MVC (SODIUM FLUORIDE, VITAMIN A PALMITATE, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID AND CY

MVC (SODIUM FLUORIDE, VITAMIN A PALMITATE, ASCORBIC ACID, CHOLECALCIFEROL, ALPHA-TOCOPHEROL ACETATE, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID AND CY
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NDC 44946-1012-4, 44946-1012-5, 44946-1012-6, 44946-1012-7, 44946-1013-4, 44946-1013-5, 44946-1013-6, 44946-1014-4, 44946-1014-5, 44946-1014-6
Set ID 50b44fd6-8747-448f-b951-234e7e17df4f
Category DIETARY SUPPLEMENT
Packager Sancilio & Company Inc
Generic Name
Product Class
Product Number
Application Number
  • HEALTH CLAIM

    Rx only

  • STATEMENT OF IDENTITY

    Nutrition Facts
    Serving Size 1 Chewable Tablet
    Serving Per Container 30 or 90
    Amount Per Serving
    (1 Chewable Tablet)
    1.0 mg0.5 mg0.25 mg%DV Adults & Children
    4 Years or More
    *
    Daily Value (%DV) not established
    Vitamin A2500 IU2500 IU2500 IU50%
    Vitamin C60 mg60 mg60 mg100%
    Vitamin D400 IU400 IU400 IU100%
    Vitamin E15 IU15 IU15 IU50%
    Thiamin1.05 mg1.05 mg1.05 mg70%
    Riboflavin1.2 mg1.2 mg1.2 mg70%
    Niacin13.5 mg13.5 mg13.5 mg68%
    Vitamin B61.05 mg1.05 mg1.05 mg53%
    Folate0.3 mg0.3 mg0.3 mg75%
    Vitamin B124.5 mcg4.5 mcg4.5 mcg75%
    Fluoride1.0 mg0.5 mg0.25 mg*

    Active ingredients

    Fluoride as sodium fluoride.

    Other Ingredients

    Xylitol, microcrystalline cellulose, mannitol, talc, magnesium stearate, sucralose, natural flavors, citric acid.

  • 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 forms to produce the more caries-resistant crystal, fluorapatite. The reaction may be expressed by the equation:

    Chemical Structure

    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 fluoride and ten essential vitamins.

    Multivitamin with 1.0 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.

    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.

  • WARNING

    Keep this and all medication out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

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

  • 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.
  • ADVERSE REACTIONS

    Allergic rash and other idiosyncrasies have been rarely reported.

  • DOSAGE AND ADMINISTRATION

    One tablet daily or as prescribed.

  • HOW SUPPLIED

    Multivitamin with 1.0 mg, 0.5 mg and 0.25 mg Fluoride Chewable Tablets are all available in 30 and 90 tablet bottles.

    STORAGE

    Store in a cool dry place. Protect from light and moisture.

  • HEALTH CLAIM

    Manufactured by:
    Sancilio & Company, Inc.
    3874 Fiscal Court #200
    Riviera Beach, FL 33404

  • PRINCIPAL DISPLAY PANEL - 1.0 mg Bottle Label

    44946-1014-5

    SCI
    Sancilio & Company, Inc.

    Developing Good Science into Great Medicine

    MVC ™-Fluoride 1.0mg*
    Multivitamin Chewable Tablets with Fluoride

    No dyes, artificial flavors or sugar

    Dietary
    Supplement

    90 tablets
    Made in the U.S.A.

    PRINCIPAL DISPLAY PANEL - 1.0 mg Bottle Label
  • PRINCIPAL DISPLAY PANEL - 0.5mg Bottle Label

    SCI
    Sancilio & Company, Inc.

    Developing Good Science into Great Medicine

    44946-1013-5
    Rx Only

    MVC® Fluoride
    0.5mg *
    MULTIVITAMIN WITH FLUORIDE CHEWABLE TABLETS

    NO DYES, ARTIFICIAL FLAVORS OR SUGAR
    SACCHARIN AND GLUTEN FREE

    MULTIVITAMIN AND FLUORIDE SUPPLEMENT

    90 Tablets
    Made in the U.S.A.

    PRINCIPAL DISPLAY PANEL - 0.5mg Bottle Label
  • PRINCIPAL DISPLAY PANEL - 0.25mg Bottle Label

    SCI
    Sancilio & Company, Inc.

