COLACE EXTRA STRENGTH STOOL SOFTNER- docusate sodium capsule, liquid filled

COLACE EXTRA STRENGTH by

Drug Labeling and Warnings

COLACE EXTRA STRENGTH by is a Otc medication manufactured, distributed, or labeled by Atlantis Consumer Healthcare Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

©2024 Atlantis Consumer Healthcare Inc.

Colace is a registered trademark of Atlantis Consumer Healthcare Inc.

A0824

INGREDIENTS AND APPEARANCE

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

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
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

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

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

Labeler - Atlantis Consumer Healthcare Inc. (118983925)