Drug Facts

Drug Facts

Drug Labeling and Warnings

Drug Details

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STOOL SOFTENER LAXATIVE- docusate sodium capsule, liquid filled 
The Kroger Co.

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

  • relieves occasional constipation (irregularity)
  • generally produces 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
  • 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 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

  • take only by mouth. Doses may be taken as a single daily dose or in divided doses.
adults and children 12 years and overtake 1-3 softgels daily 
children 2 to under 12 years of age take 1 softgel daily 
children under 2 years ask a doctor 

Other information

  • each softgel contains:sodium 6 mg
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

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, sorbitan, sorbitol, titanium dioxide

*contains one or more of these ingredients

Questions or comments?

1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredient of COLACE® Regular Strength Stool Softener **See back panel

Stool Softener Laxative

Docusate Sodium 100 mg

DEPENDABLE RELIEF OF CONSTIPATION

SOFTGELS

**Colace® is a registered trademark of Purdue Products L.P., Stamford, CT 06901. Purdue Products L.P. is not affiliated with The Kroger Co. or this product.

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

DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202

www.kroger.com

Product Label

Docusate sodium 100 mg

KROGER Stool Softener Laxative Softgels

STOOL SOFTENER LAXATIVE 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 30142-778
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)  
SORBITAN (UNII: 6O92ICV9RU)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorRED, WHITEScoreno score
ShapeOVALSize12mm
FlavorImprint Code P10;SCU2;D1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 30142-778-10100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/31/2017
2NDC: 30142-778-25250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/31/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33410/31/2017
Labeler - The Kroger Co. (006999528)

Revised: 12/2018
 
The Kroger Co.


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