HEMAX Warnings

WARNINGS AND CONTRAINDICATIONS:

WARNINGS: These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

CONTRAINDICATIONS: HEMAX™ is contraindicated in patients with a known hypersensitivity to any of the components of this product. 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 the reach of children. In case of accidental overdose, call a doctor or Poison Control Center immediately.

PRECAUTIONS: Do not exceed recommended or prescribed dose. Some patients affected with pernicious anemia may not respond to orally administered Vitamin B-12 with intrinsic factor concentrate and there is no known way to predict which patients will respond or which patients may cease to respond. Periodic examinations, laboratory studies of pernicious anemia patients are essential and recommended. If any symptoms of intolerance occur, the drug should be temporarily or permanently discontinued, which should be determined by physician.

ADVERSE REACTIONS: Adverse reactions with iron therapy in general may occur, such as: gastrointestinal intolerance, nausea, vomiting, diarrhea, dark stools or abdominal pain. Skin rashes of various types may occur. Such reactions may necessitate temporary or permanent changes in dosage or usage. Also, allergic sensitization has been reported following both oral and parenteral administration of folic acid.