Generic Name: iron supplement
Dosage Form: tablet
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Serving Size: 1 Tablet
Servings per container: 30
|Amount Per Serving:||% Daily Value|
|Vitamin A (as beta-carotene)||2100 IU||42%|
|Vitamin C (as ascorbic acid)||160 mg||267%|
|Vitamin D3 (as cholecalciferol)||400 IU||100%|
|Vitamin E (as dl-alpha-tocopheryl acetate)||40 IU||133%|
|Thiamin (Vitamin B1 as thiamin HCl)||4 mg||267%|
|Riboflavin (Vitamin B2)||4 mg||235%|
|Niacin (as niacinamide)||20 mg||100%|
|Vitamin B6 (as pyridoxine HCl)||20 mg||1000%|
|Folate (as folic acid)||1250 mcg||313%|
|Vitamin B12 (as cyanocobalamin)||30 mcg||500%|
|Iron (as carbonyl iron)||75 mg||417%|
|Magnesium (as magnesium oxide)||30 mg||8%|
|Zinc (as zinc oxide)||20 mg||133%|
|Copper (as cupric oxide)||1 mg||50%|
OTHER INGREDIENTS: Coating (FD&C Yellow#6 Lake, FD&C Blue#2 Lake, FD&C Red#40 Lake, hydroxypropyl methylcellulose, polyvinyl alcohol, triacetin, talc, titanium dioxide), croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silicon dioxide, silica, and stearic acid.
Active FE - 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 a 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, a glycoprotein secreted by the gastric mucosa, is required for active absorption of vitamin B12 from the gastrointestinal tract.
Indications and Usage for Active FE
Active FE™ is indicated for the prevention and treatment of iron deficiency anemia and/or nutritional megaloblastic anemias.1
- This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent disease.
Active FE™ is contraindicated in patients with a known hypersensitivity to any of the components of this product. Hemolytic anemia, hemochromatosis and hemosiderosis are contraindications to iron therapy.
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.
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.
Call your doctor about side effects. You may report side effects by calling GM Pharmaceuticals, Inc. at 1-888-535-0305.
Do not exceed recommended dose. The type of anemia and the underlying cause or causes should be determined before starting therapy with Active FE™. 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.
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.
Safety and effectiveness in pediatric patients have not been established.
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.
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.
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.
Take one tablet daily, or as prescribed by a licensed medical practitioner.
Children under 12
Consult a doctor.
Pregnant or Nursing
Consult a doctor.
DO NOT EXCEED THE RECOMMENDED DOSE.
How is Active FE Supplied
Active FE™ is supplied as red capsule shaped tablets with imprint FE1 in child-resistant bottles containing 30 tablets. (58809-725-30)
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container.
KEEP OUT OF REACH OF CHILDREN.
MADE IN CANADA
MANUFACTURED FOR: GM Pharmaceuticals, Inc.
Arlington, TX 76015
Covered by U.S. Patent# 7998500
PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label
GM Pharmaceuticals, Inc.
Arlington, TX 76015
Lactose, Gluten and Sugar Free
.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, iron pentacarbonyl, magnesium oxide, zinc oxide, and cupric oxide tablet
|Labeler - GM Pharmaceuticals, Inc. (793000860)|