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

  • Category: DIETARY SUPPLEMENT

Drug Label Information

Updated September 2, 2022

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  • Poly-Vi-Flor

    (Multivitamin with 0.5 mg of Fluoride and 10 mg Iron) Chewable Tablet

  • HEALTH CLAIM

    Multivitamin and Fluoride Supplement

    Supplement Facts
    Serving Size 1 Tablet
    Servings Per Container 30
    Amount Per Serving% Daily Value
    for Adults and Children
    4 or More Years of Age
    vitamin A (as retinyl acetate)600 mcg67%
    vitamin C (as sodium ascorbate)60 mg67%
    vitamin D (as cholecalciferol)10 mcg50%
    vitamin E (as d-alpha-tocopherol)10 mg67%
    thiamin (as thiamin mononitrate)1 mg83%
    riboflavin1.2 mg92%
    niacin (as niacinamide)10 mg63%
    vitamin B6 (as pyridoxine HCl)1 mg59%
    folate (from Metafolin®)200 mcg DFE50%
    vitamin B12 (as cyanocobalamin)4.5 mcg188%
    iron (as carbonyl iron)10 mg56%
    fluoride (as sodium fluoride)0.5 mg*

    *Daily Value not established

    Ingredients: Sucrose, Sorbitol, Fructose, Citric Acid, Beet Root Juice, Carrageenan USP, Grape Flavor, Raspberry Flavor, Stearic Acid, Cherry Flavor, Magnesium Stearate, Sucralose

    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.

  • WARNINGS

    WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.

  • SAFE HANDLING WARNING

    Metafolin® 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 and 10 mg Iron

    23594-100-30

    Poly-Vi-Flor®

    (Multivitamin with 0.5 mg of Fluoride and 10 mg Iron) Chewable Tablet

    MULTIVITAMIN & FLUORIDE SUPPLEMENT

    BERRY FLAVOR

    0.5 mg with iron

    30 Tablets

    CONTAINS: METAFOLIN

    AYTU BIOPHARMA

    Multivitamin with 0.5 mg of Fluoride and 10 mg Iron

  • INGREDIENTS AND APPEARANCE
    POLY-VI-FLOR 
    multivitamin and fluoride supplement tablet, chewable
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:23594-100
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A600 ug
    SODIUM ASCORBATE (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID60 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL10 ug
    .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D-10 mg
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.2 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE10 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE1 mg
    LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID200 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN4.5 ug
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON10 mg
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.5 mg
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    SORBITOL (UNII: 506T60A25R)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:23594-100-301 in 1 PACKAGE
    130 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
    shape
    size (solid drugs)10 mm
    scoring1
    flavor
    Labeler - Aytu Therapeutics, LLC (117244733)