Label: ESCAVITE D- .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, thiamine hydrochloride, riboflavin, niacin, pyridoxine hydrochloride, folic acid, hydroxocobalamin, biotin, calcium pantothenate, ferrous cysteine glycinate, magnesium oxide, zinc oxide, cupric oxide, and sodium fluoride tablet, chewable

  • NDC Code(s): 58809-829-60
  • Packager: GM Pharmaceuticals, INC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated October 2, 2016

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

  • 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.

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  • SPL UNCLASSIFIED SECTION

    Description: Escavite® D is a prescription drug multi-vitamin chewable tablet with Iron and Fluoride 0.25 mg. Escavite® D chewable tablets are dye free, off-white speckled, round shaped, cherry-flavored tablets, and are debossed with E on one side and plain on the other.

    Each chewable tablet contains:

    Vitamin A (as beta carotene)…………………………………………………. 2,500 IU

    Vitamin C (as ascorbic acid)……………………………………………………100 mg

    Vitamin D (as cholecalciferol)………………………………………………….600 IU

    Vitamin E (as dl-alpha tocopheryl acetate)…………………………………….30 IU

    Thiamine (as thiamine HCl, vitamin B1)……………………………………….1.5 mg

    Riboflavin………………………………………………………………………1.7 mg

    Niacin (as niacinamide)………………………………………………………….20 mg

    Vitamin B6 (as pyridoxine HCl)………………………………………………….2 mg

    Folic Acid, USP as CitraFolic®a [from controlled-release Citrated-pteroylmonoglutamic Acid] 400 mcg

    Vitamin B12 (as hydroxocobalamin)……………………………………………6 mcg

    Biotin…………………………………………………………………………...45 mcg

    Pantothenic Acid (as d-calcium pantothenate)………………………………….10 mg

    Iron (elemental) as AminoFerr® b [from ferrous  glycine cysteinate] and ferric pyrophosphate 6 mg

    Magnesium (as magnesium oxide)………………………………………………60 mg

    Zinc (as zinc chelate)…………………………………………………………….15 mg

    Copper (as copper chelate)………………………………………………………..2 mg

    Fluoride (as sodium fluoride)………………………………………………….0.25 mg

    Ingredient for caries prophylaxis: *Fluoride as sodium fluoride. Other Ingredients: Sucrose, Xylitol, Sunflower Oil, Microcrystalline Cellulose, Sucralose, Natural Cherry Flavor, Stearic Acid, Magnesium Stearate, Fumed Silica, and Silicon Dioxide.

    aCitraFolic® is a controlled-release form of folic acid that is pH-specific using citrates as buffers to achieve optimal absorption for targeted-GI at the proximal jejunum AND in order to meet USP requirements for folic acid dissolution and disintegration; it is patent pending. CitraFolic® uses only DMF-approved manufacturers of folic acid.

    bAminoFerr® as ferrous glycine cysteinate, also known as FERROUS CYSTEINE GLYCINATE, and has the Unique Ingredient Identifier (UNII) code 8B4OP7RK5N. AminoFerr® is a proprietary ingredient containing pure chelates without interfering ions –resulting in high solubility and adsorption; it is the only pure amino acid iron chelate supplement on the market, and is protected under US Patent No. 7,341,708.

    ESCAVITE® D

    PRESCRIPTION DRUG MULTI-VITAMIN WITH IRON AND

    FLUORIDE 0.25 mg CHEWABLE TABLETS

    Rx Only

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  • CLINICAL 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® D 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.

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  • INDICATIONS AND USAGE

    Escavite® D Multi-vitamin with Iron and Fluoride Chewable Tablets is a prescription drug 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® D Multi-vitamin with Iron and Fluoride Chewable Tablets provide 0.25 mg of fluoride in a chewable tablet form for children 4-6 years of age where the drinking water contains 0.3 through 0.6 ppm of fluoride. Escavite® D Multi-vitamin with Iron and Fluoride Chewable Tablets supply significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, Vitamin B6, folate, vitamin B12, biotin, pantothenic acid, 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® D 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.

