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BiferaRx (folic acid 1 mg heme iron polypeptide 6 mg iron dextran 22 mg cyanocobalamin 25 ug cellulose, microcrystalline 184 mg croscarmellose sodium 50 mg magnesium stearate 2.5 mg crospovidone 15 mg silicon dioxide 2.5 mg) Dailymed

  1. Human Prescription
  2. Archived
    • May Be Discontinued
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  3. Alaven Pharmaceutical LLC

Generic: folic acid, heme iron polypeptide, iron dextran, and cyanocobalamin

BiferaRx tablet - (folic acid 1 mg heme iron polypeptide 6 mg iron dextran 22 mg cyanocobalamin 25 ug cellulose, microcrystalline 184 mg croscarmellose sodium 50 mg magnesium stearate 2.5 mg crospovidone 15 mg silicon dioxide 2.5 mg) image

IMPRINT: AP 85     SHAPE: oval
    COLOR: orange    SCORE: 2

Boxed Warning

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.

  1. FDA Adverse Reactions

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Rx Only

Description


BiferaRxâ„¢ is a prescription iron supplement. BiferaRxâ„¢ 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 BiferaRxâ„¢ tablet contains:

VITAMINS


Amount per serving

Folic Acid
1 mg

B12 (as cyanocobalamin)
25 mcg

MINERALS


Iron

  as PIC (polysaccharide iron complex)
22 mg

  as HIP (heme iron polypeptide as Proferrin® Proferrin® is a registered trademark of Colorado Biolabs, Inc. Cozad, NE.BiferaRx™ is a trademark of Alaven® Pharmaceutical LLC, Marietta, GA. - 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


BiferaRxâ„¢ 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


BiferaRxâ„¢ tablets are supplied in child-resistant bottles of 90 tablets (NDC 68220-085-90) and as a Professional Sample 5 tablet buler 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 LLCMarietta, GA 30062

References Section

  • 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 Rxâ„¢ Iron Supplement

Rx Only

Manufactured for: ALAVEN® PHARMACEUTICAL LLCMarietta, GA 30062

www.BiferaRx.com

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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