of the IRLSSG, ERLSSG and the RLS Foundation,” May 2016

Administration: Oral

Do not chew or crush extended-release preparations; administer with water or juice on an empty stomach.

Administration: Pediatric

Oral: Do not chew or crush extended release preparations; administer with water or juice between meals for maximum absorption; may administer with food if GI upset occurs; do not administer with milk or milk products

Dietary Considerations

May be administered with food to prevent irritation; however, not with cereals, dietary fiber, tea, coffee, eggs, or milk.

Ferrous sulfate contains ~20% elemental iron (ie, 325 mg ferrous sulfate is equivalent to 65 mg elemental iron); ferrous sulfate exsiccated (dried) contains ~30% elemental iron.

Dietary sources of iron include beans, cereal (enriched), clams, beef, lentils, liver, oysters, shrimp, and turkey. Foods that enhance dietary absorption of iron include broccoli, grapefruit, orange juice, peppers, and strawberries. Foods that decrease dietary absorption of iron include coffee, dairy products, soy products, spinach, and tea.

Dietary reference intake (IOM 2001): Note: Dosage expressed in terms of elemental iron; ferrous sulfate contains ~20% elemental iron; ferrous sulfate exsiccated (dried) contains ~30% elemental iron.

0 to 6 months: 0.27 mg daily (adequate intake)

7 to 12 months: 11 mg daily

1 to 3 years: 7 mg daily

4 to 8 years: 10 mg daily

9 to 13 years: 8 mg daily

14 to 18 years: Males: 11 mg daily; Females: 15 mg daily; Pregnant females: 27 mg daily; Lactating females: 10 mg daily

19 to 50 years: Males: 8 mg daily; Females: 18 mg daily; Pregnant females: 27 mg daily; Lactating females: 9 mg daily

≥50 years: 8 mg daily

Storage/Stability

Iron is a leading cause of fatal poisoning in children. Store out of children’s reach and in child-resistant containers.

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 diarrhea; constipation; stool discoloration; lack of appetite; abdominal cramps; or staining of mouth, teeth, or fillings. Have patient report immediately to prescriber black, tarry, or bloody stools; severe nausea; severe vomiting; severe abdominal pain; or vomiting blood (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 health care 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:
  Administration issues:
Contraindications

Hypersensitivity to iron salts or any component of the formulation; hemochromatosis, hemolytic anemia

Warnings/Precautions

Disease-related concerns:

• Gastrointestinal disease: Avoid in patients with peptic ulcer, enteritis, or ulcerative colitis.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Blood transfusion recipients: Avoid in patients receiving frequent blood transfusions.

• Elderly: Anemia in the elderly is often caused by “anemia of chronic disease” or associated with inflammation rather than blood loss. Iron stores are usually normal or increased, with a serum ferritin >50 ng/mL and a decreased total iron binding capacity. Hence, the “anemia of chronic disease” is not secondary to iron deficiency but the inability of the reticuloendothelial system to reclaim available iron stores.

• Pediatric: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep this product out of the reach of children. In case of accidental overdose call the poison control center immediately.

• Premature infants: Avoid use in premature infants until the vitamin E stores, deficient at birth, are replenished.

Dosage form specific issues:

• Oral iron formulations: Immediate release oral iron products are preferred for treatment of iron deficiency anemia; enteric coated and slow/sustained release preparations are not desired due to poor absorption (Hershko 2014; Liu 2012).

• 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 1997; Zar 2007).

Other warnings/precautions:

• Duration of therapy: Administration of iron for >6 months should be avoided except in patients with continuous bleeding or menorrhagia.

Geriatric Considerations

Anemia in the elderly is often caused by “anemia of chronic disease,” a result of aging changes in the bone marrow, or associated with inflammation rather than blood loss. Iron stores are usually normal or increased, with a serum ferritin >50 ng/mL and a decreased total iron binding capacity. Hence, the anemia is not secondary to iron deficiency but the inability of the reticuloendothelial system to use available iron stores. Timed release iron preparations should be avoided due to their erratic absorption. Products combined with a laxative or stool softener should not be used unless the need for the combination is demonstrated.

Warnings: Additional Pediatric Considerations

Consider all iron sources when evaluating the dose of iron, including combination products, infant formulas, and liquid nutritional supplements. Some liquid preparations may temporarily stain the teeth.

