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 July 9, 2019

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

  • SPL UNCLASSIFIED SECTION

    Rx Only Dietary Supplement

  • DESCRIPTION

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

    table

  • INACTIVE INGREDIENT

    OTHER INGREDIENTS: Croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, stearic acid. Coating contains: HPMC, triacetin, titanium dioxide, Candurin® Orange (FD&C Blue #1, FD&C Red #40, FD&C Yellow #6). This product contains FD&C Yellow #6.

  • INDICATIONS & USAGE

    INDICATIONS: Niferex™ is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.

  • CONTRAINDICATIONS

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

  • 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.

  • 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.

  • ADVERSE REACTIONS

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

  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION: One softgel daily, or as directed by a physician.

  • 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.

  • 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.

  • 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 30005 1-888-61-AVION

    Rev. 0119-01 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.

  • PRINCIPAL DISPLAY PANEL

    ​Rx Only Dietary Supplement 75854-321-30

    30 Tablets Sugar Free

    Lactose Free

    Niferex ​TM

    www.niferexrx.com tablets

    Ni

  • INGREDIENTS AND APPEARANCE
    NIFEREX 
    ferrous asparto glycinate, iron, ascorbic acid, folic acid, cyanocobalamin, zinc, succinic acid, and intrinsic factor tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:75854-321
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION50 mg
    IRON DEXTRAN (UNII: 95HR524N2M) (FERRIC CATION - UNII:91O4LML611) FERRIC CATION100 mg
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID60 mg
    LEVOMEFOLIC ACID (UNII: 8S95DH25XC) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID750 ug
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID250 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN25 ug
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC15 mg
    SUCCINIC ACID (UNII: AB6MNQ6J6L) (SUCCINIC ACID - UNII:AB6MNQ6J6L) SUCCINIC ACID50 mg
    INTRINSIC FACTOR (UNII: 70BT6OQT2Q) (INTRINSIC FACTOR - UNII:70BT6OQT2Q) INTRINSIC FACTOR100 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    Colorbrown (copper colored) Scoreno score
    ShapeROUNDSize19mm
    FlavorImprint Code NxFE
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75854-321-3030 in 1 BOTTLE; Type 0: Not a Combination Product01/10/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/10/2017
    Labeler - Avion Pharmaceuticals, LLC (040348516)
    Registrant - Avion Pharmaceuticals, LLC (965450542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avion Pharmaceuticals, LLC040348516manufacture(75854-321)