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Topcare Stool Softener

Dosage form: capsule, liquid filled
Ingredients: DOCUSATE SODIUM 100mg
Labeler: Topco Associates LLC
NDC code: 36800-486

Topco Associates LLC. Stool Softener Drug Facts

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

Ask a doctor or pharmacist before use if you are

taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

When using this product

do not exceed the maximum recommended daily dosage in a 24-hour period

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. (1-800-222-1222)

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 6 mg
very low sodium
store at 20º-25ºC (68-77ºF)

Inactive ingredients

D&C red no. 33, edible ink, FD&C blue no. 1, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

1-888-423-0139

Principal Display Panel

SOFTGELS

Stool Softener

DOCUSATE SODIUM 100 mg EACH

STOOL SOFTENER LAXATIVE

Gentle

Dependable effect

Stimulant-free

actual size

COMPARE TO COLACE® active ingredient

Stool Softener Carton Image 1

Stool Softener Carton Image 2

TOPCARE STOOL SOFTENER
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-486
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCUSATE SODIUM (DOCUSATE)	DOCUSATE SODIUM	100 mg

Inactive Ingredients
Ingredient Name	Strength
D&C RED NO. 33
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
GLYCERIN
POLYETHYLENE GLYCOLS
WATER
SORBITAN
SORBITOL
TITANIUM DIOXIDE

Product Characteristics
Color	RED, WHITE (to off beige)	Score	no score
Shape	OVAL (softgel)	Size	13mm
Flavor		Imprint Code	L486
Contains

Packaging
#	Item Code	Package Description
1	NDC:36800-486-72	1 BOTTLE (BOTTLE) in 1 CARTON
1		60 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE
2	NDC:36800-486-78	100 CAPSULE, LIQUID FILLED (CAPSULE) in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	01/26/1994

Labeler - Topco Associates LLC (006935977)

Revised: 03/2012

Document Id: 19ae3f0b-5d5a-44fd-a546-7040de85505f

Set id: 93503c58-c07c-4d83-8d6c-3490f24db567

Version: 2

Effective Time: 20120319

Topco Associates LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer