Colace Fast-Acting Saline Laxative

Manufacturer
Atlantis Consumer Healthcare, Inc.
Effective date
2026-02-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:50:18

Label at a glance#

ProductColace Fast-Acting Saline Laxative
Active ingredientMagnesium Hydroxide
Label structure13 sections

Indications and uses

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

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Magnesium hydroxide 800 mg

Purpose

OTC - PURPOSE SECTION

Saline laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

Stop use and ask a doctor if

OTC - DO NOT USE SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2738919magnesium hydroxide 800 MG Oral CapsulePSN1
2738919magnesium hydroxide 800 MG Oral CapsuleSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MAGNESIUM CATION Pharmacologic Class Indexing4Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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95250459-30e4-45c1-b08a-993044f49109Product name220250805
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362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
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fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67618-102-60Colace Fast-Acting Saline Laxative1 in 1 CARTONCAPSULE11
67618-102-60Colace Fast-Acting Saline Laxative60 in 1 BOTTLE, PLASTICCAPSULE601

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67618-10267618-102-60

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colace Fast-Acting Saline LaxativeMAGNESIUM HYDROXIDEAtlantis Consumer Healthcare, Inc.572adfaf-6e26-42e5-b65d-6d356a0bdfa92026-02-06WarningsExact identifier
ndc (package): 67618-102-60
ndc (product): 67618-102
ndc11 (package): 67618010260
spl id: 1320a918-d279-411a-b08a-47b4012094d0
spl set id: 572adfaf-6e26-42e5-b65d-6d356a0bdfa9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.