Drug Facts
Active ingredient (in each suppository) Purpose
Bisacodyl USP 10 mg ................................ Stimulant laxative
Bisacodyl
FDA Label NDC 54162-006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Geritrex Corp. for the product Bisacodyl (NDC 54162-006). 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, uses, directions, dosage & administration, warnings, inactive ingredient, storage, 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
Uses
relieves occasional constipation.
this product generally produces a bowel movement in 15 minutes to 1 hour.
Directions
tear off one suppository from the strip.
tear and peel the wrapper in downward motion.
continue tearing downward 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 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.
Dosage & Administration
Adults and children 12 years and over 1 suppository once daily.
Children under 12 years Ask a doctor.
Warnings
For rectal use only.
Do not use when abdominal pain, nausea, or vomiting are present.
Ask a doctor before use if you have a sudden change in bowel habits that lasts over a period of 2 weeks.
When using this product you may experience. rectal burning. mild cramps.abdominal discomfort. faintness.
stop use and ask a doctor if you have rectal bleeding. you fill 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.
if pregnant or breast-feeding, ask a health professional before use.
Inactive Ingredient
hydrogenated vegetable oil
Storage
store at temperatures below 30'C (86'F)
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a poison control center right away.
Package Label.Principal Display Panel
Package Label (Bs10 100)
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