Your browser does not support JavaScript! BIFERARX (FOLIC ACID, HEME IRON POLYPEPTIDE, IRON DEXTRAN, AND CYANOCOBALAMIN) TABLET [ALAVEN PHARMACEUTICAL LLC]
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BIFERARX (folic acid, heme iron polypeptide, iron dextran, and cyanocobalamin) tablet
[Alaven Pharmaceutical LLC]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE: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.
Drug Label Sections

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.

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 Acid1 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 TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:68220-085
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FOLIC ACID (FOLIC ACID) FOLIC ACID1 mg
Heme Iron Polypeptide (Heme Iron Polypeptide) Heme Iron Polypeptide6 mg
IRON DEXTRAN (IRON DEXTRAN) IRON DEXTRAN22 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN25 ug
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE184 mg
CROSCARMELLOSE SODIUM50 mg
MAGNESIUM STEARATE2.5 mg
Crospovidone15 mg
SILICON DIOXIDE2.5 mg
POLYVINYL ALCOHOL 
POLYETHYLENE GLYCOL 
TALC 
TITANIUM DIOXIDE 
FD&C RED NO. 40 
FD&C BLUE NO. 2 
Product Characteristics
ColorORANGEScore2 pieces
ShapeOVALSize15mm
FlavorImprint Code AP;85
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68220-085-251 in 1 CARTON
1NDC:68220-085-055 in 1 BLISTER PACK
2NDC:68220-085-9090 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER05/01/2010
Labeler - Alaven Pharmaceutical LLC (140210829)
Establishment
NameAddressID/FEIBusiness Operations
Nexgen Pharma Inc.160356114MANUFACTURE, ANALYSIS
Establishment
NameAddressID/FEIBusiness Operations
Carton Services Inc004215968REPACK

Revised: 3/2010
 
Alaven Pharmaceutical LLC

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