Label: BISACODYL suppository
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated February 23, 2012
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- Drug Facts
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
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
- KEEP OUT OF REACH OF CHILDREN
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54162-006 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISACODYL (UNII: 10X0709Y6I) (BISACODYL - UNII:10X0709Y6I) BISACODYL 0.01 g in 2 g Inactive Ingredients Ingredient Name Strength HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54162-006-12 2 g in 1 BOX, UNIT-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 02/23/2012 Labeler - Geritrex Corp. (112796248)