BIFERARX- folic acid, cyanocobalamin, iron dextran and heme iron polypeptide tablet
Meda Pharmaceuticals
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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BiferaRx®
Iron Supplement Tablets
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:
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VITAMINS
Folic Acid......................................................................................................1 mg
B 12 (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, magnesium stearate, silicon dioxide, resin, coating (polyvinyl alcohol, hypromellose, talc, FD&C Red # 40 Aluminum Lake, polyethylene glycol, lecithin, titanium dioxide, FD&C Blue # 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.
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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 0.1 mg 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 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
- Distributed by:
Meda Pharmaceuticals Inc.
Somerset New Jersey 08873-4120
© 2014 Meda Pharmaceuticals Inc.
- 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.
MEDA PHARMACEUTICALS mark and logo are trademarks of Meda AB.
IN-6885-02 Rev 6/2014
| BIFERARX
folic acid, cyanocobalamin, iron dextran and heme iron polypeptide tablet |
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| Labeler - Meda Pharmaceuticals (051229602) |