Label: BISACODYL- bisacodyl suppository
- NDC Code(s): 70000-0573-1, 70000-0573-2
- Packager: Cardinal Health
- 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 June 17, 2021
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- Active ingredient (in each suppository)
For rectal use only.
Do not use unless directed by a doctor
- if abdominal pain, nausea or vomiting are present
- for longer than 1 week
Ask a Doctor before use if you have
noticed a sudden change in bowel habits that lasts over a perios of 2 weeks
Stop use and ask a doctor if
you have rectal bleeding or fail to have a bowel movement after using this product. These may indicate a serious condition.
- detach one suppository from the strip
- remove wrapper before inserting into rectum
- carefully insert one suppository well into the rectum, pointed end first
- retain about 15 to 20 minutes
adults and children 12 years of age and over - 1 suppository once daily
children 6 to under 12 years of age - 1/2 suppository once daily
children under 6 - do not use
- Other information
- Inactive ingredients
- Questions or comments?
- Leader Bisacodyl Suppositories
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0573 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:70000-0573-2 4 in 1 CARTON 05/19/2021 1 4 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:70000-0573-1 1 in 1 CARTON 05/19/2021 2 4 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 05/19/2021 Labeler - Cardinal Health (063997360) Registrant - DSC Laboratories, Inc. (097807374) Establishment Name Address ID/FEI Business Operations DSC Laboratories, Inc. 097807374 manufacture(70000-0573)