STOOL SOFTENER- docusate sodium capsule

Stool Softener by

Drug Labeling and Warnings

Stool Softener by is a Otc medication manufactured, distributed, or labeled by NORTHEAST PHARMA (Heartland Pharma). 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 and irregularity
• generally produces a bowel movement in 12 to 72 hours.

Warnings

Do not use

if you are presently taking mineral oil, unless directed by a doctor

Ask a doctor before use if you have

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

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 (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 25oC (77o); excursions permitted between 15-30oC (59-86oF)

Inactive Ingredients

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol

Questions or Comments ?

Call 1-800-383-0648

Principal Display Panel

Compare to active ingredient in COLACE®  REGULAR STRENGTH†

STOOL  SOFTENER

Docusate Sodium 100 mg

Stool Softener Laxative

• Gentle
• dependable
• Stimulant-Free

Softgels

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

Distributed by NORTHEAST PHARMA

South Burlington, VT 05403

www.heartlandpharma.com

Product Label

HEARTLAND PHARMA Stool Softener

INGREDIENTS AND APPEARANCE

STOOL SOFTENER 
docusate sodium capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80136-951
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)

Product Characteristics
Color	orange	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	P51
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80136-951-80	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/28/2021	06/28/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	06/28/2021	06/28/2025

Labeler - NORTHEAST PHARMA (Heartland Pharma) (081232935)