Label: POLY-VI-FLOR GUMMIES- multivitamin and fluoride supplement tablet, chewable

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

Drug Label Information

Updated December 12, 2022

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

  • Poly-Vi-Flor

    (Multivitamin with 0.5 mg of Fluoride) Chewable Gummie

    Multivitamin and Fluoride Supplement

  • HEALTH CLAIM

    Supplement Facts

    Serving Size 1 Gummie

    Servings Per Gummie 30

     Amount Per Serving  % Daily Value
    for Adults and Children
    4 or More Years of Age
     Vitamin A (as retinyl palmitate) 600 mcg 67%
     Vitamin C (as ascorbic acid) 60 mg 67%
     Vitamin D (as cholecalciferol) 15 mcg 75%
     Vitamin E (as d-alpha tocopherol acetate) 10 mg 67%
     Niacin (as Nicotinic Acid) 10 mg 63%
     Folate (as Arcofolin®) 230 mcg DFE 58%
     Vitamin B12 (as cyanocobalamin) 4.5 mcg 188%
     Fluoride (as sodium fluoride) 0.5 mg *

    *Daily Value not established

    Ingredients: Corn Syrup (Glucose), Sugar, Water, Pectin, Sodium Citrate, Citric Acid, Mixed Berry Natural Flavor, Natural Masking Agent, Red 40

    Allergen Warning: Contains fish gelatin and soy oil

  • DOSAGE & ADMINISTRATION

    Caution: This product should be chewed and is not recommended for children under age 4 due to risk of choking.

  • SAFE HANDLING WARNING

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

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

  • Principal Display Panel - MultiVitamin with 0.5 MG of Fluoride

    23594-350-30

    Poly-Vi-Flor®

    (Multivitamin with 0.5 mg of Fluoride) Chewable Gummie

    MULTIVITAMIN & FLUORIDE SUPPLEMENT

    BERRY FLAVOR

    0.5 mg

    30 Gummies

    CONTAINS:ARCOFOLIN

    AYTU BIOPHARMA

    0.5 mg Gummies Label
  • INGREDIENTS AND APPEARANCE
    POLY-VI-FLOR GUMMIES 
    multivitamin and fluoride supplement tablet, chewable
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:23594-350
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A600 ug
    SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID60 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL15 ug
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D-10 mg
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN10 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN4.5 ug
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.5 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID230 ug
    Inactive Ingredients
    Ingredient NameStrength
    CORN SYRUP (UNII: 9G5L16BK6N)  
    WATER (UNII: 059QF0KO0R)  
    PECTIN (UNII: 89NA02M4RX)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:23594-350-3030 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT12/16/2022
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    flavor
    scoring1
    shape
    size (solid drugs)18 mm
    Labeler - Aytu Therapeutics LLC (117244733)