Bisacodyl Suppository
FDA Label NDC 0574-7050

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Padagis Us Llc for the product Bisacodyl (NDC 0574-7050). 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 active ingredient (in each suppository), purpose, use, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Suppository)

Bisacodyl USP 10 mg

Purpose

Stimulant laxative

Use

  • for temporary relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 15 minutes to 1 hour

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

Ask A Doctor Or Pharmacist Before Use If You Are

taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

When Using This Product

it may cause stomach discomfort, faintness, rectal burning and milk cramps

Stop Use And Ask A Doctor If

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative because this may indicate a serious condition
  • you need to use a laxative for more than 1 week

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

adults and children 12 years of age and over

1 suppository in a single daily dose. Pull apart foil. Insert suppository well into rectum, pointed end first. Retain about 15 to 20 minutes.

children 6 to under 12 years of age

½ suppository in a single daily dose

children under 6 years of age

ask a doctor

Other Information

  • store at 20-25°C (68-77°F)

Inactive Ingredients

hydrogenated vegetable oil

Questions Or Comments?

1-800-719-9260

Package/Label Principal Display Panel

NDC 0574-7050-12

Bisacodyl Suppositories, USP

10 mg

Stimulant Laxative

Easy-open plastic packets

Tapered shape for easy insertion

UNIT DOSE

12 Suppositories

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