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  • CONTRAINDICATIONS

    This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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  • PRECAUTIONS

    The suggested dose of Escavite® D 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® D 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.

    Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

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  • DRUG INTERACTIONS

    Do not eat or drink dairy products within one hour of fluoride administration. Incompatibility of fluoride with dairy foods has been reported due to formation of calcium fluoride which is poorly absorbed.

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  • 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.

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  • OVERDOSAGE:

    Prolonged daily ingestion of excessive fluoride will result in varying degrees of Fluorosis.

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  • DOSAGE AND ADMINISTRATION

    Chew one tablet daily or as prescribed by doctor, or dentist. 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.

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  • HOW SUPPLIED

    They are available in bottles of 60 chewable tablets (NDC 58809-829-60) and 1 count physician samples (NDC 58809-829-02).

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  • 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.

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  • KEEP OUT OF REACH OF CHILDREN
  • 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 76015

    Made in Canada

    Covered by US Patent No. 7,341,708

    Patent Pending.

    R010216-1

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  • PRINCIPAL DISPLAY PANEL

    NDC 58809-829-60
    ESCAVITE D
    Prescription Multi-Vitamin
    With Iron and Fluoride
    0.25 mg
    Cherry Flavored
    Chewable Tablets
    60 Tablets
    Rx Only

    PRINCIPAL DISPLAY PANEL
NDC 58809-829-60
ESCAVITE D
Prescription Multi-Vitamin 
With Iron and Fluoride 
0.25 mg
Cherry Flavored
Chewable Tablets
60 Tablets
Rx Only

    PRINCIPAL DISPLAY PANEL
NDC 58809-829-60
ESCAVITE D
Prescription Multi-Vitamin 
With Iron and Fluoride 
0.25 mg
Cherry Flavored
Chewable Tablets
60 Tablets
Rx Only

    PRINCIPAL DISPLAY PANEL
NDC 58809-829-60
ESCAVITE D
Prescription Multi-Vitamin 
With Iron and Fluoride 
0.25 mg
Cherry Flavored
Chewable Tablets
60 Tablets
Rx Only

    Close
  • INGREDIENTS AND APPEARANCE
    ESCAVITE D 
    .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol, dl-, thiamine hydrochloride, riboflavin, niacin, pyridoxine hydrochloride, folic acid, hydroxocobalamin, biotin, calcium pantothenate, ferrous cysteine glycinate, magnesium oxide, zinc oxide, cupric oxide, and sodium fluoride tablet, chewable
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58809-829
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    .BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J) .BETA.-CAROTENE 2500 [iU]
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 100 mg
    CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 600 [iU]
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL- 30 [iU]
    THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (Thiamine ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE 1.5 mg
    RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 1.7 mg
    NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN 20 mg
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 2 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 400 ug
    HYDROXOCOBALAMIN (UNII: Q40X8H422O) (HYDROXOCOBALAMIN - UNII:Q40X8H422O) HYDROXOCOBALAMIN 6 ug
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 45 ug
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737, CALCIUM CATION - UNII:2M83C4R6ZB) PANTOTHENIC ACID 10 mg
    FERROUS CYSTEINE GLYCINATE (UNII: 8B4OP7RK5N) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 6 mg
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM OXIDE 60 mg
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 15 mg
    CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 2 mg
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.25 mg
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CHERRY (UNII: BUC5I9595W)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SORBITOL (UNII: 506T60A25R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Color WHITE (off-white, speckled) Score no score
    Shape ROUND Size 16mm
    Flavor Imprint Code E
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58809-829-60 60 in 1 BOTTLE; Type 0: Not a Combination Product 03/03/2014
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 03/03/2014
    Labeler - GM Pharmaceuticals, INC (793000860)
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