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

Maternal iron requirements increase during pregnancy. Adequate iron concentrations to the fetus can be maintained regardless of maternal iron status, except in severe cases of anemia (IOM 2001). Untreated iron deficiency and iron deficiency anemia (IDA) in a pregnant female may be associated with adverse events, including low birth weight, preterm birth, or increased perinatal mortality (ACOG 95 2008; IOM 2001; Pavord 2012).

In general, treatment of iron deficiency or IDA in pregnancy is the same as in non-pregnant females. The majority of studies note iron therapy improves maternal hematologic parameters; however, information related to clinical outcomes in the mother and neonate is limited (Peña-Rosas 2015; Reveiz 2011; Siu 2015). Oral preparations are generally sufficient; however, parenteral iron therapy may be used in females who cannot tolerate or will not take oral iron, in cases of severe iron deficiency, or when malabsorption is present (ACOG 95 2008; Pavord 2012). Ferrous sulfate has been evaluated in multiple studies as an iron supplement or for the treatment of IDA in pregnancy (Peña-Rosas 2015; Reveiz 2011). Enteric-coated and slow/sustained-release preparations may be less effective (ACOG 95 2008).

Breast-Feeding Considerations

Iron is present in breast milk (IOM 2001).

Maternal iron requirements are increased in breastfeeding women (IOM 2001). Breast milk levels of iron are maintained in females with mild to moderate iron deficiency anemia (IDA), but concentrations decrease if IDA is severe (El-Farrash 2012; Kumar 2008).

Maternal use of ferrous sulfate increases the iron content of breast milk (Marin 2012). Adverse events were not observed in breastfeeding infants following maternal use of ferrous sulfate in supplemental doses (Baykan 2006). Ferrous sulfate has been evaluated in multiple studies for the treatment of postpartum IDA (Markova 2015). The World Health Organization considers ferrous salts used for anemia to be compatible with breastfeeding (WHO 2002). All postpartum women at risk of gestational anemia (regardless of breastfeeding status) may be given oral iron with or without folic acid for 6 to 12 weeks postpartum to reduce the risk of anemia (WHO 2016c).

Adverse Reactions

>10%: Gastrointestinal: Darkening of stools (≤80%; Tolkien 2015), abdominal pain (≤70%; Tolkien 2015), heartburn (1% to 68%; Tolkien 2015), nausea (≤63%; Tolkien 2015), constipation (≤39%; Tolkien 2015), flatulence (≤36%; Tolkien 2015), vomiting (≤34%; Tolkien 2015), diarrhea (≤23%; Tolkien 2015)

<1%, postmarketing, and/or case reports: Abdominal discomfort (Tolkien 2015)

Allergy and Idiosyncratic Reactions
Toxicology
Metabolism/Transport Effects

None known.

Drug Interactions 

Alpha-Lipoic Acid: Iron Salts may decrease the absorption of Alpha-Lipoic Acid. Alpha-Lipoic Acid may decrease the absorption of Iron Salts. Risk D: Consider therapy modification

Antacids: May decrease the absorption of Iron Salts. Risk D: Consider therapy modification

Baloxavir Marboxil: Iron Salts may decrease the serum concentration of Baloxavir Marboxil. Risk X: Avoid combination

Bictegravir: Iron Salts may decrease the serum concentration of Bictegravir. Management: Bictegravir, emtricitabine, and tenofovir alafenamide can be administered with iron salts under fed conditions, but coadministration with or 2 hours after an iron salt is not recommended under fasting conditions. Risk D: Consider therapy modification

Bisphosphonate Derivatives: Iron Salts may decrease the serum concentration of Bisphosphonate Derivatives. Management: Avoid administration of oral iron supplements within: 2 hours before or after tiludronate/clodronate/etidronate; 60 minutes after oral ibandronate; or 30 minutes after alendronate/risedronate. Exceptions: Pamidronate; Zoledronic Acid.Risk D: Consider therapy modification

Cefdinir: Iron Salts may decrease the serum concentration of Cefdinir. Red-appearing, non-bloody stools may also develop due to the formation of an insoluble iron-cefdinir complex. Management: Avoid concurrent cefdinir and oral iron when possible. Separating doses by several hours may minimize interaction. Iron-containing infant formulas do not appear to interact with cefdinir. Risk D: Consider therapy modification

Deferiprone: Iron Salts may decrease the serum concentration of Deferiprone. Management: Separate administration of deferiprone and oral medications or supplements that contain polyvalent cations by at least 4 hours. Risk D: Consider therapy modification

Dimercaprol: May enhance the nephrotoxic effect of Iron Salts. Risk X: Avoid combination

