Label: IRON CHEWS- iron pentacarbonyl tablet, chewable

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated November 8, 2016

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

  • Directions

    As an Iron Supplement, one chewable tablet daily, or as directed by a health professional.

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  • SAFE HANDLING WARNING

    Keep out of reach of children.

    Protect from light, heat and moisture. Store at 59° - 86°F (15° - 30°C)

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  • STATEMENT OF IDENTITY

    Supplement Facts
    Serving Size 1 Tablet Servings per container: 60
    Amount Per Serving % Daily Value
    Infants from birth to 12 months of age
    % Daily Value
    Children under 4 years of age
    Iron (as Carbonyl Iron) 15 mg 100% 150%

    Other Ingredients : Sorbitol, microcrystalline cellulose, artificial grape flavor, magnesium stearate, silica, FD&C Blue #2 Lake, and FD&C Red #40 Lake.

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  • CAUTION

    Do not exceed recommended dosage. The treatment of any anemic condition should be under the advice and supervision of a health professional. Since oral iron products interfere with absorption of oral tetracycline antibiotics, these products should not be taken within two hours of each other. Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals. Iron-containing medication may occasionally cause constipation or diarrhea. If you are pregnant or nursing a baby, seek the advice of a health professional prior to taking this product.

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  • WARNING

    ACCIDENTAL OVERDOSE OF IRON-CONTAINING PRODUCTS IS A LEADING CAUSE OF FATAL POISONING IN CHILDREN UNDER SIX YEARS. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. IN CASE OF OVERDOSE, CALL A DOCTOR OR POISON CONTROL CENTER IMMEDIATELY.

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  • HEALTH CLAIM

    H2 pharma
    www.h2-pharma.com

    Rev. 09/16

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  • PRINCIPAL DISPLAY PANEL - 15 mg Tablet Bottle Label

    Iron Chews

    Pediatric
    Chewables

    IRON SUPPLEMENT

    Each Tablet Contains:
    Iron (as carbonyl iron) .......15 mg

    H2 pharma

    61269-910-60
    60 TABLETS

    Principal Display Panel - 15 mg Tablet Bottle Label
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  • INGREDIENTS AND APPEARANCE
    IRON CHEWS 
    iron pentacarbonyl tablet, chewable
    Product Information
    Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:61269-910
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IRON PENTACARBONYL (UNII: 6WQ62TAQ6Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 15 mg
    Inactive Ingredients
    Ingredient Name Strength
    SORBITOL (UNII: 506T60A25R)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:61269-910-60 60 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    DIETARY SUPPLEMENT 10/31/2016
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving % Daily Value
    color
    scoring 1
    shape
    size (solid drugs) 10 mm
    flavor
    Labeler - H2-Pharma, LLC (028473634)
    Establishment
    Name Address ID/FEI Business Operations
    Nexgen Pharma, Inc. 048488621 MANUFACTURE
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