Label: MULTIVITAMIN WITH FLUORIDE DROPS- vitamin a palmitate, ascorbic acid, cholecalciferol, .alpha.-tocopherol, thiamine hydrochloride, riboflavin 5-phosphate sodium, niacinamide, pyridoxine hydrochloride, cyanocobalamin, and sodium fluoride solution/ drops

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

Drug Label Information

Updated August 30, 2022

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

  • STATEMENT OF IDENTITY

    Supplement Facts
    Serving Size 1.0 mL
    Servings Per Container 50
    Amount Per Serving% Daily Value
    Children over 4 & Adults
    *
    Daily Value not established
    Vitamin A450 mcg50%
    Vitamin C35 mg39%
    Vitamin D10 mcg (400 IU)50%
    Vitamin E3.35 mg22%
    Thiamin0.5 mg42%
    Riboflavin0.6 mg46%
    Niacin8 mg50%
    Vitamin B60.4 mg24%
    Vitamin B122 mcg83%
    Fluoride0.5 mg*

    *U.S. Recommended Daily Allowance not established.

    Consult your physician for use by infants and young children 6 months to 3 years of age.

    Active ingredient for caries prophylaxis: Fluoride as sodium fluoride.

    Other ingredients: Ascorbic acid, caramel color, cherry flavor, cholecalciferol, citric acid, cyanocobalamin, d-alpha-tocopheryl acetate, ferrous sulfate, glycerin, methyl paraben, niacinamide, polysorbate 80, purified water, pyridoxine HCL, riboflavin-5-phosphate sodium, sodium benzoate, sodium fluoride, sodium hydroxide, sucralose, thiamine HCL, vitamin A palmitate.

  • CLINICAL PHARMACOLOGY

    It is well established that fluoridation of the water supply (0.7 mg/L fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries. Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with the hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite. The reaction may be expressed by the equation:

    Ca10(PO4)6(OH)2 + 2F–Ca10(PO4)6F2 + 2OH–
    (Hydroxyapatite)              (Fluorapatite)

    Three stages of fluoride deposition in tooth enamel can be distinguished:

    1. Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed.

    2. After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted.

    3. After eruption, the surface enamel acquires fluoride from water, food, supplementary fluoride and small amounts from saliva.

    MultiVitamin with Fluoride Supplement Drops provide supplementation of the diet with nine essential vitamins, and with fluoride for caries prophylaxis. The American Academy of Pediatrics recommends that children up to the age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. MultiVitamin with Fluoride Supplement Drops provide fluoride in drop form for infants and young children 6 months to 3 years of age in areas where the drinking water contains less than 0.3 ppm of fluoride and for children ages 3 to 6 years in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride.

    Each 1.0 mL dose of MultiVitamin with Fluoride Supplement Drops 0.5 mg supplies sodium fluoride (0.5 mg fluoride) plus nine essential vitamins. A half dose (0.5 mL) of MultiVitamin with Fluoride Supplement Drops 0.5 mg could also provides a daily fluoride intake of 0.25 mg; however, the dosage reduces vitamin supplementation by half. MultiVitamin with Fluoride Supplement Drops 0.5 mg supply significant amounts of vitamins A, C, D, E, thiamine, riboflavin, niacinamide, pyridoxine and cyanocobalamin to supplement the diet, and to help ensure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, infants and children obtain nine essential vitamins and fluoride.

  • WARNINGS

    As in the case of all medications, keep out of the reach of children.

  • PRECAUTIONS

    The suggested dose should not be exceeded since dental fluorosis may result from continued ingestion of large amounts of fluoride. When prescribing vitamin fluoride products:

    1. Determine the fluoride content of the drinking water.

    2. Make sure the child is not receiving significant amounts of fluoride from other medications and swallowed toothpaste.

    3. Periodically check to make sure that the child does not develop significant dental fluorosis.

  • ADVERSE REACTIONS

    Allergic rash or other idiosyncrasies have been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact H2-Pharma at 1-866-592-6438 or FDA at 1-800-FDA-1088 or via the web at www.fda.gov/medwatch for voluntary reporting of adverse reactions.

  • DOSAGE AND ADMINISTRATION

    As directed by a physician. See American Dental Association (ADA) recommended supplement schedule below. May be dropped directly into the mouth with the enclosed dropper or mixed with cereal, fruit juice, or other food.

    ADA Dietary Fluoride Supplement Schedule for Children at High Caries Risk
    AgeFluoride ion level in drinking water (ppm)*
    <0.3 ppm0.3-0.6 ppm>0.6 ppm
    *
    1.0 part per million (ppm) = 1 milligram/liter (mgL)
    2.2 mg sodium fluoride contains 1 mg fluoride ion.
    Birth - 6 monthsNoneNoneNone
    6 months - 3 years0.25 mg/dayNoneNone
    3-6 years0.50 mg/day0.25 mg/dayNone
    6-16 years1.0 mg/day0.50 mg/dayNone

    SHAKE WELL BEFORE USE.

  • HOW SUPPLIED

    MultiVitamin with Fluoride Supplement Drops 0.5 mg are available in 50 mL bottles with accompanying calibrated dropper.

    Dispense in original container.

  • RECOMMENDED STORAGE

    Store at controlled room temperature, 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. After opening, store away from direct light. Close tightly after each use. REFRIGERATION IS NOT REQUIRED.

    TAMPER EVIDENT: Do not use if seal under cap is torn, broken or missing.

  • HEALTH CLAIM

    Distributed by: H2-Pharma, LLC
    Montgomery, AL 36117
    www.h2-pharma.com

  • PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

    61269-162-50

    Drops

    MultiVitamin
    with Fluoride

    Supplement Drops

    1⅔ fl. oz. (50 mL)

    0.5 mg

    H2 pharma

    PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    MULTIVITAMIN WITH FLUORIDE DROPS 
    vitamin a palmitate, ascorbic acid, cholecalciferol, .alpha.-tocopherol, thiamine hydrochloride, riboflavin 5-phosphate sodium, niacinamide, pyridoxine hydrochloride, cyanocobalamin, and sodium fluoride solution/ drops
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:61269-162
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A450 ug  in 1 mL
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID35 mg  in 1 mL
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL10 ug  in 1 mL
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL3.35 mg  in 1 mL
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE0.5 mg  in 1 mL
    RIBOFLAVIN 5'-PHOSPHATE SODIUM DIHYDRATE (UNII: 20RD1DZH99) (RIBOFLAVIN 5'-PHOSPHATE - UNII:7N464URE7E) RIBOFLAVIN 5'-PHOSPHATE0.6 mg  in 1 mL
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE8 mg  in 1 mL
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE0.4 mg  in 1 mL
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN2 ug  in 1 mL
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARAMEL (UNII: T9D99G2B1R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FERROUS SULFATE (UNII: 39R4TAN1VT)  
    CHERRY (UNII: BUC5I9595W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:61269-162-501 in 1 CARTON
    150 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT01/04/2017
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    flavor
    Labeler - H2-Pharma, LLC (028473634)