Dolutegravir: Iron Salts may decrease the serum concentration of Dolutegravir. Management: Administer dolutegravir at least 2 hours before or 6 hours after oral iron. Administer dolutegravir/rilpivirine at least 4 hours before or 6 hours after oral iron salts. Alternatively, dolutegravir and oral iron can be taken together with food. Risk D: Consider therapy modification

Eltrombopag: Iron Salts may decrease the serum concentration of Eltrombopag. Management: Administer eltrombopag at least 2 hours before or 4 hours after oral administration of any iron-containing product. Risk D: Consider therapy modification

Entacapone: Iron Salts may decrease the serum concentration of Entacapone. Management: Consider separating doses of the agents by 2 or more hours to minimize the effects of this interaction. Monitor for decreased therapeutic effects of levodopa during concomitant therapy, particularly if doses cannot be separated. Risk D: Consider therapy modification

Ferric Hydroxide Polymaltose Complex: May decrease the serum concentration of Iron Salts. Specifically, the absorption of oral iron salts may be reduced. Management: Do not administer intravenous (IV) ferric hydroxide polymaltose complex with other oral iron salts. Therapy with oral iron salts should begin 1 week after the last dose of IV ferric hydroxide polymaltose complex. Risk D: Consider therapy modification

Histamine H2 Receptor Antagonists: May decrease the absorption of Iron Salts. Risk C: Monitor therapy

Iron Isomaltoside: May decrease the serum concentration of Iron Salts. Specifically, absorption of oral iron salts may be reduced. Management: Do not administer intravenous (IV) iron isomaltoside with other oral iron salts. Therapy with oral iron salts should begin 5 days after the last dose of IV iron isomaltoside. Risk D: Consider therapy modification

Levodopa: Iron Salts may decrease the serum concentration of Levodopa. Only applies to oral iron preparations. Management: Consider separating doses of the agents by 2 or more hours to minimize the effects of this interaction. Monitor for decreased therapeutic effects of levodopa during concomitant therapy, particularly if doses cannot be separated. Risk D: Consider therapy modification

Levothyroxine: Iron Salts may decrease the serum concentration of Levothyroxine. Management: Separate oral administration of iron salts and levothyroxine by at least 4 hours. Separation of doses is not required with parenterally administered iron salts or levothyroxine. Risk D: Consider therapy modification

Methyldopa: Iron Salts may decrease the serum concentration of Methyldopa. Risk D: Consider therapy modification

PenicillAMINE: Iron Salts may decrease the absorption of PenicillAMINE. Only oral iron salts are a concern. Management: Separate the administration of penicillamine and oral iron salts by at least 1 hour. Risk D: Consider therapy modification

Phosphate Supplements: Iron Salts may decrease the absorption of Phosphate Supplements. Management: Administer oral phosphate supplements as far apart from the administration of an oral iron salt as possible to minimize the significance of this interaction. Exceptions: Sodium Glycerophosphate Pentahydrate. Risk D: Consider therapy modification

Proton Pump Inhibitors: May decrease the absorption of Iron Salts. Risk C: Monitor therapy

Quinolones: Iron Salts may decrease the serum concentration of Quinolones. Management: Give oral quinolones at least several hours before (4 h for moxi- and sparfloxacin, 2 h for others) or after (8 h for moxi-, 6 h for cipro/dela-, 4 h for lome-, 3 h for gemi-, and 2 h for levo-, nor-, oflox-, pefloxacin, or nalidixic acid) oral iron salts Exceptions: LevoFLOXacin (Oral Inhalation). Risk D: Consider therapy modification

Tetracyclines: May decrease the absorption of Iron Salts. Iron Salts may decrease the serum concentration of Tetracyclines. Exceptions: Eravacycline. Risk D: Consider therapy modification

Trientine: May decrease the serum concentration of Iron Salts. Iron Salts may decrease the serum concentration of Trientine. Management: Trientine manufacturer recommends avoiding concurrent use with oral iron salts due to the risk for impaired GI absorption of both trientine and the iron salt. Short courses of iron may be used; however, separate administration by at least 2 hours. Risk D: Consider therapy modification

Food Interactions

Cereals, dietary fiber, tea, coffee, eggs, and milk may decrease absorption.

