Label: ZYREXAL- viatmin c, thiamine, vitamin b6, folate,vitamin b12, vitamin b3, d-ribose, coenzyme q-10 tablet

  • NDC Code(s): 72380-915-10
  • Packager: Vivera Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated February 10, 2020

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    FACTS

    Zyrexal™ is an orally administered prescription tablet
    formulation for the clinical dietary management of
    suboptimal nutritional status in patients where advanced
    folate supplementation is required and nutritional
    supplementation in physiologically stressful conditions for
    maintenance of good health is needed.

  • WARNINGS AND PRECAUTIONS

    WARNINGS AND PRECAUTIONS

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

    Tell your doctor if you have: kidney problems, thyroid disease.
    This medication should be used as directed during pregnancy
    or while breast-feeding. Consult your doctor about the risks
    and benefits. Folic acid alone is improper therapy in the
    treatment of pernicious anemia and other megaloblastic
    anemias where vitamin B12 is deficient. Folic acid in doses
    above 0.1 mg daily may obscure pernicious anemia in
    that hematologic remission can occur while neurological
    manifestations progress.

    Allergic sensitization has been reported following both oral
    and parenteral administration of folic acid. You should call
    your doctor for medical advice about serious adverse events.
    To report adverse side effects or to obtain product information,
    contact Vivera™ Pharmaceuticals, at 1-844-484-8372.

  • DOSAGE & ADMINISTRATION

    DOSAGE & ADMINISTRATION

    Usual adult dose is one (1) tablet once or twice daily or as
    prescribed by a licensed medical practitioner.*

  • HOW SUPPLIED

    HOW SUPPLIED
    Zyrexal™ tablets are supplied as a coated, white, flat, round
    tablet with “915” printed on one side, dispensed in a
    child-resistant bottle of 30ct. (72380-915-10*)

  • STORAGE AND HANDLING

    STORAGE AND HANDLING
    Store at 20°-25°C (68°-77°F); excursions permitted to 15°-
    30°C (59°-86°F) [See USP Controlled Room Temperature.]
    Protect from heat, light and moisture.

  • PREGNANCY

    If you are pregnant or nursing, ask a
    healthcare professional.

  • OTHER SAFETY INFORMATION

    KEEP OUT OF THE REACH OF CHILDREN. Do not use if
    seal is broken or missing.

  • OTHER SAFETY INFORMATION

    * This product is a prescription-folate with or without other dietary in-
    gredients that – due to increased folate levels (AUG 2 1973 FR 20750),
    requires an Rx on the label because of increased risk associated with
    masking of B12 deficiency (pernicious anemia). Based on our assess-
    ment of the risk of obscuring pernicious anemia, this product requires
    licensed medical supervision, an Rx status, and a National Drug Code
    (NDC) – or similarly-formatted product code, as required by pedigree
    reporting requirements and supply-chain control as well as – in some
    cases, for insurance-reimbursement applications.

  • Package Label

    NDC# 72380-915-10

    VIVERA™
    PHARMACEUTICALS

    Zyrexal™

    30 Tablets

    Dispensed by Prescription Only

    Supplement Facts
    Servings size: 1 Tablet                               Servings per container: 30
                                                    Amount Per Serving      %Daily Value
    Vitamin C (As Ascorbic Acid)                           125mg                138%
    Thiamine (As Thiamine HCL)                            25mg              2,083%
    Vitamin B6 (As Pyridoxal Phosphate)              12.5mg                735%
    Folate                                                1700 mcg DFE                425%
                                                         (1 mg Folic Acid)
    Vitamin B12 (As Methylcobalamin)                     1mg            41,666%
    Vitamin B3 (As Niacinamide)                            60mg                375%
    D-Ribose                                                        50mg                   *
    CoEnzyme Q-10 (As Ubiquinone)                      75mg                   *

    * % Daily Values have not been established.

    Other ingredients: Microcrystalline Cellulose,
    Magnesium Stearate, Silicone Dioxide

    Dosage: Adult dose is one (1) tablet
    once or twice daily or as prescribed by a
    licensed medical practitioner.

    If you are pregnant or nursing, ask a
    healthcare professional.

    KEEP OUT OF REACH OF CHILDREN

    STORAGE: Store at 20°-25°C (68°-77°F);
    excusions permitted to 15°-30°C (59°-86°F)
    [See USP Controlled Room Temperature.]
    Protect from heat, light , and moisture.

    Manufactured for:
    Vivera Pharmaceuticals, Inc.
    11100 Greenstone Ave.
    Santa Fe Springs, CA 90670

    MADE IN THE U.S.A.

    REV120519

    LOT NO:
    EXP. DATE:
    MFG. DATE:

    3  72380 00005  6

    Zyrexal 916-30

    RES

  • INGREDIENTS AND APPEARANCE
    ZYREXAL 
    viatmin c, thiamine, vitamin b6, folate,vitamin b12, vitamin b3, d-ribose, coenzyme q-10 tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:72380-915
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID125 mg
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE25 mg
    PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE12.5 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    METHYLCOBALAMIN (UNII: BR1SN1JS2W) (METHYLCOBALAMIN - UNII:BR1SN1JS2W) METHYLCOBALAMIN1 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE60 mg
    .BETA.-D-RIBOSE (UNII: IVV837V11N) (.BETA.-D-RIBOSE - UNII:IVV837V11N) .BETA.-D-RIBOSE50 mg
    UBIDECARENONE (UNII: EJ27X76M46) (UBIDECARENONE - UNII:EJ27X76M46) UBIDECARENONE75 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize16mm
    FlavorImprint Code 915
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72380-915-1030 in 1 BOTTLE; Type 0: Not a Combination Product02/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/07/2020
    Labeler - Vivera Pharmaceuticals, Inc. (081244342)