Bifera Rx™ Iron Supplement Tablets

Drug Labeling and Warnings

Drug Details [pdf]

BIFERARX- folic acid, heme iron polypeptide, iron dextran, and cyanocobalamin tablet 
Alaven Pharmaceutical LLC

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.

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Bifera Rx™
Iron Supplement Tablets

Rx Only

DESCRIPTION

BiferaRx™ is a prescription iron supplement. BiferaRx™ is a small oval, film-coated maroon tablet, with black core, debossed and bisected with "AP|85" on one side, and plain on the other.

Each BiferaRx™ tablet contains:

VITAMINS

Amount per serving

Folic Acid

1 mg

B12 (as cyanocobalamin)

25 mcg

MINERALS

  • * Proferrin® is a registered trademark of Colorado Biolabs, Inc. Cozad, NE.
    BiferaRx™ is a trademark of Alaven® Pharmaceutical LLC, Marietta, GA.
    		•

    Iron

      as PIC (polysaccharide iron complex)

    22 mg

      as HIP (heme iron polypeptide as Proferrin®* - bovine source, USDA certified)

    6 mg

    INACTIVE INGREDIENTS

    Microcrystalline cellulose, croscarmellose sodium, crospovidone, magnesium stearate, silicon dioxide, coating (polyvinyl alcohol, polyethylene glycol, talc, FD&C red no. 40 aluminum lake, titanium dioxide, FD&C blue no. 2 aluminum lake).

    INDICATIONS AND USAGE

    BiferaRx™ is a prescription iron supplement indicated for use in improving the nutritional status of iron deficiency.

    CONTRAINDICATIONS

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

    Hemochromatosis and hemosiderosis are contraindications to iron therapy.

    WARNING

    Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6.

    Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

    PRECAUTIONS

    Folic acid when administered as a single agent in doses above 0.1mg daily may obscure pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. While prescribing this nutritional supplement for pregnant women, nursing mothers, or for women prior to conception, their medical condition and other drugs, herbs, and/or supplements consumption should be considered.

    ADVERSE REACTIONS

    Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

    DOSAGE AND ADMINISTRATION

    One tablet daily with or without food or as prescribed by a licensed healthcare provider with prescribing authority.

    HOW SUPPLIED

    BiferaRx™ tablets are supplied in child-resistant bottles of 90 tablets (NDC: 68220-085-90) and as a Professional Sample 5 tablet blister pack (NDC: 68220-085-25).

    KEEP OUT OF REACH OF CHILDREN.

    STORAGE

    Store at controlled room temperature 20°-25°C (68°-77°F). Excursions permitted to 15°-30°C (59°-86°F). [See current USP]

    Dispense in a tight, light-resistant container to protect from light and moisture.

    U.S. Patent No. 7,585,527

    For medical inquiries call toll free 1-888-317-0001

    www.BiferaRx.com

    Manufactured for:
    ALAVEN®
    PHARMACEUTICAL LLC
    Marietta, GA 30062

    • 1. Frykman E, bystron M, Jansoon U, Edberg A, Hansen T. Side effects of iron supplements in blood donors: superior tolerance of heme iron. J Lab Clin Med. 1994; 123:561-564.

    6-085-00-01-0310
    CL085-00-01-0210

    19/03/10      6:20 PM

    PRINCIPAL DISPLAY PANEL - 90 Tablet Label

    NDC: 68220-085-90
    90 Tablets

    Bifera Rx™
    Iron Supplement

    Rx Only

    Manufactured for:
    ALAVEN®
    PHARMACEUTICAL LLC
    Marietta, GA 30062

    www.BiferaRx.com

    Principal Display Panel - 90 Tablet Label
    BIFERARX 
    folic acid, heme iron polypeptide, iron dextran, and cyanocobalamin tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 68220-085
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    HEME IRON POLYPEPTIDE (UNII: 31VDO12CJY) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION6 mg
    IRON DEXTRAN (UNII: 95HR524N2M) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION22 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN25 ug
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) 184 mg
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) 50 mg
    MAGNESIUM STEARATE (UNII: 70097M6I30) 2.5 mg
    CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK) 15 mg
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 2.5 mg
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    Product Characteristics
    ColorORANGEScore2 pieces
    ShapeOVALSize15mm
    FlavorImprint Code AP;85
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 68220-085-251 in 1 CARTON05/01/201009/30/2019
    1NDC: 68220-085-055 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC: 68220-085-9090 in 1 BOTTLE; Type 0: Not a Combination Product05/01/201009/30/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other05/01/201009/30/2019
    Labeler - Alaven Pharmaceutical LLC (140210829)

    Revised: 3/2010
    Document Id: 3b5a2f02-2e8a-4e25-8379-a5c4de354c4c
    Set id: a7c1400a-d230-45db-afff-d5f70b091ee9
    Version: 2
    Effective Time: 20100331