Bisacodyl
FDA Label NDC 68210-4106

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Bisacodyl (NDC 68210-4106). 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), purpose, uses, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, otc - pregnancy 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 (USP) 5 mg

Purpose

Stimulant laxative

Uses

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

Warnings

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

Otc - Pregnancy Or Breast Feeding

Ifpregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage & Administration

Directions

  • take with a glass of water
    •  adults and children 12 years 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 Safety Information

Other information
■ each tablet contains: magnesium 5 mg
■ store at 20-25°C (68-77°F)
■ protect from excessive humidity

Inactive Ingredients

Acacia, anhydrous calcium sulfate, anhydrous lactose,
carnauba wax, colloidal silicon dioxide, corn starch, D&C
Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum
Lake, gelatin, iron oxide, iron oxide black, iron oxide yellow
(iron oxide ochre), magnesium stearate, microcrystalline
cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate
phthalate, povidone, shellac, sodium starch glycolate, stearic
acid, sugar, talc, titanium dioxide

Otc - Questions

Questions or comments? 1-888-333-9792

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CABINET

Bisacodyl Tablets,
USP 5 mg

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