STOOL SOFTENER GENTLE RELIEF- docusate sodium capsule

Stool Softener by

Drug Labeling and Warnings

Stool Softener by is a Otc medication manufactured, distributed, or labeled by Care One (American Sales Company). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each softgel)

Docusate Sodium 100 mg

Purpose

Stool softener laxative

Purpose

Stool Softener Laxative

Uses

• temporary relief of occasional constipation and irregularity
• this product generally produces a 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 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 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

• 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 of age: ask a doctor

Other information

• each softgel contains: sodium 7 mg
• store at 25o C (77o); excursions permitted between 15-30o C (59-86o F)

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 ?

Call 1-877-753-3935 Monday- Friday 9AM- 5PM EST

Principal Display Panel

Compare to the active ingredient in Dulcolax® Stool Softener†

STOOL  SOFTENER LAXATIVE

Docusate Sodium 100 mg

FAST, DEPENDABLE RELIEF OF OCCASIONAL CONSTIPATION

SOFTGELS

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DISTRIBUTED BY FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

†This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., distributor of Dulcolax®.

Product Label

CAREONE Stool Softener Laxative

INGREDIENTS AND APPEARANCE

STOOL SOFTENER  GENTLE RELIEF
docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-244
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
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)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-244-25	1 in 1 BOX	12/30/2013	12/31/2020
1		25 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	12/30/2013	12/31/2020

Labeler - Care One (American Sales Company) (809183973)