Docusate (Lexi-Drugs)

Pronunciation

(DOK yoo sate)

Brand Names: US

Colace Clear [OTC] [DSC]; Colace [OTC]; Diocto [OTC]; DocQLace [OTC] [DSC]; Docu Soft [OTC]; Docu [OTC]; Docuprene [OTC] [DSC]; Docusil [OTC]; DocuSol Kids [OTC]; DocuSol Mini [OTC]; DOK [OTC]; Dulcolax Stool Softener [OTC]; Enemeez Mini [OTC]; Healthy Mama Move It Along [OTC]; Kao-Tin [OTC]; KS Stool Softener [OTC]; Laxa Basic [OTC]; Pedia-Lax [OTC]; Promolaxin [OTC]; Silace [OTC]; Sof-Lax [OTC] [DSC]; Stool Softener Laxative DC [OTC] [DSC]; Stool Softener [OTC]

Pharmacologic Category

Stool Softener

Dosing: Adult

Note: The following are general dosing guidelines; refer to specific product labeling for dosing instructions.

Stool softener:

Oral:

Docusate calcium: 240 mg once daily

Docusate sodium: 50 to 360 mg once daily or in divided doses

Rectal: 283 mg per 5 mL: 283 mg (1 enema) 1 to 3 times daily

Ceruminolytic (off-label use): Intra-aural: Administer 1 mL of docusate sodium in 2 mL syringes; if no clearance in 15 minutes, irrigate with 50 or 100 mL lukewarm normal saline (Singer 2000)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Pediatric

Constipation (occasional), treatment; stool softener:

Docusate sodium:

Oral:

Manufacturer’s labeling:

Children 2 years to <12 years: 50 to 150 mg/day in single or divided doses

Children ≥12 years and Adolescents: 50 to 360 mg/day in single or divided doses

Alternate dosing:

Weight-directed dosing: Infants and Children: 5 mg/kg/day in 1 to 4 divided doses (Nelson 1996)

Age-directed (fixed) dosing:

Infants ≥6 months and Children <2 years: 12.5 mg 3 times daily (NICE 2010)

Children ≥2 and Adolescents: 40 to 150 mg/day in 1 to 4 divided doses (Kliegman 2011); in children ≥12 years and adolescents, doses up to 500 mg/day divided may be used (NICE 2010)

Rectal:

Children 2 to <12 years:

100 mg/5 mL: 100 mg (1 unit) once daily

283 mg/5 mL: 283 mg (1 unit) once daily

Children ≥12 years and Adolescents: 283 mg/5mL: 283 mg (1 unit) 1 to 3 times daily

Docusate calcium: Children ≥12 years and Adolescents: 240 mg once daily

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Use: Labeled Indications

Stool softener: Prevention of straining during defecation and constipation associated with hard, dry stools; relief of occasional constipation

Use: Off-Label: Adult

  CeruminolyticLevel of Evidence [B]

Data from a small, prospective, randomized, double-blind controlled study comparing the intra-aural use of docusate to triethanolamine polypeptide (not available in the US) and subsequent irrigation with lukewarm normal saline as needed supports the use of docusate intra-aurally as a ceruminolytic Ref. Despite these data, the use of saline is still considered to be first-line Ref. Additional trials may be necessary to further define the role of intra-aural docusate in the treatment of this condition.

Level of Evidence Definitions
  Level of Evidence Scale
Administration: Oral

Administer as a single daily dose or in divided doses; ensure adequate fluid intake. Mix docusate liquid (50 mg per 5 mL) with milk or fruit juice to prevent throat irritation.

Administration: Rectal

For rectal use only. Lubricate tip prior to insertion by placing a few drops of the liquid from the enema on the shaft prior to insertion; may also apply a few drops of enema contents or lubricant to the anus prior to insertion. Gently insert lubricated applicator tip into rectum. Grasp bottle firmly and squeeze slowly to empty the contents. Discard after administration.

