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 Publix Supermarkets, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Docusate sodium 100 mg

Purpose

Stool softener laxative

Uses

• relieves occasional constipation (irregularity)
• 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 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 professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) 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 5 mg
• store at 77ºF (25ºC); excursions permitted between 59-86ºF (15-30ºC)

Inactive ingredients

ammonium hydroxide, anhydrous citric, D&C red #33, ethyl alcohol, FD&C blue #1 FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, lecithin, mineral oil, n-butyl alcohol, polyethylene glycol, potassium hydroxide, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Principal Display Panel

†Compare to the active ingredient in Colace® Regular Strength Stool Softener

Stool Softener

DOCUSATE SODIUM 100 mg

STOOL SOFTENER LAXATIVE

• Gentle
• Dependable
• Stimulant-free

SOFTGELS

**This product is not manufactured or distributed by Avrio HealthL.P., distributor of Colace® Regular Strength Stool Softener.

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

DISTRIBUTED BY PUBLIX SUPER MARKETS, INC.,

3300 PUBLIX CORPORATE PARKWAY, LAKELAND, FL 33811

1-888-267-3037

Product Label

PUBLIX 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: 56062-241
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)
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)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITAN (UNII: 6O92ICV9RU)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
AMMONIA (UNII: 5138Q19F1X)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MINERAL OIL (UNII: T5L8T28FGP)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
ALCOHOL (UNII: 3K9958V90M)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)

Product Characteristics
Color	red, white	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	PC18
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 56062-241-60	60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/26/2021
2	NDC: 56062-241-10	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/26/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	02/26/2021

Labeler - Publix Supermarkets, Inc. (006922009)