STOOL SOFTENER- docusate sodium capsule, liquid filled 
EQUATE (Wal-Mart Stores, Inc.)

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 Ingredients (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener

Uses

  • relieves occasional constipation (irregularity)
  • generally produces a bowel movement in 12 to 72 hours

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 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 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 - 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

  • each softgel contains: sodium 6 mg
  • store at controlled room temperature 15º-30ºC (59º-86ºF)

Inactive Ingredients

D &C Red #33, edible ink, FD&C Blue #1, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, titanium dioxide.

Questions or comments?

1-888-287-1915

Principal Display Panel

Compare to the active ingredient in Colace® *    

Stool Softener

Docusate Sodium, 100 mg

  • Relieves constipation
  • Gentle and effective
  • Stimulant free for comfortable relief

*This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace®

Gluten free

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Satisfaction guaranteed- for questions or comments please call 1-888-287-1915

Product Labeling

Equate stool softener

Docusate sodium 100 mg capsules

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-111
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
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITE, REDScoreno score
ShapeOVALSize12mm
FlavorImprint Code P10;51A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49035-111-061 in 1 BOX03/01/201212/31/2020
160 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33403/01/201212/31/2020
Labeler - EQUATE (Wal-Mart Stores, Inc.) (051957769)
Registrant - P & L Development, LLC (800014821)

Revised: 4/2013
Document Id: 93df5e1d-3502-494d-9fe3-96d8575132ab
Set id: 8790de36-d6f4-4fe8-bfc8-c31be0eeddc7
Version: 3
Effective Time: 20130423
 
EQUATE (Wal-Mart Stores, Inc.)