Label: POLY-VI-FLOR- multivitamin and fluoride supplement suspension/ drops

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

Drug Label Information

Updated March 5, 2021

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  • Poly-Vi-Flor

  • HEALTH CLAIM

    Multivitamin and Fluoride Supplement

    Supplement Facts
    Serving Size 1 mL • Servings Per Container 50
    % Daily Value
    Amount Per 1 mLInfants
    through
    12 months    		Children
    1 through 3
    years of age
    vitamin D (as cholecalciferol)10 mcg100%67%
    vitamin E (as d-alpha-tocopheryl acetate)3.35 mg67%56%
    thiamin (as thiamin HCl)0.5 mg137%100%
    riboflavin0.6 mg150%120%
    niacin (as niacinamide)8 mg200%133%
    vitamin B6 (as pyridoxine HCl)0.4 mg133%80%
    folate (from Metafolin®)230 mcg DFE288%153%
    fluoride (as sodium fluoride)0.25 mg**

    *Daily Value not established

    Ingredients: Glycerin, Water, Fructose, Xylitol, Polysorbate 80, Natural Flavoring, Citric Acid, Soy Lecithin, Potassium Sorbate, Sodium Benzoate

    U.S. Patent Numbers: 5,997,915; 6,254,904; 6,011,040; 6,441,168

    Metafolin® is a registered trademark of Merck KGaA, Darmstadt, Germany

    Distributed by: Aytu BioScience, Inc.
    Englewood, CO 80112
    1-855-298-8246
    www.aytubio.com

  • How to Use the Enclosed Dropper

    Fill the dropper to the 1 mL line to provide the full daily dosage. Use full dosage, regardless of age or weight, unless your child's doctor recommends a different dosage. Dispense with a single squeeze.

    Dosing Tips

    Drops may be given by dispensing directly into the mouth. Drops may also be mixed with formula, fruit juice, cereal or other foods to increase your child's acceptance.

  • SAFE HANDLING WARNING

    Shake well before use.

    This product comes with a child-resistant cap. Refrigeration not required. After opening, store away from direct sunlight.

  • WARNING

    As with all medicines, keep out of the reach of children.

  • PRINCIPAL DISPLAY PANEL - Poly-Vi-Flor with 0.25 mg of Fluoride

    23594-500-50

    Poly-Vi-Flor®

    Essential Vitamins for Infants & Toddlers

    FRUITY FLAVOR

    MULTIVITAMIN AND FLUORIDE SUPPLEMENT

    0.25 mg

    NOT SUBSTITUTABLE

    CONTAINS: METAFOLIN

    1 2/3 FL OZ (50 mL)

    AYTU BioScience

    Poly-Vi-Flor with 0.25 mg of Fluoride

  • INGREDIENTS AND APPEARANCE
    POLY-VI-FLOR 
    multivitamin and fluoride supplement suspension/ drops
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:23594-500
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL10 ug  in 1 mL
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D-3.35 mg  in 1 mL
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE0.5 mg  in 1 mL
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN0.6 mg  in 1 mL
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE8 mg  in 1 mL
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE0.4 mg  in 1 mL
    LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID230 ug  in 1 mL
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    XYLITOL (UNII: VCQ006KQ1E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:23594-500-501 in 1 PACKAGE
    150 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    dietary supplement09/01/2016
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    flavor
    Labeler - Aytu Therapeutics, LLC (117244733)
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