COLACE FAST-ACTING SALINE LAXATIVE- magnesium hydroxide capsule

Colace Fast-Acting Saline Laxative by

Drug Labeling and Warnings

Colace Fast-Acting Saline Laxative by is a Otc medication manufactured, distributed, or labeled by Atlantis Consumer Healthcare, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each capsule)

Magnesium hydroxide 800 mg

Purpose

Saline laxative

Uses

• for relief of occasional constipation (irregularity)
• this product generally produces bowel movement in 30 minutes to 6 hours

Warnings

Ask a doctor before use if you have

• kidney disease
• a magnesium-restricted diet
• stomach pain, nausea or vomiting
• noticed a sudden change in bowel habits that lasts over 2 weeks

Ask a doctor or pharmacist before use if you are

taking a prescription drug. This product may interact with certain prescription drugs.

Stop use and ask a doctor if

• you have rectal bleeding or fail to have a bowel movement after using this product. These could be signs of a serious condition.
• you need to use a laxative for more than1 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.

Directions

• drink a full glass (8 oz) of liquid with each dose
• dose may be taken as a single daily dose, in divided doses, or as directed by a doctor
• do not exceed the maximum recommended daily dose in a 24 hour period

• Adults and children 12 years of age and over: Take 3 to 6 capsules
• Children 6 to under 12 years of age: Take 2 to 3 capsules
• Children under 6 years of age: Ask a doctor

Other information

• each capsule contains magnesium 335mg and sodium 1mg
• store at 20°C to 25°C (68°F to 77°F)

Inactive ingredients

croscarmellose sodium, crospovidone, gelatin, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid.

Questions?

1-833-288-2684

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Constipation Relief In
As Little As 30 Minutes

Colace®
Magnesium Hydroxide, 800mg
Saline Laxative

NEW!
FAST-ACTING
LAXATIVE

√ Gentle, Effective Constipation Relief
√ Works Naturally With Your Body
√ Cramp & Stimulant-Free

60 Capsules

Retain this carton for
important information.
For added savings, visit:
colacecapsules.com

Dist. by: Atlantis Consumer Healthcare Inc.
Bridgewater, NJ 08807 USA
Questions? 1-833-288-2684
©2025 Atlantis Consumer Healthcare Inc.
Colace is a registered trademark of Atlantis
Consumer Healthcare Inc.

A1125

R54369

INGREDIENTS AND APPEARANCE

COLACE FAST-ACTING SALINE LAXATIVE 
magnesium hydroxide capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67618-102
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Magnesium Hydroxide (UNII: NBZ3QY004S) (Magnesium Cation - UNII:T6V3LHY838)	Magnesium Hydroxide	800 mg

Inactive Ingredients
Ingredient Name	Strength
Croscarmellose Sodium (UNII: M28OL1HH48)
Crospovidone, Unspecified (UNII: 2S7830E561)
Gelatin, Unspecified (UNII: 2G86QN327L)
Magnesium Stearate (UNII: 70097M6I30)
Microcrystalline Cellulose (UNII: OP1R32D61U)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Stearic Acid (UNII: 4ELV7Z65AP)

Product Characteristics
Color	WHITE	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	CL800
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67618-102-60	1 in 1 CARTON	03/16/2026
1		60 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	03/16/2026

Labeler - Atlantis Consumer Healthcare, Inc. (118983925)

Registrant - Atlantis Consumer Healthcare, Inc. (118983925)