Test Interactions

False-positive for blood in stool by the guaiac test

Monitoring Parameters

Iron deficient anemia: Hemoglobin and hematocrit; consider additional tests such as RBC count, RBC indices, serum ferritin, transferrin saturation, total iron-binding capacity, serum iron concentration, and erythrocyte protoporphyrin concentration (CDC 1998)

Cancer and chemotherapy-induced anemia: Serum iron, total iron-binding capacity, transferrin saturation, or ferritin levels (baseline and periodic) (Rizzo 2010)

CKD associated anemia (patients not on dialysis): To monitor response to iron therapy: Hemoglobin, serum ferritin, transferrin saturation (KDIGO 2013)

Reference Range

Serum iron:

Males: 75 to 175 mcg/dL (SI: 13.4 to 31.3 micromole/L)

Females: 65 to 165 mcg/dL (SI: 11.6 to 29.5 micromole/L)

Serum ferritin (Ineck 2008):

Males: 15 to 200 ng/dL

Females: 12 to 150 ng/dL

Total iron binding capacity: 230 to 430 mcg/dL

Transferrin: 204 to 360 mg/dL

Percent transferrin saturation: 20% to 50%

Advanced Practitioners Physical Assessment/Monitoring

May cause GI irritation. Monitor GI function (observe for epigastric pain, nausea, dark stools, vomiting, stomach cramping, constipation).

Nursing Physical Assessment/Monitoring

May cause GI irritation. Monitor GI function (observe for epigastric pain, nausea, dark stools, vomiting, stomach cramping, constipation).

Dosage Forms: US

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

Elixir, Oral:

FeroSul: 220 (44 Fe) MG/5ML (473 mL) [contains alcohol, usp, fd&c yellow #6 (sunset yellow), propylene glycol, saccharin sodium, sodium benzoate; lemon flavor]

Iron Supplement: 220 (44 Fe) MG/5ML (473 mL) [contains fd&c yellow #6 (sunset yellow), sodium benzoate]

Generic: 220 (44 Fe) MG/5ML (5 mL [DSC], 473 mL)

Liquid, Oral:

Generic: 220 (44 Fe) MG/5ML (473 mL)

Solution, Oral:

BProtected Pedia Iron: 75 (15 Fe) MG/ML (50 mL) [alcohol free, gluten free; contains sodium metabisulfite; citrus flavor]

Fer-In-Sol: 75 (15 Fe) MG/ML (50 mL) [contains alcohol, usp, sodium bisulfite]

Fer-Iron: 75 (15 Fe) MG/ML (50 mL [DSC]) [contains sodium metabisulfite; lemon flavor]

Iron Supplement Childrens: 75 (15 Fe) MG/ML (50 mL) [alcohol free, dye free, gluten free, lactose free; contains sodium bisulfite]

Generic: 75 (15 Fe) MG/ML (50 mL)

Syrup, Oral:

Generic: 300 (60 Fe) MG/5ML (5 mL)

Tablet, Oral:

FeroSul: 325 (65 Fe) MG [contains fd&c blue #2 aluminum lake, fd&c red #40 aluminum lake]

FeroSul: 325 (65 Fe) MG [contains fd&c red #40 aluminum lake, fd&c yellow #6 aluminum lake]

Ferro-Bob: 325 (65 Fe) MG [DSC]

Generic: 325 (65 Fe) MG

Tablet, Oral [preservative free]:

FerrouSul: 325 (65 Fe) MG [gluten free, sodium free; contains brilliant blue fcf (fd&c blue #1), fd&c blue #2 (indigotine), fd&c red #40, fd&c yellow #6 (sunset yellow)]

Generic: 325 (65 Fe) MG

Tablet Delayed Release, Oral:

Generic: 324 (65 Fe) MG, 325 (65 Fe) MG

Tablet Extended Release, Oral:

Slow Fe: 142 (45 Fe) MG [contains fd&c blue #1 aluminum lake, fd&c red #40 aluminum lake, fd&c yellow #6 aluminum lake]

Tablet Extended Release, Oral [preservative free]:

Slow Iron: 160 (50 Fe) MG [gluten free]

Generic: 140 (45 Fe) MG [DSC]

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Liquid, Oral:

Generic: 150 (30 Fe) MG/5ML (10ml, 250ml, 500ml)

Anatomic Therapeutic Chemical (ATC) Classification
  • B03AA07
Generic Available (US)

Yes

Pricing: US

Elixir (FeroSul Oral)

220 (44 Fe) mg/5 mL (per mL): $0.01

Elixir (Ferrous Sulfate Oral)

220 (44 Fe) mg/5 mL (per mL): $0.01 – $0.02

Liquid (Ferrous Sulfate Oral)

