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 TOP CARE (Topco Associates LLC). 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
• 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 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

ammonium hydroxide, anhydrous citric acid, 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

Questions or comments?

Call 1-888-309-9030

Principal Display Panel

COMPARE TO COLACE® REGULAR STRENGTH STOOL SOFTENER ACTIVE INGREDIENT

Stool Softener

DOCUSATE SODIUM 100 mg

STOOL SOFTENER LAXATIVE

• Gentle
• Dependable
• Stimulant-free

SOFTGELS

**This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® Regular Strength 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 TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

www.topcarebrand.com

Product Label

TOPCARE HEALTH 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: 36800-638
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)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ALCOHOL (UNII: 3K9958V90M)
AMMONIA (UNII: 5138Q19F1X)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MINERAL OIL (UNII: T5L8T28FGP)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

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: 36800-638-25	250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/05/2021
2	NDC: 36800-638-60	1 in 1 BOX	02/05/2021
2		60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC: 36800-638-10	1 in 1 BOX	02/05/2021
3		100 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	02/05/2021

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