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Ferrous Sulfate (Richmond Pharmaceuticals Inc.)

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TABLET 100 TABLET in 1 BOTTLE (54738-963-13) Label Information

Complete Ferrous Sulfate Information

  • 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.


  • SPL UNCLASSIFIED SECTION

    SAVE CARTON FOR COMPLETE PRODUCT INFORMATION

    Supplement Facts
    % Daily Value
    Iron (as ferrous sulfate) 65 mg 360%

  • INDICATIONS & USAGE

    SUGGESTED USE: 


  • PURPOSE

    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 (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


  • 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.


  • DOSAGE & ADMINISTRATION

    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.


  • KEEP OUT OF REACH OF CHILDREN

    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

    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 Type HUMAN OTC DRUG Item Code (Source) NDC:54738-963
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color RED Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54738-963-13 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 11/05/2008
    Labeler - Richmond Pharmaceuticals Inc. (043569607)
    Establishment
    Name Address ID/FEI Business Operations
    Advance Pharmaceutical Inc. 078301063 MANUFACTURE(54738-963)