Label: FERROUS SULFATE- ferrous sulfate, dried tablet, film coated

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated December 9, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients (in each Caplet)

    Dried Ferrous Sulfate 325 mg

  • Purpose

    Iron Supplement Therapy

    Ferrous Sulphate is an iron supplement for iron deficiency and iron deficiency anemia when the need for such therapy has been determined by a physician.

  • Warnings

    Do not exceed recommended dosage. The treatment of any anemic condition should be under the advice and supervision of a physician. Since oral iron products interfere with absorption of certain antibiotics, these products should not be taken within tow hours of each other. Occasional gastrointestinal discomfort (such as nausea) may be minimized by taking with meals. Iron-containing products may occasionally cause constipation or diarrhea.

    If are pregnant or nursing a baby, seek the advise of a health professional before using this products.

    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.

  • Direction

    *
    adults and children 12 years and over : take 1 tablet daily or as directed by a doctor
    *
    Children under 12 years : consult a physician..
  • Other information

    *
    Store at room temperature
  • Inactive ingredients

    Starch USP, Calcium Carbonate USP, Guar Gum , Magnesium Stearate USP, Talc USP, Colloidal Silicon Dioxide USP, , Carnuba Wax

  • PRINCIPAL DISPLAY PANEL - Shipping Label

    FERROUS SULFATE TABLETS USP 325 MG

    Each film coated tablet contains:
    Ferrous Sulfate tablet USP 325 mg
    (Equivalent to 65 mg of elimental IRON)

    LOT NO:QUANTITY: 15000
    DRUM NO:NDC NO: 68210-1520-1
    MFG. DATE:EXP. DATE:

    WARNING :
    KEEP OUT OF THE REACH OF CHILDREN

    STORE AT CONTROLLED ROOM TEMPRATURE OF 59° – 86°F (15° – 30°C)
    PROTECT FROM LIGHT, MOISTURE AND FREEZING

    THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
    CONTENTS SHOULD BE APPROVED,REPACKAGED IMMEDIATELY AND LABELED IN STRICT
    CONFORMANCE WITH THE F.D & C.ACT AND REGULATIONS THEREUNDER

    MANUFACTURED BY:
    LIC NO :      GUJ/DRUGS/G/505
    MARKSANS PHARMA LTD
    UDYOGNAGAR,NAVSARI-396445
    INDIA

    MANUFACTURED FOR:
    SPIRIT PHARMACEUTICALS LLC
    225 LINCOLN HWY, STE 205
    FAIRLESS HILLS , PA 19030
    PH.# 215 943 4000, FAX.#215 943 4039

    CAUTION : "FOR MANUFACTURING, PROCESSING OR REPACKING"

    Principal Display Panel - Shipping Label
  • INGREDIENTS AND APPEARANCE
    FERROUS SULFATE 
    ferrous sulfate, dried tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68210-1520
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERROUS SULFATE, DRIED (UNII: RIB00980VW) (IRON - UNII:E1UOL152H7) FERROUS SULFATE, DRIED325 mg
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    GUAR GUM (UNII: E89I1637KE)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    TALC (UNII: 7SEV7J4R1U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Product Characteristics
    ColorGREENScoreno score
    ShapeTRIANGLESize14mm
    FlavorImprint Code FS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68210-1520-11 in 1 DRUM
    115000 in 1 BAG
    2NDC:68210-1520-21 in 1 DRUM
    210000 in 1 BAG
    3NDC:68210-1520-31 in 1 DRUM
    31000 in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER12/15/2010
    Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)
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