Bisac-10 Bisacodyl Stimulant Laxative
FDA Label NDC 81440-102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Galen Pharmaceuticals Limited for the product Bisac-10 Bisacodyl Stimulant Laxative (NDC 81440-102). 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 drug facts, active ingredient (in each suppository), purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Suppository)
Bisacodyl 10 mg
Purpose
Laxative
Uses
• for relief of occasional constipation
• this product generally produces bowel movement in 1/4 to 1 hour
Warnings
For rectal use only
Do not use
• laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor
• laxative products for a period longer than 1 week unless directed by a doctor
Ask a doctor before use if you have noticed a sudden change in bowel habits that persists over a period of 2 weeks
When using this product
it may cause • abdominal discomfort • faintness
• rectal burning • mild cramps
• store at temperatures not above 86°F (30°C)
Stop use and ask a doctor if
• rectal bleeding
• failure to have a bowel movement which occurs after use of a laxative may indicate a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• adults and children 12 years of age: 1 suppository, once daily
• suppository should be moistened with water before inserting.
Other Information
• store in well closed containers
Inactive Ingredients
polyethylene glycol
Questions? +1-863-434-1782
You may also report serious side effects to this phone number.
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Packaging
Image (8144010212 1)
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