Label: FERROUS GLUCONATE tablet

  • NHRIC Code(s): 0574-0508-01, 0574-0508-11, 0574-0508-10
  • Packager: Padagis US LLC
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated October 30, 2024

If you are a consumer or patient please visit this version.

  • STATEMENT OF IDENTITY

    Dietary Supplement

  • 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 gluconate) 38 mg

    208%

    Other ingredients: Colloidal Silicon Dioxide, Corn Starch, Talc, Powdered Cellulose, Sodium Starch Glycolate, Stearic Acid, Titanium Dioxide, Polyethylene Glycol, Sucrose, Calcium Carbonate, Magnesium Stearate, Copovidone, Shellac, Cocoa Butter, FD&C Blue No. 1 Aluminum Lake, Maltodextrin, Hypromellose, Riboflavin, Carnauba Wax, White Wax.

    Distributed by Padagis®
    Minneapolis, MN 55427

    02-23

  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

    Ferrous Gluconate Tablets, USP 324 mg

    Dietary Supplement

    CONTAINS: Each tablet contains 324 mg of ferrous gluconate, equivalent to 38 mg of elemental iron, providing 208% 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 three to four times daily.
    Children: Consult a physician.

    NET CONTENTS 100 TABLETS

    100 ct bottle label
  • INGREDIENTS AND APPEARANCE
    FERROUS GLUCONATE 
    ferrous gluconate tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:0574-0508
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERROUS GLUCONATE (UNII: U1B11I423Z) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION38 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SUCROSE (UNII: C151H8M554)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    COPOVIDONE K25-31 (UNII: D9C330MD8B)  
    SHELLAC (UNII: 46N107B71O)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    RIBOFLAVIN (UNII: TLM2976OFR)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:0574-0508-01100 in 1 BOTTLE
    2NHRIC:0574-0508-1110 in 1 CARTON
    210 in 1 BLISTER PACK
    3NHRIC:0574-0508-101000 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 - Padagis US LLC (967694121)