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Iferex 150 Forte (Nnodum Pharmaceuticals)

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CAPSULE 100 CAPSULE in 1 BOTTLE (63044-198-01) Label Information

Complete Iferex 150 Forte Information

  • SPL UNCLASSIFIED SECTION

    Polysaccharide Iron Complex

    Hematinic Capsules

    NDC 63044-0198-01


  • WARNING:

    Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this products out of the reach of children. In case of accidental overdose, call a doctor or poison control immediately.


  • PURPOSE

    Rx Only


  • DESCRIPTION:

    IFEREX â„¢ 150 Forte Capsules are a highly water soluble complex of iron/low molecular weight polysaccharide and vitamins.


  • INDICATIONS:

    For treatment of iron deficiency anemia and/or nutritional megaloblastic anemias due to inadequate diet.


  • KEEP OUT OF REACH OF CHILDREN

    WARNING: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin 812 is deficient. Keep out of the reach of children. Close tightly and keep out of reach of children. Contains iron, which can be harmful or fatal to children in large doses.


  • PRECAUTIONS:

    Folic acid in doses above 0..1 mg - 0..4 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.

    Pediatric Use Safety and effectiveness in pediatric patients has not been established.

    GERIATRIC USE:

    Clinical studies on this product have not been performed in sufficient numbers of 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, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.


  • ADVERSE REACTIONS:

    Adverse reactions with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.


  • DOSAGE AND ADMINISTRATION:

    Adults: One capsule daily or as directed by a physician.

    Each capsule contains:
    Iron (Elemental)    150 mg
    (as polysaccharide-iron complex)
    Folic Acid     1 mg
    Vitamin 812        25 mc


  • ACTIVE INGREDIENT

    OTHER INGREDIENTS: Microcrystalline Cellulose,Gelatin,Magnesium Strearate, D&C Red #28, Titanium Dioxide, FD&C red #3, D&C Yellow #10, and FD&C Blue # 1


  • HOW SUPPLIED

    IFEREX â„¢ 150 Forte Capsules are Opaque maroon cap/opaque maroon NDC 63044-0198-01.

    Supplied in 100 count bottle.


  • INACTIVE INGREDIENT

    STORAGE: Store at controlled 20°C - 25°C (68°-77°F); excursions permitted to 15°C-30°C (59°- 86°F).

    Manufactured for
    Nnodum Pharmaceuticals
    Cincinnati, Ohio 45229


  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    9f3bf415-figure-01

  • INGREDIENTS AND APPEARANCE
    IFEREX 150 FORTE 
    iron, cyanocobalamin and folic acid capsule
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63044-198
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON 150 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 25 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    GELATIN (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    Color BROWN (maroon) Score no score
    Shape CAPSULE Size 7mm
    Flavor Imprint Code Z198
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63044-198-01 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 10/28/2007
    Labeler - Nnodum Pharmaceuticals (960457273)
    Establishment
    Name Address ID/FEI Business Operations
    JLM Pharmatech 966721805 MANUFACTURE