Label: FERROUS SULFATE - ferrous sulfate tablet

  • 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 04/13

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  • Supplement Facts[/S]

    Serving Size: 1 Tablet
    Amount per Tablet
    % Daily Value
    Iron (as ferrous sulfate)  65 mg 360 %
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  • SUGGESTED USE

    One (1) tablet daily, preferably after meals or as directed by the doctor. As directed by the doctor. Adults:Children:

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  • Active Ingredient

    U.S. RDA* EACH TABLET CONTAINS:                  %

    Elemental Iron 65 mg     360

    (Equivalent to 325 mg of Ferrous Sulfate)

    * U.S. Recommended Daily Allowance  

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  • Inactive Ingredients

    Croscarmellose sodium, dicalcium phosphate, FD&C RED#40 (Al-lake), FD&C yellow #6 (Al-lake), hypromellose, magnesium stearate, microcrystalline cellulose, PEG 400, titanium dioxide

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  • Purpose

    Iron Supplement

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  • WARNING:

    Accidental overdose of iron containing products is a leading cause of fatal poisoning in children under 6. . In case of accidental overdose, call a doctor or Poison Control Center immediately. Keep this product out of reach of children

    The treatment of any anemic condition should be under the advice and supervision of doctor. Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals. Iron-containing medication may occasionally cause constipation or diarrhea. WARNINGS: Do not exceed recommended dosage.

    As with any drug, if you are pregnant or nursing baby, seek the advice of a health professional before using this product.   

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  • DRUG INTERACTION PRECAUTION

    Since oral iron products interfere with absorption of oral tetracycline antibiotics , these products should not be taken within two hours of each other.

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  • DOSAGE AND ADMINISTRATION

    Calcium 20 mg (2% daily value) Store in a dry place at controlled room temperature at 15-30 °C (59°-86° F). Do not expose to excessive heat or moisture. Each tablet contains:

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  • Questions or Comments

    DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED

    TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS BROKEN OR DAMAGED

    Distributed by: Qualitest Pharmaceuticals, Inc.

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  • FERROUS SULFATE (IRON SUPPLEMENT) TABLET
  • INGREDIENTS AND APPEARANCE
    FERROUS SULFATE  
    iron supplement tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50436-5891(NDC:0603-0179)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FERROUS SULFATE (FERROUS CATION) FERROUS CATION 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM  
    CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE  
    FD&C RED NO. 40  
    FD&C YELLOW NO. 6  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOL 400  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color RED Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50436-5891-1 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 02/19/2001
    Labeler - Unit Dose Services (831995316)
    Registrant - Unit Dose Services (831995316)
    Establishment
    Name Address ID/FEI Business Operations
    Unit Dose Services 831995316 REPACK(50436-5891)
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