Label: FESTAL PLUS- ursodeoxycholic acid, simethicone, pancreatin, cellulase ap3 tablet

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

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Drug Label Information

Updated November 22, 2018

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  • ACTIVE INGREDIENT

    Ursodeoxycholic Acid, Pancreatin, Simethione

  • PURPOSE

    digestion

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    children under 7 years of age: consult a doctor
    take 1-2 tablet as symptoms accur, as directed by a doctor

  • WARNINGS

    Ask a doctor before use if you have taking a prescription drug. Antacids may interact with certain prescription drugs.
    When using this product
    ■ Do not take more than 4 tablet in 24 hours
    ■ Do not use the maximum dosage for more than 2 weeks
    Keep out of reach of children

  • INACTIVE INGREDIENT

    Dextrin, stearic acid, talc, polyethylene glycol 6000, Cellulase AP3

  • DOSAGE & ADMINISTRATION

    For oral use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    FESTAL PLUS 
    ursodeoxycholic acid, simethicone, pancreatin, cellulase ap3 tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72689-0010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    URSODIOL (UNII: 724L30Y2QR) (URSODIOL - UNII:724L30Y2QR) URSODIOL10 mg
    PANCRELIPASE (UNII: FQ3DRG0N5K) (PANCRELIPASE LIPASE - UNII:8MYC33932O) PANCRELIPASE LIPASE315 mg
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE30 mg
    Inactive Ingredients
    Ingredient NameStrength
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeOVALSize15mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72689-0010-110 in 1 BLISTER PACK; Type 0: Not a Combination Product11/21/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/21/2018
    Labeler - OASIS TRADING (689991468)
    Registrant - OASIS TRADING (689991468)
    Establishment
    NameAddressID/FEIBusiness Operations
    OASIS TRADING689991468manufacture(72689-0010)
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