Label: BISACODYL- 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 March 8, 2012
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- ACTIVE INGREDIENT (in each suppository)
For rectal use only
Do not use
laxative products for a period longer than one week unless directed by a doctor
Ask a doctor before use if you have
• abdominal pain, nausea or vomiting
• a sudden change in bowel habits that lasts longer than 2 weeks
Stop use and ask a doctor
if rectal bleeding occurs or you fail to have a bowel movement after using a laxative. This may indicate a serious condition.
- IF PREGNANT OR BREAST FEEDING,
- KEEP OUT OF REACH OF CHILDREN SECTION
- OTHER INFORMATION
- INACTIVE INGREDIENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-102 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 Hydrogenated Palm Kernel Oil (UNII: FM8D1RE2VP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-102-53 12 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 09/10/1997 Labeler - CARDINAL HEALTH, INC. (097537435) Registrant - G&W Laboratories, Inc. (001271188) Establishment Name Address ID/FEI Business Operations G&W Laboratories, Inc. 001271188 MANUFACTURE