MVC

Sancilio & Company Inc

Multivitamin with Fluoride Chewable Tablets

FULL PRESCRIBING INFORMATION: CONTENTS*

• CLINICAL PHARMACOLOGY
• MVC INDICATIONS AND USAGE
• WARNING
• CAUTION
• PRECAUTIONS
• MVC ADVERSE REACTIONS
• MVC DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
  • STORAGE

FULL PRESCRIBING INFORMATION

This insert is for 1.0 mg strength tablets, 0.5 mg strength tablets, and 0.25 mg strength tablets.

Rx Only

This product is a prescription product for the clinical dietary management of the metabolic processes of caries prophylaxis and supplementation of the diet with 10 vitamins.

Patent Pending

7, 30 and 90 Tablets per bottle and 30 count blister

Each Chewable Tablet contains:

Active ingredient: Fluoride as Sodium Fluoride

Inactive Ingredients: Xylitol, microcrystalline cellulose, malic acid, citric acid, talc, magnesium stearate, orange flavor, sucralose.

CLINICAL PHARMACOLOGY

It is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries.

Multivitamin with Fluoride Chewable Tablets provide sodium fluoride and ten essential vitamins in a chewable tablet. Because tablets are chewable, they provide a topical as well as systemic source of fluoride.

Hydroxyapatite is the principal crystal of 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:

• 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 inwards is apparently restricted.
• After eruption, the surface enamel acquires fluoride from the water, food, supplementary fluoride and smaller amounts of saliva.

MVC INDICATIONS AND USAGE

Multivitamin with Fluoride Chewable Tablets is a prescription product for the clinical dietary management of the metabolic processes of caries prophylaxis, and provides supplementation of the diet with ten essential vitamins.

Multivitamin with 1.0 mg Fluoride Chewable Tablets provide 1.0 mg of fluoride in tablet form for children 6-16 years of age in areas where the water fluoride is less than 0.3 ppm. NDC 44946-1014-4 (30 count), NDC 44946-1014-5 (90 count), NDC 44946-1014-6 (30 count blister).

Multivitamin with 0.5mg Fluoride Chewable Tablets provide 0.5 mg of fluoride in tablet form for children 4-6 years of age where the water fluoride level is less than 0.3 ppm, and for children 6 years of age and above where the drinking water contains 0.3 through 0.6 ppm of fluoride. NDC 44946-1013-4 (30 count), NDC 44946-1013-5 (90 count), NDC 44946-1013-6 (30 count blister).

Multivitamin with 0.25 mg Fluoride 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. 44946-1012-7 (7 count), NDC 44946-1012-4 (30 count) , NDC 44946-1012-5 (90 count), NDC 44946-1012-6 (30 count blister).

Multivitamin with Fluoride Chewable Tablets supply significant amounts of Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B₆, vitamin B₁₂, and folate 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 ten essential vitamins and the important mineral, 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 Multivitamin with Fluoride Chewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential.

WARNING

As in the case of all medications, keep out of the reach of children.

Should be chewed. This product, as all chewable tablets, is not recommended for children under age 4 due to risk of choking.

CAUTION

Do not eat or drink dairy products within one hour of fluoride administration.

PRECAUTIONS

The suggested dose of Multivitamin with Fluoride Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.

Before prescribing Multivitamin with Fluoride Chewable Tablets:

• Determine the fluoride content of the drinking water from 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.

MVC ADVERSE REACTIONS

Allergic rash and other idiosyncrasies have been rarely reported.

MVC DOSAGE AND ADMINISTRATION

One tablet daily, to be dissolved in the mouth or chewed before swallowing, preferrably at bedtime after brushing teeth.

HOW SUPPLIED

Chewable tablets containing multivitamins with 1.0 mg fluoride are off-white,speckled, orange flavor, hexagon-shaped tablets. Debossed "SCI" on one side and "1003" on the other. Available in 30 and 90 tablet bottles and 30 count blister. NDC 44946-1014-4 (30 count), NDC 44946-1014-5 (90 count), NDC 44946-1014-6 (30 count blister).

Chewable tablets containing multivitamins with 0.5 mg fluoride are off-white,speckled, orange flavor, modified triangle-shaped tablets. Debossed "SCI" on one side and "1005" on the other. Available in 30 and 90 tablet bottles and 30 count blister. NDC 44946-1013-4 (30 count), NDC 44946-1013-5 (90 count), NDC 44946-1013-6 (30 count blister).

Chewable tablets containing multivitamins with 0.25 mg fluoride are off-white,speckled, orange flavor, round-shaped tablets. Debossed "SCI" on one side and "1001" on the other. Available in 7, 30 and 90 tablet bottles and 30 count blister. 44946-1012-7 (7 count sample size), NDC 44946-1012-4 (30 count) , NDC 44946-1012-5 (90 count), NDC 44946-1012-6 (30 count blister).

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.

Warning: Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

Manufactured by: Sancilio & Company, Inc
3874 Fiscal Court # 200
Riviera Beach, FL 33404 USA

PRINCIPAL DISPLAY PANEL - 1.0 mg 90 Tablet Bottle Label

NDC 44946-1014-5

Rx Only

Sancilio & Company, Inc.
Developing Good Science into Great Medicine

MVC™-Fluoride 1.0mg*
Multivitamin Chewable Tablets with Fluoride

No dyes, artificial flavors or sugar

90 tablets
Made in the U.S.A.

PRINCIPAL DISPLAY PANEL - 0.5 mg 90 Tablet Bottle Label

NDC 44946-1013-5

Rx Only

Sancilio & Company, Inc.
Developing Good Science into Great Medicine

MVC™-Fluoride 0.5mg*
Multivitamin Chewable Tablets with Fluoride

No dyes, artificial flavors or sugar

90 tablets
Made in the U.S.A.

PRINCIPAL DISPLAY PANEL - 0.25 mg 90 Tablet Bottle Label

NDC 44946-1012-5

Rx Only

Sancilio & Company, Inc.
Developing Good Science into Great Medicine

MVC™-Fluoride 0.25mg*
Multivitamin Chewable Tablets with Fluoride

No dyes, artificial flavors or sugar

90 tablets
Made in the U.S.A.