STOOL SOFTENER LAXATIVE- docusate sodium capsule 
Care One (Retail Business Services, LLC.)

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Drug Facts

Active Ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener laxative

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 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 care 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 overtake 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 of age 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 1-877-753-3935 Monday- Friday 9AM- 5PM EST

Principal Display Panel

Compare to the active ingredient in Dulcolax® Stool Softener†

STOOL  SOFTENER LAXATIVE

Docusate Sodium 100 mg

FAST, DEPENDABLE RELIEF OF OCCASIONAL CONSTIPATION

SOFTGELS

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 FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

Product Label

Docusate sodium 100 mg

CAREONE Stool Softener Laxative

STOOL SOFTENER LAXATIVE 
docusate sodium capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-862
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)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
Product Characteristics
ColororangeScoreno score
ShapeOVALSize12mm
FlavorImprint Code P51
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72476-862-251 in 1 BOX08/02/2020
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 DrugM00708/02/2020
Labeler - Care One (Retail Business Services, LLC.) (967989935)

Revised: 3/2024
Document Id: fe569f8e-d50f-4acc-89a5-8e4d55b9e7ff
Set id: eb7f3d65-8741-407d-b3f3-1d9dda19684d
Version: 4
Effective Time: 20240305
 
Care One (Retail Business Services, LLC.)