Stool Softener by TOP CARE (Topco Associates LLC) Drug Facts

Stool Softener by

Drug Labeling and Warnings

Stool Softener by is a Otc medication manufactured, distributed, or labeled by TOP CARE (Topco Associates LLC). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STOOL SOFTENER EXTRA STRENGTH- docusate sodium capsule, liquid filled 
TOP CARE (Topco Associates LLC)

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Drug Facts

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, gelatin, glycerin, mannitol, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol

Questions or comments?

Call 1-877-753-3935 Monday- Friday 9AM-5PM EST

Principal Display Panel

EXTRA STRENGTH

Stool Softener

Docusate Sodium 250 mg

Stool softener laxative

Stimulant-free Relief of constipation

Softgels

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

Distributed by McKesson

6555 State Highway 161 Irving, TX 75039

www.healthmart.com

Product Label

TOPCARE HEALTH Extra Strength Stool Softener Laxative

STOOL SOFTENER  EXTRA STRENGTH
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-159
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)

Product Characteristics
Color	orange	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	P4
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-159-10	100 in 1 BOTTLE; Type 0: Not a Combination Product	11/01/2021	11/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M007	11/01/2021	11/01/2023

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

Revised: 6/2024

Document Id: 2ce8e833-6717-4dea-b61e-765395510d78

34390-5

Set id: 1dd52fb4-a923-46cd-b9d0-1d1f867d1c7f

Version: 4

Effective Time: 20240618