Label: D-VITE PEDIATRIC ORAL LIQUID- cholecalciferol 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
     Amount Per mL (dropperful)                                                          % Daily Value                                                                
                                                                 Infants through 12 months of age      Children 1 through 4 years of age
    400 IU                                                                        100%                                                          100%  

  • HEALTH CLAIM

    D-VITE Drops provides essential vitamin that helps your baby's body absorb calcium for strong bones and teeth.*

    D-VITE Drops complements your breast milk to help provide optimal nutrition for your baby. *

    * This statment 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:  As with medicine, Keep out of reach of children.

  • 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
    D-VITE PEDIATRIC ORAL LIQUID 
    cholecalciferol solution
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:71399-7401
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CARAMEL (UNII: T9D99G2B1R)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:71399-7401-550 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement12/18/2019
    Labeler - Akron Pharma (067878881)
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