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Docusate Sodium by Pharmaceutical Associates, Inc.

Dosage form: liquid
Ingredients: Docusate Sodium 50mg in 5mL
Labeler: Pharmaceutical Associates, Inc.
NDC Code: 0121-0544

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

PRINCIPAL DISPLAY PANEL - 10 mL Cup Label

Delivers 10 mL
NDC 0121-0544-10

DOCUSATE SODIUM
LIQUID (SUGAR FREE)

100 mg/10 mL
STOOL SOFTENER LAXATIVE

FOR INSTITUTIONAL USE ONLY

PHARMACEUTICAL ASSOCIATES, INC.
GREENVILLE, SC 29605
SEE INSERT

F05441001

DOCUSATE SODIUM 
docusate sodium liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0121-0544
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Docusate Sodium (Docusate) Docusate Sodium50 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Saccharin Sodium 
Propylene Glycol 
Trisodium Citrate Dihydrate 
Anhydrous Citric Acid 
Sorbitol 
Glycerin 
Water 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0121-0544-1612 BOTTLE in 1 CASE
1473 mL in 1 BOTTLE
2NDC:0121-0544-1010 TRAY in 1 CASE
210 CUP, UNIT-DOSE in 1 TRAY
210 mL in 1 CUP, UNIT-DOSE
3NDC:0121-0544-2510 TRAY in 1 CASE
310 CUP, UNIT-DOSE in 1 TRAY
325 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 - Pharmaceutical Associates, Inc. (044940096)
Establishment
NameAddressID/FEIOperations
Pharmaceutical Associates, Inc.097630693MANUFACTURE(0121-0544)

Revised: 11/2016
 
Pharmaceutical Associates, Inc.

← See all Docusate Sodium brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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