Active Ingredient
Bisacodyl USP 5mg.
Bisacodyl
FDA Label NDC 11534-013
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 11534-013). 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 active ingredient, purpose, indications and usage, warnings, ask doctor before use if you have, when using this product, stop use and ask a doctor if, if pregnant or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
Ask Doctor Before Use If You Have
Stomach pain, nausea or vomiting
A sudden change in bowel habits that lasts for more than 2 weeks.
When Using This Product
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.
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
If Pregnant Or Breast Feeding
Ask a health professional before use.
Dosage And Administration
Dosage and Administration text
Keep Out Of Reach Of Children
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
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)
Inactive Ingredient
Calcium sulfate, carnuba wax, colloidal silicon dioxide, croscarmellose sodium, D & C yellow # 10, edible ink, FD & C yellow #6, gelatin, hydroxypropylymethyl cellulose, kaolin, lactose, magnesium stearate, methacrylic acid copolymer, microcrystalline celloluse, mineral oil, polyethylene glycol, propylene glycol, stearic acid, sucrose, sugar, talc, titanium dioxide, triethyl citrate.
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