Active Ingredient (In Each Tablet)
Bisacodyl USP, 5 mg
Laxative Tablet
FDA Label NDC 37835-241
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bi-mart for the product Laxative (NDC 37835-241). 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 (in each tablet), purpose, uses, do not use, ask a 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
Laxative
Uses
- for temporary relief of occasional constipation and irregularity
- this product generally produces bowel movement in 6 to 12 hours
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 2 weeks
When Using This Product
- do not chew or crush tablet(s)
- do not use within 1 hour after taking an antacid or milk
- it may cause stomach discomfort, faintness, and cramps
Stop Use And Ask A Doctor If
- you have rectal bleeding or fail to have a bowel movement after using this product. These could be signs of a serious condition.
- you need to use a laxative for more than 1 week
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- take with a glass of water
| adults and children 12 years of age and over | take 1 to 3 tablets in a single daily dose |
| children 6 to under 12 years of age | take 1 tablet in a single daily dose |
| children under 6 years of age | ask a doctor |
Other Information
- store at 20°-25°C (68°-77°F)
Inactive Ingredients
Colloidal silicon dioxide, hypromellose-5, magnesium stearate, maltodextrin, methacrylic acid, microcrystalline cellulose, neelicert FD&C yellow 10 Al Lake, neelicert FD&C yellow 6 Al Lake, PEG 400, sodium starch glycolate, talc, titanium dioxide, triethyl citrate.
Questions?
call toll-free 1-844-912-4012
Other
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BI-MART
Eugene, OR 97402
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