{"adverse_reactions":["ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid."],"boxed_warning":["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."],"contraindications":["CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contraindications to iron therapy."],"description":["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 Iron as PIC (polysaccharide iron complex) 22 mg as HIP (heme iron polypeptide as Proferrin ® Proferrin ® is a registered trademark of Colorado Biolabs, Inc. Cozad, NE. BiferaRx™ is a trademark of Alaven ® Pharmaceutical LLC, Marietta, GA. - 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)."],"description_table":["<table width=\"50%\"> <col width=\"36%\"/> <col width=\"14%\"/> <tbody> <tr> <td styleCode=\"Toprule \" valign=\"top\"> <paragraph> <content styleCode=\"bold\">Amount per serving</content> </paragraph> </td> <td styleCode=\"Toprule \" valign=\"top\"/> </tr> <tr> <td valign=\"top\"> <paragraph>Folic Acid</paragraph> </td> <td valign=\"top\"> <paragraph>1 mg</paragraph> </td> </tr> <tr> <td styleCode=\"Botrule \" valign=\"top\"> <paragraph>B12 (as cyanocobalamin)</paragraph> </td> <td styleCode=\"Botrule \" valign=\"top\"> <paragraph>25 mcg</paragraph> </td> </tr> </tbody> </table>","<table width=\"50%\"> <col width=\"36%\"/> <col width=\"14%\"/> <tbody> <tr> <td styleCode=\"Toprule \" valign=\"top\"> <paragraph>Iron</paragraph> </td> <td styleCode=\"Toprule \" valign=\"top\"/> </tr> <tr> <td valign=\"top\"> <paragraph> as PIC (polysaccharide iron complex)</paragraph> </td> <td valign=\"top\"> <paragraph>22 mg</paragraph> </td> </tr> <tr> <td styleCode=\"Botrule \" valign=\"top\"> <paragraph> as HIP (heme iron polypeptide as Proferrin<sup>&#xAE;</sup> <footnote ID=\"_RefID0EKIAC\">Proferrin<sup>&#xAE;</sup> is a registered trademark of Colorado Biolabs, Inc. Cozad, NE. BiferaRx&#x2122; is a trademark of Alaven<sup>&#xAE;</sup> Pharmaceutical LLC, Marietta, GA.</footnote> - bovine source, USDA certified)</paragraph> </td> <td styleCode=\"Botrule \" valign=\"top\"> <paragraph>6 mg</paragraph> </td> </tr> </tbody> </table>"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION One tablet daily with or without food or as prescribed by a licensed healthcare provider with prescribing authority."],"effective_time":"20100331","how_supplied":["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."],"id":"3b5a2f02-2e8a-4e25-8379-a5c4de354c4c","indications_and_usage":["INDICATIONS AND USAGE BiferaRx™ is a prescription iron supplement indicated for use in improving the nutritional status of iron deficiency."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 90 Tablet Label NDC 68220-085-90 90 Tablets B ifera R x™ Iron Supplement Rx Only Manufactured for: ALAVEN ® PHARMACEUTICAL LLC Marietta, GA 30062 www.BiferaRx.com Principal Display Panel - 90 Tablet Label"],"precautions":["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."],"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."],"set_id":"a7c1400a-d230-45db-afff-d5f70b091ee9","spl_product_data_elements":["BiferaRx FOLIC ACID, Heme Iron Polypeptide, IRON DEXTRAN, and CYANOCOBALAMIN FOLIC ACID FOLIC ACID HEME IRON POLYPEPTIDE FERROUS CATION IRON DEXTRAN FERRIC CATION CYANOCOBALAMIN CYANOCOBALAMIN MICROCRYSTALLINE CELLULOSE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE CROSPOVIDONE (15 MPA.S AT 5%) SILICON DIOXIDE POLYVINYL ALCOHOL, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED TALC TITANIUM DIOXIDE FD&C RED NO. 40 FD&C BLUE NO. 2 AP;85"],"spl_unclassified_section":["Rx Only","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","6-085-00-01-0310 CL085-00-01-0210 19/03/10 6:20 PM"],"storage_and_handling":["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."],"version":"2"}