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 27, 2023

If you are a consumer or patient please visit this version.

  • Poly-Vi-Flor

    (Multivitamin with 0.25 mg of Fluoride)

    Poly-Vi-Flor Drop are specifically designed to help meet the nutritional needs of your growing infant or toddler.

    • Poly-Vi-Flor Drops are the ideal vitamin supplement during your child's transition to solid foods, during growth spurts, or for the picky eater.
    • One daily dose of Poly-Vi-Flor Drops provides 7 essential vitamins and is fruit flavored.
    • Drops are dye-free and gluten-free.
  • Health Claim

    Multivitamin and Fluoride Supplement

    Supplement Facts
    Serving Size 1 mL • Servings Per Container 50
      % Daily Value
     Amount Per 1 mL Infants
    through
    12 months
     Children
    1 through 3
    years of age
     vitamin D (as cholecalciferol) 10 mcg 100%67%
     vitamin E (as d-alpha-tocopheryl acetate) 3.35 mg 67%56%
     niacin (as niacinamide) 8 mg 200%133%
     vitamin B6 (as pyridoxine HCl) 0.4 mg133%80%
     folate (from Metafolin®) 200 mcg DFE250%133%
     fluoride (as sodium fluoride) 0.25 mg* *

    *Daily Value not established

    Ingredients: Glycerin, Water, Fructose, Ascorbic Acid, Polysorbate 80, Natural Flavoring, Soy Lecithin, Potassium Sorbate

  • Dosage and Administration

    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 of the dropper bulb.  It is normal for a small amount to remain in the tip.

    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.

    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.

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

    Distributed by: Aytu Therapeutics, LLC
    Denver, CO80237
    1-855-298-8246
    www.aytubio.com

  • Principal Display Panel

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

    23594-550-50

    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 BioPharma

    Dispense under a physician’s order

    Bottle Label

    Bottle Label

    Carton Label

    Carton Label

  • INGREDIENTS AND APPEARANCE
    POLY-VI-FLOR 
    multivitamin and fluoride supplement suspension/ drops
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:23594-550
    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
    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 ACID200 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)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:23594-550-501 in 1 PACKAGE
    150 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT12/23/2022
    Labeler - Aytu Therapeutics LLC (117244733)