STOOL SOFTENER LAXATIVE EXTRA STRENGTH- 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 TOP CARE (Topco Associates LLC). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each softgel)

Docusate sodium 250 mg

Purpose

 Stool softener laxative

Uses

• for relief of occasional constipation
• this product generally produces a bowel movement within 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
• noticed a sudden change in bowel habits that last 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 right away.

Directions

• adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
• children under 12 years of age: ask a doctor

Other information

• each softgel contains: sodium 15 mg
• store between  20-25ºC(68-77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive Ingredients

edible white ink, FD&C red #40, FD&C yellow #6,elatin, glycerin, mannitol, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol

Questions or comments?

Call toll free 1-888-423-0139

Principal Display Panel

EXTRA STRENGTH

Stool Softener

DOCUSATE SODIUM, 250 mg

STOOL SOFTENER LAXATIVE

• Easy to swallow
• Relieves constipation

SOFTGELS

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

DISTRIBTRED BY TOPCO ASSOCIATES LLC

ELT GROVE VILLAGE, IL 60007

www.topcarebrand.com

topcare®topco.com

Product Label

TOPCARE HEALTH Extra Strength Stool Softener

INGREDIENTS AND APPEARANCE

STOOL SOFTENER LAXATIVE  EXTRA STRENGTH
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-568
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	250 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)
MANNITOL (UNII: 3OWL53L36A)
SORBITAN (UNII: 6O92ICV9RU)

Product Characteristics
Color	ORANGE	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	P20
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-568-10	100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/29/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part334	11/29/2019

Labeler - TOP CARE (Topco Associates LLC) (006935977)