stool softener by The Kroger Co. Drug Facts

stool softener by

Drug Labeling and Warnings

stool softener by is a Otc medication manufactured, distributed, or labeled by The Kroger Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STOOL SOFTENER- 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 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

Docusate sodium 100 mg

 

STOOL SOFTENER 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-110
Route of Administration	ORAL

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 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)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	RED, WHITE	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	P10;51A
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-110-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/12/2010	12/31/2019
2	NDC: 30142-110-25	250 in 1 BOTTLE; Type 0: Not a Combination Product	07/12/2010	12/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	07/12/2010	12/31/2019

Labeler - The Kroger Co. (006999528)

Revised: 12/2018

Document Id: 12d5a39f-b77f-446c-9c05-9c5922432a30

34390-5

Set id: c74cd4d0-4574-49fe-a685-ed434d53a576

Version: 2

Effective Time: 20181220

 

The Kroger Co.