Other
Drug Facts
Bisacodyl
FDA Label NDC 50090-5385
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by A-s Medication Solutions for the product Bisacodyl (NDC 50090-5385). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient (in each suppository)
Bisacodyl USP, 10 mg
Otc - Purpose
Purpose
Stimulant Laxative
Indications & Usage
Uses
- relieves occasional constipation
- this product generally produces a bowel movement in 15 minutes to 1 hour
Warnings
Warnings
For rectal use only
Otc - Do Not Use
Do not use
when abdominal pain, nausea, or vomiting are present.
Otc - Ask Doctor
Ask a doctor before use if you have a sudden change in bowel habits that lasts over a period 2 weeks.
Otc - When Using
When using this product you may experience
- rectal burning
- mild cramps
- abdominal discomfort
- faintness
Otc - Stop Use
Stop use and ask a doctor if
- you have rectal bleeding or you fail to have bowel movement after using a laxative. These may be signs of a serious condition.
- you need to use a laxative product for more than one week
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
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.
Dosage & Administration
Directions
- tear off one suppository from the strip
- peel apart the wrapper
- continue peeling apart to almost the full length of the suppository (see illustration at the right)
- 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 about 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 under 12 years | Ask a doctor |
Storage And Handling
Other information
- store at temperatures below 25 C (77F)
- Made in India
Inactive Ingredient
Inactive ingredient hard fat
Otc - Questions
Questions or Comments? 1-800-540-3765
How Supplied
Product: 50090-5385
NDC: 50090-5385-0 6 SUPPOSITORY in a BLISTER PACK
* Please review the disclaimer below.
