Label: TRI-VITE PEDIATRIC ORAL SOLUTION- vitamin a palmitate, sodium ascorbate, cholecalciferol solution

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

Drug Label Information

Updated May 13, 2021

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  • STATEMENT OF IDENTITY

                                                                                                Supplement Facts

     Serving size:  1 mL Daily
     Serving per container:  50
     Amount per 1mL (dropperful)                                                                           % Daily Value
                                                                             Infants through 12 Months of age            Children 1 through 4 Years of age
     Vitamin A     225 mcg                                                               50%                                                             30%
     Vitamin C      35 mg                                                               100%                                                              88%
     Vitamin D      10 mcg                                                             100%                                                            100%

  • HEALTH CLAIM

    TRI-VITE Drops is designed to help meet the nutritional needs of your growing infant.*

    * 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:  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
    TRI-VITE PEDIATRIC ORAL SOLUTION 
    vitamin a palmitate, sodium ascorbate, cholecalciferol solution
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:71399-7504
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A.225 mg  in 1 mL
    SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID35 mg  in 1 mL
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL.01 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CARAMEL (UNII: T9D99G2B1R)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:71399-7504-550 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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