Administration: Pediatric

Oral: Docusate liquid products may have bitter taste due to active ingredient, consider mixing with milk, fruit juice, or infant formula to mask taste; ensure adequate fluid intake

Rectal: Empty contents of enema into rectum, discard disposable administration device

Dietary Considerations

Some products may contain sodium.

Storage/Stability

Store at room temperature. Protect from freezing, heat humidity, and light.

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 abdominal cramps. Have patient report immediately to prescriber rectal irritation (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:
  International issues:
Contraindications

OTC labeling: When used for self-medication, do not use for longer than 7 days; when abdominal pain, nausea, or vomiting is present; or concomitantly with mineral oil (oral products only)

Warnings/Precautions

Dosage forms specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain 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 1997; CDC 1982); some data suggests that benzoate displaces bilirubin.

• Enema: For rectal use only; lubricate tip prior to insertion. Discontinue use and notify health care provider if rash around the anus/rectal irritation occurs or if resistance is encountered with insertion; forcing the tube may result in injury or damage to the rectum.

Other warnings/precautions:

• Self-medication (OTC use): When used for self-medication (OTC), patients should be instructed to contact healthcare provider prior to use if nausea, stomach pain, or vomiting are present, or if a sudden change in bowel habits occurs and persists over 14 days. Patients should discontinue use and notify healthcare provider if rectal bleeding occurs, if a bowel movement fails to occur after use, or if use is needed >7 days.

Geriatric Considerations

A safe agent to be used in the elderly. Some evidence that doses <200 mg are ineffective. Stool softeners are unnecessary if stool is well hydrated or “mushy” and soft; shown to be ineffective used long-term.

Warnings: Additional Pediatric Considerations

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

Hypomagnesemia was reported in a newborn following chronic maternal overuse of docusate sodium throughout pregnancy (Schindler 1984). Treatment of constipation in pregnant women is similar to that of nonpregnant patients and medications may be used when diet and lifestyle modifications are not effective. Agents other than docusate are preferred for initial treatment. Docusate sodium may be used if needed, but may not be as effective as other agents (ACG [Christie 2007]).

Breast-Feeding Considerations

It is not known if docusate is present in breast milk; because there is some systemic absorption, use of other agents may be preferred in breastfeeding women (Lewis 1985). Diarrhea was noted in a breastfeeding infant following maternal use of danthron and docusate sodium (Greenhalf 1973).

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

1% to 10%: Respiratory: Throat irritation (liquid)

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

None known.

Drug Interactions 

There are no known significant interactions.

Monitoring Parameters

Rectal: Periodic rectal exams are recommended in patients with impaired rectal function, especially loss of sensation.

Advanced Practitioners Physical Assessment/Monitoring

Instruct patient in proper use (avoid excessive or prolonged use).

Nursing Physical Assessment/Monitoring

Instruct patient in proper use (avoid excessive or prolonged use).

Dosage Forms: US

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

Capsule, Oral, as calcium:

Kao-Tin: 240 mg [sodium free; contains brilliant blue fcf (fd&c blue #1), fd&c red #40, fd&c yellow #6 (sunset yellow)]

Kao-Tin: 240 mg [DSC] [sodium free; contains fd&c red #40]

Stool Softener: 240 mg [contains brilliant blue fcf (fd&c blue #1), fd&c red #40, fd&c yellow #6 (sunset yellow)]

Stool Softener Laxative DC: 240 mg [DSC] [contains fd&c red #40]

Generic: 240 mg

Capsule, Oral, as sodium:

Colace: 50 mg [DSC]

Colace: 100 mg [contains fd&c red #40, fd&c yellow #6 (sunset yellow)]

Colace Clear: 50 mg [DSC] [dye free]

DocQLace: 100 mg [DSC] [contains fd&c red #40, fd&c yellow #6 (sunset yellow)]

Docu Soft: 100 mg

Docusil: 100 mg

DOK: 100 mg [contains fd&c red #40, fd&c yellow #6 (sunset yellow)]

DOK: 250 mg [DSC]

DOK: 250 mg [contains fd&c red #40, fd&c yellow #6 (sunset yellow)]

