Stool Softener by The Kroger Co. / P & L Development, LLC Drug Facts

Drug Details [pdf]

STOOL SOFTENER- docusate sodium capsule
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

Uses

temporary relief of occasional constipation
this product generally produces a bowel movement within 12 to 72 hours

Warnings

Do not use

if abdominal pain, nausea, or vomiting are present

Ask a doctor before use if

you notice a sudden change in bowel habits that persists over a period of 2 weeks
you are presently taking mineral oil

Stop use and ask a doctor if

rectal bleeding or failure to have a bowel movement occur after use which may indicate 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 immediately (1-800-222-1222).

Directions

take with a glass of water

adults and children 12 years of age 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 of age	ask a doctor

Other information

each softgel contains: sodium 6 mg
store at controlled room temperature 15º-30ºC (59º-86ºF)

Inactive ingredients

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special

Questions or comments?

1-800-632-6900

Principal Display Panel

Compare to Active Ingredient in DULCOLAX® STOOL SOFTENER *See bottom panel

Dependable relief of occasional constipation

Stool Softener

GENTLE RELIEF

Docusate Sodium 100 mg

SOFTGELS

*Dulcolax® is a registered trademark of Boehringer Ingelheim Consumer Healthcare, Ridgefield, CT 06877. Boehringer Ingelheim Consumer Healthcare is not affiliated with The Kroger Co. or this product.

Distributed by The Kroger Co.

Cincinnati, Ohio 45202

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Label

Kroger Stool Softener

STOOL SOFTENER
docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-009
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	ORANGE	Score	no score
Shape	OVAL	Size	13mm
Flavor		Imprint Code	P51
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 30142-009-25	1 in 1 BOX	08/24/2010	12/31/2019
1		25 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part334	08/24/2010	12/31/2019

Labeler - The Kroger Co. (006999528)

Registrant - P & L Development, LLC (800014821)

Revised: 12/2018

Document Id: af396b3b-1a05-4f45-9ab7-8f05df8d1b6f

Set id: 296659f8-ce44-453e-b245-bd8ae215e012

Version: 3

Effective Time: 20181217

The Kroger Co.