DOCUSATE SODIUM- docusate sodium capsule 
Major Pharmaceuticals

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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Drug Facts

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

  • 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 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 (1-800-222-1222)  right away.

Directions

adults and children 12 years and overtake 1 to 3 softgels daily.
children 2 to under 12 years of agetake 1 softgel daily
children under 2 years ask a doctor

Other information

Inactive ingredients

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water sorbitan, sorbitol

Questions or comments?

 Call 1-800-616-2471

Principal Display Panel

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

Docusate sodium 100 mg

Stool Softener Laxative

Softgels

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

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by:

MAJOR® PHARMACEUTICALS

17177 N Laurel Park Drive, Suite 233

Livonia, MI 48152

Product Label

Docusate Sodium 100 mg

MAJOR PHARMACEUTICALS Stool Softener Laxative

DOCUSATE SODIUM 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6998
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 (UNII: 2G86QN327L)  
SORBITAN (UNII: 6O92ICV9RU)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize12mm
FlavorImprint Code P51
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-6998-60100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/28/2020
2NDC:0904-6998-801000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/28/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33402/28/2020
Labeler - Major Pharmaceuticals (191427277)

Revised: 6/2023
Document Id: 7d52bdde-d69a-495e-af21-d39b5d4edeb2
Set id: eb5e036b-dc1c-4a8d-b2c6-de1395384c57
Version: 5
Effective Time: 20230621
 
Major Pharmaceuticals