Otc - Active Ingredient
Active ingredeint (in each tablet)
Bisacodyl 5 mg
Bisacodyl Tablet, Coated
FDA Label NDC 41226-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kroger Company for the product Bisacodyl (NDC 41226-003). 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, inactive ingredient, otc - purpose, indications & usage, dosage & administration, warnings, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Inactive Ingredient
Acadia, 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 Phthalates, Povidone, Shellac, Sodium Starch Glycolate, Stearic Acid, Sugar, Talc, Titanium Dioxide
Otc - Purpose
Stimulant Laxative
Indications & Usage
Uses:
relieves occasional constipation and irregularity
this product generally produces a bowel movement in 6 to 12 hours
Dosage & Administration
DOSAGE & ADMINISTRATION
- adults and children 12 years and over: take 1 to 3 tablets in a single daily dose
- children 6 to under 12 years: take 1 tablet in a single daily dose
- children under 6 years: ask a doctor
Warnings
Warnings
- Warning: 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 two weeks.
- When using this product: Do not chew or crush tablet(s); Do not use within 1 hour after taking an antacid or milk; Do not use this product if you have stomach discomfort, faintness or cramps.
Otc - Keep Out Of Reach Of Children
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.
Package Label.Principal Display Panel
25 Ct (14r Bisacodyl 25tab)
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