Label: FERROUS SULFATE 324MG ENTERIC COATED- ferrous sulfate tablet, delayed release

  • NHRIC Code(s): 69375-003-10
  • Packager: Nationwide Pharmaceutical, LLC
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated April 17, 2020

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  • HEALTH CLAIM

    Ferrous Sulfate
    Enteric-Coated Tablets
    324mg
    Dietary Supplement

  • CONTAINS

    Each tablet contains 324 mg of ferrous sulfate, equivalent to 65 mg of elemental iron, providing 362% 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.

  • SAFE HANDLING WARNING

    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. Incase of accidental overdose, call a doctor or poison control center immediately.
  • 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]

  • STATEMENT OF IDENTITY

    Supplement Facts
    Serving Size 1 Tablet
    Amount Per Tablet% Daily Value
    Iron (as ferrous sulfate)65 mg362%

    Other ingredients: Microcrystalline Cellulose, Dibasic Calcium Phosphate Dihydrate, Croscarmellose Sodium, Stearic Acid, Magnesium Stearate, Triacetin, FD&C Red No. 40, Silicon Dioxide, Hypromellose, Methacrylic Acid, Mineral Oil

  • HEALTH CLAIM

    Packaged For: Nationwide Pharmaceutical, LLC
    San Antonio, Tx 78232 (4-20)

  • PRINCIPAL DISPLAY PANEL - 324 mg Tablet Bottle Label

    Nationwide
    Pharmaceutical

    NDC 69375-0003-10

    Ferrous Sulfate
    Enteric-Coated Tablets

    324mg
    Dietary
    Supplement

    CONTAINS: Each tablet contains 324 mg of ferrous sulfate,
    equivalent to 65 mg of elemental iron, providing 362% 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.

    Net Contents 100 Tablets

    PRINCIPAL DISPLAY PANEL - 324 mg Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    FERROUS SULFATE 324MG ENTERIC COATED 
    ferrous sulfate tablet, delayed release
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:69375-003
    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)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TRIACETIN (UNII: XHX3C3X673)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:69375-003-10100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT03/25/2020
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring2
    shape
    size (solid drugs)11 mm
    imprint
    Labeler - Nationwide Pharmaceutical, LLC (079265801)
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