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): 28595-433-30
  • Packager: Allegis Pharmaceuticals, LLC
  • Category: DIETARY SUPPLEMENT

Drug Label Information

Updated January 19, 2016

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  • HEALTH CLAIM

    Iron Supplement
    Rx

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  • STATEMENT OF IDENTITY

    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 Blue#2 Lake, FD&C Red#40 Lake, FD&C Yellow#6 Lake, hydroxypropyl methylcellulose, polyvinyl alcohol, talc, titanium dioxide, triacetin), croscarmellose sodium, magnesium stearate, microcrystalline cellulose, pregelatinized starch, silica, silicon dioxide, and stearic acid.

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  • 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.

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  • INDICATIONS AND USAGE

    ACTIVE FE™ is an oral prescription multi-vitamin/multi-mineral dietary supplement for the use in improving the nutritional status of patients with iron deficiency. 1


    1
    This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent disease.
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  • CONTRAINDICATIONS

    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.

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  • 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 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 Allegis Pharmaceuticals, LLC at 1-866-633-9033.

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  • 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™. 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

    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.

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  • 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.

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  • 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.

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  • DIRECTIONS

    Adults

    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.

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  • HOW SUPPLIED

    ACTIVE FE™ is supplied as red capsule shaped tablets with imprint FE1 in child-resistant bottles containing 30 tablets. (28595-433-302)


    2
    This product is a prescription-folate with or without other dietary ingredients that – due to increased folate levels (AUG 2 1973 FR 20750), requires an Rx on the label because of increased risk associated with masking of B12 deficiency (pernicious anemia). Based on our assessment of the risk of obscuring pernicious anemia, this product requires licensed medical supervision, an Rx status, and a National Drug Code (NDC) – or similarly-formatted product code, as required by pedigree reporting requirements and supply-chain control as well as – in some cases, for insurance-reimbursement applications.All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician's supervision. There are no implied or explicit claims on therapeutic equivalence.
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  • STORAGE

    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.

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  • HEALTH CLAIM

    Rx
    MADE IN CANADA

    MANUFACTURED FOR:
    Allegis Pharmaceuticals, LLC

    Canton, MS 39046

    Rev. 01/2016
    Covered by U.S. Patent# 7998500

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  • PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label

    28595-433-30

    ACTiVE FE

    Iron Supplement

    ALLEGIS PHARMACEUTICALS

    30 Tablets
    Rx

    Manufactured for:
    Allegis Pharmaceuticals, LLC
    Canton, MS 39046

    Lactose, Gluten and Sugar Free

    Principal Display Panel - 30 Tablet Bottle Label
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  • INGREDIENTS AND APPEARANCE
    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
    Product Information
    Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:28595-433
    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)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:28595-433-30 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    DIETARY SUPPLEMENT 01/18/2016
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving % Daily Value
    color
    scoring 1
    shape
    size (solid drugs) 18 mm
    imprint
    Labeler - Allegis Pharmaceuticals, LLC (792272861)
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