Escavite D

GM Pharmaceuticals, Inc.

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

FULL PRESCRIBING INFORMATION: CONTENTS*

• PHARMACOLOGY
• ESCAVITE D INDICATIONS AND USAGE
• WARNINGS
• PRECAUTIONS
  • Drug Interactions
• ESCAVITE D ADVERSE REACTIONS
• RECOMMENDED USE
• HOW SUPPLIED
  • STORAGE
• REFERENCES
• PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label

FULL PRESCRIBING INFORMATION

Rx Only

Nutrition Facts
Serving Size: 1 Chewable Tablet
Amount Per Tablet		% Daily Value Adults & Children 4 Years or More
Vitamin A (as beta carotene)	2500 IU	50%
Vitamin C (as ascorbic acid)	100 mg	167%
Vitamin D (as cholecalciferol)	600 IU	150%
Vitamin E (as dl-alpha tocopheryl acetate)	30 IU	100%
Thiamine (as thiamine HCl, vitamin B1)	1.5 mg	100%
Riboflavin	1.7 mg	100%
Niacin (as nicotinic acid)	20 mg	100%
Vitamin B6 (as pyridoxine HCl)	2 mg	100%
Folic Acid, USP as CitraFolic® CitraFolic® 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. [from controlled -release Citrated-pteroylmonoglutamic Acid]	400 mcg	100%
Vitamin B12 (as hydroxocobalamin)	6 mcg	100%
Biotin	45 mcg	15%
Pantothenic Acid (as d-calcium pantothenate)	10 mg	100%
Iron (elemental) as AminoFerr® AminoFerr® 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. [from ferrous glycine cysteinate]	6 mg	33%
Magnesium (as magnesium oxide)	60 mg	15%
Zinc (as zinc oxide)	15 mg	100%
Copper (as cupric oxide)	2 mg	100%
Fluoride (as sodium fluoride)	0.25 mg	Daily value not established.

Ingredient for caries prophylaxis: Daily value not established. Fluoride as sodium fluoride.

Other Ingredients: Citric Acid, Cherry Flavor, Dextrose Cerelose, Fumed Silica, Magnesium Stearate, Microcrystalline Cellulose, Silicon Dioxide, Sorbitol, Stearic Acid, Sucralose, Xylitol.

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:

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 D INDICATIONS AND USAGE

Escavite^® D 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^® D Multi-vitamin with Iron and Fluoride Chewable Tablets provide 0.25mg 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.

WARNINGS

This product contains iron.

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^® 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.

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.

ESCAVITE D 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

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

HOW SUPPLIED

Escavite^® D Multi-vitamin with Iron and Fluoride Chewable Tablets 0.25 mg are dye free, off-white speckled, round shaped, cherry-flavored chewable tablets debossed with E on one side and plain on the other. They are available in bottles of 60 chewable tablets (Product Code 58809-829-60) and 1 count physician samples (Product Code 58809-829-02).

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.

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
Rev. 02/14

Covered by US Patent No. 7,341,708 and patent pending.

PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label

58809-829-60

Escavite^® D

MULTI-VITAMIN SUPPLEMENT
WITH IRON AND FLUORIDE
0.25 mg

Cherry Flavored
CHEWABLE TABLETS

Rx Only

^GMPharmaceuticals, Inc.

60 Tablets