DOCUSATE SODIUM SOFTGELS 50MG (DYE FREE)- docusate sodium capsule, liquid filled

Docusate Sodium softgels 50mg (Dye Free) by

Drug Labeling and Warnings

Docusate Sodium softgels 50mg (Dye Free) by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Time Cap Laboratories, Inc., MARKSANS PHARMA LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient (in each softgel)

Docusate sodium USP 50 mg

PURPOSE

Purpose

Stool softener

INDICATIONS & USAGE

Uses

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

WARNINGS

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

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 (1-800-222-1222).

DOSAGE & ADMINISTRATION

Directions

• Take only by mouth. Doses may be taken as a single daily dose or in divided doses.

• adults and children 12 years and over: take 1-6 softgels daily
• children 2 to under 12 years of age:

  take 1-3 softgels daily

• children under 2 years: ask a doctor

OTHER SAFETY INFORMATION

Other information

• each softgel contains: sodium 3 mg VERY LOW SODIUM
• Keep tightly closed. Store at 25°C (77°F); excursions permitted between 15°-30°C (59-86°F)

INACTIVE INGREDIENT

Inactive ingredients ferrosoferric oxide, gelatin, glycerin, polyethylene glycol, propylene glycol, noncrystallizing sorbitol solution, purified water, shellac

QUESTIONS

Questions or comments? Call 1-877-290-4008

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM SOFTGELS 50MG (DYE FREE)  
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-652
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg

Inactive Ingredients
Ingredient Name	Strength
NONCRYSTALLIZING SORBITOL SOLUTION (UNII: 9E0S3UM200)
WATER (UNII: 059QF0KO0R)
GELATIN (UNII: 2G86QN327L)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
SHELLAC (UNII: 46N107B71O)

Product Characteristics
Color	yellow (light yellow to yellow)	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code	128
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-652-03	1 in 1 CARTON	03/06/2025
1		30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	03/06/2025

Labeler - CVS Pharmacy (062312574)

Registrant - Time Cap Laboratories, Inc. (037052099)

Establishment
Name	Address	ID/FEI	Business Operations
MARKSANS PHARMA LIMITED		925822975	manufacture(51316-652)