Active Ingredient (In Each Tablet)
Bisacodyl USP, 5 mg
Stimulant Laxative Tablet, Delayed Release
FDA Label NDC 69452-541
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bionpharma Inc. for the product Stimulant Laxative (NDC 69452-541). 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, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stimulant laxative
Uses
■ for relief of occasional constipation and irregularity
■ this product generally produces bowel movement in 6 to 12 hours
Warnings
Allergy alert: Contains FD&C Yellow No. 5 (tartrazine) as a color additive.
Do Not Use
■ if you cannot swallow without chewing
Ask A Doctor Before Use If You Have
■ abdominal pain, nausea or vomiting ■ noticed a sudden change in bowel habits that persists over a period of 2 weeks
Ask A Doctor Or Pharmacist Before Use If You Are
■ taking any other drug
When Using This Product
■ it may cause stomach discomfort, faintness and cramps ■ do not chew or crush tablet(s) ■ do not use within 1 hour after
taking an antacid or milk
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 for a period longer 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 right away.
Directions
■ do not use more than directed
■ take with a glass of water
| adults and children 12 years of age and over | 1 to 3 tablets in a single daily dose |
| children 6 to under 12 years of age | 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)
■ protect from excessive humidity
Inactive Ingredients
colloidal silicon dioxide, FD&C yellow #5 (tartrazine), FD&C yellow #6, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and methyl methacrylate copolymer, microcrystalline cellulose, pharmaceutical imprinting ink, sodium starch glycolate, talc, titanium dioxide, triacetin, triethyl citrate
Questions?
call 1-888-235-2466
300'S Count
* compare to the active ingredient in Dulcolax® Laxative
a+ health TM
stimulant laxative
bisacodyl delayed-release
tablets USP, 5 mg
gentle, dependable
constipation relief
300 tablets
enteric coated tablets
Front (Front)
Back (Back)
* Please review the disclaimer below.