220 (44 Fe) mg/5 mL (per mL): $0.01

Solution (BProtected Pedia Iron Oral)

75 (15 Fe) mg/mL (per mL): $0.17

Solution (Fer-In-Sol Oral)

75 (15 Fe) mg/mL (per mL): $0.21

Solution (Ferrous Sulfate Oral)

75 (15 Fe) mg/mL (per mL): $0.09 – $0.18

Syrup (Ferrous Sulfate Oral)

300 (60 Fe) mg/5 mL (per mL): $0.63

Tablet, controlled release (Slow Fe Oral)

142 (45 Fe) mg (per each): $0.23

Tablet, EC (Ferrous Sulfate Oral)

324 (65 Fe) mg (per each): $0.06 – $0.11

325 (65 Fe) mg (per each): $0.05 – $0.82

Tablets (FeroSul Oral)

325 (65 Fe) mg (per each): $0.02

Tablets (Ferrous Sulfate Oral)

325 (65 Fe) mg (per each): $0.01 – $0.11

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

Replaces iron, found in hemoglobin, myoglobin, and other enzymes; allows the transportation of oxygen via hemoglobin

Pharmacodynamics/Kinetics

Onset of action: Hematologic response: Oral: ~3 to 10 days

Peak effect: Reticulocytosis: 5 to 10 days; hemoglobin increases within 2 to 4 weeks

Absorption: Iron is absorbed in the duodenum and upper jejunum; in persons with normal serum iron stores, 10% of an oral dose is absorbed; this is increased to 20% to 30% in persons with inadequate iron stores. Food and achlorhydria will decrease absorption

Protein binding: To transferrin

Excretion: Urine, sweat, sloughing of the intestinal mucosa, and menses

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Do not prescribe tetracyclines simultaneously with iron since GI tract absorption of both tetracycline and iron may be inhibited. Liquid preparations may temporarily stain the teeth.

Effects on Bleeding

No information available to require special precautions

Index Terms

Feosol Original; Ferric Sulfate; Ferrous Sulphate; FeSO4; Iron Sulfate; Slow FE

References

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

American College of Obstetricians and Gynecologists, “ACOG Practice Bulletin No. 95: Anemia in Pregnancy,” Obstet Gynecol, 2008, 112(1):201-7.[PubMed 18591330]

Aurora RN, Kristo DA, Bista SR, et al; American Academy of Sleep Medicine. The treatment of restless legs syndrome and periodic limb movement disorder in adults—an update for 2012: practice parameters with an evidence-based systematic review and meta-analyses: an American Academy of Sleep Medicine clinical practice guideline. Sleep. 2012;35(8):1039-1062.[PubMed 22851801]

Baker RD, Greer FR; Committee on Nutrition American Academy of Pediatrics. Diagnosis and prevention of iron deficiency and iron-deficiency anemia in infants and young children (0-3 years of age). Pediatrics. 2010;126(5):1040-1050.[PubMed 20923825]

Baykan A, Yalçin SS, Yurdakök K. Does maternal iron supplementation during the lactation period affect iron status of exclusively breast-fed infants? Turk J Pediatr. 2006;48(4):301-307.[PubMed 17290563]

Carney LN, Nepa A, Cohen SS, et al. Parenteral and Enteral Nutrition Support: Determining the Best Way to Feed. In: Corkins MR, Balint J, Bobo E, et al, eds. The A.S.P.E.N Pediatric Nutrition Support Core Curriculum. American Society of Parenteral and Enteral Nutrition. Silver Spring, MD: 2010; 440-441.

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]

Centers for Disease Control and Prevention (CDC), “Recommendations to Prevent and Control Iron Deficiency in the United States,” MMWR Recomm Rep, 1998, 47(RR-3):1-29.[PubMed 9563847]

Corkins MR, Balint J, Bobo E, et al, eds. The A.S.P.E.N Pediatric Nutrition Support Core Curriculum. 2nd ed. Silver Spring: MD: American Society of Parenteral and Enteral Nutrition, 2015.

Davis BJ, Rajput A, Rajput ML, Aul EA, Eichhorn GR. A randomized, double-blind placebo-controlled trial of iron in restless legs syndrome. Eur Neurol. 2000;43(2):70-75.[PubMed 10686463]

El-Farrash RA, Ismail EA, Nada AS. Cord blood iron profile and breast milk micronutrients in maternal iron deficiency anemia. Pediatr Blood Cancer. 2012;58(2):233-238. doi: 10.1002/pbc.23184.[PubMed 21548016]

Fer-In-Sol (ferrous sulfate) [prescribing information]. Evansville, IN: Mead Johnson & Company; received December 2018.

