Label: FE C TAB - ascorbic acid and iron pentacarbonyl tablet 

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 09/13

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  • SPL UNCLASSIFIED SECTION

    FE C Tab

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  • SPL UNCLASSIFIED SECTION

    f14a4a6a-figure-01

    Inactive ingredients: Black iron oxide, dicalcium phosphate, FD&C Blue #2, FD&C Red #40, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, propylene glycol, red iron oxide, silicon dioxide, stearic acid, titanium dioxide, triacetin, yellow iron oxide.

    STORE AT CONTROLLED ROOM TEMPERATURE 20°-25°C (68°-77°F)

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  • SPL UNCLASSIFIED SECTION

    DIRECTIONS: Adults and Children 12 years and over – One tablet daily or as directed by a physician. Children under 12 years: Consult a physician.

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  • SPL UNCLASSIFIED SECTION

    WARNINGS: Do not exceed recommended dosage. The treatment of any anemic condition should be under the advice and supervision of a physician. 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 products may occasionally cause constipation or diarrhea. If you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

    WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product 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

    DO NOT ACCEPT IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.

    Manufactured for: Boca Pharmacal, LLC Coral Springs, FL 33065
    www.bocapharmacal.com    1-800-354-8460  Rev. 08/13     077T

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    FE C TAB 
    iron, vitamin c tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64376-803
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 250 mg
    IRON PENTACARBONYL (FERROUS CATION) FERROUS CATION 100 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE  
    STEARIC ACID  
    FERROSOFERRIC OXIDE  
    TITANIUM DIOXIDE  
    HYPROMELLOSES  
    FD&C BLUE NO. 2  
    CELLULOSE, MICROCRYSTALLINE  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
    MAGNESIUM STEARATE  
    POLYETHYLENE GLYCOLS  
    FD&C RED NO. 40  
    FERRIC OXIDE RED  
    FERRIC OXIDE YELLOW  
    PROPYLENE GLYCOL  
    TRIACETIN  
    Product Characteristics
    Color RED Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64376-803-01 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 08/19/2010
    Labeler - Boca Pharmacal, LLC (170266089)
    Registrant - Boca Pharmacal, LLC (170266089)
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