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Name:Biferarx
Manufacturer:Alaven Pharmaceutical Llc
Category:Prescription Marketed Drugs


Bifera Rx™ Iron Supplement Tablets

BIFERARX - folic acid, heme iron polypeptide, iron dextran and cyanocobalamin tablet 
Alaven Pharmaceutical LLC

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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Bifera Rx™
Iron Supplement Tablets

Rx Only

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

*
Proferrin® is a registered trademark of Colorado Biolabs, Inc. Cozad, NE.
BiferaRx™ is a trademark of Alaven® Pharmaceutical LLC, Marietta, GA.
Iron
  as PIC (polysaccharide iron complex) 22 mg
  as HIP (heme iron polypeptide as Proferrin®* - 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).

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.

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 0.1mg 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.

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 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

  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.

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

Principal Display Panel - 90 Tablet Label

BIFERARX 
folic acid, heme iron polypeptide, iron dextran, and cyanocobalamin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68220-085
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
Heme Iron Polypeptide (Heme Iron Polypeptide) Heme Iron Polypeptide 6 mg
IRON DEXTRAN (IRON DEXTRAN) IRON DEXTRAN 22 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 25 ug
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE 184 mg
CROSCARMELLOSE SODIUM 50 mg
MAGNESIUM STEARATE 2.5 mg
Crospovidone 15 mg
SILICON DIOXIDE 2.5 mg
POLYVINYL ALCOHOL  
POLYETHYLENE GLYCOL  
TALC  
TITANIUM DIOXIDE  
FD&C RED NO. 40  
FD&C BLUE NO. 2  
Product Characteristics
Color ORANGE Score 2 pieces
Shape OVAL Size 15mm
Flavor Imprint Code AP;85
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68220-085-25 1 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK (68220-085-05)
1 NDC:68220-085-05 5 TABLET ( TABLET) in 1 BLISTER PACK This package is contained within the CARTON (68220-085-25)
2 NDC:68220-085-90 90 TABLET ( TABLET) in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 05/01/2010

Labeler - Alaven Pharmaceutical LLC (140210829)
Establishment
Name Address ID/FEI Operations
Nexgen Pharma Inc. 160356114 MANUFACTURE, ANALYSIS
Establishment
Name Address ID/FEI Operations
Carton Services Inc 004215968 REPACK

Revised: 03/2010 Alaven Pharmaceutical LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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