Label: BIFERARX- folic acid, heme iron polypeptide, iron dextran and cyanocobalamin tablet

  • NDC Code(s): 68220-085-05, 68220-085-25, 68220-085-90
  • Packager: Alaven Pharmaceutical LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 03/10

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

  • BOXED WARNING(What is this?)

    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.

    Close
  • SPL UNCLASSIFIED SECTION

    Rx Only

    Close
  • 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).

    Close
  • INDICATIONS AND USAGE

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

    Close
  • CONTRAINDICATIONS

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

    Hemochromatosis and hemosiderosis are contraindications to iron therapy.

    Close
  • 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.

    Close
  • ADVERSE REACTIONS

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

    Close
  • DOSAGE AND ADMINISTRATION

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

    Close
  • 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.

    Close
  • SPL UNCLASSIFIED SECTION

    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

    Close
  • REFERENCES

    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.
    Close
  • SPL UNCLASSIFIED SECTION

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

    19/03/10      6:20 PM

    Close
  • 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
    Close
  • INGREDIENTS AND APPEARANCE
    BIFERARX 
    folic acid, heme iron polypeptide, iron dextran, and cyanocobalamin tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68220-085
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
    Heme Iron Polypeptide (Heme Iron Polypeptide) Heme Iron Polypeptide 6 mg
    IRON DEXTRAN (IRON DEXTRAN) IRON DEXTRAN 22 mg
    CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 25 ug
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE 184 mg
    CROSCARMELLOSE SODIUM 50 mg
    MAGNESIUM STEARATE 2.5 mg
    Crospovidone 15 mg
    SILICON DIOXIDE 2.5 mg
    POLYVINYL ALCOHOL  
    POLYETHYLENE GLYCOL  
    TALC  
    TITANIUM DIOXIDE  
    FD&C RED NO. 40  
    FD&C BLUE NO. 2  
    Product Characteristics
    Color ORANGE Score 2 pieces
    Shape OVAL Size 15mm
    Flavor Imprint Code AP;85
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68220-085-25 1 in 1 CARTON
    1 NDC:68220-085-05 5 in 1 BLISTER PACK
    2 NDC:68220-085-90 90 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 05/01/2010
    Labeler - Alaven Pharmaceutical LLC (140210829)
    Establishment
    Name Address ID/FEI Business Operations
    Nexgen Pharma Inc. 160356114 MANUFACTURE, ANALYSIS
    Establishment
    Name Address ID/FEI Business Operations
    Carton Services Inc 004215968 REPACK
    Close