Colace
FDA Label NDC 54868-2337

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Colace (NDC 54868-2337). 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 drug facts colace 100 mg active ingredient (in each capsule), purpose, uses, do not use, ask a doctor before use if you have, other information, inactive ingredients, other, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts Colace 100 Mg Active Ingredient (In Each Capsule)

Docusate sodium 100 mg

Purpose

Stool softener

Uses

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

Do Not Use

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

Ask A Doctor Before Use If You Have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel movements that continues over a period of 2 weeks

Other Information

  • each tablet contains: sodium 5 mg
    VERY LOW SODIUM
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

    • Keep tightly closed.

Inactive Ingredients

D&C Red No. 33, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, PEG 400, propylene glycol, sorbitol, titanium dioxide

Other

Additional bar code label applied by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146

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