Label: BISACODYL- bisacodyl suppository
- NDC Code(s): 68016-084-08
- Packager: Pharmacy Value Alliance LLC
- 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 November 3, 2021
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- Active ingredient (in each suppository)
For rectal use only
Ask a Doctor before using any laxative if you have
- stomach pain, nausea or vomiting
- a sudden change in bowel habits that lasts more than 2 weeks
Stop use and ask a doctor if
- you have rectal bleeding or no bowel movement after using laxative products. These could be signs of a very serious condition.
- you need to use a laxative for more than 1 week
adults and children 12 years of age and over - 1 suppository in a single daily dose. Peel open plastic. Insert suppository well into rectum, pointed end first. Retain about 15 to 20 minutes.
children 6 to under 12 years of age - 1/2 suppository in a sinle daily dose
children under 6 years of age - ask a doctor
- Other information
- Inactive ingredients
- Premier Value Bisacodyl Suppositories
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-084 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:68016-084-08 2 in 1 CARTON 06/03/2019 1 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 06/03/2019 Labeler - Pharmacy Value Alliance LLC (101668460) Registrant - DSC Laboratories, Inc. (097807374) Establishment Name Address ID/FEI Business Operations DSC Laboratories, Inc. 097807374 manufacture(68016-084)