Label: MULTIVITAMIN WITH FLUORIDE- .alpha.-tocopherol acetate, dl-, ascorbic acid, cyanocobalamin, folic acid, niacin, pyridoxine, riboflavin, sodium fluoride, thiamine mononitrate, vitamin a and vitamin d tablet, chewable

  • NDC Code(s): 58657-163-01, 58657-163-90
  • Packager: Method Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated February 22, 2021

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  • SPL UNCLASSIFIED SECTION

    MULTIVITAMIN WITH FLUORIDE

    Disclaimer: This drug has not been found by FDA to be safeand effective, and this labeling has not been approved by FDA.

    Prescribing Information

    Each Fluoride Chewable Tablet Contains:

    Supplement Facts

    Dosage Size 1 Chewable Tablet

    Amount per Tablet% DV Adults and Children
    4 years or More
    Vitamin A (as Vitamin A acetate)2500 IU50%
    Vitamin C (as ascorbic acid)60 mg100%
    Vitamin D (as cholecalciferol)400 IU100%
    Vitamin E (dl-alpha tocopherol acetate
    )
    15 IU50%
    Thiamine (as thiamine)1.05 mg70%
    Riboflavin (as riboflavin)1.2 mg71%
    Niacin (as niacinamide)13.5 mg68%
    Vitamin B6 (as pyridoxine HCl)1.05 mg53%
    Folate (as folic acid)300 mcg75%
    Vitamin B12 (as cyanocobalamin)4.5 mcg75%
    Fluoride (as sodium fluoride)0.25 mg*

    *Daily value (DV) not established

    Multivitamin with Fluoride 0.25 mg Chewable Tabletsactive ingredient for caries prophylaxis: Fluoride as sodium fluoride

    Multivitamin with Fluoride 0.25 mg Chewable Tabletsprovide sodium fluoride and ten essential vitamins in a chewable tablet.

    Other ingredients: citric acid, magnesium stearate, mannitol, microcrystalline cellulose, orange flavor, sucralose, talc, xylitol.

  • 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 0.25 mg 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: 

    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 the water, food, supplementary fluoride and smaller amounts from saliva.

  • INDICATIONS AND USAGE

    Supplementation of the diet with ten essential vitamins.

    Supplementation of the diet with fluoride for caries prophylaxis.

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

    Multivitamin with Fluoride 0.25 mg Chewable Tablets supply significant amounts of Vitamins A, C, D, E, thiamine, 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 supplements.

    Children using Multivitamin with Fluoride 0.25 mg Chewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential. Multivitamin with Fluoride Chewable Tablets is a prescription product for the clinical dietary management of the metabolic processes of caries prophylaxis and provides supplementation of the diet with ten essential vitamins.

  • WARNING

    Keep out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

    CAUTION

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

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

  • PRECAUTION

    The suggested dose of Multivitamin with Fluoride 0.25 mg Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.

     Before prescribing Multivitamin with Fluoride 0.25 mg 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.

  • ADVERSE REACTIONS

    Allergic rash and other idiosyncrasies have been rarely reported.

  • DOSAGE AND ADMINISTRATION

    One tablet daily, to be dissolved in the mouth or chewed before swallowing. Do not give a chewable tablet to a child younger than 4 years old.

  • HOW SUPPLIED

    Multivitamin Chewable tablets containing 0.25 mg fluoride are round yellowish/cream tablets with orange and yellow speckles. Debossed with “M163” on one side.

    NDC: 58657-163-90 (90 count)

    NDC: 58657-163-01 (100 count)

  • STORAGE

    Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature.

    Dispense in a tight, light resistant container with a child-resistant closure as defined in the USP/NF. All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

    Manufactured For:
    Method Pharmaceuticals
    Fort Worth, TX 76118

    Rev. 06/2019

  • PRINCIPAL DISPLAY PANEL

    NDC 58657-163-90
    Multivitamin
    with Fluoride
    Chewable Tablets
    0.25 mg
    Orange Flavor
    Rx Only
    90 Tablets

    PRINCIPAL DISPLAY PANEL 
NDC 58657-163-90
Multivitamin
with Fluoride
Chewable Tablets
0.25 mg
Orange Flavor 
Rx Only
90 Tablets

  • PRINCIPAL DISPLAY PANEL

    NDC 58657-163-01
    Multivitamin
    with Fluoride
    Chewable Tablets
    0.25 mg
    Orange Flavor
    Rx Only
    100 Tablets

    PRINCIPAL DISPLAY PANEL 
NDC 58657-163-01
Multivitamin
with Fluoride
Chewable Tablets
0.25 mg
Orange Flavor 
Rx Only
100 Tablets

  • INGREDIENTS AND APPEARANCE
    MULTIVITAMIN WITH FLUORIDE 
    .alpha.-tocopherol acetate, dl-, ascorbic acid, cyanocobalamin, folic acid, niacin, pyridoxine, riboflavin, sodium fluoride, thiamine mononitrate, vitamin a and vitamin d tablet, chewable
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:58657-163
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A2500 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID60 mg
    VITAMIN D (UNII: 9VU1KI44GP) (VITAMIN D - UNII:9VU1KI44GP) VITAMIN D400 [iU]
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-15 [iU]
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.05 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.2 mg
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN13.5 mg
    PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE1.05 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID300 ug
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN4.5 ug
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    TALC (UNII: 7SEV7J4R1U)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Coloryellow (yellowish/cream) Scoreno score
    ShapeROUNDSize9mm
    FlavorORANGEImprint Code M163
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58657-163-9090 in 1 BOTTLE; Type 0: Not a Combination Product07/20/2018
    2NDC:58657-163-01100 in 1 BOTTLE; Type 0: Not a Combination Product07/20/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/20/2018
    Labeler - Method Pharmaceuticals, LLC (060216698)
    Establishment
    NameAddressID/FEIBusiness Operations
    Monarch PCM, LLC080000294manufacture(58657-163)