Otc - Active Ingredient
Bisacodyl USP 5mg.
Bisacodyl
FDA Label NDC 11534-156
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sunrise Pharmaceutical Inc for the product Bisacodyl (NDC 11534-156). 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, otc - purpose, indications and usage, warnings, otc - ask doctor, otc - when using, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Stimulant laxative.
Indications And Usage
For temporary 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.
Otc - Ask Doctor
If you have
Stomach pain, nausea or vomiting
A sudden change in bowel habits that lasts for more than 2 weeks.
Otc - When Using
Do not chew or crush tablet(s).
It may cause stomach discomfort, faintness and cramps.
Do not use within 1 hour after taking an antacid or milk.
Otc - Stop Use
And ask a doctor if:
You have rectal bleeding or no bowel movement after using this product. These could be signs of serious condition.
You need to use laxative for more than 1 week
Otc - Pregnancy Or Breast Feeding
Ask a health professional before use.
Otc - Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away.
Dosage And Administration
Take with a glass of water
| Adults and children 12 years and over | 1 to 3 tablets in a single daily dose |
| Children 6 to under 12 years | 1 tablet in a single daily dose |
| Children under 6 years | Ask a doctor |
OTHER INFORMATION
Store at 20(-25(C(68(-77(F). Protect from excessive humidity.
Inactive Ingredient
Acacia, 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, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide.
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