Dulcolax
FDA Label NDC 54868-3155

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 Dulcolax (NDC 54868-3155). 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, warnings, ask a doctor before use if you have, stop use and ask a doctor if, directions, other information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredient (in each suppository)Purpose
Bisacodyl USP 10 mg .................................... Stimulant laxative

Warnings

For rectal use only

Ask A Doctor Before Use If You Have

  • stomach pain, nausea or vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

    • When using this product it may cause stomach discomfort, faintness, rectal burning and mild cramps

Stop Use And Ask A Doctor If

  • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
  • you need to use a laxative for more than 1 week

Directions

adults and children 12 years of age and over1 suppository in a single daily dose. Peel open plastic. Insert suppository well into rectum, pointed end first. Retain about 15 to 20 minutes.
children 6 to under 12 years of age1/2 suppository in a single daily dose
children under 2 years of ageask a doctor

Other Information

  • do not store above 30°C (86°F)

Inactive Ingredient

hydrogenated vegetable oil

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