TL-Fluorivite

TRIGEN Laboratories, Inc.

MULTI-VITAMIN WITH IRON AND FLUORIDE 0.25mg CHEWABLE TABLETS

FULL PRESCRIBING INFORMATION: CONTENTS*

• PHARMACOLOGY
• PRECAUTIONS
• ADVERSE REACTION
• RECOMMENDED USE
• HOW SUPPLIED
• STORAGE
• PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

FULL PRESCRIBING INFORMATION

Rx Only

DESCRIPTION

Chewable tablets containing multivitamins with iron and fluoride 0.25 mg are sugar free, dye free, off-white speckled, round shape, fruit flavor chewable tablets debossed TL on one side and 530 on the other.

Inactive ingredients: Xylitol, Carregeenan, Microcrystalline Cellulose, Natural Fruit Flavor, Citric Acid, Croscarmellose Sodium, Silicon Dioxide, Crospovidone, Magnesium Stearate, Sucralose.

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. TL-Fluorivite Chew 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 of 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:

• Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed.
• After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted.
• After eruption, the surface enamel acquires fluoride from water, food supplementary fluoride and smaller amounts from saliva.

TL-Fluorivite Chew 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.

TL-Fluorivite Chew multi-vitamin with Iron and Fluoride 0.25mg Chewable Tablets provide 0.25 mg 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.

TL-Fluorivite Chew multi-vitamin with Iron and Fluoride Chewable Tablets supply significant amount 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 the 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 TL-Fluorivite Chew 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.

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 TL-Fluorivite Chew multi-vitamin with Iron and Fluoride Chewable Tablets should not be exceeded, since dental fluorosis may result for continued ingestion of large amounts of fluoride.

Before prescribing TL-Fluorivite Chew multi-vitamin with Iron and Fluoride Chewable Tablets:

• Determine the fluoride content of the drinking water form all major sources.
• Make sure the child is not receiving significant amounts of fluoride from other sources such as medications and swallowed toothpaste.
• 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 REACTION

Allergic rash and other idiosyncrasies have been rarely reported.

RECOMMENDED USE

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

HOW SUPPLIED

TL-Fluorivite Chew is supplied in child-resistant bottles of 100 chewable tablets.

STORAGE

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

KEEP OUT OF REACH OF CHILDREN.

Manufactured For:
TRIGEN Laboratories, Inc.
Sayreville, NJ 08872
www.trigenlab.com

Rev. 09/12

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

13811-530-10
R_x Only

TL-Fluorivite
Chew

Multivitamin Supplement
with Iron and Fluoride

Natural Fruit Flavor

100 CHEWABLE TABLETS

TRIGEN
LABORATORIES