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
GM Pharmaceuticals, Inc.
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.
|Serving Size: 1 Chewable Tablet|
|Amount Per Tablet||% Daily Value Adults &
Children 4 Years or More
|Vitamin A||1000 IU||20%|
|Vitamin C||100 mg||180%|
|Vitamin D||400 IU||100%|
|Vitamin E||30 IU||100%|
|Vitamin B6||2 mg||100%|
|Folic Acid||400 mcg||100%|
|Vitamin B12||9 mcg||150%|
|Pantothenic Acid||10 mg||100%|
Ingredient for caries prophylaxis: * Fluoride as sodium fluoride.
Other Ingredients: Xylitol, microcrystalline cellulose, povidone, magnesium stearate, fruit flavor, talc, sucralose.
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.
MULTI-VITAMIN WITH IRON AND FLUORIDE 0.25mg CHEWABLE TABLETS
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.
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:
|Ca 10(PO 4) 6(OH) 2 + 2F- →Ca 10(PO 4)F 2 + 2OH -|
Three stages of fluoride deposition in tooth enamel can be distinguished:
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.
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.
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:
Your doctor or dentist is the best source of counsel and guidance in your child's fluoride supplementation.
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.
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.
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.
Manufactured for: GM Pharmaceuticals, Inc. Arlington, TX 76012
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
|Labeler - GM Pharmaceuticals, Inc. (793000860)|