Label: FERROUS GLUCONATE tablet

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

Drug Label Information

Updated October 31, 2023

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  • 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 mg208%

    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.

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

    (01-08)

  • FERROUS GLUCONATE TABLET

    Label Image
  • INGREDIENTS AND APPEARANCE
    FERROUS GLUCONATE 
    ferrous gluconate tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:50090-0269(NDC: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:50090-0269-330 in 1 BOTTLE
    2NHRIC:50090-0269-290 in 1 BOTTLE, PLASTIC
    3NHRIC:50090-0269-0100 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 - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-0269) , REPACK(50090-0269)
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