Garcia-Borreguero D, Ferini-Strambi L, Kohnen R, et al; European Federation of Neurological Societies; European Neurological Society; European Sleep Research Society. European guidelines on management of restless legs syndrome: report of a joint task force by the European Federation of Neurological Societies, the European Neurological Society and the European Sleep Research Society. Eur J Neurol. 2012;19(11):1385-1396.[PubMed 22937989]

Hershko C and Camaschella C. How I treat unexplained refractory iron deficiency anemia. Blood. 2014;123(3):326-333. doi: 10.1182/blood-2013-10-512624.[PubMed 24215034]

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

Ineck B, Mason BJ, Lyons W. Chapter 104. Anemias. Pharmacotherapy: A Pathophysiologic Approach. DiPiro JT, ed. New York, NY: McGraw-Hill Medical; 2008.

IOM (Institute of Medicine), Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc, Washington, DC: National Academy Press, 2001.

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

Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2012 clinical practice guidelines for the evaluation and management of chronic kidney disease. Kidney Inter. 2013;3(suppl):1-150. Available at http://kdigo.org/clinical_practice_guidelines/pdf/KDIGO-Anemia%20GL.pdf

Kliegman RM, Stanton BMD, St. Geme J, Schor NF, eds. Nelson Textbook of Pediatrics. 20th ed. Philadelphia, PA: Saunders Elsevier; 2016.

Kumar A, Rai AK, Basu S, et al. Cord blood and breast milk iron status in maternal anemia. Pediatrics. 2008;121(3):e673-e677. doi: 10.1542/peds.2007-1986.[PubMed 18310187]

Lipschitz DA, “The Anemia of Chronic Disease,” J Am Geriatr Soc, 1990, 38(11):1258-64.[PubMed 2123218]

Liu K, Kaffes AJ. Iron deficiency anaemia: a review of diagnosis, investigation and management. Eur J Gastroenterol Hepatol. 2012;24(2):109-116.[PubMed 22157204]

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

Marin GH, Mestorino N, Errecalde J, et al. Personalised iron supply for prophylaxis and treatment of pregnant women as a way to ensure normal iron levels in their breast milk. J Med Life. 2012;5(1):29-32.[PubMed 22574084]

Markova V, Norgaard A, Jørgensen KJ, et al. Treatment for women with postpartum iron deficiency anaemia. Cochrane Database Syst Rev. 2015;(8):CD010861. doi: 10.1002/14651858.CD010861.pub2.[PubMed 26270434]

Marx JJM, “Normal Iron Absorption and Decreased Red Cell Iron Uptake in the Aged,” Blood, 1979, 53:204-11.[PubMed 760850]

Pavord S, Myers B, Robinson S, et al; British Committee for Standards in Haematology. UK guidelines on the management of iron deficiency in pregnancy. Br J Haematol. 2012;156(5):588-600.[PubMed 22512001]

Peña-Rosas JP, De-Regil LM, Garcia-Casal MN, et al. Daily oral iron supplementation during pregnancy. Cochrane Database Syst Rev. 2015;7:CD004736. doi: 10.1002/14651858.CD004736.pub5.[PubMed 26198451]

Reveiz L, Gyte GM, Cuervo LG, et al. Treatments for iron-deficiency anaemia in pregnancy. Cochrane Database Syst Rev. 2011;10:CD003094. doi: 10.1002/14651858.CD003094.pub3.[PubMed 21975735]

Rimon E, Kagansky N, Kagansky M, et al, “Are We Giving Too Much Iron? Low-Dose Iron Therapy is Effective in Octogenarians,” Am J Med, 2005, 118(10):1142-7.[PubMed 16194646]

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Schanler RJ, Feldman-Winter L, Landers S, et al. Concerns with early universal iron supplementation of breastfeeding infants. Pediatrics. 2011;127(4):e1097.[PubMed 21460097]

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Siu AL; U.S. Preventive Services Task Force. Screening for iron deficiency anemia and iron supplementation in pregnant women to improve maternal health and birth outcomes: U.S. Preventive Services Task Force Recommendation Statement. Ann Intern Med. 2015;163(7):529-36. doi: 10.7326/M15-1707.[PubMed 26344176]

