Label: ZELCOM- flubendazol tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated November 21, 2018

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  • ACTIVE INGREDIENT

    Flubendazol

  • PURPOSE

    Flubendazol is an anthelmintic (an-thel-MIN-tik) or anti-worm medication. It prevents newly hatched insect larvae (worms) from growing or multiplying in your body

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    ■ adult and children 2 years of age and older: 1 tablet

    ■ children under 1 years of age: ask a doctor

  • WARNINGS

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

  • INACTIVE INGREDIENT

    cellulose, corn starch, magnesium stearate, sodium starch

  • DOSAGE & ADMINISTRATION

    For oral use only

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    ZELCOM 
    flubendazol tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72689-0009
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FLUBENDAZOLE (UNII: R8M46911LR) (FLUBENDAZOLE - UNII:R8M46911LR) FLUBENDAZOLE500 mg
    Inactive Ingredients
    Ingredient NameStrength
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorpinkScoreno score
    ShapeOVALSize12mm
    FlavorImprint Code ZELCOM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72689-0009-11 in 1 BLISTER PACK; Type 0: Not a Combination Product11/16/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/15/2018
    Labeler - OASIS TRADING (689991468)
    Registrant - OASIS TRADING (689991468)
    Establishment
    NameAddressID/FEIBusiness Operations
    OASIS TRADING689991468manufacture(72689-0009)
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