Ferrex 150 Forte Plus Capsules

Medical Foods: Medical foods are intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone. Although a medical-food product is intended for use under the active and ongoing medical supervision, FDA does not require a prescription. Rev. 6/11

Sumalate (Ferrous Asparto Glycinate) is a registered trademark of Albion International Inc., Clearfield, Utah and is licensed exclusively to Breckenridge Pharmaceutical, Inc., for certain iron products.

Adverse reactions: Adverse reactions with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Adverse reactions with iron therapy are usually transient. Precautions: General: Do not exceed recommended dose. The type of anemia and the underlying cause or causes should be determined before starting with Ferrex 150 Forte Plus. Since the anemia may be a result a systemic disturbance, such as recurrent blood loss, the underlying cause or causes should be corrected, if possible. Folic Acid in doses about 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using this product since folic acid may make the symptoms of pernicious anemia. Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Overdosage: The clinical course of acute iron overdosage can be variable. Initial symptoms may include abdominal pain, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, hypotension, tachycardia, metabolic acidosis, hyperglycemia, dehydration, drowsiness, pallor, cyanosis, lassitude, seizures, shock and coma. Warnings: Warning: Accidental overdose of iron-containing products is the 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. If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, or health-care provider before using or continuing use. Contraindications: Ferrex 150 Forte Plus is contraindicated in patients with a known hypersensitivity to any of the components of this product. Hemochromatosis and hemosiderosis are contraindications to the use of this product. To report a serious adverse event contact: 1-800-367-3395.