STORAGE AND HANDLING SECTION.


STORAGE. Store at 20-25C (68-77F); excursions permitted to 15-30C (59-86F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in tight, light-resistant container.

GENERAL PRECAUTIONS SECTION.


General. Do not exceed recommended dose. The type of anemia and the underlying cause or causes should be determined before starting therapy with ACTIVE FE(TM). Since the anemia may be result of systemic disturbance, such as recurrent blood loss, the underlying cause or causes should be corrected, if possible.

GERIATRIC USE SECTION.


Geriatric Use. Clinical studies on this product have not been performed in subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious and start at the lower end of the dosing range.

HOW SUPPLIED SECTION.


HOW SUPPLIED. ACTIVE FE(TM) is supplied as red capsule shaped tablets with imprint FE1 in child-resistant bottles containing 30 tablets. (58809-725-30). STORAGE. Store at 20-25C (68-77F); excursions permitted to 15-30C (59-86F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in tight, light-resistant container.

INDICATIONS & USAGE SECTION.


INDICATIONS AND USAGE. ACTIVE FE(TM) is indicated for the prevention and treatment of iron deficiency anemia and/or nutritional megaloblastic anemias.This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent disease.

OVERDOSAGE SECTION.


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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PRINCIPAL DISPLAY PANEL 30 Tablet Bottle Label. 58809-725-30ACTiVE FE(TM) Iron Supplement GMPharmaceuticals, Inc.30 TabletsRxManufactured for: GM Pharmaceuticals, Inc. Arlington, TX 76015Lactose, Gluten and Sugar Free. PRINCIPAL DISPLAY PANEL 30 Tablet Bottle Label.

PEDIATRIC USE SECTION.


Pediatric Use. Safety and effectiveness in pediatric patients have not been established.

PRECAUTIONS SECTION.


PRECAUTIONS. General. Do not exceed recommended dose. The type of anemia and the underlying cause or causes should be determined before starting therapy with ACTIVE FE(TM). Since the anemia may be result of systemic disturbance, such as recurrent blood loss, the underlying cause or causes should be corrected, if possible.. Folic Acid. Folic acid in doses above 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 mask the symptoms of pernicious anemia.. Pediatric Use. Safety and effectiveness in pediatric patients have not been established.. Geriatric Use. Clinical studies on this product have not been performed in subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious and start at the lower end of the dosing range.

SPL UNCLASSIFIED SECTION.


Professional Labeling.

ADVERSE REACTIONS SECTION.


ADVERSE REACTIONS. Adverse reactions with iron therapy may include GI irritations, constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.Carbonyl iron based products may decrease the absorption of medicines. Talk to your doctor and pharmacist before taking carbonyl products if you take any prescription or over-the-counter medicines.

BOXED WARNING SECTION.


WARNING. Accidental overdose of iron-containing products is leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call doctor or poison control center immediately.

CLINICAL PHARMACOLOGY SECTION.


CLINICAL PHARMACOLOGY. Iron is an essential component in the formation of hemoglobin. Adequate amounts of iron are necessary for effective erythropoiesis. Iron also serves as cofactor of several essential enzymes, including cytochromes that are involved in electron transport. Folic acid is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic acid is converted in the liver and plasma to its metabolically active form, tetrahydrofolic acid, by dihydrofolate reductase. Vitamin B12 is required for the maintenance of normal erythropoiesis, nucleoprotein and myelin synthesis, cell reproduction and normal growth. Intrinsic factor, glycoprotein secreted by the gastric mucosa, is required for active absorption of vitamin B12 from the gastrointestinal tract.

CONTRAINDICATIONS SECTION.


CONTRAINDICATIONS. ACTIVE FE(TM) is contraindicated in patients with known hypersensitivity to any of the components of this product. Hemolytic anemia, hemochromatosis and hemosiderosis are contraindications to iron therapy.

DESCRIPTION SECTION.


Supplement FactsServing Size: TabletServings per container: 30Amount Per Serving:% Daily ValueVitamin (as beta-carotene)2100 IU42%Vitamin (as ascorbic acid)160 mg267%Vitamin D3 (as cholecalciferol)400 IU100%Vitamin (as dl-alpha-tocopheryl acetate)40 IU133%Thiamin (Vitamin B1 as thiamin HCl)4 mg267%Riboflavin (Vitamin B2)4 mg235%Niacin (as niacinamide)20 mg100%Vitamin B6 (as pyridoxine HCl)20 mg1000%Folate (as folic acid)1250 mcg313%Vitamin B12 (as cyanocobalamin)30 mcg500%Iron (as carbonyl iron)75 mg417%Magnesium (as magnesium oxide)30 mg8%Zinc (as zinc oxide)20 mg133%Copper (as cupric oxide)1 mg50%OTHER INGREDIENTS: Coating (FD&C Yellow6 Lake, FD&C Blue2 Lake, FD&C Red40 Lake, hydroxypropyl methylcellulose, polyvinyl alcohol, triacetin, talc, titanium dioxide), croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide, silica, and stearic acid.

DOSAGE & ADMINISTRATION SECTION.


DIRECTIONS. Adults. Take one tablet daily, or as prescribed by licensed medical practitioner.. Children under 12. Consult doctor.. Pregnant or Nursing. Consult doctor.. DO NOT EXCEED THE RECOMMENDED DOSE.

WARNINGS SECTION.


WARNINGS. Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.. WARNING. Accidental overdose of iron-containing products is leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call doctor or poison control center immediately.. Call your doctor about side effects. You may report side effects by calling GM Pharmaceuticals, Inc. at 1-888-535-0305.