Label: FERROUS SULFATE tablet

  • NDC Code(s): 54738-963-13
  • Packager: Richmond Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 23, 2019

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    Supplement Facts
    % Daily Value
    Iron (as ferrous sulfate) 65 mg360%
  • SUGGESTED USE: 

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

    Children: As directed by the doctor.

  • EACH TABLET CONTAINS:                                                                  % U.S. RDA*

    Elemental Iron 65 mg (Equivalent to 325 mg of Ferrous Sulfate)                        60

    *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

  • BOXED WARNING (What is this?)

    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 a 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 a 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.

  • OTHER INFORMATION:

    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?

    call 804-270-4498, 8:30 am - 4:30 pm ET, Monday – Friday

    TAMPER EVIDENT: DO NOT USE IF A BLISTER PACKAGE UNIT IS TORN, BROKEN OR SHOW ANY SIGN OF TAMPERING

    *Richmond Pharmaceuticals, Inc. is not affiliated with the owner of the registered trademark FEOSOL®.

    Distributed by: Richmond Pharmaceuticals, Inc., Richmond, VA 23233, USA

    CR1210

    Principle Display Panel

    NDC 54738-963-13

    Compare to Active Ingredient in Feosol ®*

    Ferrous Sulfate Tablets
    325 mg (5 gr)

    Red

    Iron Supplement
    100 Tablets (25x4) UNIT DOSE

    Richmond Pharmaceuticals, Inc.
    Richmond, VA 23233

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    39803ffc-figure-01
  • 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:54738-963-13100 in 1 BOTTLE; Type 0: Not a Combination Product11/05/2008
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/05/2008
    Labeler - Richmond Pharmaceuticals Inc. (043569607)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advance Pharmaceutical Inc.078301063manufacture(54738-963)