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BiferaRx

Generic Name: folic acid, cyanocobalamin, iron dextran and heme iron polypeptide
Dosage Form: tablet

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.

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, 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 for BiferaRx

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.

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.

BiferaRx Dosage and Administration

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

How is BiferaRx 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

PRINCIPAL DISPLAY PANEL – 90-COUNT BOTTLE

NDC 0037-6885-90
90 Tablets
Rx Only

BiferaRx®

Distributed by:
Meda Pharmaceuticals Inc.
Somerset, New Jersey 08873-4120

BiferaRx 
folic acid, cyanocobalamin, iron dextran and heme iron polypeptide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0037-6885
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 25 ug
IRON DEXTRAN (FERRIC CATION) FERRIC CATION 22 mg
HEME IRON POLYPEPTIDE (FERROUS CATION) FERROUS CATION 6 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
CROSPOVIDONE  
MAGNESIUM STEARATE  
SILICON DIOXIDE  
POLYVINYL ALCOHOL  
LECITHIN, SOYBEAN  
TITANIUM DIOXIDE  
FD&C BLUE NO. 2  
Product Characteristics
Color RED (maroon) Score 2 pieces
Shape OVAL Size 14mm
Flavor Imprint Code 68;85
Contains         
Packaging
# Item Code Package Description
1 NDC:0037-6885-90 90 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/31/2012
Labeler - Meda Pharmaceuticals (051229602)
Revised: 06/2015
 
Meda Pharmaceuticals
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