DOCUSATE SODIUM- docusate sodium capsule, liquid filled 
American Health Packaging

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, USP
Stool Softener Laxative
Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener laxative

Uses

Warnings

Do not use

Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks.

Stop use and ask a doctor if you have rectal bleeding or you fail to have a bowel movement after use of a laxative. This may indicate a serious condition.

If pregnant or breast-feeding, ask a health care 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

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

adults and children 12 years of age and over

take 1 to 3 softgels daily

children 2 to under 12 years of age

take 1 softgel daily

children under 2 years of age

ask a doctor

Other information

Inactive ingredients

FD&C Red #40, FD&C Yellow #6, Gelatin USP, Glycerin USP, Polyethylene Glycol 400 NF, Purified Water USP, Sorbital USP

The drug product contained in this package is from NDC # 61301-8001, SWISSCAPS Romania srl.

Distributed by:
American Health Packaging
2550 John Glenn Avenue, Suite A
Columbus, OH 43217

712901
0412901/0216PS

Principal Display Panel – Carton – 100 mg

100 mg Docusate Sodium Softgels Carton Label

NDC 60687- 129-01

DOCUSATE SODIUM, USP
Stool Softener Laxative

100 mg

100 Softgels (10 x 10)

The drug product contained in this package is from
NDC # 61301-8001, SWISSCAPS Romania srl.

Packaged and Distributed by:
American Health Packaging
Columbus, OH 43217

712901
0412901/0119

Principal Display Panel - Blister – 100 mg

100 mg Docusate Sodium Softgel Blister

DOCUSATE SODIUM, USP
Stool Softener Laxative
Softgel    100 mg

DOCUSATE SODIUM 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60687-129
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
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
Colorred (Reddish) Scoreno score
ShapeOVALSize12mm
FlavorImprint Code SCU1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60687-129-01100 in 1 BOX, UNIT-DOSE11/25/2015
1NDC:60687-129-111 in 1 BLISTER PACK; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33411/25/2015
Labeler - American Health Packaging (929561009)

Revised: 10/2022
Document Id: ea3f3d6d-abd8-5a52-e053-2995a90a2a45
Set id: be7cab51-ce7e-465d-95db-083e69288cfd
Version: 6
Effective Time: 20221004
 
American Health Packaging