BiferaRx (Folic acid Heme Iron polypeptide Iron Dextran, Cyanocobalamin Tablets): Uses, Dosage, Side Effects, Interactions, Warning

PROFESSIONAL SIDE EFFECTS

Drug Description

What is BiferaRx and how is it used?

BiferaRx is an over the counter and prescription medicine used to treat the symptoms of Anemia, Poor Diet, Surgery Recovery and Pregnancy. BiferaRx may be used alone or with other medications.

BiferaRx belongs to a class of drugs called Iron Productions, Vitamin and Mineral Combinations.

It is not known if BiferaRx is safe and effective in children younger than 12 years of age.

What are the possible side effects of BiferaRx?

BiferaRx may cause serious side effects including:

hives,
difficulty breathing,
swelling of your face, lips, tongue, or throat,
rash,
itching, and
severe dizziness

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of BiferaRx include:

constipation,
diarrhea,
upset stomach, and
dark or black stool

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of BiferaRx. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

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 & Dosage

INDICATIONS

BiferaRx™ is a prescription iron supplement indicated for use in improving the nutritional status of iron deficiency.

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.

For medical inquiries call toll free 1-888-317-0001. www.BiferaRx.com. Manufactured for: ALAVEN PHARMACEUTICAL LLC, Marietta, GA 30062.Revised: Mar 2010

Side Effects & Drug Interactions

SIDE EFFECTS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

DRUG INTERACTIONS

No information provided.

Warnings & Precautions

WARNINGS

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.

Overdosage & Contraindications

OVERDOSE

No information provided.

CONTRAINDICATIONS

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Hemochromatosis and hemosiderosis are contraindications to iron therapy.

Clinical Pharmacology

CLINICAL PHARMACOLOGY

No information provided.

Medication Guide

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

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