STOOL SOFTENER- docusate sodium capsule, liquid filled 
EQUATE (Walmart 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

Warnings - Do not use

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

 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

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

*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 Type HUMAN OTC DRUG Item Code (Source) NDC:49035-111
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 100 mg
Inactive Ingredients
Ingredient Name Strength
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 GLYCOLS (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color RED, WHITE Score no score
Shape OVAL Size 12mm
Flavor Imprint Code P10;51A
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49035-111-06 1 in 1 BOX
1 60 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part334 03/01/2012
Labeler - EQUATE (Walmart Stores, Inc.) (051957769)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 4/2013
Document Id: 26d6f847-ae05-4ea2-869c-e8108b5846f7
Set id: 8790de36-d6f4-4fe8-bfc8-c31be0eeddc7
Version: 2
Effective Time: 20130423
 
EQUATE (Walmart Stores, Inc.)