DOCUSATE SODIUM capsule, liquid filled

Docusate sodium by

Drug Labeling and Warnings

Docusate sodium by is a Otc medication manufactured, distributed, or labeled by APNAR PHARMA LP, APNAR PHARMA LLP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient (In each softgel)

Docusate Sodium.... 100 mg

PURPOSE

Purpose

Stool softener laxative

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 last 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 a signs of a serious condition.
• you need to use a stool softner laxative for more than 1 week

If pregnant or breast-feeding,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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 to 3 softgels daily
children 2 to under 12 years of age : take 1 softgel daily
children under 2 years : ask a doctor

STORAGE AND HANDLING

Other Information

each softgel contains: sodium 5 mg
store between 20ºC - 25ºC (68-77ºF);excursions permitted between 15-30ºC (59-86ºF)

INACTIVE INGREDIENT

Gelatin, Glycerin, Sorbitol Sorbitan solution, Purified water , D&C Red #40, D&C Yellow #6, White Ink

QUESTIONS

Questions or Comments ?

Call 1-855-642-2594

SPL UNCLASSIFIED SECTION

Compare to the active ingredient in Colace® Regular Strength Stool Softener†

†This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® Regular Strength Stool Softener.

Rev.: 03/2023

Manufactured by:
Apnar Pharma LLP
East Windsor, NJ 08520

PRINCIPAL DISPLAY PANEL

NDC: 24689-130-01

Docusate Sodium 100mg

Stool Softener Laxative

MADE IN USA

100 Softgels

INGREDIENTS AND APPEARANCE

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 24689-130
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Product Characteristics
Color	red	Score	no score
Shape	OVAL (Oblong)	Size	13mm
Flavor		Imprint Code	AD2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 24689-130-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/25/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M007	09/25/2023

Labeler - APNAR PHARMA LP (079568229)

Establishment
Name	Address	ID/FEI	Business Operations
APNAR PHARMA LLP		118530917	analysis(24689-130) , manufacture(24689-130) , pack(24689-130)