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.

Drug Label Information

Updated December 14, 2020

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  • Active ingredient (in each suppository)

    Bisacodyl USP 10mg

  • Purpose

    Stimulant Laxative

  • Use

    • for temporary relief of occasional constipation and irregularity
    • this product generally produces bowel movement in 15 minutes to 1 hour
  • Warnings

    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

    When using this product

    it may cause stomach discomfort, faintness, rectal burning and mild cramps

    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

    If pregnant or breast feeding,

    ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    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

    • do not store above 30ºC (86ºF)
  • Inactive ingredients

    hydrogenated vegetable oil

  • Premier Value Bisacodyl Suppositories

    Premier Value Bisacodyl 8ctPVBisacodyl8.jpg

    The product package shown above represents a sample of that currently in use. Additional packaging may also be available.

    Bisacodyl Suppositories 8ct

    Distributed by

    Pharmacy Value Alliance, LLC

    407 East Lancaster Avenue

    Wayne, PA 19087

  • INGREDIENTS AND APPEARANCE
    BISACODYL  
    bisacodyl suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-084
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL10 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-084-082 in 1 CARTON06/03/2019
    14 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33406/03/2019
    Labeler - Pharmacy Value Alliance LLC (101668460)
    Registrant - DSC Laboratories, Inc. (097807374)
    Establishment
    NameAddressID/FEIBusiness Operations
    DSC Laboratories, Inc.097807374manufacture(68016-084)
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