Otc - Active Ingredient
Active ingredient (in each suppository) Purpose
Bisacodyl USP 10 mg.............................................................Stimulant Laxative
Bisacodyl Suppository
FDA Label NDC 83720-550
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oncor Pharmaceuticals for the product Bisacodyl (NDC 83720-550). 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 otc - active ingredient, dosage & administration, warning, otc - ask doctor, otc - when using, stop use and ask a doctor if, pregnancy, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Dosage & Administration
Uses
- relieves occasional constipation
- this product generally produces a bowel movement in 15 minutes 1 hour
Warning
for rectal use only
Do not usewhen abdominal pain, nausea, or vomiting are present.
Otc - Ask Doctor
Ask a doctor before use if you havea sudden change in bowel habits that lasts over a period od 2 weeks.
Otc - When Using
When using this productyou may experience
- rectal burning
- mild cramps
- abdominal discomfort
- faintness
Stop Use And Ask A Doctor If
- you have rectal bleeding or you fail to have a bowel movement after using a laxative. These may be signs of a serious condition.
- you need to use a laxative for more than one week
Pregnancy
If pregnant or breast-feeding,ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Spl Medguide
If swallowed, get medical help or contact a Poison Control Center right away.
You may report side effects by calling Oncor Pharmaceuticals
(9 a.m. to 5 p.m. EST), at 1-443-876-7600 or FDA at 1-800-FDA-1088.
Directions
- tear off one suppository from the strip
- peel apart the wrapper
- continue peeling apart to almost the full length of the suppository
- gently remove the suppository from the wrapper
- lie on your side and push suppository, with 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 a short time before use.
| Adults and children 12 years and over | 1 suppository once daily |
| Children 6 to under 12 years | 1/2 suppository once daily |
| Children under 6 years | Ask a doctor |
Other Information
store at temperatures below 25 oC (77 oF)
Inactive Ingredient
hydrogenated vegetable oil
Otc - Purpose
TAMPER EVIDENT:SUPPOSITORIES ARE WRAPPED IN TAMPER EVIDENT SEALED WRAPPERS. DO NOT USE IF WRAPPER IS TORN OR OPEN WHEN PURCHASED.
Principal Display Panel
Oncor Pharmaceuticals
NDC 83720-550-25
12 Suppositories
10 mg each
Bisacodyl Suppositories
Fast Acting Smulant Laxative
Manufactured In USA For :
Oncor Pharmaceuticals
6755 Business Pkwy Suite 202
Elkridge, MD 21075
United States.
Rev. 12/24
* Please review the disclaimer below.
