Thirty Madison Inc. 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.

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 20-25°C (68-77°F)

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, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Questions?

1-800-719-9260

Principal Display Panel

Do not use if printed seal under cap is broken or missing

Compare to Colace® Active Ingredient

evens

Distributed by: Thirty Madison, Inc. New York, NY 10001

Stool Softener

Laxative

Docusate Sodium 100 mg

Relieves constipation

Gentle

100 softgels

STOOL SOFTENER
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71713-801
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	100 mg

Ingredient Name	Strength
Inactive Ingredients
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, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SORBITAN (UNII: 6O92ICV9RU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71713-801-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	01/04/2022	07/31/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M007	01/04/2022	07/31/2024

Labeler - THIRTY MADISON INC (080774087)

Revised: 10/2024

Document Id: fea7495b-8e98-441e-be41-a67bf08e1dce

Set id: 355c75c0-c491-4f9e-9136-7f738966f4fc

Version: 2

Effective Time: 20241031

THIRTY MADISON INC