Label: FERROUS SULFATE tablet, film coated

  • Category: DIETARY SUPPLEMENT

Drug Label Information

Updated March 20, 2020

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  • Supplement Facts

    Serving Size: 1 Tablet

          Amount per Tablet             % Daily Value

    Iron (as dried ferrous sulfate) 65mg 361%

    Active Ingredient (in each tablet) Purpose

    Ferrous Sulfate Dietary Supplement

  • Warning:

    Since oral iron products interfere with absorption of oral tetracycline antibiotics, these products should not be taken within two hours of each other. Iron-containing products may cause constipation or diarrhea. As with any dietary supplement, if you are pregnant or nursing a baby, seek 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 reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

  • Directions

    Adults and Children 12 years of age and over:

    1 tablet daily, preferably after a meal, or as directed by a physician.

    Children under 12 years of age:

    Consult a physician. Do not chew or crush tablet.

    Inactive Ingredients:

    Colloidal Silicon Dioxide, Croscarmellose Sodium, FD&C Blue #1, FD& C Yellow # 6, Hypromellose, Microcrystalline Cellulose, Mineral Oil, Polyethylene Glycol 400, Titanium Dioxide, Vegetable Magnesium Stearate, Vegetable Stearic Acid

  • Other Information:

    • Store in a cool, dry place at controlled room temperature 15-30ºC (59-86ºF)
    • Protect from moisture
    • Store in original container for better identification
    • Use by expiration date on package

    Contains the following:

    • Sodium: 0.83mg per tablet
    • Calcium: 11.04mg per tablet
    • Magnesium: 0.21mg per tablet
    • Potassium: 0.006mg per tablet

    Manufactured for/Distributed by:

    Marlex Pharmaceuticals, Inc.,
    New Castle, DE 19720

    Rev. 1/20 HP

  • PRINCIPAL DISPLAY PANEL

    NDC 10135-0690-01
    Ferrous Sulfate
    Film-Coated Tablets
    325 mg

    100 Tablets

    PRINCIPAL DISPLAY PANEL
NDC 10135-0690-01
Ferrous Sulfate 
Film-Coated Tablets
325 mg
100 Tablets

  • INGREDIENTS AND APPEARANCE
    FERROUS SULFATE 
    ferrous sulfate tablet, film coated
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:10135-690
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION65 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:10135-690-01100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT03/01/2020
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)10 mm
    Labeler - Marlex Pharmaceuticals Inc (782540215)