Label: 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
- NDC Code(s): 58809-725-30
- Packager: GM Pharmaceuticals, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated August 22, 2014
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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.Close
- 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 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.Close
- INDICATIONS AND USAGE
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.Close
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.
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
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.Close
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.Close
- HOW 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.
- SPL UNCLASSIFIED SECTION
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
- INGREDIENTS AND APPEARANCE
.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
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58809-725 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength .BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) .BETA.-CAROTENE 2100 [iU] ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 160 mg CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 400 [iU] .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL- 40 [iU] THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE 4 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 4 mg NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 20 mg PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 20 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1250 ug CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 30 ug IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 75 mg MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE 30 mg ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 20 mg CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 1 mg Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6 (UNII: H77VEI93A8) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C RED NO. 40 (UNII: WZB9127XOA) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYVINYL ALCOHOL (UNII: 532B59J990) TRIACETIN (UNII: XHX3C3X673) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color RED Score no score Shape OVAL Size 18mm Flavor Imprint Code FE1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58809-725-30 1 in 1 CARTON 1 30 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 11/11/2013 Labeler - GM Pharmaceuticals, Inc. (793000860)