Your browser does not support JavaScript! STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [THE KROGER CO.]
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STOOL SOFTENER (docusate sodium) capsule, liquid filled
[The Kroger Co.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active Ingredient (in each capsule)

Docusate Sodium 100 mg

Purpose

Stool softener

Uses

  • for the prevention of dry, hard stools
  • for relief of occasional constipation.

This product generally produces a bowel movement within 12 to 72 hours.

Warnings - Do not use

  • if you are currently taking mineral oil, unless directed by a doctor
  • when abdominal pain, nausea or vomiting are present
  • for longer than one week unless directed by a doctor

Ask a doctor before use if

you notice a sudden change in bowel habits that persists over a period of 2 weeks

Stop use and ask a doctor if

  • you have rectal bleeding
  • you fail to have a bowel movement after use

If pregnant or breastfeeding

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 of age and over: take 1- 3 capsules preferably at bedtime
  • children 6 to 12 years of age: take 1 capsule at bedtime

Other information

  • each softgel contains: sodium 6 mg
  • store at controlled room temperature 15o - 30o C (59o- 86o F)
  • do not use if imprinted safety seal under cap is broken or missing.

Inactive Ingredients

D&C Red #33, edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special, and titanium dioxide

May also contain: FD&C blue #1 and purified water

Questions or Comments?

Call toll free 1-800-632-6900

Principal Display Panel

Compare to COLACE® active ingredient *See back panel

docusate sodium 100 mg

stool softener capsules

relieves constipation

*Colace® is a registered trademark of Purdue Pharma L.P., stamford, CT 06901-3431. The Kroger Co. is not affiliated with Purdue Pharma L.P.

DISTRIBUTED BY THE KROGER CO.,

CINCINNATI, OHIO 45202

Product Labeling

The kroger co. stool softener

Docusate sodium 100 mg

 

STOOL SOFTENER 
docusate sodium capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:30142-110
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCUSATE SODIUM (DOCUSATE) DOCUSATE SODIUM100 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 33 
FD&C RED NO. 40 
FD&C YELLOW NO. 6 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
SORBITOL 
TITANIUM DIOXIDE 
FD&C BLUE NO. 1 
WATER 
Product Characteristics
ColorRED, WHITEScoreno score
ShapeOVALSize13mm
FlavorImprint Code P10;51A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-110-01100 in 1 BOTTLE
2NDC:30142-110-25250 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33407/12/2010
Labeler - The Kroger Co. (006999528)

Revised: 9/2012
 
The Kroger Co.

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