Otc - Active Ingredient
In each tablet: Bisacodyl 5mg
Bisacodyl Tablet, Coated
FDA Label NDC 11673-182
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Target Corporation for the product Bisacodyl (NDC 11673-182). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, 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
Acacia, Anhydrous CalciumSulfate, Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Corn Starch,
D&C Yellow #10 Aluminum Lake, Gelatin, Iron Oxide, Iron Oxide Black, Iron Oxide Yellow(Iron Oxide Ochre),
FD&C Yellow #6, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol (PEG) 400,
Polyvinyl Acetate Phthalates, Povidone, Shellac, Sodium Starch Glycolate, Stearic Acid, Sugar, Talc, Titanium Dioxide
Otc - Purpose
PURPOSE
Stimulant Laxative
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.
Indications & Usage
Uses:
- relieves occasional constipation and irregularity
- This product generally produces a bowel movement in 6 to 12 hours
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.
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
* Please review the disclaimer below.
