Label: MULTI VITAMIN WITH FLUORIDE- sodium fluoride, vitamin a acetate, ascorbic acid, sodium ascorbate, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid and cyanocobalamin tablet, chewable 

  • Label RSS
  • NDC Code(s): 0603-4381-21, 0603-4381-28, 0603-4382-21, 0603-4382-28, view more
    0603-4383-21, 0603-4383-28
  • Packager: Qualitest Pharmaceuticals
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 11/12

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

  • ACTIVE INGREDIENT

    This is an image of the Nutrition Facts panel.

    Active ingredient for caries prophylaxis:  Fluoride as sodium fluoride.

    Other Ingredients:

    Artificial grape flavor, ascorbic acid, cholecalciferol, compressible sugar, D&C Red #7 calcium lake, FD&C Blue #1 aluminum lake, folic acid, magnesium stearate, microcrystalline cellulose, niacinamide, polyethylene glycol, pyridoxine, riboflavin, sodium ascorbate, stearic acid, thiamine, vitamin A acetate, vitamin B12 and vitamin E acetate.

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  • 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.

    Multivitamin with Fluoride Chewable Tablets provide sodium fluoride and ten essential vitamins in a chewable tablet. Because the tablets are chewable, they provide a topical as well as systemic source of fluoride.

    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:

    This is an image of the reaction between hydroxyapatite and 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 the water, food, supplementary fluoride and smaller amounts from saliva.
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  • INDICATIONS AND USAGE

    Supplementation of the diet with ten essential vitamins.

    Supplementation of the diet with fluoride for caries prophylaxis.

    Multivitamin with 1 mg Fluoride Chewable Tablets provide fluoride in tablet form for children 6-16 years of age in areas where the water fluoride level is less than 0.3 ppm.

    Multivitamin with 0.5 mg Fluoride Chewable Tablets provide fluoride in tablet form for children 4-6 years of age where the water fluoride level is less than 0.3 ppm, and for children 6 years of age and above where the drinking water contains 0.3 through 0.6 ppm of fluoride.

    Multivitamin with 0.25 mg Fluoride Chewable Tablets provide fluoride in tablet form for children 4-6 years of age where the drinking water contains 0.3 through 0.6 ppm of fluoride.

    Multivitamin with Fluoride Chewable Tablets supply significant amounts of Vitamins A, C, D, E, thiamin, riboflavin, niacin, vitamin B6, vitamin B12, and folate 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, children obtain ten essential vitamins and the important mineral, fluoride.

    The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation.

    Children using Multivitamin with Fluoride Chewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential.

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  • WARNING

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

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

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  • PRECAUTIONS

    The suggested dose of Multivitamin with Fluoride Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.

    Before prescribing Multivitamin with Fluoride Chewable Tablets:

    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 sources such as medications and swallowed toothpaste.
    3. Periodically check to make sure that the child does not develop significant dental fluorosis.

    Do not eat or drink dairy products within one hour of medication administration.

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  • ADVERSE REACTIONS

    Allergic rash and other idiosyncrasies have been rarely reported.

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  • DOSAGE AND ADMINISTRATION

    One tablet daily or as prescribed.

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  • HOW SUPPLIED

    Multi-vitamin with Fluoride Chewable Tablets Grape are available as follows:

    • 1 mg:         Bottles of 100:  NDC 0603-4383-21
                         Bottles of 500:  NDC 0603-4383-28
    • 0.5 mg:      Bottles of 100:  NDC 0603-4382-21
                         Bottles of 500:  NDC 0603-4382-28
    • 0.25 mg:    Bottles of 100:  NDC 0603-4381-21
                         Bottles of 500:  NDC 0603-4381-28
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  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    QUALITEST PHARMACEUTICALS
    130 Vintage Drive
    Huntsville, AL 35811

