Label: BISACODYL LAXATIVE- bisacodyl suppository
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 4, 2010
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- ACTIVE INGREDIENT (in each suppository)
For rectal use only. May cause abdominal discomfort, faintness, rectal burning, and mild cramps.
Do not use
- more than one per day
- for a period of longer than one week unless directed by a doctor
- laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor
- if seal under product lid is torn, damaged, or open
Ask a doctor before use
- if you have noticed a sudden change in bowel habits that persist over a period of two weeks
- if you are pregnant or nursing a baby
Stop use and ask a doctorif you have rectal bleeding or fail to have a bowel movement after using a laxative. This may indicate a serious condition.
- SPL UNCLASSIFIED SECTION
- OTHER INFORMATION
- INACTIVE INGREDIENT
COMPARE TO DULCOLAX® ACTIVE INGREDIENT
For prompt relief of constipation often in 15 minutes to 1 hour
8 SUPPOSITORIES 10 mg EACH
FOR YOUR SAFETY, SUPPOSITORIES ARE PACKAGED IN PAMPER-EVIDENT SEALED PLASTIC WRAPPER. DO NOT USE IF PLASTIC WRAPPER IS TORN OR OPEN.
*This product is not manufactured or distributed by Boehringer Ingelhem
Pharmaceuticals, Inc., owner of the registered trademark Dulcolax®.
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INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-598 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength bisacodyl (UNII: 10X0709Y6I) (bisacodyl - UNII:10X0709Y6I) bisacodyl 10 mg Inactive Ingredients Ingredient Name Strength fat, hard (UNII: 8334LX7S21) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49348-598-67 8 in 1 BOX Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part334 08/08/2005 Labeler - McKesson (177667227)