Active Ingredient (In Each Suppository)
Bisacodyl USP, 10mg
Bisacodyl Suppository
FDA Label NDC 0904-7142
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Major Pharmaceuticals for the product Bisacodyl (NDC 0904-7142). 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, ask a doctor before using any laxative 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 and irregularity
- this product generally produces bowel movement in 15 minutes to 1 hour
Warnings
For rectal use only
Do Not Use
- more than once per day
- for a period longer than one week unless directed by a doctor
- laxative products when abdominal pain, nausia, or vomiting are present unless directed a doctor
Ask A Doctor Before Using Any Laxative If You Have
- notice a sudden change in bowel habits that lasts more than 2 weeks
When Using This Product
- may cause stomach discomfort, faintness, 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 a laxative. 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
Adults and children 12 years of age and over - One suppository once daily
Children 6 to under 12 years of age - 1/2 suppository once daily
Children under 6 - Ask a doctor
- Detach one suppository from the strip and remove the foil
- Carefully insert one suppository well into the rectum, pointed end first
- Do not use more than once per day
- Retain about 15 to 20 minutes
Other Information
- Storage temperature not to exceed 30°C (86°F)
- Indiviually sealed for your protection. Do not use if foil is torn or open.
Inactive Ingredients
hydrogenated vegetable oil
Questions Or Comments?
(800) 616-2471
Major Bisacodyl Suppositories
Major Bisacodyl 12 (Major Bisacodyl 12)
Major_Bisacodyl_12.jpg
The product package shown above represents a sample of that currently in use. Additional packaging may also be available.
Bisacodyl Suppositories 12ct
Distributed by
Major Pharmaceuticals
Livonia, MI 48152
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