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

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

Drug Label Information

Updated April 11, 2016

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

  • STATEMENT OF IDENTITY

    DESCRIPTION: Av-VITE FB Forte Tablets are an orally administered prescription dietary supplement for the management of patients requiring increased folate levels.

     Av-VITE FB Forte Tablets 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 B12 (as Cyanocobalamin) 2 mg 33333%

    Other Ingredients: Dibasic Calcium Phosphate Dihydrate, Microcrystalline Cellulose, Opadry II Beige 40L17427 (Titanium Dioxide, Polydextrose, Hypromellose 3cP, Hypromellose 6cP, Triacetin, Hypromellose 50cP, Polyethylene Glycol 8000, FD&C Yellow # 6 Aluminum Lake, FD&C Blue # 2 Aluminum Lake, FD&C Red #40 Aluminum Lake), Croscarmellose Sodium, Opadry II Clear #Y-19-7483 (Hypromellose 6cP, Maltodextrin, Hypromellose 3cP, Polyethylene Glycol 400, Hypromellose 50cP) Magnesium Stearate.

    Contains: FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake

    Close
  • WARNINGS

    ALLERGY STATEMENT: 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.

    Close
  • HEALTH CLAIM

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

    Close
  • WARNINGS

    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.

    Close
  • WARNINGS

    INTERACTIONS: 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 which may interact 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).

    Close
  • HEALTH CLAIM

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

    Close
  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION: 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). 

    Close
  • HEALTH CLAIM

    HOW SUPPLIED: Av-VITE FB Forte Tablets are round, coated, beige colored tablets imprinted on one side with "V201", and are supplied in bottles of 90 tablets NDC 42291-151-90.

    Close
  • SAFE HANDLING WARNING

    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.

    Manufactured for:                     
    AvKARE, Inc.
    Pulaski, TN 38478                 

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

    Close
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    AvKARE
    NDC
    42291-151-90

    Av-VITE FB Forte

    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)
    2 mg 33333%

    Other Ingredients: Dibasic Calcium Phosphate Dihydrate, Microcrystalline Cellulose, Opadry II Beige 40L17427 (Titanium Dioxide, Polydextrose, Hypromellose 3cP, Hypromellose 6cP, Triacetin, Hypromellose 50cP, Polyethylene Glycol 8000, FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C RED #40 Aluminum Lake), Croscarmellose Sodium, Opadry ll Clear #Y-19-7483 (Hypromellose 6cP, Maltodextrin, Hypromellose 3cP, Polyethylene Glycol 400, Hypromellose 50cP) Magnesium Stearate

    Contains: FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake.

    DESCRIPTION:
    Av-VITE FB Forte 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 tablet(s) 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 to 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 04/16 (P)

    1 label
    2 label
    Close
  • INGREDIENTS AND APPEARANCE
    AV-VITE FB FORTE  
    pyridoxine hydrochloride, folic acid, and cyanocobalamin tablet, coated
    Product Information
    Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:42291-151(NDC:76439-365)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 25 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 2.5 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 2 mg
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Polydextrose (UNII: VH2XOU12IE)  
    TRIACETIN (UNII: XHX3C3X673)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:42291-151-90 90 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    DIETARY SUPPLEMENT 11/05/2015
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving % Daily Value
    color
    scoring 1
    shape
    size (solid drugs) 9 mm
    imprint
    Labeler - AvKARE, Inc. (796560394)
    Close