NUFERA (ASCORBIC ACID, CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLATE MAGNESIUM, FOLIC ACID, CYANOCOBALAMIN, AND IRON PENTACARBONYL) TABLET [CARWIN PHARMACEUTICAL ASSOCIATES, LLC]

NUFERA (ASCORBIC ACID, CHOLECALCIFEROL, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLATE MAGNESIUM, FOLIC ACID, CYANOCOBALAMIN, AND IRON PENTACARBONYL) TABLET [CARWIN PHARMACEUTICAL ASSOCIATES, LLC]
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NDC 15370-265-30
Set ID 8b7a7851-d0a4-4efc-a141-dcffeda8d1cf
Category DIETARY SUPPLEMENT
Packager CarWin Pharmaceutical Associates, LLC
Generic Name
Product Class
Product Number
Application Number
  • STATEMENT OF IDENTITY

    Supplement Facts
    Serving Size: 1 TabletServings per container: 30
    Amount per serving%DV*
    *
    Percent Daily Value
    Vitamin C (as ascorbic acid)170 mg283%
    Vitamin D3 (as cholecalciferol)1000 IU250%
    Vitamin B6 (as pyridoxine HCl)15 mg750%
    Folate (630 mcg of L-methylfolate magnesium, molar equivalent to 600 mcg of L-methylfolic acid; and 400 mcg of folic acid)1 mg250%
    Vitamin B12 (as cyanocobalamin)16 mcg267%
    Iron (as carbonyl iron)125 mg694%

    INACTIVE INGREDIENTS: Microcrystalline Cellulose, Pregelatinized Starch, Calcium Carbonate, Docusate Sodium, Red Coating (Hydroxypropyl Methylcellulose, Anthocyanin Extract Powder, Polyvinyl Alcohol, Triacetin, TALC, Titanium Dioxide), Silicon Dioxide, Croscarmellose Sodium, Hydroxypropyl Cellulose, Magnesium Stearate, Stearic Acid, Fumed Silica.

  • INDICATIONS

    NuFera™ is a multivitamin and mineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.

  • CONTRAINDICATIONS

    NuFera™ is contraindicated in patients with a known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contraindicated to iron therapy.

  • WARNINGS

    WARNING: ACCIDENTAL OVERDOSE OF IRON-CONTAINING PRODUCTS IS A LEADING CAUSE OF FATAL POISONING IN CHILDREN UNDER 6 YEARS OF AGE.
  • 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 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

  • PRECAUTIONS

    General

    Do not exceed recommended dose. The type of anemia and the underlying cause or causes should be determined before starting therapy with NuFera™. 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.

    PEDIATRIC USE

    Safety and effectiveness in pediatric population have not been established.

    GERIATRIC USE

    In general, dose selection in elderly population should be cautious and start at the lower end of the dosing range.

  • ADVERSE REACTIONS

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

    Adverse reactions with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Adverse reactions with iron therapy are usually transient.

    Carbonyl iron based products may decrease the absorption of medicines. Talk to your doctor or pharmacist before taking carbonyl products.

    You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact CarWin Pharmaceutical Associates, LLC at 1-985-288-5122.

  • 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.

  • DIRECTIONS

    One tablet daily with or without food or as prescribed by your healthcare provider.

  • HOW SUPPLIED

    NuFera™ is available as red oblong tablets with imprint "265" in child-resistant bottles containing 30 tablets (15370-265-30) and in a 3ct professional sample (15370-265-03).

  • STORAGE

    Store at 20°-25°C (68°-77°F); excursions permitted to at 15°-30°C (59°-86°F) [see USP]. Protect from light and moisture and avoid excessive heat. Dispense in a tight, light resistant container as defined by the USP using a child-resistant closure.

  • SAFE HANDLING WARNING

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

    These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

    TAMPER EVIDENT: Do not use if seal is broken or missing.

  • HEALTH CLAIM

    Manufactured for:
    CarWin Pharmaceutical Associates, LLC
    Slidell, LA 70461

    MADE IN CANADA

    Rx

    CW-250-SB-02
    Rev. 11/15

  • PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label

    15370-265-30

    NuFERA
    IRON SUPPLEMENT

    125 mg CARBONYL IRON

    Rx
    30 Tablets

    See attached labeling for complete product information.
    Rev. 11/2015

    PRINCIPAL DISPLAY PANEL - 30 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    NUFERA 
    ascorbic acid, cholecalciferol, pyridoxine hydrochloride, levomefolate magnesium, folic acid, cyanocobalamin, and iron pentacarbonyl tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:15370-265
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID170 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL1000 [iU]
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE15 mg
    LEVOMEFOLATE MAGNESIUM (UNII: 1VZZ62R081) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID600 ug
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID400 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN16 ug
    IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION125 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    KERACYANIN (UNII: V0N2VMB4FV)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    TRIACETIN (UNII: XHX3C3X673)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYDROXYPROPYL CELLULOSE (TYPE H) (UNII: RFW2ET671P)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:15370-265-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Dietary Supplement12/16/2015
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring2
    shape
    size (solid drugs)19 mm
    imprint
    Labeler - CarWin Pharmaceutical Associates, LLC (079217215)