Stool Softener by The Kroger Co. Drug Facts

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 softgel)

Docusate sodium 100 mg

Purpose

Stool softener laxative

Uses

for temporary relief of occasional constipation and irregularity
this product generally produces bowel movement in 12 to 72 hours

Warnings

Ask a doctor before use if you have

stomach pain
nausea
vomiting
a sudden change in bowel habits that lasts more than 2 weeks

Ask a doctor or pharmacist before use if you are

presently taking mineral oil.

Stop use and ask a doctor if

you have rectal bleeding or no bowel movement after using 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. (1-800-222-1222)

Directions

take with a glass of water

adults and children 12 years 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	ask a doctor

Other information

each softgel contains: sodium 7 mg
store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

edible ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, medium-chain triglycerides*, polyethylene glycol, propylene glycol*, purified water, sorbitan, sorbitol

*contains one or more of these ingredients

Questions or comments?

1-800-632-6900

Principal Display Panel

COMPARE TO the active ingredient of DULCOLAX® **See bottom panel

Stool Softener

Docusate Sodium,100 mg

GENTLE RELIEF

Gentle & Dependable Relief of Occasional Constipation

SOFTGELS

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

DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202

www.kroger.com

TAMPER EVIDENT: 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 Softgel

STOOL SOFTENER
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-244
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)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	ORANGE	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	P51;S77;SCU1
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 30142-244-25	1 in 1 BOX	12/30/2013	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	12/30/2013	12/31/2019

Labeler - The Kroger Co. (006999528)

Revised: 12/2018

Document Id: 8fc10676-1e4a-45b1-8cd3-ad7fe563bdd1

Set id: adc9dead-1204-4aa9-91a3-a37b2924b0e6

Version: 2

Effective Time: 20181214

The Kroger Co.