Label: FE-VITE IRON ORAL SOLUTION- ferrous sulfate solution

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated March 18, 2023

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  • STATEMENT OF IDENTITY

                                                                                                Supplement Facts
    Serving Size: 1 mL Daily
    Serving per container:  50
    Amount per 1 mL (dropperful)                                                                               % Daily Value
                                                                                  Infants through 12 Months of age         Children 1 through 4 years of age
    Iron (as Ferrous Sulfate)   15 mg                                                     100%                                                  150%

  • HEALTH CLAIM

    Although nutrition improvement have significantly reduced the incidence of iron deficiency, the condition continue to affect many young children.*

    One daily dose of Pediatric Iron drops has 100% DV of iron for infants and 150% DV for children age of 1-4 Years.

    * This statement has not been evaluated by the Food and Drug Administration.  This product is not intended to diagnose, treat, cure, or prevent any disease.

  • SAFE HANDLING WARNING

    Storage:  Store at room temperature 15º -30ºC(59º - 86ºF).  Protect from freezing.  After opening, store away from direct light.  Refrigerator is not required.

  • WARNINGS

    WARNING:  Accidental overdose of iron-containing products is a leading cause of fatal 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.

  • PRECAUTIONS

    SHAKE WELL BEFORE USE.

  • DOSAGE & ADMINISTRATION


    Directions for use:

    Administer this supplement using only the device provided.  Shake bottle well and fill dropper to 1.0 ml. line.  Dosage not to exceed 1.0 ml. per day unless doctor recommends another dosage.  Dispense directly into mouth or mixed with formula, fruit juice, cereal, or other foods.  Rinse and retain device for further dosing of this product.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    FE-VITE IRON ORAL SOLUTION 
    ferrous sulfate solution
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:71399-7480
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FERROUS SULFATE (UNII: 39R4TAN1VT) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    SORBITOL (UNII: 506T60A25R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARAMEL (UNII: T9D99G2B1R)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:71399-7480-550 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement01/04/2021
    Labeler - Akron Pharma (067878881)
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