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

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

Drug Label Information

Updated April 8, 2019

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 mLInfantsChildren Under Age 4 Years
    Vitamin A (as palmitate) 1125 IU75%45%
    Vitamin D3 (as cholecalciferol) 300 IU75%75%
    L-methylfolate Calcium (as Metafolin®) 200 mcg162%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

  • 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.

  • 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.

  • WARNING

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

  • 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

  • INGREDIENTS AND APPEARANCE
    TRI-VI-FLOR 
    multivitamin and fluoride supplement suspension/ drops
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:23594-700
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A1125 [iU]  in 50 mL
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL300 [iU]  in 50 mL
    LEVOMEFOLATE CALCIUM (UNII: A9R10K3F2F) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID200 ug  in 50 mL
    FLUORIDE ION (UNII: Q80VPU408O) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.25 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:23594-700-501 in 1 PACKAGE
    150 mL 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
    flavor
    Labeler - Cerecor, Inc. (968799028)