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Docusate Sodium by Pharmaceutical Associates, Inc.

Medically reviewed on June 28, 2018

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

Drug Facts

Active ingredient (in each mL)

Docusate sodium 50 mg

Purpose

Stool softener

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours

Warnings

Do not use
  • if you are presently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use if you have
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if
  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
  • you need to use a stool softener laxative for more than 1 week
  • rash occurs

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions
  • Dose once daily
  • take with 6 to 8 oz of milk, juice or infant formula to mask the bitter taste.
adults and children 12 years and older5 to 20 mL (1 to 4 teaspoonfuls)
children 6 to under 12 years of age5 to 10 mL (1 to 2 teaspoonfuls)
children 3 to under 6 years of age2.5 to 5 mL (1/2 to 1 teaspoonful)
children under 3 yearsask a doctor

Other information
  • Sodium content: 14 mg/ 5 mL
  • Store at controlled room temperature, 20° - 25°C (68° - 77°F)
  • Protect from freezing
  • Protect from light
  • Purple colored, cherry flavored liquid supplied in the following:
NDC 0121-0544-16:16 fl oz (473 mL) bottle
NDC 0121-0544-10:10 mL unit dose cup. Case contains 100 unit dose cups of 10 mL packaged in 10 trays of 10 unit dose cups each.
NDC 0121-0544-25:25 mL unit dose cup. Case contains 100 unit dose cups of 25 mL packaged in 10 trays of 10 unit dose cups each.

Inactive ingredients

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

Questions or comments?

Call 1-800-845-8210

MANUFACTURED BY

Pharmaceutical
Associates, Inc.
Greenville, SC 29605

PRINCIPAL DISPLAY PANEL - 10 mL Cup Tray Label

NDC 0121-0544-10

Docusate Sodium Liquid
(SUGAR FREE)

100 mg/10 mL

STOOL SOFTENER LAXATIVE

USUAL DOSAGE: See attached Drug Facts

This unit-dose package is not child-resistant.

Store at 20° - 25°C (68° - 77°F)
[See USP Controlled Room Temperature].

10 x 10 mL Unit-Dose Cups

Pharmaceutical
Associates, Inc.
Greenville, SC 29605

T0544100218
R02/18

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)

 
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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