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Docusate Sodium by Cardinal Health

Medically reviewed on Aug 9, 2017

Dosage form: liquid
Ingredients: DOCUSATE SODIUM 100mg in 10mL
Labeler: Cardinal Health
NDC Code: 55154-9401

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Docusate Sodium Liquid

STOOL SOFTENER LAXATIVE

DESCRIPTION

Each 5 mL (teaspoonful) contains docusate sodium 50 mg.

Inactive Ingredients

Citric acid, D&C Red No. 33, flavoring, glycerin, propylene glycol, purified water, sodium citrate, sodium saccharin, and sorbitol.

Sodium Content: 14 mg/5 mL.

INDICATIONS

For the relief of occasional constipation due to hard stools. The effect on stools is usually apparent 1 to 3 days after the first dose.

DIRECTIONS

As directed by a physician or once daily as follows: Adults and children 12 years of age and over: oral dosage is 5 to 20 mL (1 to 4 teaspoonfuls). Children 6 to under 12 years of age: oral dosage is 5 to 10 mL (1 to 2 teaspoonfuls). Children 3 to under 6 years of age: oral dosage is 2.5 to 5 mL (1⁄2 to 1 teaspoonful). Children under 3 years of age: consult a physician. The higher doses are recommended for initial therapy. Dosage should be adjusted to individual response. If desired, the product may be administered in a 6 to 8 oz glass of milk or fruit juice or in infant formula to mask the bitter taste.

WARNINGS

Do not use laxative products when abdominal pain, nausea, or vomiting are present, or use for a period longer than 1 week, unless directed by a physician. If you have noticed a sudden change in bowel habits that persists over a period of 2 weeks, consult a physician before using a laxative. Rectal bleeding or failure to have a bowel move- ment after the use of a laxative may indicate a serious condition. Discontinue use and consult your physician. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product. May cause rash in some cases.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

DRUG INTERACTION PRECAUTION

Do not take this product if you are presently taking mineral oil or a prescription drug, unless directed by a physician.

STORAGE

Keep tightly closed. Store at controlled room temperature, 20° to 25°C (68° to 77°F). Protect from freezing. Protect from light.

R04/14

Pharmaceutical
Associates, Inc.
Greenville, SC 29605

Repackaged By:
Cardinal Health

Zanesville, OH 43701

L32992030717

Principal Display Panel

Docusate Sodium Liquid

100 mg/ 10mL

Stool Softener Laxative

5 Cups

DOCUSATE SODIUM 
docusate sodium liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-9401(NDC:0121-0544)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
D&C RED NO. 33 
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
SODIUM CITRATE, UNSPECIFIED FORM 
SACCHARIN SODIUM 
SORBITOL 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55154-9401-55 CUP, UNIT-DOSE in 1 BAG
110 mL in 1 CUP, UNIT-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33402/16/1983
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIOperations
Cardinal Health188557102REPACK(55154-9401)

 
Cardinal Health

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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