Label: BEVITROL- amylase, protease, lipase capsule

  • Category: DIETARY SUPPLEMENT

Drug Label Information

Updated December 15, 2021

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  • PRINCIPAL DISPLAY PANEL

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  • STATEMENT OF IDENTITY

    Bevitrol is an orally administered prescription digestive enzyme dietary supplement formulation for the clinical dietary
    management of suboptimal nutritional status in patients where advanced supplementation is required and nutritional
    supplementation in physiologically stressful conditions for maintenance of good health is needed.


    Bevitrol should be administered under the supervision of a licensed medical practitioner.

  • DOSAGE & ADMINISTRATION

    Bevitrol is an orally administered prescription digestive enzyme supplement formulation for the clinical dietary
    management of suboptimal nutritional status in patients where advanced supplementation is required and nutritional
    supplementation in physiologically stressful conditions for maintenance of good health is needed.

    Usual adult dose is 1 capsule daily with or without food. Do not exceed 3 capsules per day.

  • HEALTH CLAIM

    Bevitrol is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has
    limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has
    other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the
    modification of a normal diet alone.

    All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.
    This product may be administered only under a physician’s supervision. There are no implied or explicit claims on
    therapeutic equivalence.


    Manufactured for:
    Misemer Pharmaceutical, Inc.
    Ripley, MS 38663


    Item 0710
    Rev. 0921

  • PRECAUTIONS

    Bevitrol should only be used under the direction and supervision of a licensed medical practitioner. Use with caution
    in patients that may have a medical condition, are pregnant, lactating, trying to conceive, under the age of 18, or taking
    medications.

  • SAFE HANDLING WARNING

    Bevitrol is supplied as red and white capsules dispensed in white HDPE plastic bottles of 30ct.
    Item 0276-0710-30

    Store at controlled room temperature 15°-30°C (59°F-86°F). Keep in cool dry place. Call your doctor about side effects.
    You may report side effects to FDA at 1-800-FDA-1088. KEEP THIS OUT OF THE REACH OF CHILDREN.
    Dispense by Prescription

  • WARNINGS

    This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

  • INGREDIENTS AND APPEARANCE
    BEVITROL 
    amylase, protease, lipase capsule
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:0276-0710
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PANCRELIPASE AMYLASE (UNII: YOJ58O116E) (PANCRELIPASE AMYLASE - UNII:YOJ58O116E) PANCRELIPASE AMYLASE112500 [USP'U]
    PANCRELIPASE PROTEASE (UNII: 3560D81V50) (PANCRELIPASE PROTEASE - UNII:3560D81V50) PANCRELIPASE PROTEASE112500 [USP'U]
    PANCRELIPASE LIPASE (UNII: 8MYC33932O) (PANCRELIPASE LIPASE - UNII:8MYC33932O) PANCRELIPASE LIPASE9000 [USP'U]
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:0276-0710-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement12/01/2021
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    shape
    size (solid drugs)20 mm
    scoring1
    color
    Labeler - Misemer Pharmaceutical (784121365)
    Registrant - Misemer Pharmaceutical (784121365)