Stoffel NU, Cercamondi CI, Brittenham G, et al. Iron absorption from oral iron supplements given on consecutive versus alternate days and as single morning doses versus twice-daily split dosing in iron-depleted women: two open-label, randomised controlled trials. Lancet Haematol. 2017;4(11):e524-e533. doi: 10.1016/S2352-3026(17)30182-5.[PubMed 29032957]

Tolkien Z, Stecher L, Mander AP, Pereira DI, Powell JJ. Ferrous sulfate supplementation causes significant gastrointestinal side-effects in adults: a systematic review and meta-analysis. PLoS One. 2015;10(2):e0117383.[PubMed 25700159]

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Wang J, O’Reilly B, Venkataraman R, Mysliwiec V, Mysliwiec A. Efficacy of oral iron in patients with restless legs syndrome and a low-normal ferritin: a randomized, double-blind, placebo-controlled study. Sleep Med. 2009;10(9):973-975.[PubMed 19230757]

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Brand Names: International

Aktiferrin (HU); Brisofer (PH); Conferon (HU); Duroferon (FI, NO, SE); Eribell (PY); Femas (JP); Feosol (PH); Feospan (AE, BF, BJ, CI, CY, EG, ET, GH, GM, GN, HK, IQ, IR, JO, KE, LB, LR, LY, MA, ML, MR, MU, MW, NE, NG, OM, SA, SC, SD, SL, SN, SY, TN, TZ, UG, YE, ZA, ZM, ZW); Feospan Z (AE); Fer-In-Sol (AR, BR, CL, CZ, GR, HK, PE, SA, VE); Ferglobin (PH); Ferlea (AR); Fero-Gradumet (BE, ES, LU, NL, PL); Feroba (KR); Feromin (BH, QA); Feromin Oral Drops (SA); Ferro Duretter (DK); Ferro-grad (IT); Ferro-Gradumet (AE, AT, AU, BG, CH, CY, EG, HU, ID, IL, IQ, IR, JO, LB, LY, OM, PT, SA, SY, YE); Ferro-Liquid (AU); Ferrogamma (DE); Ferrogard (JO); Ferrograd (GB, IE, MT); Ferrograd C (IE); Ferrogradumet (RO); Ferrolent (CR, DO, GT, HN, NI, PA, SV); Ferrophor (DE); Ferroplex ”Era” (DK); Ferrostatin (JP); Ferrosterol (UY); Fersulph (LK); Haemoprotect (DE); Hemobion (MX); Iberol Drops (LK); Inshel (TW); Irovit (BH); Kdiron (BH, QA); Kidiron (TH); Liquifer (NL); Microfer (GR); Mol-Iron (CO); Pediafer (LB); Pharmafer (LB); Plastufer (DE); Plexafer (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZA, ZM, ZW); Retafer (FI, HR, MY); Slow-Fe (AE, BB, BM, BS, BZ, CY, EG, GY, IQ, IR, JM, JO, LB, LY, OM, SA, SR, SY, TT, YE); Sorbifer (HU); Tardyferon (AE, BH, CY, ES, FR, HU, IL, LU, QA); Valdefer (MX)

Ferrous Sulfate (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

(FER us SUL fate)

Brand Names: US

BProtected Pedia Iron [OTC]; Fer-In-Sol [OTC]; Fer-Iron [OTC] [DSC]; FeroSul [OTC]; Ferro-Bob [OTC] [DSC]; FerrouSul [OTC]; Iron Supplement Childrens [OTC]; Iron Supplement [OTC]; Slow Fe [OTC]; Slow Iron [OTC]

