WARNING: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

You should contact your healthcare provider for medical advice about adverse events. To report a serious adverse event, contact US Pharmaceutical Corporation, P.O. Box 360465, Decatur, GA 30036.

INDICATIONS AND USAGE: For the treatment of iron deficiency anemia and folate deficiency anemia. Hemocyte-F is indicated in pregnancy for the prevention and treatment of iron deficiency and to supply a maintenance dosage of folic acid.

CONTRAINDICATIONS: Hemocyte-F is contraindicated in patients with known hypersensitivity to any of its ingredients. Also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.

PRECAUTIONS: General: Anemia is a manifestation that requires appropriate investigation to determine its cause or causes. No single regimen fits all cases, and the status of the patient observed in follow-up is the final criterion for adequacy of therapy. Periodic clinical and laboratory studies are considered essential. Blood examinations including hemoglobin and hematocrit should be done at the usual intervals to make certain therapy is adequate. Use with care in the presence of peptic ulcer, regional enteritis and ulcerative colitis. Folic acid, especially in doses above 0.1 mg - 0.4 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive.

Usage in Pregnancy: Before Hemocyte-F is prescribed for megaloblastic anemia in pregnancy, appropriate diagnostic exclusion of Addisonian pernicious anemia, (due to faulty or blocked absorption for Vitamin B12, or extrinsic factor, on either a genetic, immunological or surgical basis), should be carried out. Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: No clinical studies have been performed in patients 65 and over to determine whether older persons respond differently from younger persons. Dosage should always begin at the low end of the dosage scale and should consider that elderly persons may have decreased hepatic, renal, or cardiac function, and of concomitant disease.

ADVERSE REACTIONS: Ferrous fumarate has been implicated in some instances of gastrointestinal disturbances, including abdominal cramps, diarrhea, constipation, heartburn, nausea and vomiting. Reducing the dose and administering it with meals will minimize these effects in the sensitive patient. Increasing fiber in the diet can relieve constipation. Iron may turn stools black. This is a harmless effect that is a result of unabsorbed iron. Allergic sensitization has been reported following oral administration of folic acid.

OVERDOSAGE: Iron: Signs and Symptoms: Acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness and coma. The estimated lethal dose of orally ingested elemental iron is 300 mg per kg of body weight. Hemocyte-F should be stored beyond the reach of children to protect against accidental iron poisoning. Keep this product and all drugs out of reach of children.

Treatment: For specific therapy, exchange transfusion and chelating agents should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk, administer intravenous fluids and electrolytes and use oxygen.

DOSAGE AND ADMINISTRATION: Usual adult dose is one tablet taken orally daily or as prescribed by a physician.

HOW SUPPLIED: Hemocyte-F are maroon film coated round tablets debossed with "US" logo on one side and “F” on the other side. Hemocyte-F are supplied in child resistant unit dose packs of 100 tablets and 30 tablets. Boxes of 100’s: NDC 52747-306-70, Boxes of 30’s: NDC 52747-306-30. Dispense in a tight, light resistant container as defined in the USP/NF with a child resistant closure. Store at controlled room temperature 15°C-30°C (59°F-86°F). Keep in a cool, dry place.

Rx only.