Label: TRI-VITAMIN WITH FLUORIDE- vitamin a, ascorbic acid, vitamin d, and sodium fluoride solution/ drops

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

Drug Label Information

Updated December 27, 2017

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  • HEALTH CLAIM

    SHAKE WELL BEFORE USING

  • DIRECTIONS

    Use as directed by a physician.

    How to Use:

    Fill dropper to appropriate line and dispense with a single squeeze of the dropper bulb. The full dose will be given. It is normal for a small amount to remain in the tip of the dropper.

    Do not accept if tamper evident box seal is broken or missing.

    Figure
  • STATEMENT OF IDENTITY

    Ingredients

    *
    Each 1 mL of Tri-Vitamin Drops contains 0.5 mg Fluoride from 1.1 mg Sodium Fluoride (NaF).
    Vitamin A1500 IU
    Vitamin C35 mg
    Vitamin D400 IU
    Fluoride* (as Sodium Fluoride)0.5 mg

    Other Ingredients

    Glycerin, water, polysorbate 80, sodium hydroxide, propylene glycol, sucralose, fruit flavor, methyl paraben, caramel color, propyl paraben.

  • Storage

    Store in a cool, dry place at room temperature 20°-25°C (68°-77°F) away from heat and sunlight. Store in original container.

    KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. IF OVERDOSAGE IS SUSPECTED, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY 1-800-222-1222.

  • Caution

    Do not use this product if you are allergic to any of the ingredients. Take this product at least 2 hours before or after taking any products containing calcium (including milk, yogurt, other dairy products) or aluminum/magnesium hydroxide (e.g., certain antacids/laxatives) since these may decrease effectiveness.

    Prolonged daily ingestion of excessive fluoride may result in varying degrees of dental fluorosis.

  • HEALTH CLAIM

    Manufactured by: Sancilio & Co., Inc.
    Riviera Beach, FL 33404 USA

  • PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label

    44946-1036-8

    SCI
    Sancilio &
    Company, Inc.
    Developing Good Science into Great Medicine

    Tri-Vitamin Drops
    with Fluoride

    VITAMINS A, C, D & FLUORIDE DROPS

    NO DYES OR SUGAR
    SACCHARIN AND GLUTEN FREE

    0.5
    mg/mL

    1⅔ FL. OZ. (50 mL)

    Dispense under a
    physician's order†

    Dietary
    Supplement

    PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    TRI-VITAMIN WITH FLUORIDE 
    vitamin a, ascorbic acid, vitamin d, and sodium fluoride solution/ drops
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:44946-1036
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T) Vitamin A1500 [iU]  in 1 mL
    Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid35 mg  in 1 mL
    Vitamin D (UNII: 9VU1KI44GP) (Vitamin D - UNII:9VU1KI44GP) Vitamin D400 [iU]  in 1 mL
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Sodium hydroxide (UNII: 55X04QC32I)  
    Propylene glycol (UNII: 6DC9Q167V3)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:44946-1036-850 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Dietary Supplement12/20/2011
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    flavor
    Labeler - Sancilio & Company Inc (176681257)
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