Colace Capsule, Liquid Filled
FDA Label NDC 67618-111

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 (NDC 67618-111). 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 otc - active ingredient, otc - purpose, indications & usage, otc - do not use, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - 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

Otc - Active Ingredient

Drug Facts

Colace 50 mg

Active ingredients
(in each soft gel)

Docusate sodium 50 mg

Otc - Purpose

Purpose

Stool softener

Indications & Usage

Uses

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

Otc - Do Not Use

Warnings

Do not use

  • if you are presently taking mineral oil, unless told to do so by a doctor

Otc - Ask 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

Otc - Stop Use

Stop use and ask a doctor if

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
  • you need to use a stool softener laxative for more than 1 week

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

Dosage Forms & 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 overtake 1-6 soft gels daily
children 2 to under 12 years of agetake 1-3 soft gels daily
children under 2 yearsask a doctor

How Supplied

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.

©2016, Purdue Products L.P.

Dist. by: Purdue Products L.P.
Stamford, CT 06901-3431

304199-0C

Package Label.Principal Display Panel

Colace 50mg
28 Clear Soft Gels

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