Bisacodyl
FDA Label NDC 54868-2497

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 Bisacodyl (NDC 54868-2497). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient (in each tablet)Bisacodyl 5 mg

Otc - Purpose

PurposeLaxative

Indications & Usage

Uses
  • relieves occasional constipation
  • generally produces bowel movement in 6-12 hours

Warnings

Warnings

Otc - Do Not Use

Do not use
  • for longer than one week
  • when abdominal pain, nausea or vomiting are present
  • in children under 6 years of age
  • in persons who cannot swallow without chewing

Otc - Ask Doctor

Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two weeks

Otc - Ask Doctor/Pharmacist

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.

Otc - When Using

When using this product
  • do not take dose within one hour of taking an antacid or milk
  • you may experience abdominal discomfort, faintness and cramps

Otc - Stop Use

Stop use and ask a doctor if
  • you have rectal bleeding
  • you fail to have a bowel movement after use of this product
    • These may indicate a serious condition.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

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

Dosage & Administration

DirectionsDO NOT CHEW TABLETSadults and children 12 years and over: 1-3 tablets once dailychildren 6 to 11 years: 1 tablet once dailychildren under 6 years: ask a doctor

Storage And Handling

Other informationstore at 20°-25°C (68°-77°F)

Inactive Ingredient

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?call 1-800-645-2158 9 am - 5 pm ET, Monday - Friday

Package Label.Principal Display Panel


Bottle Label (2497)

Bottle Label (2497)


Bisacodyl

Delayed-Release Tablets USP, 5 mg

Enteric Coated Stimulate Laxative

NDC 54868-2497-0

100 tablets



Distributed by:
Physicians Total Care, Inc.
Tulsa, Oklahoma      74146


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