Activeingredient(In Eachsuppository)
Bisacodyl (USP) 10 mg
Bisacodyl Laxative Suppository
FDA Label NDC 71457-501
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Invaderm Corporation for the product Bisacodyl Laxative (NDC 71457-501). 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 activeingredient(in eachsuppository), purpose, use, warnings, do not use, 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
Use
- for relief of occasional constipation and irregularity
- this product generally 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 1 week
Ask A Doctor Before Use If You Have
noticed a sudden change in bowel habits that lasts more than 2 weeks
When Using This Product
it may cause abdominal discomfort, faintness, rectal burning and mild cramps
Stop Use And Ask A Doctor If
- you have rectal bleeding or fail
- you fail to have a bowel movement after using a laxative. These could be signs of a serious condition.
- you need to use a laxative for more than one 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
- detach 1 suppository from the strip; remove wrapper before inserting into the rectum as follows:
- hold suppository with pointed end up
- carefully separate tabs with fingernail
- slowly pull apart by pulling tabs down on both side
- remove suppository from wrapper (see illustration at the right)
- gently remove the suppository from the wrapper
- lie on your side and push suppository, pointed end first, high into the rectum so it will not slip out
- retain it for 15 to 20 minutes
- Do not exceed recommended dose
- if suppository seems soft, place in refrigerator for short time before use
Directions (Directions)
| Adults and children 12 years and over | 1 suppository once daily |
| Children under 12 years | Ask a doctor |
Other Information
- store at temperature below 30°(86°F)
Inactive Ingredient
hydrogenated vegetable oil
Principal Display Panel
Bisacodyl USP 10 mg
12 SUPPOSITORIES
12ct (12ct)
* Please review the disclaimer below.
