Label: FERROUS SULFATE tablet

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

Drug Label Information

Updated December 3, 2025

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  • STATEMENT OF IDENTITY

    Dietary Supplement

  • CONTAINS:

    Each tablet contains 324 mg of ferrous sulfate, equivalent to 65 mg of elemental iron, providing 361% of the U.S. recommended daily intake (RDI) of iron for adults and children 4 and older.

  • DIRECTIONS FOR USE:

    Do not crush or chew tablets. Adult Serving Size: 1 tablet two to three times daily. Children: Consult a physician.

  • WARNINGS

    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 (1-800-222-1222).

  • WARNINGS:

    Do not take within 2 hours of taking oral tetracycline antibiotics, since oral iron products tend to interfere with absorption of tetracycline. May cause gastrointestinal discomfort, nausea, constipation or diarrhea. If you are pregnant or nursing a baby, seek advice of a health professional before using this product. U.S. Consumer Product Safety Commission requires that iron-containing medicines and vitamins with iron be packaged in child-resistant closures. Parents should always properly resecure safety closures.

  • STORAGE:

    Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]

  • Supplement Facts

    Serving Size 1 Tablet
    Amount Per Tablet% Daily Value
    Iron (from 324 mg of Ferrous Sulfate)65 mg361%

    Other ingredients:Microcrystalline Cellulose, Methacrylic Acid Copolymer, Croscarmellose Sodium. Crospovidone, Hypromellose, Stearic Acid, Polydextrose, FD&C Red #40 Lake, Talc, Triacetin, Sodium Lauryl Sulfate, Silicon Dioxide, Triglycerides, Titanium Dioxide, Glycerol Monostearate, Triethyl Citrate, FDC Blue #2 Lake and Polysorbate 80.

  • 16 HOW SUPPLIED

    Ferrous Sulfate Tablets are available as follows:

    Each tablet contains 324mg of ferrous sulfate, equivalent to 65mg of elemental iron, providing 361% of the U.S. recommended daily intake (RDI) of iron for adults and children 4 and older.

    Available in bottles of 100 tablets (72789-436-01)

  • PRINCIPAL DISPLAY PANEL - 324 mg Tablet Bottle Label

    72789-436-01

    Ferrous Sulfate
    Enteric-Coated
    Tablets

    324 mg

    Dietary
    Supplement

    Marketed and Packaged By:
    PD-Rx Pharmaceuticals, Inc
    Oklahoma City, OK 73127
    1-405-942-3040 V.12.24.0

    100 Tablets
    TAMPER EVIDENT: DO NOT USE IF
    SAFETY SEAL IS BROKEN OR MISSING FROM BOTTLE.

    PRINCIPAL DISPLAY PANEL - 324 mg Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    FERROUS SULFATE 
    ferrous sulfate tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:72789-436
    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
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    METHACRYLIC ACID (UNII: 1CS02G8656)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIACETIN (UNII: XHX3C3X673)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    1,2-DILINOLEOYL-3-OLEOYL-SN-GLYCEROL (UNII: 0NXD3O2NER)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:72789-436-01100 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT12/20/2024
    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
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