Dulcolax Stool Softener: 100 mg [contains fd&c red #40, fd&c yellow #6 (sunset yellow)]

KS Stool Softener: 100 mg [stimulant free; contains brilliant blue fcf (fd&c blue #1), fd&c red #40, methylparaben, propylparaben, tartrazine (fd&c yellow #5)]

Laxa Basic: 100 mg

Sof-Lax: 100 mg [DSC]

Stool Softener: 100 mg

Stool Softener: 100 mg [contains fd&c red #40, fd&c yellow #10 (quinoline yellow), fd&c yellow #6 (sunset yellow)]

Stool Softener: 100 mg, 250 mg [DSC] [contains fd&c red #40, fd&c yellow #6 (sunset yellow)]

Stool Softener: 100 mg [stimulant free; contains brilliant blue fcf (fd&c blue #1), fd&c red #40, fd&c yellow #6 (sunset yellow)]

Stool Softener: 100 mg, 250 mg [stimulant free; contains fd&c red #40, fd&c yellow #6 (sunset yellow)]

Generic: 100 mg, 250 mg

Enema, Rectal, as sodium:

DocuSol Kids: 100 mg/5 mL (5 ea) [contains polyethylene glycol]

DocuSol Mini: 283 mg (5 ea)

Enemeez Mini: 283 mg (5 mL)

Liquid, Oral, as sodium:

Diocto: 50 mg/5 mL (473 mL [DSC]) [contains fd&c red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben; vanilla flavor]

Diocto: 50 mg/5 mL (473 mL) [contains parabens, polyethylene glycol]

Docu: 50 mg/5 mL (10 mL, 473 mL) [contains methylparaben, polyethylene glycol, propylene glycol, propylparaben, sodium benzoate; vanilla flavor]

Pedia-Lax: 50 mg/15 mL (118 mL) [contains edetate disodium, methylparaben, polyethylene glycol, propylene glycol, propylparaben; fruit punch flavor]

Silace: 150 mg/15 mL (473 mL) [lemon-vanilla flavor]

Generic: 50 mg/5 mL (10 mL); 150 mg/15 mL (473 mL)

Syrup, Oral, as sodium:

Diocto: 60 mg/15 mL (473 mL [DSC]) [contains fd&c red #40, menthol, methylparaben, polyethylene glycol, propylparaben, sodium benzoate; peppermint flavor]

Diocto: 60 mg/15 mL (473 mL) [contains fd&c red #40, propylene glycol, saccharin sodium, sodium benzoate]

Silace: 60 mg/15 mL (473 mL) [contains alcohol, usp; peppermint flavor]

Generic: 60 mg/15 mL (25 mL)

Tablet, Oral, as sodium:

Docuprene: 100 mg [DSC] [contains sodium benzoate]

DOK: 100 mg

DOK: 100 mg [scored]

Healthy Mama Move It Along: 100 mg [scored; stimulant free; contains sodium benzoate]

Promolaxin: 100 mg [scored; contains sodium benzoate]

Stool Softener: 100 mg [contains sodium benzoate]

Generic: 100 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • A06AA02
Generic Available (US)

May be product dependent

Pricing: US

Capsules (Colace Oral)

100 mg (per each): $0.33

Capsules (Docusate Calcium Oral)

240 mg (per each): $0.04 – $0.12

Capsules (Docusate Sodium Oral)

100 mg (per each): $0.02 – $0.12

250 mg (per each): $0.04 – $0.24

Capsules (Docusil Oral)

100 mg (per each): $0.05

Capsules (DOK Oral)

100 mg (per each): $0.04

250 mg (per each): $0.12

Capsules (DSS Oral)

250 mg (per each): $0.08

Capsules (Kao-Tin Oral)

240 mg (per each): $0.14

Enema (DocuSol Kids Rectal)

100 mg/5 mL (per each): $2.46

Enema (DocuSol Mini Rectal)

283 mg (per each): $2.46

Enema (Enemeez Mini Rectal)

