BiferaRx
Bifera Rx™ Iron Supplement Tablets
FULL PRESCRIBING INFORMATION: CONTENTS*
- BIFERARX DESCRIPTION
- BIFERARX INDICATIONS AND USAGE
- BIFERARX CONTRAINDICATIONS
- PRECAUTIONS
- BIFERARX ADVERSE REACTIONS
- BIFERARX DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- PRINCIPAL DISPLAY PANEL - 90 Tablet Label
FULL PRESCRIBING INFORMATION
Rx Only
BIFERARX 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®
BiferaRx™ is a trademark of Alaven® Pharmaceutical LLC, Marietta, GA. |
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).
BIFERARX INDICATIONS AND USAGE
BiferaRx™ is a prescription iron supplement indicated for use in improving the nutritional status of iron deficiency.
BIFERARX CONTRAINDICATIONS
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Hemochromatosis and hemosiderosis are contraindications to iron therapy.
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.
BIFERARX ADVERSE REACTIONS
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
BIFERARX 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
- 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
BiferaRxFOLIC ACID, Heme Iron Polypeptide, IRON DEXTRAN, and CYANOCOBALAMIN TABLET
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