Bisacodyl
FDA Label NDC 16103-367

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharbest Pharmaceuticals Inc. for the product Bisacodyl (NDC 16103-367). 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 tablet), otc - purpose, indications & usage, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Bisacodyl 5 mg

Otc - Purpose

Stimulant laxative

Indications & Usage

  • For temporary relief of occasional constipation and irregularity
  • This product generally produces bowel movement in 6 to 12 hours

Do Not Use

If you cannot swallow without chewing

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

  • do not chew or crush tablet(s)
  • it may cause stomach discomfort, faintness and cramps
  • do not use within 1 hour after taking an antacid or milk

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

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

Take with a glass of water

adults and children 12 years of age and over
1 to 3 tablets in a single daily dose
children 6 to under 12 years of age
1 tablet in a single daily dose
children under 6 years of age
ask a doctor

Other Information

  • Store at 20 - 250C (68-770F)
  • Protect from excessive humidity

Questions?

Adverse drug event call: (866) 562-2756

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