Drug Facts

Active ingredient (in each softgel)

Docusate Sodium 250 mg

Purpose

Stool softener

Uses

relieves occasional constipation (irregularity)
• generally produces a bowel movement within 12 to 72 hours.

Warnings

Do not useif 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

Stop use and ask a doctor if

you have rectal bleeding or fail to have a bowel movement after use of a laxative.
These can be signs of a serious condition
you need to use a stool softner laxative for more than 1 week

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

adults and children 12 years of age and older	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 15mg
store at 20-25°C (68-77°F).
Keep carton for full product information

Inactive ingredients

gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol. Softgels are imprinted with edible, dye-free ink.

Questions?

1-833-288-2684

Principal Display Panel

EXTRA STRENGTH

#1 DOCTOR RECOMMENDED

Stool Softner Brand

COLACE

Docusate Sodium, 250mg

EXTRA STRENGTH

Stool Softner

√Gentle & Effective

√Relieves Constipation

√Cramp & Stimulant-Free

√Dye & Preservative-Free √

60 Clear Soft Gels

Retain this carton for important information.

Dis. By: Atlantis Consumer Healthcare Inc.

Bridgewater, NJ 08807 USA

Questions? 1-833-288-2684

Colace is a registered trademark of Atlantis Consumer Healthcare Inc.

A0824

COLACE EXTRA STRENGTH STOOL SOFTNER
docusate sodium capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67618-201
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	250 mg

Ingredient Name	Strength
Inactive Ingredients
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	white	Score	no score
Shape	OVAL	Size	12mm
Flavor		Imprint Code	C250
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:67618-201-60	60 in 1 BOTTLE; Type 0: Not a Combination Product	08/05/2024
2	NDC:67618-201-12	2 in 1 PACKAGE	07/01/2025
2		60 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M007	08/05/2024

Labeler - Atlantis Consumer Healthcare Inc. (118983925)

Docusate Sodium - Stool Softener Laxative