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

  • NDC Code(s): 23594-300-30
  • Packager: Zylera Pharmaceuticals, LLC
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated December 18, 2017

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  • Poly-Vi-Flor

    (Multivitamin with .5 mg of Fluoride) Chewable Tablet

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  • HEALTH CLAIM

    Multivitamin and Fluoride Supplement

    Supplement Facts
    Serving Size 1 Tablet
    Amount Per Tablet U.S. Recommended Daily Allowance (%)
    Adults and Children 4 or More Years of Age
    Vitamin A 2000 IU 40%
    Vitamin C 60 mg 100%
    Vitamin D 400 IU 100%
    Vitamin E 15 IU 50%
    Thiamin 1 mg 67%
    Riboflavin 1.2 mg 71%
    Niacin 10 mg 50%
    Vitamin B6 1 mg 53%
    L-methylfolate Calcium (as Metafolin®) 200 mcg *
    Vitamin B12 4.5 mcg 75%
    Fluoride 0.5 mg *

    *U.S. Recommended Daily Allowance has not been established

    INGREDIENTS: SUCROSE, SORBITOL, FRUCTOSE, CITRIC ACID, BEET ROOT JUICE, NAT. RASPBERRY FLV., GRAPE FLAVOR, STEARIC ACID, CARRAGEENAN, CHERRY FLAVOR, MAGNESIUM STEARATE, SUCRALOSE

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  • DOSAGE & ADMINISTRATION

    Distributed by:
    Zylera Pharmaceuticals
    Research Triangle Park, NC 27713

    Should be chewed.

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  • SAFE HANDLING WARNING

    This product, as all chewable tablets, is not recommended for children under age 4 due to risk of choking.

    U.S. Patent No. 5,997,915 U.S. Patent No. 6,254,904
    U.S. Patent No. 6,011,040 U.S. Patent No. 6,441,168

    Metafolin® is a registered trademark of Merck KGaA, Darmstadt, Germany
    *CAS# 151533-22-1

    Questions or comments?
    Please call Zylera Medical Affairs at 1-866-416-9637

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  • PRINCIPAL DISPLAY PANEL - Multivitamin with .5 mg of Fluoride

    23594-300-30

    Poly-Vi-Flor

    (Multivitamin with .5 mg of Fluoride) Chewable Tablet

    MULTIVITAMIN & FLUORIDE SUPPLEMENT

    BERRY FLAVOR

    0.5 mg

    30 Tablets

    CONTAINS: METAFOLIN

    Zylera Pharmaceuticals

    Multivitamin with .5 mg of Fluoride

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  • INGREDIENTS AND APPEARANCE
    POLY-VI-FLOR 
    multivitamin and fluoride supplement tablet, chewable
    Product Information
    Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:23594-300
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A 2000 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 60 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 400 [iU]
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL 15 [iU]
    THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 1 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 1.2 mg
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN 10 mg
    PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 1 mg
    LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID 200 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 4.5 ug
    FLUORIDE ION (UNII: Q80VPU408O) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.5 mg
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:23594-300-30 1 in 1 PACKAGE
    1 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    dietary supplement 09/01/2016
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving % Daily Value
    color
    shape
    size (solid drugs) 10 mm
    scoring 1
    flavor
    Labeler - Zylera Pharmaceuticals, LLC (032546121)
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