FDA Label for Bisacodyl
View Indications, Usage & Precautions
Bisacodyl Product Label
The following document was submitted to the FDA by the labeler of this product Kroger Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredeint (in each tablet)
Bisacodyl 5 mg
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
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