Brand Names: Canada

Fer-In-Sol; Ferodan

Warning
  • Accidental overdose of drugs that have iron in them is a leading cause of deadly poisoning in children younger than 6 years of age. Keep away from children. If this drug is taken by accident, call a doctor or poison control center right away.
What is this drug used for?
  • It is used to aid diet needs.
  • It is used to treat or prevent low iron in the body.
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to ferrous sulfate 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 any of these health problems: Too much iron in your body or anemia from a cause other than low iron.
  • 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.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • This drug may affect certain lab tests. Tell all of your health care providers and lab workers that you take this drug.
  • If you are allergic to tartrazine, talk with your doctor. Some products have tartrazine.
  • This drug prevents many other drugs from getting into the body. If you take other drugs, check with your doctor or pharmacist to see if you need to take them at some other time than this drug.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
  • Liquid (drops):
  • If you are allergic to sulfites, talk with your doctor. Some products have sulfites.
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.
  • Black, tarry, or bloody stools.
  • Fever.
  • Very upset stomach or throwing up.
  • Very bad belly pain.
  • Throwing up blood or throw up that looks like coffee grounds.
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:
  • All products:
  • Belly pain.
  • Diarrhea.
  • Constipation.
  • Change in color of stool to green.
  • Not hungry.
  • Upset stomach or throwing up.
  • Stomach cramps.
  • All liquid products:
  • Staining of the mouth, teeth, or fillings.
  • 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 products:
  • This drug works better if you take it on an empty stomach. You may take this drug with food if it causes an upset stomach. Some foods like eggs, whole grain breads, cereal, dairy products, coffee, and tea may make this drug not work as well. If this drug causes an upset stomach, talk with your doctor about the best way to take this drug with food.
  • If antacids are used, they may need to be taken at some other time than this drug. Talk with your doctor or pharmacist.
  • Tablets and capsules:
  • Swallow whole. Do not chew, break, or crush.
  • Take with a full glass of water.
  • Liquid (drops):
  • Only use the measuring device that comes with this liquid drug.
  • Shake well before use.
  • You may put this drug right in the mouth or you may mix it with formula, fruit juice, cereal or other food, water or juice. Take the whole dose.
  • Liquid (elixir):
  • 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.
  • Mix liquid with water or juice and drink it from a straw for less stains on your teeth. Rinse your mouth.
What do I do if I miss a dose?
  • 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.
How do I store and/or throw out this drug?
  • All products:
  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • 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.
  • All liquid products:
  • Do not freeze.
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.
Ferrous Sulfate (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

(FER us SUL fate)

Brand Names: US

BProtected Pedia Iron [OTC]; Fer-In-Sol [OTC]; Fer-Iron [OTC] [DSC]; FeroSul [OTC]; Ferro-Bob [OTC] [DSC]; FerrouSul [OTC]; Iron Supplement Childrens [OTC]; Iron Supplement [OTC]; Slow Fe [OTC]; Slow Iron [OTC]

Brand Names: Canada

Fer-In-Sol; Ferodan

Warning
  • Accidental overdose of drugs that have iron in them is a leading cause of deadly poisoning in children younger than 6 years of age. Keep away from children. If this drug is taken by accident, call a doctor or poison control center right away.
What is this drug used for?
  • It is used to aid diet needs.
  • It is used to treat or prevent low iron in the body.
  • It may be given to your child for other reasons. Talk with the doctor.
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 any of these health problems: Too much iron in the body or anemia from a cause other than low iron.
  • 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.
  • Have your child’s blood work checked often. Talk with your child’s doctor.
  • 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.
  • If your child is allergic to tartrazine, talk with your child’s doctor. Some products have tartrazine.
  • This drug stops many drugs from getting into the body. If your child takes other drugs, check with the doctor to see if you need to give them at some other time than this drug.
  • 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.
  • Liquid (drops):
  • If your child is allergic to sulfites, talk with your child’s doctor. Some products have sulfites in them.
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.
  • Black, tarry, or bloody stools.
  • Fever.
  • Very upset stomach or throwing up.
  • Very bad belly pain.
  • Throwing up blood or throw up that looks like coffee grounds.
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:
  • All products:
  • Belly pain.
  • Upset stomach or throwing up.
  • Diarrhea.
  • Constipation.
  • Change in color of stool to green.
  • Not hungry.
  • Stomach cramps.
  • All liquid products:
  • Staining of the mouth, teeth, or fillings.
  • 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 products:
  • This drug works better if your child takes it on an empty stomach. Your child may take this drug with food if it causes an upset stomach. Some foods like eggs, whole grain breads, cereal, dairy products, coffee, and tea may make this drug not work as well. If this drug causes an upset stomach, talk with the doctor about the best way to give this drug with food.
  • If antacids are used, they may need to be given at some other time than this drug. Talk with your child’s doctor or pharmacist.
  • Tablets and capsules:
  • 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):
  • Only use the measuring device that comes with this liquid drug.
  • Shake well before use.
  • You may put this drug right in your child’s mouth or you may mix it with formula, fruit juice, cereal or other food, water or juice. Be sure to give the whole dose.
  • Liquid (elixir):
  • 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.
  • Mix liquid with water or juice and have your child drink it from a straw for less stains on his/her teeth. Have your child rinse mouth.
What do I do if my child misses a dose?
  • 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.
How do I store and/or throw out this drug?
  • All products:
  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • 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.
  • All liquid products:
  • Do not freeze.
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.