Label: FERROUS SULFATE tablet

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated September 25, 2014

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  • Active Ingredients

    Supplemental Facts

    Serving Size 1 Tablet              Servings per Container 100

    Amount Per Tablet                   % Daily Value

    Iron (as Ferrous Sulfate)           65 mg      361%

    Calcium                                  20 mg         2%

  • Purpose

    NATURAL IRON SUPPLEMENT

  • Keep out of reach of children.

    WARNING: Accidental overdose of iron-containing  products is a leading cause of poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

  • Indications and Usage

    NATURAL IRON SUPPLEMENT. The treatment of any anemic condition should be under the advise and supervision of a doctor.

  • WARNINGS: PRECAUTIONS:

    WARNING: Do not exceed recommended dosage. The treatment of any anemic condition should be under the advice and supervision of a doctor. Occasional gastrointestinal discomfort like nausea may be minimized with meals. Iron-containing drugs may cause constipation or diarrhea.


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

  • DIRECTIONS:

    Adults only. One tablet daily, preferably with a meal or as directed by a physician.

  • Other Ingredients:

    Dicalcium phosphate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, FD and C red #40 (AL Lake), FD and C blue #2/Indigo Carmine (Al Lake), macrogol, PEG 400, silicon dioxide, titanium dioxide, talc, vanillin.

  • STORAGE:

    Store between 15° - 30° C (59° -86° F)

  • FERROUS SULFATE Product Label

    58607-113-10

    NATURAL IRON SUPPLEMENT

    FERROUS SULFATE
    5 gr (325 mg)

    100 Tablets

    MADE WITH PRIDE IN THE U.S.A.

    M.E. Pharmaceuticals, Inc.
    Richmond, IN 47374

    Lot No:
    Exp Date:

    MEPharm FerrousSulfate Label

  • INGREDIENTS AND APPEARANCE
    FERROUS SULFATE 
    ferrous sulfate tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58607-113
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION65 mg
    CALCIUM (UNII: SY7Q814VUP) (CALCIUM - UNII:SY7Q814VUP) CALCIUM20 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    VANILLIN (UNII: CHI530446X)  
    Product Characteristics
    Colorred (RED) Scoreno score
    ShapeROUND (ROUND) Size4mm
    FlavorImprint Code NONE
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58607-113-10100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/01/2014
    Labeler - MARTIN EKWEALOR PHARMACEUTICALS, INC. (624528386)
    Registrant - MARTIN EKWEALOR PHARMACEUTICALS, INC (624528386)
    Establishment
    NameAddressID/FEIBusiness Operations
    MARTIN EKWEALOR PHARMACEUTICALS, INC624528386manufacture(58607-113)
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