BiferaRx

• If you have an allergy to any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have too much iron in your body.

This is not a list of all drugs or health problems that interact with BiferaRx.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take BiferaRx. This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• If you are allergic to tartrazine, talk with your doctor. Some products have tartrazine.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using BiferaRx while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Black, tarry, or bloody stools.
• Fever.
• Very upset stomach or throwing up.
• Very bad belly pain.
• Throwing up blood or throw up that looks like coffee grounds.
• Stomach cramps.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Hard stools (constipation).
• Change in color of stool to green.
• Loose stools (diarrhea).
• Belly pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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).

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contraindications to iron therapy.

NDC 0037-6885-90
90 Tablets
Rx Only

BiferaRx®

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