The following Structured Product Label (SPL) was submitted to the FDA by Martin Ekwealor Pharmaceuticals, Inc. for the product Myferon 150 (NDC 58607-111). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding supplemental facts, indications:, warning: keep this product out of reach of children., indications and usage:, warning:, dosage and administration:, inactive ingredients other ingredients:, description:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Serving Size: 1 Capsule
Amount Per Serving % Daily Value
Iron (Elemental) 150 mg 833%
(As Polysaccharide Iron Complex)
prevention and treatment of iron deficiency and/or other nutritional megaloblastic anemias
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.
Myferon 150 is indicated for the prevention and treatment of iron deficiency anemia and/or nutritional megaloblastic anemias.
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.
One or two capsules daily or as prescribed by a physician.
D and C Red #7, D and C Red #28, D and C Yellow #10, FD and C Blue #1, FD and C Red #40, FD and C Yellow #6, Gelatin, Pharmaceutical Glaze, Sodium Lauryl Sulfate, Titanium Dioxide, Dicalcium Phosphate.
Myferon 150, Polysaccharide Iron Complex capsules are a preparation of ferric Iron complexed to a low molecular weight polysaccharide. This polysaccharide is obtained by extensive hydrolysis of starch.
Myferon 150 is a dark brown powder that when dissolved in water, forms a very dark brown solution. As an organic complex, polysaccharide iron contains no free iron. It is tasteless, odorless and readily soluble in water.
Iron is an essential compound in the formation of hemoglobin. Adequate amounts of iron are necessary for the effective erythropoiesis. Iron also serves as a cofactor of several essential enzymes, including cytochromes that are involved in electron transport.
A radioiscope tracer study in man demonstrated that absorption of a polysacchride-iron is comparable to that of ferrous sulfate. Clinical studies demonstrate that polysaccharide-iron produces good hematological response shown by increases in hemoglobin and hematocrit in children and adult patients. Polysaccharide-iron is effective in maintaining the hematopoietic status in end-stage kidney disease patients receiving epoetin alfa therapy.
Myferon 150 is contraindicated in patients with a known hypersensitivity to any of the components of this product. Hemochromatosis and hemosiderosis are contraindications to iron therapy.
The type of anemia and the underlying cause or causes should be determined before initiating treatment with Myferon 150. Since the anemia may be a result of a systemic disturbance, such as recurrent blood loss, the underlying cause or causes should be corrected if possible. As with all oral iron preparations, Myferon 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.
Adverse reactions with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stool and abdominal pain. Adverse reactions with iron are usually transient.
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.
Chronic toxicity studies in rats and dogs administered polysaccharide-iron complex showed that a daily dosage of 250 mg iron/kg for three months has no adverse effects. The Oral LD 50 of polysaccharide-iron complex was estimated to be greater than 5000 mg. iron/kg in rats.
Myferon 150 capsules are supplied in unit dose blister packs, 10 capsules per card, orange/brown capsules.
Store at 25° C (77° F); excursions permitted to 15°-30° C (59°-86° F). See USP controlled room temperature.
M.E. PHARMACEUTICALS, Inc.
58607-111-85
Myferon™ 150
Polysaccharide Iron Complex Capsules
150 mg of elemental iron
Well tolerated
Well absorbed
100 Unit Dose Capsules
Mfg by M.E. Pharmaceuticals, Inc.
Richmond, IN 47374 USA
Mepharm Myferon150 Label (Mepharm Myferon150)
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