Label: AV-VITE FB - folic acid, pyridoxine hydrochloride and cyanocobalamin tablet

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated April 12, 2016

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

  • HEALTH CLAIM

    Prescription Folic Acid-Containing Dietary Supplement

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  • STATEMENT OF IDENTITY

    DESCRIPTION: The Av-VITE FB Tablet is an orally administered prescription dietary supplement for management of patients requiring increased folate levels.

    The Av-VITE FB Tablet should be administered under the supervision of a licensed medical practitioner.

    Supplement Facts
    Serving Size: 1 Tablet
    Amount per Serving % Daily Value
    Vitamin B6 (as Pyridoxine HCl) 25 mg             1250%
    Folic Acid 2.5 mg 625%
    Vitamin B(as Cyanocobalamin) 1 mg   16667%
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  • HEALTH CLAIM

    Other ingredients: Dibasic Calcium Phosphate Dihydrate, Microcrystalline Cellulose Ph101, Opadry II Pink 85F140140, (Polyvinyl Alcohol-Part Hydrolyzed, Titanium Dioxide, Macrogol/Peg, Talc, Carmine High Tint 50%, FD&C Blue #2/Indigo Carmine Al 3% - 5%), Croscarmellose Sodium, Opadry II Clear #Y-19-7483 (HPMC 2910/Hypromellose 6cP, Maltodextrin, HPMC 2910/Hypromellose 3cP, Macrogol/Peg 400, HPMC 2910/Hypromellose 50cP), Magnesium Stearate, NF.

    Contains: FD&C Blue #2 and Carmine.

    ALLERGY STATEMENTS:
    This product has been manufactured in a facility that also manufactures products containing milk and soy. Individuals with allergic tendencies to these substances should use discretion.

    Allergic reactions have been reported following the use of oral folate.

    Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with cobalamin.

    Paresthesia, somnolence, nausea, and headaches have been reported with pyridoxine.

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  • HEALTH CLAIM

    CONTRAINDICATIONS: This product is contraindicated in patients with a known hypersensitivity to any of the components contained in this product. .

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  • HEALTH CLAIM

    INTERACTIONS: Drugs which may interact with folate include but are not limited to:

    Drugs which may interact with folate include but are not limited to:
    • First generation anticonvulsants (folate may reduce their effectiveness)
    • Capecitabine (folate may enhance its toxicity)
    • Fluorouracil (folate may enhance its toxicity)

    Drugs that may interfere with folate metabolism include, but are not limited to:
    • Dihydrofolate Reductase Inhibitors
    • Fluoxetine
    • Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
    • Sulfasalazine
    • Warfarin

    Drugs which may interfere with the absorption of folate from the gastrointestinal tract or decrease plasma levels include, but are not limited to:
    • Cholestyramine
    • Colestipol
    • Oral Contraceptives
    • Methylprednisolone
    • Pancreatic Enzymes
    • Pentamidine
    • Smoking and Alcohol
    • Sulfasalazine
    • Metformin

    Drugs which may interact with vitamin B6 include, but are not limited to:
    • Levodopa (the action of levodopa may be antagonized by vitamin B6)

    Drugs which may interact with vitamin B12 include but are not limited to:
    • Antibiotics, cholestyramine, colchicines, colestipol, metformin, para-aminosalicylic, and potassium chloride (may decrease the absorption of vitamin B12).
    • Nitrous oxide (can produce a functional vitamin B12 deficiency).

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  • HEALTH CLAIM

    PREGNANCY and NURSING MOTHERS: The Av-VITE FB Tablets is not intended for use as a prenatal/postnatal multivitamin for lactating and nonlactating mothers. This product contains only B vitamins. Talk with your medical practitioner before using if pregnant or lactating.

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  • HEALTH CLAIM

    DIRECTIONS FOR USE: One to two tablets daily or as directed by a licensed medical practitioner.

    STORAGE: Store at room temperature 15° to 30°C (59° to 86°F). Protect from light and moisture. Dispense in a tight, light-resistant container.

    
HOW SUPPLIED: Av-VITE Tablets are supplied as round, coated, Pink colored tablets imprinted on one side with "V209", and are supplied in bottles of 90 tablets.  NDC 42291-149-90


    
KEEP THIS OUT OF REACH OF CHILDREN.

    
All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

    
Call your medical practitioner about side effects. You may report side effects by calling AvKARE, Inc. at 1-855-361-3993 or FDA at 1-800-FDA-1088.

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  • HEALTH CLAIM

    Manufactured for:
    AvKARE, Inc.
    Pulaski, TN  38478

    Mfg. Rev. 06/15
    AV Rev. 12/15 (P)

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    AvKARE
    NDC
    42291-149-90

    Av-VITE FB

    Prescription Folic Acid-Containing Dietary Supplement

    90 Tablets
    Must be used under the supervision of a physician.

    Supplement Facts
    Serving Size: 1 Tablet
    Amount Per Serving % Daily Value
    Vitamin B6
    (as Pyridoxine HCl)
    25 mg 1250%
    Folic Acid 2.5 mg 625%
    Vitamin B12
    (as Cyanocobalamin)
    1 mg 16667%

    Other Ingredients: Dibasic Calcium Phosphate Dihydrate, Microcrystalline Cellulose Ph101,
    Opadry II Pink 85F140140, (Polyvinyl Alcohol-Part Hydrolyzed, Titanium Dioxide, Macrogol/Peg, Talc, Carmine High Tint 50%, FD&C Blue #2/Indigo Carmine Al 3% - 5%), Croscarmellose Sodium, Opadry II Clear #Y-19-7483, (HPMC 2910/Hypromellose 6cP, Maltodextrin, HPMC 2910/Hypromellose 3cP, Macrogol/Peg 400, HPMC 2910/Hypromellose 50cP), Magnesium Stearate, NF.

    Contains: FD&C Blue #2 and Carmine.

    DESCRIPTION: Av-VITE FB is an orally administered prescription dietary supplement and should be administered
    under the supervision of a licensed medical practitioner. See package insert for complete product information.

    DIRECTION FOR USE: 1 or 2 tablets daily or as directed by a physician.

    WARNING: Keep this and all medications out of the reach of children.

    CAUTION: High levels of folic acid may, especially in older adults, hide signs of Vitamin B-12 deficiency (such as
    pernicious anemia), a condition that can cause nerve damage.

    STORAGE: Store at room temperature, 15ºC to 30ºC (59ºF - 86ºF).

    Call your licensed medical practitioner about side effects. You may report side effects by calling AvKARE at
    855-361-3993 or FDA at 1-800-FDA-1088.

    Manufactured for:
    AvKARE, Inc.
    Pulaski, TN 38478

    Mfg. Rev. 06-15          AV Rev. 04/16 (P)

    label 1
    label 1 back
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  • INGREDIENTS AND APPEARANCE
    AV-VITE FB  
    folic acid, pyridoxine hydrochloride and cyanocobalamin tablet
    Product Information
    Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:42291-149(NDC:76439-364)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 2.5 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 25 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 1 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Calcium Phosphate, Dibasic, Dihydrate (UNII: O7TSZ97GEP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Fd&c Blue No. 2 (UNII: L06K8R7DQK)  
    TALC (UNII: 7SEV7J4R1U)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:42291-149-90 90 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Dietary Supplement 01/06/2016
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving % Daily Value
    color
    scoring 1
    shape
    size (solid drugs) 8 mm
    imprint
    Labeler - AvKARE, Inc. (796560394)
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