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FERROUS SULFATE (SPIRIT PHARMACEUTICALS,LLC)

Available Formats

Dosage Form Package Information Links
TABLET, FILM COATED 1 BOTTLE in 1 CARTON (68210-1520-0) > 100 TABLET, FILM COATED in 1 BOTTLE Label Information
TABLET, FILM COATED 1 BAG in 1 DRUM (68210-1520-3) > 1000 TABLET, FILM COATED in 1 BAG Label Information
TABLET, FILM COATED 1 BAG in 1 DRUM (68210-1520-1) > 15000 TABLET, FILM COATED in 1 BAG Label Information
TABLET, FILM COATED 1 BAG in 1 DRUM (68210-1520-2) > 10000 TABLET, FILM COATED in 1 BAG Label Information

Complete FERROUS SULFATE Information

  • 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 - 65 mg Tablet Carton

    Ferrous
    Sulfate

    NDC # 68210-1520-0

    Iron Supplement
    Therapy

    • #1 doctor recommended
      iron supplement
    • Easy to swallow
    • 65 mg of elemental iron per
      tablet – 360% of daily value

    TAMPER EVIDENT –
    SEE SIDE PANEL

    100
    TABLETS

    PRINCIPAL DISPLAY PANEL - 65 mg Tablet Carton

  • INGREDIENTS AND APPEARANCE
    FERROUS SULFATE 
    ferrous sulfate, dried tablet, film coated
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68210-1520
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    FERROUS SULFATE, DRIED (UNII: RIB00980VW) (IRON - UNII:E1UOL152H7) FERROUS SULFATE, DRIED 325 mg
    Inactive Ingredients
    Ingredient Name Strength
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    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
    Color GREEN Score no score
    Shape TRIANGLE Size 14mm
    Flavor Imprint Code FS
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68210-1520-0 1 in 1 CARTON
    1 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 12/15/2010
    Labeler - SPIRIT PHARMACEUTICALS,LLC (179621011)