STOOL SOFTENER- docusate sodium capsule, liquid filled 
TOP CARE (Topco Associates LLC)

----------

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 directed by a doctor.

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

Stop use and ask a doctor if

  • you have rectal bleeding or no bowel movement after using a laxative. These could be 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 right away.

Directions

adults and children 12 years and over take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses. 
children 2 to under 12 years of age  take 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 toll free 1-888-423-0139

Principal Display Panel

COMPARE TO DULClOLAX® STOOL SOFTENER ACTIVE INGREDIENT**

Stool Softener

DOCUSATE SODIUM 100 mg • STOOL SOFTENER LAXATIVE

Fast, dependable relief of occasional constipation

SOFTGELS

**This product is not manufactured or distributed by Chattem, Inc., distributor of Dulcolax® Stool Softener

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY TOPCO ASSOCIATED LLC

ELK GROVE VILLAGE, IL 60007

topcare@topco.com

www.topcarebrand.com

Product Labeling

Docusate Sodium 100 mg

TOPCARE Stool Softener

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-862
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)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize12mm
FlavorImprint Code P51
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-862-251 in 1 BOX02/28/202012/30/2024
125 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00702/28/202012/30/2024
Labeler - TOP CARE (Topco Associates LLC) (006935977)

Revised: 6/2024
Document Id: e897f55f-a58d-4678-b664-7ade46b96fe4
Set id: 67eb6a12-a390-4f55-a99a-0bde9db44e4f
Version: 4
Effective Time: 20240619
 
TOP CARE (Topco Associates LLC)