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Escavite D

Generic Name: multi-vitamin supplement with iron and fluoride
Dosage Form: tablet, chewable

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.

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

Rx Only

Nutrition Facts
Serving Size: 1 Chewable Tablet
Amount Per Tablet % Daily Value Adults & Children 4 Years or More
*
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.
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.
Daily value not established.
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® * [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® [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  

Ingredient for caries prophylaxis: 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:

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.

Indications and Usage for Escavite D

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.

This statement has not been evaluated by the food and drug administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

Warnings

This product contains iron.

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.

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.

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 is Escavite D 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

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 LABEL Item Code (Source) NDC:58809-829
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
.BETA.-CAROTENE (.BETA.-CAROTENE) .BETA.-CAROTENE 2500 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 100 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 600 [iU]
.ALPHA.-TOCOPHEROL, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL, DL- 30 [iU]
THIAMINE HYDROCHLORIDE (THIAMINE ION) THIAMINE HYDROCHLORIDE 1.5 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.7 mg
NIACIN (NIACIN) NIACIN 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 2 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 400 ug
HYDROXOCOBALAMIN (HYDROXOCOBALAMIN) HYDROXOCOBALAMIN 6 ug
BIOTIN (BIOTIN) BIOTIN 45 ug
CALCIUM PANTOTHENATE (PANTOTHENIC ACID and CALCIUM CATION) PANTOTHENIC ACID 10 mg
FERROUS CYSTEINE GLYCINATE (FERROUS CATION) FERROUS CATION 6 mg
MAGNESIUM OXIDE (MAGNESIUM CATION) MAGNESIUM OXIDE 60 mg
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 15 mg
CUPRIC OXIDE (CUPRIC CATION) CUPRIC CATION 2 mg
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.25 mg
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE  
CHERRY  
DEXTROSE  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
SORBITOL  
STEARIC ACID  
SUCRALOSE  
XYLITOL  
Product Characteristics
Color WHITE (off-white, speckled) Score no score
Shape ROUND Size 16mm
Flavor Imprint Code E
Contains         
Packaging
# Item Code Package Description
1 NDC:58809-829-60 60 TABLET, CHEWABLE in 1 BOTTLE
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)
Revised: 03/2014
 
GM Pharmaceuticals, Inc.
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