Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
.BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J), ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41), .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01), THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J), RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR), NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8R
GM Pharmaceuticals, Inc.
.BETA.-CAROTENE
.BETA.-CAROTENE 2100 [iU]
ORAL
PRESCRIPTION DRUG
ACTIVE FE™ is indicated for the prevention and treatment of iron deficiency anemia and/or nutritional megaloblastic anemias.1 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.
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.
unapproved drug other
ACTIVE FE- .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 GM PHARMACEUTICALS, INC. _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._ ---------- ACTIVE FE™ IRON SUPPLEMENT RX SUPPLEMENT FACTS 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. PROFESSIONAL LABELING 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 B is required for Leggi il documento completo