STOOL SOFTENER DOCUSATE SODIUM- docusate sodium capsule, gelatin coated 
Magno-Humphries, Inc.

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Stool Softener Docusate Sodium

Drug Facts

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener

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

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

Directions

 adults and children 12 years of age and older 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

Inactive ingredients

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special

Questions?

call toll-free 1-800-935-6737

Package Labeling:

Label13

STOOL SOFTENER DOCUSATE SODIUM 
docusate sodium capsule, gelatin coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54257-902
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 YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorredScoreno score
ShapeOVALSize12mm
FlavorImprint Code SCU1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54257-902-02100 in 1 BOTTLE; Type 0: Not a Combination Product01/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00701/24/2020
Labeler - Magno-Humphries, Inc. (063251433)

Revised: 10/2023
Document Id: 08bf70ec-89c9-36e5-e063-6294a90a6772
Set id: 9d22d642-8aed-d17e-e053-2995a90ae182
Version: 6
Effective Time: 20231027
 
Magno-Humphries, Inc.