DOCUSATE SODIUM- docusate sodium capsule, liquid filled 
APNAR PHARMA LP

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.

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DOCUSATE SODIUM SOFTGELS

Active Ingredient (In each softgel)

Docusate Sodium.... 100 mg

Purpose

Stool softener laxative

Uses

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

Stop use and ask a doctor if

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 (1-800-222-1222) right away.

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

Other Information

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

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

Questions or Comments ?

Call 1-855-642-2594

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

NDC 24689-130-01

Docusate Sodium 100mg

Stool Softener Laxative

MADE IN USA

100 Softgels

Docusate Sodium Softgel lable-100mg

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24689-130
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorredScoreno score
ShapeOVAL (Oblong) Size13mm
FlavorImprint Code AD2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24689-130-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/25/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00709/25/2023
Labeler - APNAR PHARMA LP (079568229)
Establishment
NameAddressID/FEIBusiness Operations
APNAR PHARMA LLP118530917analysis(24689-130) , manufacture(24689-130) , pack(24689-130)

Revised: 9/2023
Document Id: 05b0732b-0130-78ee-e063-6294a90a839a
Set id: 05b0732b-012f-78ee-e063-6294a90a839a
Version: 1
Effective Time: 20230919
 
APNAR PHARMA LP