Label: FERROUS SULFATE tablet

  • NHRIC Code(s): 0574-0608-01, 0574-0608-11, 0574-0608-10
  • Packager: Paddock Laboratories, LLC
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated August 23, 2017

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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 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.

  • 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.
  • 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 (as ferrous sulfate)65 mg362%

    Other ingredients: Corn Starch, Calcium Stearate, Powdered Cellulose, Lactose, Talc, Copovidone, Polyethylene Glycol, Maltodextrin, Sucrose, Povidone, Calcium Carbonate, Titanium Dioxide, Magnesium Stearate, Shellac, Cocoa Butter, FD&C Red No. 40 Aluminum Lake, Sodium Starch Glycolate A, Sodium Lauryl Sulfate, Colloidal Silicon Dioxide, Methacrylic Acid Copolymer Type C, Sodium Hydroxide, Simethicone Emulsion, Diethyl Phthalate, Hypromellose, Carnauba Wax, White Wax.

    Packaged by: Paddock Laboratories, Inc.
    Minneapolis, MN 55427

    (01-08)

  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

    Perrigo®

    NDC 0574-0608-01

    Ferrous Sulfate
    Enteric-Coated Tablets

    324 mg

    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 - 100 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    FERROUS SULFATE 
    ferrous sulfate tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:0574-0608
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    CALCIUM STEARATE (UNII: 776XM7047L)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    TALC (UNII: 7SEV7J4R1U)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    SUCROSE (UNII: C151H8M554)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SHELLAC (UNII: 46N107B71O)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    DIETHYL PHTHALATE (UNII: UF064M00AF)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:0574-0608-01100 in 1 BOTTLE
    2NHRIC:0574-0608-1110 in 1 CARTON
    210 in 1 BLISTER PACK
    3NHRIC:0574-0608-101000 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT08/06/2012
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)11 mm
    Labeler - Paddock Laboratories, LLC (967694121)
    Establishment
    NameAddressID/FEIBusiness Operations
    Paddock Laboratories, LLC967694121LABEL, PACK
    Establishment
    NameAddressID/FEIBusiness Operations
    Quality By Design Packaging, Inc.830254210PACK
    Establishment
    NameAddressID/FEIBusiness Operations
    Lomapharm Rudolf Lohmann GmbH KG315866525MANUFACTURE
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