Active Ingredient (In Each Suppository)
Bisacodyl USP 10mg
Bisacodyl Suppository
FDA Label NDC 68016-084
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmacy Value Alliance Llc for the product Bisacodyl (NDC 68016-084). 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 suppository), purpose, use, warnings, ask a doctor before using any laxative 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
Use
- for temporary relief of occasional constipation and irregularity
- this product generally produces bowel movement in 15 minutes to 1 hour
Warnings
For rectal use only
Ask A Doctor Before Using Any Laxative If You Have
- stomach pain, nausea or vomiting
- a sudden change in bowel habits that lasts more than 2 weeks
When Using This Product
it may cause stomach discomfort, faintness, rectal burning and mild cramps
Stop Use And Ask A Doctor If
- you have rectal bleeding or no bowel movement after using laxative products. These could be signs of a very 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.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
adults and children 12 years of age and over - 1 suppository in a single daily dose. Peel open plastic. Insert suppository well into rectum, pointed end first. Retain about 15 to 20 minutes.
children 6 to under 12 years of age - 1/2 suppository in a sinle daily dose
children under 6 years of age - ask a doctor
Other Information
- do not store above 30°C (86°F)
Inactive Ingredients
hydrogenated vegetable oil
Premier Value Bisacodyl Suppositories
Premier Value Bisacodyl 8ct (Pvbisacodyl8)
The product package shown above represents a sample of that currently in use. Additional packaging may also be available.
Bisacodyl Suppositories 8ct
Distributed by
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue
Wayne, PA 19087
* Please review the disclaimer below.