    Developing Good Science into Great Medicine

    44946-1012-5
    Rx Only

    MVC® Fluoride
    0.25mg *
    MULTIVITAMIN WITH FLUORIDE CHEWABLE TABLETS

    NO DYES, ARTIFICIAL FLAVORS OR SUGAR
    SACCHARIN AND GLUTEN FREE

    MULTIVITAMIN AND FLUORIDE SUPPLEMENT

    90 Tablets
    Made in the U.S.A.

    PRINCIPAL DISPLAY PANEL - 0.25mg Bottle Label
  • INGREDIENTS AND APPEARANCE
    MVC 
    sodium fluoride, vitamin a palmitate, ascorbic acid, cholecalciferol, alpha-tocopherol acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid and cyanocobalamin tablet, chewable
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:44946-1014
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion1 mg
    Vitamin A Palmitate (UNII: 1D1K0N0VVC) (Vitamin A - UNII:81G40H8B0T, Retinol - UNII:G2SH0XKK91) Vitamin A2500 [iU]
    Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid60 mg
    Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol400 [iU]
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) (.Alpha.-Tocopherol - UNII:H4N855PNZ1) .Alpha.-Tocopherol15 [iU]
    Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine1.05 mg
    Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin1.2 mg
    Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide13.5 mg
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride1.05 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid0.3 mg
    cyanocobalamin (UNII: P6YC3EG204) (cyanocobalamin - UNII:P6YC3EG204) cyanocobalamin4.5 ug
    Inactive Ingredients
    Ingredient NameStrength
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Malic Acid (UNII: 817L1N4CKP)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Xylitol (UNII: VCQ006KQ1E)  
    Talc (UNII: 7SEV7J4R1U)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:44946-1014-44 in 1 BOX
    124 in 1 BOX
    130 in 1 BOTTLE
    2NHRIC:44946-1014-54 in 1 BOX
    224 in 1 BOX
    290 in 1 BOTTLE
    3NHRIC:44946-1014-630 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Dietary Supplement12/20/2009
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)12 mm
    imprint
    flavor
    MVC 
    sodium fluoride, vitamin a palmitate, ascorbic acid, cholecalciferol, alpha-tocopherol acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid and cyanocobalamin tablet, chewable
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:44946-1013
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion0.5 mg
    Vitamin A Palmitate (UNII: 1D1K0N0VVC) (Vitamin A - UNII:81G40H8B0T, Retinol - UNII:G2SH0XKK91) Vitamin A2500 [iU]
    Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid60 mg
    Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol400 [iU]
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) (.Alpha.-Tocopherol - UNII:H4N855PNZ1) .Alpha.-Tocopherol15 [iU]
    Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine1.05 mg
    Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin1.2 mg
    Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide13.5 mg
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride1.05 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid0.3 mg
    cyanocobalamin (UNII: P6YC3EG204) (cyanocobalamin - UNII:P6YC3EG204) cyanocobalamin4.5 ug
    Inactive Ingredients
    Ingredient NameStrength
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Malic Acid (UNII: 817L1N4CKP)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Xylitol (UNII: VCQ006KQ1E)  
    Talc (UNII: 7SEV7J4R1U)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:44946-1013-44 in 1 BOX
    124 in 1 BOX
    130 in 1 BOTTLE
    2NHRIC:44946-1013-54 in 1 BOX
    224 in 1 BOX
    290 in 1 BOTTLE
    3NHRIC:44946-1013-630 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Dietary Supplement12/20/2009
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)12 mm
    imprint
    flavor
    MVC 
    sodium fluoride, vitamin a palmitate, ascorbic acid, cholecalciferol, alpha-tocopherol acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid and cyanocobalamin tablet, chewable
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:44946-1012
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion0.25 mg
    Vitamin A Palmitate (UNII: 1D1K0N0VVC) (Vitamin A - UNII:81G40H8B0T, Retinol - UNII:G2SH0XKK91) Vitamin A2500 [iU]
    Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid60 mg
    Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol400 [iU]
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) (.Alpha.-Tocopherol - UNII:H4N855PNZ1) .Alpha.-Tocopherol15 [iU]
    Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine1.05 mg
    Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin1.2 mg
    Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide13.5 mg
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride1.05 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid0.3 mg
    cyanocobalamin (UNII: P6YC3EG204) (cyanocobalamin - UNII:P6YC3EG204) cyanocobalamin4.5 ug
    Inactive Ingredients
    Ingredient NameStrength
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Malic Acid (UNII: 817L1N4CKP)  
    Microcrystalline Cellulose (UNII: OP1R32D61U)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Xylitol (UNII: VCQ006KQ1E)  
    Talc (UNII: 7SEV7J4R1U)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:44946-1012-77 in 1 BOTTLE, PLASTIC
    2NHRIC:44946-1012-44 in 1 BOX
    224 in 1 BOX
    230 in 1 BOTTLE
    3NHRIC:44946-1012-54 in 1 BOX
    324 in 1 BOX
    390 in 1 BOTTLE
    4NHRIC:44946-1012-630 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Dietary Supplement12/20/2009
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    scoring1
    shape
    size (solid drugs)13 mm
    imprint
    flavor
    Labeler - Sancilio & Company Inc (176681257)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sancilio & Company Inc080018491MANUFACTURE, RELABEL, REPACK

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