Label: NIFEREX- ferrous asparto glycinate, iron, ascorbic acid, folic acid, cyanocobalamin, zinc, succinic acid, and intrinsic factor tablet

  • NDC Code(s): 75854-321-30
  • Packager: Avion Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated January 20, 2017

If you are a consumer or patient please visit this version.

  • BOXED WARNING(What is this?)

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

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  • DESCRIPTION

    DESCRIPTION: Niferex for oral administrationis a prenatal/postnatal iron supplement that is a round, copper colored tablet with NxFE embossed on one side.

     Supplement Facts

    Serving Size: 1 tablet

    Amount per Serving:

    % Daily
       Value

     Iron (as Sumalate® (ferrous asparto glycinate 50 mg) 150 mg

     and polysaccharide iron complex 100 mg)

     150 mg  833%
     Vitamin C (as ascorbic acid)  60 mg  100%

     Folate (as 1.4 mg Quatrefolic® ((6S)-5, methyltetrahydrofolate

     glucosamine salt molar equivalent to 750 mcg of folic acid)

     and folic acid, USP 250 mcg)

     1 mg  250%
     Vitamin B12 (as cyanocobalamin)  25 mcg  417%
     Zinc (as zinc-bisglycinate chelate  15 mg  100%
     Succinic Acid  50 mg  †
     Desiccated Stomach Substance  100 mg  †
    † Daily Value (DV) not established

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  • INACTIVE INGREDIENT

    OTHER INGREDIENTS: Dicalcium phosphate, microcrystalline cellulose, croscarmelose sodium, vegetable stearate, silicon dioxide.

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  • INDICATIONS & USAGE

    INDICATIONS: Niferex™ is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.

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  • CONTRAINDICATIONS

    CONTRAINDICATIONS: Niferex™ is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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  • PRECAUTIONS

    PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

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  • ADVERSE REACTIONS

    ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

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  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one tablet daily or as directed by a physician.

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  • HOW SUPPLIED

    HOW SUPPLIED: Bottles of 30 tablets (75854-321-30). The listed product number is not a National Drug Code. Instead, Avion Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.

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  • STORAGE AND HANDLING

    STORAGE: Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

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  • SPL UNCLASSIFIED SECTION

    Quatrefolic® is a registered trademark of Gnosis, SpA. Covered by one or more claims of U.S. Patent #7,947,662 CAS #1181972-37-1

    Sumalate® is a registered trademark of Albion Laboratories, Inc., covered by one or more claims of U.S. Patent Nos. 6,716,814, 8,007,846 and 8,425,956.

    MANUFACTURED FOR:
    Avion Pharmaceuticals, LLC
    Alpharetta, GA 30022 1-888-61-AVION
    Rev. 0117-01 AV-428

    THESE STATEMENTS  HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR INTENDED TO DIAGNOSE, PREVENT ANY DISEASE.

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  • PRINCIPAL DISPLAY PANEL

    ​Rx Only Dietary Supplement       75854-321-30

    30 Tablets                                      Sugar Free

    Lactose Free

    Niferex​TM

    www.niferexrx.com            tablets

    Label

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  • INGREDIENTS AND APPEARANCE
    NIFEREX 
    ferrous asparto glycinate, iron, ascorbic acid, folic acid, cyanocobalamin, zinc, succinic acid, and intrinsic factor tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75854-321
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 50 mg
    IRON DEXTRAN (UNII: 95HR524N2M) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION 100 mg
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 60 mg
    LEVOMEFOLIC ACID (UNII: 8S95DH25XC) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID 750 ug
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 250 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 25 ug
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC 15 mg
    SUCCINIC ACID (UNII: AB6MNQ6J6L) (SUCCINIC ACID - UNII:AB6MNQ6J6L) SUCCINIC ACID 50 mg
    INTRINSIC FACTOR (UNII: 70BT6OQT2Q) (INTRINSIC FACTOR - UNII:70BT6OQT2Q) INTRINSIC FACTOR 100 mg
    Inactive Ingredients
    Ingredient Name Strength
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Color brown (copper colored) Score no score
    Shape ROUND Size 19mm
    Flavor Imprint Code NxFE
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:75854-321-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 01/23/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 01/23/2017
    Labeler - Avion Pharmaceuticals, LLC (965450542)
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