Label: FERROUS SULFATE- ferrous sulfate 325 mg green tablet, film coated

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

Drug Label Information

Updated July 23, 2019

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  • Supplement Facts

    Serving Size 1 Tablet

    Servings Per Container 1000

     Amount Per Serving    % Daily Value
     Iron (as ferrous sulfate) 65 mg361%

    Other ingredients: croscarmellose sodium, dicalcium phosphate, FD&C blue #1, FD&C yellow #6, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium starch glycolate, stearic acid, talc, titanium dioxide, triacetin

    Formula: Each tablet contains 202 mg of dried ferrous sulfate USP (65 mg of elemental iron), equivalent to 325 mg of ferrous sulfate USP.

  • Directions:

    Adults and children over 12 years age: 1 tablet daily preferably with a meal or as directed by a doctor. Children under 12 years of age: consult a doctor. Do not exceed recommended dosage.

  • Caution:

    Since oral iron products interfere with absorption of certain antibiotics; these products should not be taken within two hours of each other. if you are pregnant, nursing or taking any medications, consult your doctior befoe use. Discontinue use and consult your doctor if any adverse reactions occur. 

    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.

  • SAFE HANDLING WARNING

    Store at room temperature. Keep tightly closed in a cool dry place.

    Questions or comments? (866) 562-2756 Mon-Fri 8 AM to 4 PM EST

  • PRINCIPAL DISPLAY PANEL

    *Compare to the active ingredient in Feosol®

    Ferrous 

    Sulfate

    Iron Supplement

    325 mg

    43063990 Label

  • INGREDIENTS AND APPEARANCE
    FERROUS SULFATE 
    ferrous sulfate 325 mg green tablet, film coated
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:43063-990
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:43063-990-9090 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement07/22/2019
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)10 mm
    Labeler - PD-Rx Pharmaceuticals, Inc. (156893695)
    Registrant - PD-Rx Pharmaceuticals, Inc. (156893695)
    Establishment
    NameAddressID/FEIBusiness Operations
    PD-Rx Pharmaceuticals, Inc.156893695repack(43063-990)
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