Label: MULTI-VIT WITH FLUORIDE- dl-alpha-tocopheryl acetate and ascorbic acid and cholecalciferol and cyanocobalamin and niacinamide and pyridoxine hydrochloride and riboflavin and fluoride and thiamine hydrochloride and vitamin a palmitate solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 11, 2019

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

  • DESCRIPTION

     Supplement Facts
     Dosage Size 1 mL (Mark on Dropper)
     Amount Per
    1 mL 
    % Daily Value
    InfantsChildren Under
    Age 4 Years
     Vitamin A 1500 IU 100% 60%
     Vitamin C 35 mg 100% 88%
     Vitamin D 400 IU 100% 100%
     Vitamin E 5 IU 100% 50%
     Thiamin 0.5 mg 100% 71%
     Riboflavin 0.6 mg 100% 75%
     Niacin 8 mg 100% 89%
     Vitamin B6 0.4 mg 100% 57%
     Vitamin B12 2 mcg 100% 67%
     Fluoride 0.25 mg * *
      *Daily Value (DV) not established

    Active ingredient for caries prophylaxis:
    Each 1 mL contains 0.25 mg fluoride as sodium fluoride.

    Other ingredients:

    ascorbic acid (Vitamin C), caramel color, cholecalciferol (Vitamin D3), cyanocobalamin (Vitamin B12), dl-alpha-tocopheryl acetate (Vitamin E), ferrous sulfate, flavors, glycerin, niacinamide, polysorbate 80, purified water, pyridoxine hydrochloride (Vitamin B6), riboflavin 5’-phosphate sodium (Vitamin B2), sodium hydroxide, thiamine hydrochloride (Vitamin B1), vitamin A palmitate

  • CLINICAL PHARMACOLOGY:

    It is well established that fluoridation of the water supply (1 ppm 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. Three stages of fluoride deposition in tooth enamel can be distinguished:1 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 smaller amounts from saliva.

  • INDICATIONS AND USAGE:

    Supplementation of the diet with nine essential vitamins. Supplementation of the diet with fluoride for caries prophylaxis. MULTI-VIT with FLUORIDE 0.25 mg drops were developed to provide fluoride in drop form for infants and young children from 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.2, 3 Each 1 mL supplies sodium fluoride (0.25 mg fluoride) plus nine essential vitamins. MULTI-VIT with FLUORIDE 0.25 mg drops supply significant amounts of vitamins A, C, D, E, thiamin, riboflavin, niacin, vitamin B6 and vitamin B12 to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, infants and children obtain nine essential vitamins plus fluoride.

  • WARNING:

    As with all medicines, 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 MULTI-VIT with FLUORIDE 0.25 mg drops: 1) Determine the fluoride content of the drinking water from all major sources. 2) Make sure the child is not receiving significant amounts of fluoride from other sourcessuch as medications and swallowed toothpaste. 3) Periodically check to make sure that the child does not develop significant dental fluorosis. MULTI-VIT with FLUORIDE 0.25 mg drops should be dispensed in the original plastic container, since contact with glass leads to instability and precipitation. (The amount of sodium fluoride in a 50-mL size is well below the maximum to be dispensed at one time according to recommendations of the American Dental Association.)

  • ADVERSE REACTIONS:

    Allergic rash and other idiosyncrasies have been rarely reported.

  • DOSAGE AND ADMINISTRATION:

    1 mL daily, or as prescribed. May be dropped directly into mouth with dropper, or mixed with fruit juice, cereal or other food. USE FULL DOSAGE.

    DISPENSE in original container.

  • STORAGE AND HANDLING

    Occasional deepening of color has no significant effect on vitamin potency.

    After opening, store away from direct light.

    Your doctor or dentist is the best source of counsel and guidance in your child’s fluoride supplementation.

  • REFERENCES

    1. Brudevold F, McCann HG. Fluoride and caries control - Mechanism of action. In: Nizel AE, ed. The Science of Nutrition and Its Application in Clinical Dentistry. Philadelphia: WB Saunders Co.; 1966;331-347.
    2. American Academy of Pediatrics, Committee on Nutrition: Fluoride Supplementation for Children: Interim Policy Recommendations. Pediatrics. 1995;95:777.
    3. American Dental Association Council on Dental Therapeutics. New Fluoride Schedule Adopted. ADA News. May 16, 1994;12-14.
  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    QUALITEST PHARMACEUTICALS
    130 VINTAGE DRIVE
    HUNTSVILLE, AL 35811

    Rev. 3/15 R6
    8268010

  • PRINCIPAL DISPLAY PANEL - carton

    This is an image of the carton for Multi-Vit with Fluoride 0.25 mg Drops 50 mL.
  • PRINCIPAL DISPLAY PANEL - label

    This is an image of the label for Multi-Vit with Fluoride 0.25 mg Drops 50 mL.
  • INGREDIENTS AND APPEARANCE
    MULTI-VIT WITH FLUORIDE 
    dl-alpha-tocopheryl acetate and ascorbic acid and cholecalciferol and cyanocobalamin and niacinamide and pyridoxine hydrochloride and riboflavin and fluoride and thiamine hydrochloride and vitamin a palmitate solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0603-1449
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A1500 [iU]  in 1 mL
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID35 mg  in 1 mL
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]  in 1 mL
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-5 [iU]  in 1 mL
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (Thiamine ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE0.5 mg  in 1 mL
    RIBOFLAVIN 5'-PHOSPHATE SODIUM (UNII: 20RD1DZH99) (FLAVIN MONONUCLEOTIDE - UNII:7N464URE7E) FLAVIN MONONUCLEOTIDE0.6 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 ION0.25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    FERROUS SULFATE (UNII: 39R4TAN1VT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Product Characteristics
    ColorBROWNScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0603-1449-471 in 1 CARTON04/18/199703/31/2021
    150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER04/18/199703/31/2021
    Labeler - Par Pharmaceutical (011103059)