Label: FERROUS SULFATE tablet

  • NDC Code(s): 54738-963-01, 54738-963-03
  • Packager: Richmond Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 23, 2019

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  • Supplement Facts[/S]

    Serving Size: 1 Tablet
    Amount per Tablet    		% Daily Value
     Iron (as ferrous sulfate)  65 mg  360 %
  • SUGGESTED USE

    Adults: One (1) tablet daily, preferably after meals or as directed by the doctor. Children: As directed by the doctor.

  • Active Ingredient

    EACH TABLET CONTAINS:                  % U.S. RDA*

    Elemental Iron 65 mg     360

    (Equivalent to 325 mg of Ferrous Sulfate)

    * U.S. Recommended Daily Allowance  

  • Inactive Ingredients

    Croscarmellose sodium, dicalcium phosphate, FD&C RED#40 (Al-lake), FD&C yellow #6 (Al-lake), hypromellose, magnesium stearate, microcrystalline cellulose, PEG 400, titanium dioxide

  • Purpose

    Iron Supplement

  • 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 exceed recommended dosage. The treatment of any anemic condition should be under the advice and supervision of doctor. Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals. Iron-containing medication may occasionally cause constipation or diarrhea.

    As with any drug, if you are pregnant or nursing baby, seek the advice of a health professional before using this product.   

  • DRUG INTERACTION PRECAUTION

    Since oral iron products interfere with absorption of oral tetracycline antibiotics , these products should not be taken within two hours of each other.

  • DOSAGE AND ADMINISTRATION

    Each tablet contains: Calcium 20 mg (2% daily value) Store in a dry place at controlled room temperature at 15-30 °C (59°-86° F). Do not expose to excessive heat or moisture.

  • Questions or Comments

    DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP  IS MISSING OR DAMAGED

    Call 804-270-4498 Monday-Friday, 8.30 am – 4.30 pm ET

  • Package Label

    FERROUS SULFATE TABLETS 325 mg (5 gr)

    Iron Supplement

    NDC: 54738-963-01 – 100 Tablets 

    NDC: 54738-963-03 – 1000 TABLETS

    IMG_4683

  • INGREDIENTS AND APPEARANCE
    FERROUS SULFATE 
    ferrous sulfate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54738-963
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION325 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorredScoreno score
    ShapeROUNDSize8mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54738-963-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2015
    2NDC:54738-963-031000 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/01/2015
    Labeler - Richmond Pharmaceuticals, Inc. (043569607)
    Registrant - Advance Pharmaceutical Inc. (078301063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advance Pharmaceutical Inc.078301063manufacture(54738-963)
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