Active Ingredient (In Each Capsule)
Magnesium hydroxide 800 mg
Colace Fast-acting Saline Laxative Capsule
FDA Label NDC 67618-102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Atlantis Consumer Healthcare, Inc. for the product Colace Fast-acting Saline Laxative (NDC 67618-102). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient (in each capsule), purpose, uses, warnings, ask a doctor or pharmacist before use if you are, stop use and ask a doctor if, if pregnant or breast-feeding, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Carton (Carton)
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