BiferaRx

Meda Pharmaceuticals Inc.

FULL PRESCRIBING INFORMATION: CONTENTS*

• BIFERARX DESCRIPTION
  • Each BiferaRx® tablet contains:
• BIFERARX INDICATIONS AND USAGE
• BIFERARX CONTRAINDICATIONS
• PRECAUTIONS
• BIFERARX ADVERSE REACTIONS
• BIFERARX DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• STORAGE
• PRINCIPAL DISPLAY PANEL – 90-COUNT BOTTLE

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 “68|85” on one side, and plain on the other.

Each BiferaRx® tablet contains:

VITAMINS
Folic Acid......................................................................................................1 mg
B₁₂ (as cyanocobalamin)............................................................................25 mcg

MINERALS
Iron
   as Polysaccharide Iron Complex................................................................22mg
   as HIP (heme iron polypeptide as Proferrin^®*- bovine source,
   USDA certified)..........................................................................................6 mg

OTHER INGREDIENTS
Microcrystalline cellulose, dibasic calcium phosphate, crospovidone, resin, protease (Alcalase Enzyme), sucrose, magnesium stearate, silicon dioxide, coating (polyvinyl alcohol, hypromellose, talc, FD&C Red # 40 Aluminum Lake, polyethylene glycol, lecithin, titanium dioxide, FD&C Blue # 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.

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 0037-6885-90)

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).

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

To report SUSPECTED ADVERSE REACTIONS contact Meda Pharmaceuticals Inc. at 1-888-349-5556 or FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch

www.BiferaRx.com

Manufactured by:
Nexgen Pharma
Colorado Springs, CO 80905

For:

MEDA PHARMACEUTICALS®
Meda Pharmaceuticals Inc.
Somerset New Jersey 08873-4120

U.S. Patent Nos. 7,585,527 and 8,080,520
*Proferrin® is a registered trademark of Colorado BioLabs, Inc., Cozad, NE.

BIFERARX and the BIFERA logo are registered trademarks, and the BIFERARX logo is a trademark of Alaven Pharmaceutical LLC, used under license by Meda Pharmaceuticals Inc.

© 2012 Meda Pharmaceuticals Inc.          IN-6885-01

                                                                Rev 01/12

PRINCIPAL DISPLAY PANEL – 90-COUNT BOTTLE

NDC 0037-6885-90
90 Tablets
Rx Only

BiferaRx®
Manufactured by:
Nexgen Pharma
Colorado Springs
Colorado 80905

For:
MEDA PHARMACEUTICALS®
Meda Pharmaceuticals Inc.
Somerset, New Jersey 08873-4120

www.BiferaRx.com