Active Ingredients (Per Suppository)
Bisacodyl USP, 10 mg
Bisacodyl Suppository
FDA Label NDC 82568-0028
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aarna Usa Inc. for the product Bisacodyl (NDC 82568-0028). 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 ingredients (per suppository), purpose, otc - keep out of reach of children, uses, warnings, do not use laxative products, ask a doctor before use if you have, 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
Laxative
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Uses
- for relief of occasional constipation
- this product usually produces bowel movement in 1/4 to 1 hour
Warnings
For rectal use only.
Do Not Use Laxative Products
- when abdominal pain, nausea or vomiting are present
- for a period longer than one week
Ask A Doctor Before Use If You Have
noticed a sudden change in bowel habits that persist over a period of 2 weeks
When Using This Product
it may cause abdominal discomfort, faintness, rectal burning and mild cramps
Stop Use And Ask A Doctor If
rectal bleeding occurs, or you fail to have a bowel movement after using a laxative. This may indicate a serious condition.
If Pregnant Or Breast-Feeding
ask a health professional before use.
Directions
- adults and children 12 years of age and older
- detach one suppository from the strip
- remove from wrapper before inserting into the rectum
- the rectal suppository dose is one suppository per day or as directed by a doctor
- children under 12 years of age consult a doctor
Other Information
store below 30° C (86° F)
Inactive Ingredient
hydrogenated vegetable oil
Package Label.Principal Display Panel
Manufactured for:
Aarna USA Inc.
Leland, NC 28451
www.aarnaus.com
* Please review the disclaimer below.