283 mg (per mL): $0.45

Liquid (Docusate Sodium Oral)

150 mg/15 mL (per mL): $0.01

Liquid (Pedia-Lax Oral)

50 mg/15 mL (per mL): $0.05

Syrup (Docusate Sodium Oral)

60 mg/15 mL (per mL): $0.10

Tablets (Docusate Sodium Oral)

100 mg (per each): $0.09

Tablets (DOK Oral)

100 mg (per each): $0.03

Tablets (Healthy Mama Move It Along Oral)

100 mg (per each): $0.15

Tablets (Promolaxin Oral)

100 mg (per each): $0.99

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

Reduces surface tension of the oil-water interface of the stool resulting in enhanced incorporation of water and fat allowing for stool softening (Roering, 2010)

Pharmacodynamics/Kinetics

Onset of action: Oral: 12 to 72 hours; Rectal: 2 to 15 minutes

Excretion: Feces (Gattuso 1994)

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Throat irritation.

Effects on Bleeding

No information available to require special precautions

Index Terms

Dioctyl Calcium Sulfosuccinate; Dioctyl Sodium Sulfosuccinate; Docusate Calcium; Docusate Potassium; Docusate Sodium; DOSS; DSS

References

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

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]

Christie J, Rose S. Constipation, diarrhea, hemorrhoids, and fecal incontinence. In: Pregnancy in gastrointestinal disorders. Bethesda (MD): ACG Monograph American College of Physicians; 2007. Available at https://www.acg.gi.org

Colace (docusate sodium) [prescribing information]. Stamford, CT: Purdue Products LP; November 2012.

Colace Clear (docusate sodium) [prescribing information]. Stamford CT: Purdue Products LP.

Diocto Liquid 50 mg/5 mL (docusate sodium) [prescribing information]. Livonia, MI: Rugby Laboratories; February 2013.

Diocto Syrup 60 mg/15 mL (docusate sodium) [prescribing information]. Livonia, MI: Rugby Laboratories; April 2013.

DocuSol Kids (docusate sodium) [prescribing information]. Phoenix, AZ: Summit Pharmaceuticals.

DocuSol Mini-Enema (docusate sodium) [prescribing information]. Phoenix, AZ: Alliance Labs.

DOK (docusate sodium) [prescribing information]. Livonia, MI: Major Pharmaceuticals; June 2018.

Enemeez (docusate sodium) [prescribing information]. Phoenix, AZ: Alliance Labs.

Gattuso JM, Kamm MA. Adverse effects of drugs used in the management of constipation and diarrhoea. Drug Saf. 1994;10(1):47-65.[PubMed 8136086]

Greenhalf JO, Leonard HS. Laxatives in the treatment of constipation in pregnant and breast-feeding mothers. Practitioner. 1973;210(256):259-263.[PubMed 4570522]

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

Kao-Tin (docusate calcium) [prescribing information]. Livonia, MI: Major Pharmaceuticals; January 2015.

Lewis JH, Weingold AB. The use of gastrointestinal drugs during pregnancy and lactation. Am J Gastroenterol. 1985;80(11):912-923.[PubMed 2864852]

McCarter DF, Courtney AU, Pollart SM. Cerumen impaction. Am Fam Physician. 2007;75(10):1523-1528.[PubMed 17555144]

National Collaborating Centre for Women’s and Children’s Health (UK). Constipation in children and young people: diagnosis and management of idiopathic childhood constipation in primary and secondary care. London, UK: RCOG Press; 2010.[PubMed 22220325]

Roerig JL, Steffen KJ, Mitchell JE, Zunker C. Laxative abuse: epidemiology, diagnosis and management. Drugs. 2010;70(12):1487-1503.[PubMed 20687617]

Schindler AM, “Isolated Neonatal Hypomagnesaemia Associated With Maternal Overuse of Stool Softener,” Lancet, 1984, 2(8406):822.[PubMed 6207396]

Singer AJ, Sauris E, and Viccellio AS, “Ceruminolytic Effects of Docusate Sodium: A Randomized, Controlled Trial,” Ann Emerg Med, 2000, 36(3):228-32.[PubMed 10969225]

Stool Softener DC Laxative (docusate calcium) [prescribing information]. Livonia, MI: Rugby Laboratories; April 2013.

