Official product label reference

Colace — Atlantis Consumer Healthcare, Inc.

This page contains 11 source sections for DOCUSATE SODIUM, oral route. Label set a1591da0-a1a9-9583-3cf5-788b8fee3814, version 13.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours

Purpose

Forms and strengths

Directions Take only by mouth. Doses may be taken as a single daily dose or in divided doses. adults and children 12 years and over take 1-6 soft gels daily children 2 to under 12 years of age take 1-3 soft gels daily children under 2 years ask a doctor Table text from source: | adults and children 12 years and over | take 1-6 soft gels daily | children 2 to under 12 years of age | take 1-3 soft gels daily | children under 2 years | ask a doctor

Active ingredient

Drug Facts

Do not use

Warnings Do not use if you are presently taking mineral oil, unless told to do so by a doctor

Ask a doctor before use

Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks

When to stop use and seek help

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movementafter use of a laxative. These could be signs of a serious condition. you need to use a stool softener laxative for more than1 week

Pregnancy or breast feeding

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

Child safety

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

Supply and packaging

Other information each soft gel contains: sodium 3 mg VERY LOW SODIUM store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F). Keep tightly closed.

Inactive ingredient

Inactive ingredients gelatin, glycerin, PEG 400, propylene glycol, sorbitol Soft gels are imprinted with edible dye-free ink. Dist. by: Atlantis Consumer Healthcare Inc. Bridgewater, NJ 08807 Questions? 1-833-288-2684 ©2023 Atlantis Consumer Healthcare Inc. Colace is a registered trademark of Atlantis Consumer Healthcare Inc.

Official sources and product identifiers

DailyMed — complete source labelVerify the current version and original formatting, including tables and diagrams.
openFDA — structured source recordMachine-readable label source, linked by the exact label set ID.

Substances listed: DOCUSATE SODIUM

RxNorm identifiers: 1247759, 1247761

Package NDC codes

67618-111-28, 67618-111-42, 67618-111-60, 67618-111-10

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.

Colace drug information