STOOL SOFTENER- docusate sodium capsule, liquid filled

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

• relieves occasional constipation (irregularity)
• generally produces a bowel movement within 12 to 72 hours

Warnings

Do not use

if you presently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use if you have

• stomach pain
• nausea
• vomiting
• noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if

• you have rectal bleeding or fail to have a bowel movement after use of 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 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 only by mouth. Doses may be taken as a single daily dose or in divided doses.

• adults and children 12 years and over: take 1-3 softgels daily
• 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 6 mg
• store at 25o C (77o F); excursions permitted between 15- 30o C (59o- 86o F)

Inactive Ingredients

D&C Red #33*, D&C yellow# 10*, edible ink, FD&C blue #1*, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, lecithin*, medium chain triglycerides*, polyethylene glycol, propylene glycol*, purified water, sorbitan, sorbitol, titanium dioxide

*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 Colace® Stool Softener†

STOOL SOFTENER LAXATIVE

Docusate sodium 100 mg

GLUTEN FREE

SOFTGELS

†This product is not manufactured or distributed by Purdue Products L.P., distributor of Colace® Stool Softener.     

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

DISTRIBUTED BY FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

1-877-846-9949

Product Label

CAREONE Stool Softener Laxative Softgels

INGREDIENTS AND APPEARANCE

STOOL SOFTENER 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-238
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)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	RED, WHITE	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	P10;S78;SCU2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41520-238-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2013	12/31/2020
2	NDC: 41520-238-25	250 in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2013	12/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	07/08/2013	12/31/2020

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