Surfak (docusate calcium) [prescribing information]. Chattanooga, TN: Chattem, Inc.

Brand Names: International

Audiwax (PH); Coloxyl (AU, NZ); Cusate (TH); Dewax (BH, JO, SA); Diocaps (CR, DO, GT, HN, NI, PA, SV); Dioctyl (GB); Docusaat FNA (NL); Docuset (BD); Docusoft (IL); Docusol (GB); Doslax (IN); Dulcocomfort (EC); Egycusate (EG); Emtix (FI); Green Morning (KR); Irwax (PH); Jamylene (FR); Klyx (FI, NL, NO, SE); Lambanol (IT); Lassativo (EG); Laxadine (ID); Laxol (PL); Molcer (GB); Molcer Ear Drops (LK); Mulin (JO); Norgalax (AE, BE, CH, CY, DE, GB, IQ, IR, KW, LB, LU, LY, NL, OM, QA, RU, SA, SY, UA, VN, YE); Norgalax Micro-enema (GB); Otoclear (PH); Otosol (PH); Otowax (PH); Purgeron (JP); Regutol (AE, CY, IQ, IR, KW, LB, LY, OM, SA, SY, YE); Soliwax (GB); Soluwax Ear Drops (MY, SG); Wax-Eze (HK); Waxsol (AU, BH, GB, IE, JO, LB, LK, NZ, QA, SA); Wondril (EG); Yal (CZ); Yi Ke Long (CN)

Docusate (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

(DOK yoo sate)

Brand Names: US

Colace Clear [OTC] [DSC]; Colace [OTC]; Diocto [OTC]; DocQLace [OTC] [DSC]; Docu Soft [OTC]; Docu [OTC]; Docuprene [OTC] [DSC]; Docusil [OTC]; DocuSol Kids [OTC]; DocuSol Mini [OTC]; DOK [OTC]; Dulcolax Stool Softener [OTC]; Enemeez Mini [OTC]; Healthy Mama Move It Along [OTC]; Kao-Tin [OTC]; KS Stool Softener [OTC]; Laxa Basic [OTC]; Pedia-Lax [OTC]; Promolaxin [OTC]; Silace [OTC]; Sof-Lax [OTC] [DSC]; Stool Softener Laxative DC [OTC] [DSC]; Stool Softener [OTC]

Brand Names: Canada

Apo-Docusate Calcium [OTC]; Apo-Docusate Sodium [OTC]; Calax [OTC]; Colace [OTC]; Docusate Sodium Odan [OTC]; Dom-Docusate Sodium [OTC]; Dosolax [OTC]; Dulcocomfort Stool Softener [OTC]; Euro-Docusate C [OTC]; Jamp-Docusate [OTC]; Novo-Docusate Calcium [OTC]; Novo-Docusate Sodium [OTC]; PHL-Docusate Sodium [OTC]; PMS-Docusate Calcium [OTC]; PMS-Docusate Sodium [OTC]; ratio-Docusate Sodium [OTC]; Selax [OTC]; Silace [OTC]; Sirop Docusate De Sodium [OTC]; Soflax C [OTC]; Soflax [OTC]; Taro-Docusate [OTC]; Teva-Docusate Calcium [OTC]; Teva-Docusate Sodium [OTC]

