STOOL SOFTENER LAXATIVE- docusate sodium capsule, liquid filled

Stool Softener Laxative by

Drug Labeling and Warnings

Stool Softener Laxative by is a Otc medication manufactured, distributed, or labeled by Care One (Retail Business Services, LLC.). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Docusate Sodium USP, 100 mg

Purpose

Stool softener laxative

Uses

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

Warnings

Do not use

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

Ask a doctor before use if

• 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 using a laxative. These could be a sign of a serious condition.
  
• you need to use a stool softener 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 (1-800-2222-1222) right away.

Directions

• take with a glass of water
  

• adults and children 12 years and over: take 1-3 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); excursion permitted between 15-30ºC (59-86ºF)

Inactive ingredients

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

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

†This product is not manufactured or distributed by Chattem, Inc., distributor of Dulcolax® Stool Softener.

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: ADUSA DISTRIBUTION, LLC

SALISBURY, NC 28147

Product Label

CARE ONE Stool Softener Laxative

INGREDIENTS AND APPEARANCE

STOOL SOFTENER LAXATIVE 
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72476-107
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)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	red	Score	no score
Shape	CAPSULE	Size	13mm
Flavor		Imprint Code	PC1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72476-107-25	1 in 1 BOX	04/30/2023
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 Drug	M007	04/30/2023

Labeler - Care One (Retail Business Services, LLC.) (967989935)