Active Ingredient (In Each Tablet)
Bisacodyl USP 5 mg
Bisacodyl Tablet, Coated
FDA Label NDC 72090-131
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pioneer Life Sciences, Llc for the product Bisacodyl (NDC 72090-131). 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, use, warnings, directions, other information, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stimulant laxative
Use
■ for 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
Directions
■ Take with a glass of water
| adults and children12 years of age and over | start with 1 tablet/day. If needed increase to 2 or 3 tablets a day in a single daily dose. |
| children 6 to under 12 years | 1 tablet per day |
| children under 6 years | ask a doctor |
Other Information
■ store at 20°-25°C (68°-77°F)
■ protect from excessive humidity
Inactive Ingredients
Colloidal silicon dioxide, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, sodium starch glycolate, talc, opadry clear contain hypromellose, triacetin and talc. Opadry enteric coating orange contain fd&c yellow # 5, fd&c yellow # 6, methacrylic acid copolymer, talc, titanium dioxide, triethyl citrate
Questions?
Call +1 (732) 994-2808 or email [email protected]
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