Label: IFEREX 150 - iron capsule 

  • Label RSS
  • NDC Code(s): 63044-203-01, 63044-203-61
  • Packager: Nnodum Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 12/09

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  • BOXED WARNING(What is this?)

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

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  • SPL UNCLASSIFIED SECTION

    (Polysaccharide-Iron Complex) Hematinic

    NDC 63044-0203-61

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  • DESCRIPTION:

    IFEREX ™ 150 Capsules are a highly water soluble complex of iron and a low molecular weight polysaccharide.

    ACTIONS AND USES: IFEREX™ 150 is an easily assimilated source of iron for treatment of uncomplicated iron deficiency anemia. Because IFEREX™ 150 is a polysaccharide bound iron complex, it is relatively nontoxic and there are relatively few, if any, gastrointestinal side effects associated with iron therapy, thus permitting full therapeutic dosage (150 - 300 mg elemental iron daily) in a single dose if desirable. There is no staining of teeth and no metallic aftertaste.

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  • INDICATIONS:

    Iferex 150 is indicated for the prevention and treatment of iron deficiency anemia and / or nutritional megalobastic anemias.

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  • CONTRAINDICATIONS:

    In patients with hemochromatosis and hemosiderosis and in those with known hypersensitivity to any of the ingredients.

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

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  • WARNINGS:

    Keep out of reach of children. Contains iron, which can be harmful or fatal to children in large doses.

    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.

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  • DOSAGE AND ADMINISTRATION:

    Adults - 1 to 2 capsules daily; pediatric patients, as directed by a physician.

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  • HOW SUPPLIED:

    IFEREX™ 150 Capsules are  brown cap/opaque orange body imprinted “ZIKS” (Cap)/”0203” (body), NDC 63044-0203-61 Supplied in Unit Dose Packs containing 10 capsules per card.

    Each capsule contains:

    Iron (Elemental) . . . . . . . . . . . . . . . . . . . . . . . . . 150 mg

    (as polysaccharide-iron complex)

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  • INACTIVE INGREDIENTS:

    Black Iron oxide,FD&C Red #28, FD&C Yellow # 10, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, magnesium stearate, microcrystalline cellulose,Red Iron Oxide, and Titanium Dioxide

    KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. IN CASE OF ACCIDENTAL OVERDOSE, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

    Storage: Store at controlled room temperature 15°-30°C (59°-86°F).

    Manufactured for
    Nnodum  Pharmaceutical
    Cincinnati, Ohio 45229

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    IFEREX 150 
    polysaccharide-iron complex capsule
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:63044-203
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IRON (IRON) IRON 150 mg
    Inactive Ingredients
    Ingredient Name Strength
    FERROSOFERRIC OXIDE  
    D&C BLUE NO. 1  
    D&C RED NO. 40  
    D&C YELLOW NO. 6  
    GELATIN  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    FERRIC OXIDE RED  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color ORANGE (opaque orange body) , BROWN (brown cap) Score no score
    Shape CAPSULE Size 7mm
    Flavor Imprint Code ZIKS;0203
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:63044-203-61 10 in 1 BOX, UNIT-DOSE
    1 10 in 1 BLISTER PACK
    2 NDC:63044-203-01 100 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
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