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

  • NDC Code(s): 23594-700-50
  • Packager: Zylera Pharmaceuticals, LLC
  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated December 18, 2017

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

  • Tri-Vi-Flor
  • HEALTH CLAIM

    Multivitamin and Fluoride Supplement

    Supplement Facts
    Serving Size 1 mL Dropperful Daily
    Servings Per Container 50
    % Daily Value
    Amount Per 1 mL Infants Children Under Age 4 Years
    Vitamin A (as palmitate) 1125 IU 75% 45%
    Vitamin D3 (as cholecalciferol) 300 IU 75% 75%
    L-methylfolate Calcium (as Metafolin®) 200 mcg 162% 81%
    Fluoride (as sodium fluoride) 0.25 mg * *

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

    OTHER INGREDIENTS: Sucrose, water, citric acid, sodium benzoate, potassium sorbate.

    Distributed by: Zylera Pharmaceuticals
    Research Triangle Park, NC 27713

    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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  • 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.

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  • 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.

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  • WARNING

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

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

    23594-700-50

    Tri-Vi-Flor

    Essential Vitamins for Infants & Toddlers

    FRUITY FLAVOR

    MULTIVITAMIN AND FLUORIDE SUPPLEMENT

    0.25 mg

    NEW FORMULATION
    NOT SUBSTITUTABLE

    CONTAINS: METAFOLIN

    1 2/3 FL OZ (50 mL)

    Zylera Pharmaceuticals

    Tri-Vi-Flor with 0.25 mg of Fluoride

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  • INGREDIENTS AND APPEARANCE
    TRI-VI-FLOR 
    multivitamin and fluoride supplement suspension/ drops
    Product Information
    Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:23594-700
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A 1125 [iU]  in 50 mL
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 300 [iU]  in 50 mL
    LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID 200 ug  in 50 mL
    FLUORIDE ION (UNII: Q80VPU408O) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.25 mg  in 50 mL
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:23594-700-50 1 in 1 PACKAGE
    1 50 mL 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
    flavor
    Labeler - Zylera Pharmaceuticals, LLC (032546121)
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