Drug Facts : Active Ingredient
(in each suppository)
Bisacodyl 10 mg
Gentle Laxative Bisacodyl Suppository
FDA Label NDC 13709-321
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Neilmed Pharmaceuticals Inc for the product Gentle Laxative Bisacodyl (NDC 13709-321). 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 drug facts : active ingredient, drug facts, uses, warnings, do not use, ask a doctor before use, 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
Drug Facts
Purpose
Bisacodyl 10 mg ................................. Stimulant Laxative
Uses
■ for relief of occasional constipation
■ this product generally produces bowel movement in 15 to 60 minutes
Warnings
■ For rectal use only
Do Not Use
■ when abdominal pain, nausea or vomiting are present
■ for a period longer than 1 week
Ask A Doctor Before Use
if you have noticed a sudden change in bowel habits that lasts over a period of 2 weeks
When Using This Product
it may cause abdominal discomfort, faintness, rectal bleeding and mild cramps
Stop Use And Ask A Doctor If
■ you have rectal bleeding
■ you fail to have a bowel movement after using this product. This 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 right away.
Dosage & Administration
Directions
■ detach one suppository from the strip
■ remove wrapper before inserting into the rectum
adults and children 12 and over : 1 suppository once daily
children 6 to under 12 years : ½ suppository once daily
children under 6 years : do not use
Other Information
■ Store at room temperature. Do not exceed 30° C (86° F)
■ Lot No. & Exp. Date: see wrapper or box
Inactive Ingredient
hydrogenated vegetable oil
Questions?
Adverse Drug Event Call: 1(877) 477-8633
Tamper Evident Seal:
Do not use if wrapper on an individual suppository is broken or missing.
Intended Use Of The Device
Prompt, predictable relief from constipation
* Please review the disclaimer below.
