Colace Tablet, Film Coated
FDA Label NDC 67618-110

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 67618-110). 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

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

Otc - Purpose

Purpose

Stool softener

Stimulant laxative

Indications & Usage

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 hours

Otc - Do Not Use

Do not use

  • laxative products for longer than 1 week unless told to do so by a doctor
  • 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.

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, preferably in the evening, or in divided doses
    • adults and children 12 years and overtake 2-4 tablets daily
    children 6 to under 12 years of agetake 1-2 tablets daily
    children 2 to under 6 years of agetake up to 1 tablet daily
    children under 2ask a doctor

How Supplied

Other information

  • each tablet contains: calcium 10 mg, sodium 4 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

dicalcium phosphate, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, sodium benzoate, talc, and titanium dioxide

©2016, Purdue Products L.P.

Mfd. for: Purdue Products L.P.
Stamford, CT 06901-3431

By: Purdue Pharma, 575 Granite Court
Pickering, ON L1W 3W8, Canada

304205-0A

Package Label.Principal Display Panel

Colace 2-In-1
30 Tablets

Colace 2-In-1 Sample Packaging
30 Tablet

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