Active Ingredient (In Each Suppository)
Bisacodyl USP, 10mg
Bisacodyl Suppository
FDA Label NDC 70000-0573
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health for the product Bisacodyl (NDC 70000-0573). 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, uses, warnings, do not use unless directed by a doctor, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, 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 temporary relief of occasional constipation
- this product generally produces bowel movement in 15 minutes to 1 hour
Warnings
For rectal use only.
Do Not Use Unless Directed By A Doctor
- if abdominal pain, nausea or vomiting are present
- for longer than 1 week
Ask A Doctor Before Use If You Have
noticed a sudden change in bowel habits that lasts over a perios of 2 weeks
When Using This Product
it may cause abdominal discomfort, faitness, rectal burning and mild cramps
Stop Use And Ask A Doctor If
you have rectal bleeding or fail to have a bowel movement after using this product. These may indicate a serious condition.
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 (1-800-222-1222) right away.
Directions
- detach one suppository from the strip
- remove wrapper before inserting into rectum
- carefully insert one suppository well into the rectum, pointed end first
- retain about 15 to 20 minutes
adults and children 12 years of age and over - 1 suppository once daily
children 6 to under 12 years of age - 1/2 suppository once daily
children under 6 - do not use
Other Information
- Store at room remperature do not to exceed 30°C (86°F)
- Lot No. & Exp. Date: see wrapper or box
Inactive Ingredients
hydrogenated vegetable oil
Questions Or Comments?
(800) 492-5988
Leader Bisacodyl Suppositories
LeaderBisSupp.jpg
Leader Bisacodyl Suppositories (Leaderbissupp)
The product package shown above represents a sample of that currently in use. Additional packaging may also be available.
Bisacodyl Suppositories
Distributed by
Major Pharmaceuticals
Livonia, MI 48152
* Please review the disclaimer below.