What is this drug used for?
  • It is used to treat constipation.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to docusate 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: Bowel block, belly pain, upset stomach, rectal bleeding, throwing up, or change in bowel habits lasting longer than 2 weeks.
  • If you are taking mineral oil.
  • 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?
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Do not use this drug for more than 1 week unless told to do so by your doctor.
  • If you have rectal bleeding or you do not have a bowel movement after using this drug, talk with your doctor.
  • Do not use other laxatives or stool softeners unless told to do so by the doctor.
  • If you are on a low-sodium or sodium-free diet, talk with your doctor. Some of these products have sodium.
  • 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.
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:
  • All products:
  • 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.
  • Rectal enema:
  • Rectal irritation.
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:
  • Stomach cramps.
  • 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:
  • Follow how to take this drug as you have been told by your doctor. Do not use more than you were told to use.
  • All oral products:
  • Take with or without food.
  • Take with a full glass of water.
  • Liquid:
  • Mix liquid with milk, juice, or formula as you have been told.
  • 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.
  • Some of these drugs need to be shaken before use. Be sure you know if this product needs to be shaken before using it.
  • Rectal enema:
  • Use enema rectally.
What do I do if I miss a dose?
  • 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.
How do I store and/or throw out this drug?
  • Store at room temperature. Do not freeze.
  • 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.
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.
Docusate (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

(DOK yoo sate)

Brand Names: US

Colace Clear [OTC] [DSC]; Colace [OTC]; Diocto [OTC]; DocQLace [OTC] [DSC]; Docu Soft [OTC]; Docu [OTC]; Docuprene [OTC] [DSC]; Docusil [OTC]; DocuSol Kids [OTC]; DocuSol Mini [OTC]; DOK [OTC]; Dulcolax Stool Softener [OTC]; Enemeez Mini [OTC]; Healthy Mama Move It Along [OTC]; Kao-Tin [OTC]; KS Stool Softener [OTC]; Laxa Basic [OTC]; Pedia-Lax [OTC]; Promolaxin [OTC]; Silace [OTC]; Sof-Lax [OTC] [DSC]; Stool Softener Laxative DC [OTC] [DSC]; Stool Softener [OTC]

Brand Names: Canada

Apo-Docusate Calcium [OTC]; Apo-Docusate Sodium [OTC]; Calax [OTC]; Colace [OTC]; Docusate Sodium Odan [OTC]; Dom-Docusate Sodium [OTC]; Dosolax [OTC]; Dulcocomfort Stool Softener [OTC]; Euro-Docusate C [OTC]; Jamp-Docusate [OTC]; Novo-Docusate Calcium [OTC]; Novo-Docusate Sodium [OTC]; PHL-Docusate Sodium [OTC]; PMS-Docusate Calcium [OTC]; PMS-Docusate Sodium [OTC]; ratio-Docusate Sodium [OTC]; Selax [OTC]; Silace [OTC]; Sirop Docusate De Sodium [OTC]; Soflax C [OTC]; Soflax [OTC]; Taro-Docusate [OTC]; Teva-Docusate Calcium [OTC]; Teva-Docusate Sodium [OTC]

What is this drug used for?
  • It is used to treat constipation.
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: Bowel block, belly pain, upset stomach, rectal bleeding, throwing up, or change in bowel habits lasting longer than 2 weeks.
  • If your child is taking mineral oil.
  • This drug may interact with other drugs or health problems.
  • 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?
  • 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.
  • Do not give this drug for more than 1 week unless told to do so by your child’s doctor.
  • Do not give other laxatives or stool softeners unless told to do so by your child’s doctor.
  • If your child has rectal bleeding or does not have a bowel movement after using this drug, talk with your child’s doctor.
  • If your child is on a low-sodium or sodium-free diet, talk with the doctor. Some of these products have sodium.
  • 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.
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:
  • All products:
  • 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.
  • Rectal enema:
  • Rectal irritation.
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:
  • Stomach cramps.
  • 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:
  • Follow how to give this drug as you have been told by your child’s doctor. Do not give more than you were told to give.
  • All oral products:
  • Give this drug with or without food.
  • Give this drug with a full glass of water.
  • Liquid:
  • Mix liquid with milk, juice, or formula as you have been told.
  • 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.
  • Some of these drugs need to be shaken before use. Be sure you know if this product needs to be shaken before using it.
  • Rectal enema:
  • Give enema rectally.
What do I do if my child misses a dose?
  • 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.
How do I store and/or throw out this drug?
  • Store at room temperature. Do not freeze.
  • 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.
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.