Home > Drugs A-Z > FERROUS SULFATE

FERROUS SULFATE (Qualitest Pharmaceuticals)

Available Formats

Dosage Form Package Information Links
TABLET 100 TABLET in 1 BLISTER PACK (0603-0179-29) Label Information
TABLET 1000 TABLET in 1 BOTTLE (0603-0179-32) Label Information

Complete FERROUS SULFATE Information

  • Supplement Facts[/S]

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

  • SUGGESTED USE

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


  • Active Ingredient

    EACH TABLET CONTAINS:                  % U.S. RDA*

    Elemental Iron 65 mg     360

    (Equivalent to 325 mg of Ferrous Sulfate)

    * U.S. Recommended Daily Allowance  


  • 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


  • Purpose

    Iron Supplement


  • WARNING:

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

    WARNINGS: Do not exceed recommended dosage. 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.

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


  • 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.


  • DOSAGE AND ADMINISTRATION

    Each tablet contains: 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.


  • 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.


  • Package Label

    bc435fed-figure-01
    bc435fed-figure-02

    FERROUS SULFATE TABLETS 325 mg (5 gr)

    Iron Supplement

    NDC: 0603-0179-29 – (100 Tablets (4 x 25) Unit Dose

    NDC: 0603-0179-32 – 1000 TABLETS


  • INGREDIENTS AND APPEARANCE
    FERROUS SULFATE 
    iron supplement tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0603-0179
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    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:0603-0179-29 100 in 1 BLISTER PACK; Type 0: Not a Combination Product 02/19/2001 03/31/2018
    2 NDC:0603-0179-32 1000 in 1 BOTTLE; Type 0: Not a Combination Product 02/19/2001 03/30/2020
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 02/19/2001 03/30/2020
    Labeler - Qualitest Pharmaceuticals (011103059)
    Establishment
    Name Address ID/FEI Business Operations
    Advance Pharmaceutical, Inc. 078301063 MANUFACTURE(0603-0179)