Label: ESCAVITE- sodium fluoride, vitamin a acetate, biotin, magnesium, zinc, copper, calcium pantothenate, folic acid, iron, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, and cyanocobalamin tablet, chewable

  • 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 March 29, 2012

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

  • SPL UNCLASSIFIED SECTION

    Nutrition Facts
    Serving Size: 1 Chewable Tablet
    Amount Per Tablet% Daily Value Adults &
    Children 4 Years or More
    *
    Daily value not established.
    Vitamin A1000 IU20%
    Vitamin C100 mg180%
    Vitamin D400 IU100%
    Vitamin E30 IU100%
    Thiamine1.5 mg100%
    Riboflavin1.7 mg100%
    Niacin20 mg100%
    Vitamin B62 mg100%
    Folic Acid400 mcg100%
    Vitamin B129 mcg150%
    Biotin45 mcg15%
    Pantothenic Acid10 mg100%
    Iron7.5 mg42%
    Magnesium60 mg15%
    Zinc7.5mg50%
    Copper1 mg50%
    Fluoride0.25 mg*

    Ingredient for caries prophylaxis: * Fluoride as sodium fluoride.

    Other Ingredients: Xylitol, microcrystalline cellulose, povidone, magnesium stearate, fruit flavor, talc, sucralose.

  • BOXED WARNING (What is this?)

    WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdosage, call a doctor or a poison control center immediately.

  • SPL UNCLASSIFIED SECTION

    ESCAVITE™
    MULTI-VITAMIN WITH IRON AND FLUORIDE 0.25mg CHEWABLE TABLETS

    Rx Only

    ESCAVITE - sodium fluoride, vitamin A acetate, ascorbic acid, cholecalciferol, alpha-tocopherol acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, ferrous fumarate, magnesium oxide, zinc oxide, and cupric oxide tablet, chewable.

    GM Pharmaceuticals, Inc.

    ----------------------------------------

  • PHARMACOLOGY

    It is well established that fluoridation of the water supply (1 ppm fluoride) during period of tooth development leads to a significant decrease in the incidence of dental caries. Escavite multi-vitamin with Iron and Fluoride Chewable Tablets provide sodium fluoride, magnesium, zinc, copper, twelve essential vitamins, and iron in a chewable tablet. Because 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)F2 + 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 smaller amounts from saliva.

    Escavite multi-vitamin with Iron and Fluoride Chewable Tablets is a prescription product for the dietary management of the metabolic processes of caries prophylaxis, and provides supplementation of the diet with twelve essential vitamins, magnesium, zinc, copper and iron.

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

    Escavite multi-vitamin with Iron and Fluoride Chewable Tablets supply significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, folate, biotin, pantothenic acid, magnesium, zinc, copper 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 twelve essential vitamins and the important minerals, magnesium, zinc, copper, iron, and fluoride.

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

    Children using Escavite multi-vitamin with Iron and 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

    Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under age 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or Poison Control Center immediately.

    Tablets should be chewed or crushed before they are swallowed.

    This product is not recommended for children under age 4 due to risk of choking.

  • PRECAUTIONS

    The suggested dose of Escavite multi-vitamin with Iron and Fluoride Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.

    Before prescribing Escavite multi-vitamin with Iron and 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.

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

  • ADVERSE REACTIONS

    Allergic rash and other idiosyncrasies have been rarely reported.

    To report adverse side effects or to obtain product information, contact GM Pharmaceuticals at 1-888-535-0305.

  • RECOMMENDED USE

    One tablet daily or as prescribed by doctor, or dentist.

  • DESCRIPTION

    Chewable tablets containing multivitamins with iron and fluoride 0.25mg are sugar free, dye free, off-white speckled, round shape, fruit flavor chewable tablets. Debossed EVT on one side. Available in bottles of 100 tablets.

  • STORAGE

    Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature. Protect from light and moisture.

    Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF.

  • REFERENCES

    1. Brudevoid 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 Company, 1966, pp 331-347.
    2. American Academy of Pediatrics, Committee on Nutrition: Fluoride Supplementation for Children: Interim Policy Recommendations. Pediatrics. 1995; 95 (5):777.
    3. American Dental Association Council on Dental Therapeutics. New Fluoride Schedule Adopted. ADA News. May 16, 1994; 12-14.

    Manufactured for: GM Pharmaceuticals, Inc. Arlington, TX 76012
    Rev. 09/11

  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

    58809-888-01

    ESCAVITE

    MULTI-VITAMIN
    WITH IRON AND FLUORIDE
    0.25mg

    CHEWABLE TABLETS

    MULTI-VITAMIN SUPPLEMENT
    WITH IRON
    AND FLUORIDE

    Rx Only

    GMPharmaceuticals, Inc.

    100 Tablets

    Principal Display Panel - 100 Tablet Bottle Label
  • INGREDIENTS AND APPEARANCE
    ESCAVITE  
    sodium fluoride, vitamin a acetate, biotin, magnesium, zinc, copper, calcium pantothenate, folic acid, iron, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, and cyanocobalamin tablet, chewable
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:58809-888
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Sodium Fluoride0.25 mg
    Vitamin A Acetate (UNII: 3LE3D9D6OY) (Vitamin A - UNII:81G40H8B0T) Vitamin A Acetate1000 [iU]
    Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04) Biotin45 ug
    Magnesium (UNII: I38ZP9992A) (Magnesium Oxide - UNII:3A3U0GI71G) Magnesium60 mg
    Zinc (UNII: J41CSQ7QDS) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc7.4 mg
    Copper (UNII: 789U1901C5) (Cupric Oxide - UNII:V1XJQ704R4) Copper1 mg
    Calcium Pantothenate (UNII: 568ET80C3D) (Calcium Pantothenate - UNII:568ET80C3D) Calcium Pantothenate10 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid0.4 mg
    Iron (UNII: E1UOL152H7) (Ferrous Cation - UNII:GW89581OWR) Iron7.5 mg
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID100 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE30 [iU]
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE - UNII:X66NSO3N35) THIAMINE MONONITRATE1.5 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.7 mg
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE2 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN9 ug
    Inactive Ingredients
    Ingredient NameStrength
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Xylitol (UNII: VCQ006KQ1E)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Talc (UNII: 7SEV7J4R1U)  
    Povidone (UNII: FZ989GH94E)  
    Product Characteristics
    ColorWHITE (Off-white, speckled) Scoreno score
    ShapeROUNDSize16mm
    FlavorFRUITImprint Code EVT
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58809-888-01100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER02/01/2012
    Labeler - GM Pharmaceuticals, Inc. (793000860)