Label: NOVADHA BABY DHA- omega-3 fatty acids, cholecalciferol, and .alpha.-tocopherol liquid

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

Drug Label Information

Updated February 1, 2016

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  • STATEMENT OF IDENTITY

    Supplement Facts
    SERVING SIZE 5 ml*
    SERVINGS PER BOTTLE: 12
    Amount Per Serving% Daily Value
    * Infants under 1 year of age.
    *
    Refer to back of box for suggested use.
    †
    Daily Value not established
    Calories45
    Total Fat5.0 g†
    Vitamin A230-902 IU15-61%
    Vitamin D-3400 IU100%
    Total Omega-3s1050 mg†
      EPA (Eicosapentaenoic Acid)350 mg†
      DHA (Docosahexaenoic Acid)485 mg†
    Other Omega-3s215 mg†

    OTHER INGREDIENTS: Purified arctic cod liver oil, rosemary extract (a natural preservative), D-alpha tocopherol, cholecalciferol in medium chain triglycerides.

    No gluten, milk derivative or artificial colors or flavors

  • WARNING

    Consult with your physician before using this product if your child is allergic to iodine, using blood thinners, or anticipates surgery.

  • SAFE HANDLING WARNING

    Do not use if seal is broken or missing.

  • SUGGESTED USE

    Shake well before use.

    As a dietary supplement for infants and children ranging from 5 to 35 pounds in weight. Take as directed unless otherwise instructed by your child's physician.

  • HEALTH CLAIM

    Distributed by:
    Gensavis    ®
    PHARMACEUTICALS LLC

    Gensavis Pharmaceuticals, LLC
    Corpus Christi, TX 78415

    Manufactured in the USA

    Questions or Comments?
    Call 972-836-7783
    Monday–Friday, 9:00am to 4:30pm EST
    Or visit our website at
    www.novaferrum.com

  • PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

    NovaDHA™
    PEDIATRIC DROPS
    DIETARY SUPPLEMENT

    omega-3
    supplement

    For Infants & Children
    Under 4 Years of Age

    2 FL OZ (60 mL)

    PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    NOVADHA   BABY DHA
    omega-3 fatty acids, cholecalciferol, and .alpha.-tocopherol liquid
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:52304-719
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Omega-3 Fatty Acids (UNII: 71M78END5S) (Omega-3 Fatty Acids - UNII:71M78END5S) Omega-3 Fatty Acids1050 mg  in 5 mL
    Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol400 [iU]  in 5 mL
    .Alpha.-Tocopherol (UNII: H4N855PNZ1) (.Alpha.-Tocopherol - UNII:H4N855PNZ1) .Alpha.-Tocopherol6 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    Rosemary (UNII: IJ67X351P9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:52304-719-5060 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT02/01/2016
    Labeler - Gensavis Pharmaceuticals, LLC (961905879)
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