Label: FERROUS GLUCONATE tablet

  • NHRIC Code(s): 69367-165-04, 69367-165-07
  • Packager: Westminster Pharmaceuticals, LLC
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated February 9, 2024

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

  • DESCRIPTION

    Each tablet contains 324 mg of ferrous gluconate, equivalent to 38 mg of elemental iron, providing 211% 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.

  • STATEMENT OF IDENTITY

    Supplement Facts
    Serving Size 1 Tablet
    Amount Per Tablet% Daily Value *
    *
    Percent Daily Value (DV) are based on a 2000 calorie diet. Your daily value may be higher or lower depending on your calorie intake.
    Iron (as ferrous gluconate)38 mg211%

    Other Ingredients: Microcrystalline Cellulose, Dicalcium Phosphate Dihydrated, Croscarmellose Sodium, Stearic Acid (Vegetable), Silicon Dioxide, Magnesium Stearate (Vegetable), Sodium Starch Glycolate, Hypromellose, Polyethylene Glycol, FD&C Yellow #6, FD&C Blue #1, Titanium Dioxide.

  • 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 medicine and vitamins with iron be packaged in child-resistant closures. Parents should always properly resecure safety closures.

  • Storage

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

    You may report side effects by calling 1-844-221-7294.

  • HEALTH CLAIM

    Manufactured for:
    Westminster Pharmaceuticals, LLC
    Nashville, TN 37217
    Rev. 05/22

  • PRINCIPAL DISPLAY PANEL - 324 mg Tablet Bottle Label

    69367-165-04

    Ferrous Gluconate
    Tablets, USP
    Iron Supplement

    324 mg

    100 Tablets

    Westminster
    Pharmaceuticals

    Principal Display Panel - 324 mg Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    FERROUS GLUCONATE 
    ferrous gluconate tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:69367-165
    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
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE B POTATO (UNII: 27NA468985)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:69367-165-04100 in 1 BOTTLE, PLASTIC
    2NHRIC:69367-165-071000 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT07/31/2017
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)11 mm
    imprint
    Labeler - Westminster Pharmaceuticals, LLC (079516651)