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Purpose

Dietary Supplement

Manufacturer

Breckenridge

Active Ingredients

1 Capsule: Iron (Elemental) (as Polysaccharide-Iron) 150 mg

Directions

One or two capsules daily or as prescribed by a physician. Store at 25 degrees C (77 degrees F); excursions permitted to 15-30 degrees C (59-86 degrees F). See USP controlled room temperature.

Inactive Ingredients

Sodium Lauryl Sulfate; Gelatin; Microcrystalline Cellulose; Stearic Acid; Polyethylene Glycol; Citric Acid; Croscarmellose Sodium; Titanium Dioxide; FD&C Yellow No. 5 Lake;* Polyvinylpyrrolidone; FD&C Blue No. 1 Lake; FD&C Red No. 40 Lake; FD&C Red No. 3 Lake; *Contains FD&C Yellow #5 Lake (Tartrazine) as a Color Additive

Uses

Ferrex 150 is indicated for the prevention and treatment of iron deficiency anemia and/or nutritional megaloblastic anemias.

Warnings

CONTRAINDICATIONS: Ferrex 150 is contraindicated in patients with a known hypersensitivity to any of the components of this product. Hemachromatosis and hemosiderosis are contraindications to iron therapy. The type of anemia and the underlying cause or causes should be determined before initiating treatment with Ferrex 150. Since the anemia may be a result of a systematic disturbance, such as a recurrent blood loss, the underlying cause or causes should be corrected if possible. As with all oral iron preparations, Ferrex 150 should be stored out of the reach of children to protect against accidental iron poisoning. Patients should not exceed the recommended dosage unless directed by a physician. Patients should be informed that iron products can cause dark or black stools. 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. ADVERSE REACTIONS: Adverse reactions with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stool and abdominal pain. Adverse reactions with iron therapy are usually transient. OVERDOSE: The clinical cause of acute iron overdose 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. The Oral LD 50 of polysaccharide-iron complex was estimated to be greater than 5000 mg iron/1 kg in rats. Chronic toxicity studies in rats and dogs administered polysaccharide-iron complex showed that a daily dosage of 250 mg iron/kg for three months had no adverse effects. Keep this and all medications out of the reach of children.
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