    8183001
    R10/12-R3

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  • PRINCIPAL DISPLAY PANEL
  • PRINCIPAL DISPLAY PANEL
  • PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    MULTI VITAMIN WITH FLUORIDE 
    multi vitamin with fluoride tablet, chewable
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0603-4381
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 0.25 mg
    VITAMIN A ACETATE (VITAMIN A) VITAMIN A ACETATE 2500 [iU]
    ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 24 mg
    SODIUM ASCORBATE (ASCORBIC ACID) SODIUM ASCORBATE 36 mg
    CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
    .ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL ACETATE, DL- 15 [iU]
    THIAMINE MONONITRATE (Thiamine ION) THIAMINE MONONITRATE 1.05 mg
    RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.2 mg
    NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 13.5 mg
    PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 1.05 mg
    FOLIC ACID (FOLIC ACID) FOLIC ACID 0.3 mg
    CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 4.5 ug
    Inactive Ingredients
    Ingredient Name Strength
    RAW SUGAR  
    D&C RED NO. 7  
    FD&C BLUE NO. 1  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    STEARIC ACID  
    Product Characteristics
    Color PURPLE Score no score
    Shape ROUND Size 13mm
    Flavor GRAPE Imprint Code 4378;V
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0603-4381-21 100 in 1 BOTTLE, PLASTIC
    2 NDC:0603-4381-28 500 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 10/09/2009
    MULTI VITAMIN WITH FLUORIDE 
    multi vitamin with fluoride tablet, chewable
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0603-4382
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 0.5 mg
    VITAMIN A ACETATE (VITAMIN A) VITAMIN A ACETATE 2500 [iU]
    ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 24 mg
    SODIUM ASCORBATE (ASCORBIC ACID) SODIUM ASCORBATE 36 mg
    CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
    .ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL ACETATE, DL- 15 [iU]
    THIAMINE MONONITRATE (Thiamine ION) THIAMINE MONONITRATE 1.05 mg
    RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.2 mg
    NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 13.5 mg
    PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 1.05 mg
    FOLIC ACID (FOLIC ACID) FOLIC ACID 0.3 mg
    CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 4.5 ug
    Inactive Ingredients
    Ingredient Name Strength
    RAW SUGAR  
    D&C RED NO. 7  
    FD&C BLUE NO. 1  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    STEARIC ACID  
    Product Characteristics
    Color PURPLE Score no score
    Shape SQUARE Size 13mm
    Flavor GRAPE Imprint Code 4379;V
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0603-4382-21 100 in 1 BOTTLE, PLASTIC
    2 NDC:0603-4382-28 500 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 10/09/2009
    MULTI VITAMIN WITH FLUORIDE 
    multi vitamin with fluoride tablet, chewable
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0603-4383
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 1 mg
    VITAMIN A ACETATE (VITAMIN A) VITAMIN A ACETATE 2500 [iU]
    ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 24 mg
    SODIUM ASCORBATE (ASCORBIC ACID) SODIUM ASCORBATE 36 mg
    CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
    .ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL ACETATE, DL- 15 [iU]
    THIAMINE MONONITRATE (Thiamine ION) THIAMINE MONONITRATE 1.05  mg
    RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.2 mg
    NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 13.5 mg
    PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 1.05 mg
    FOLIC ACID (FOLIC ACID) FOLIC ACID 0.3 mg
    CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 4.5 ug
    Inactive Ingredients
    Ingredient Name Strength
    RAW SUGAR  
    D&C RED NO. 7  
    FD&C BLUE NO. 1  
    MAGNESIUM STEARATE  
    CELLULOSE, MICROCRYSTALLINE  
    POLYETHYLENE GLYCOLS  
    STEARIC ACID  
    Product Characteristics
    Color PURPLE Score no score
    Shape ROUND Size 13mm
    Flavor GRAPE Imprint Code 4380;V
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0603-4383-21 100 in 1 BOTTLE, PLASTIC
    2 NDC:0603-4383-28 500 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 10/09/2009
    Labeler - Qualitest Pharmaceuticals (011103059)
    Establishment
    Name Address ID/FEI Business Operations
    Vintage Pharmaceuticals-Huntsville 825839835 MANUFACTURE(0603-4381, 0603-4382, 0603-4383)
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