Label: BISACODYL- bisacodyl suppository
- NDC Code(s): 0904-7142-12, 0904-7142-60
- Packager: Major Pharmaceuticals
- 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 May 5, 2021
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- Active ingredient (in each suppository)
For rectal use only
Do not use
- more than once per day
- for a period longer than one week unless directed by a doctor
- laxative products when abdominal pain, nausia, or vomiting are present unless directed a doctor
Ask a Doctor before using any laxative if you have
- notice a sudden change in bowel habits that lasts more than 2 weeks
Stop use and ask a doctor if
you have rectal bleeding or fail to have a bowel movement after using a laxative. These may indicate a serious condition.
Adults and children 12 years of age and over - One suppository once daily
Children 6 to under 12 years of age - 1/2 suppository once daily
Children under 6 - Ask a doctor
- Detach one suppository from the strip and remove the foil
- Carefully insert one suppository well into the rectum, pointed end first
- Do not use more than once per day
- Retain about 15 to 20 minutes
- Other information
- Inactive ingredients
- Questions or comments?
- Major Bisacodyl Suppositories
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0904-7142 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) 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:0904-7142-12 2 in 1 CARTON 05/05/2021 1 6 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0904-7142-60 100 in 1 CARTON 05/05/2021 2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 05/05/2021 Labeler - Major Pharmaceuticals (191427277) Registrant - DSC Laboratories, Inc. (097807374) Establishment Name Address ID/FEI Business Operations DSC Laboratories, Inc. 097807374 manufacture(0904-7142)