Vitamins A, C, D and Fluoride Drops

STATEMENT OF IDENTITY SECTION

*U.S. Recommended Daily Allowance not established.

Consult your physician for use by infants and young children 6 months to 3 years of age.

Active ingredient for caries prophylaxis: Fluoride as sodium fluoride.

Other ingredients: Ascorbic acid, caramel color, cherry flavor, cholecalciferol, citric acid, ferrous sulfate, glycerin, methyl paraben, polysorbate 80, purified water, sodium benzoate, sodium fluoride, sodium hydroxide, sucralose, vitamin A palmitate.

CLINICAL PHARMACOLOGY

It is well established that fluoridation of the water supply (0.7 mg/L fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries. 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:

Vitamins A, C, D and Fluoride Drops 0.5 mg provide supplementation of the diet with three essential vitamins, and with fluoride for caries prophylaxis. The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. Vitamins A, C, D and Fluoride Drops 0.5 mg provide fluoride in drop form for infants and young children 6 months to 3 years of age in areas where the drinking water contains less than 0.3 ppm of fluoride and for children ages 3 to 6 years in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride.

Each 1.0 mL dose of Vitamins A, C, D and Fluoride Drops 0.5 mg supplies sodium fluoride (0.5 mg fluoride) plus significant amounts of vitamins A, C, and D in a single easy-to-use preparation.

• 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 small amounts from saliva.

WARNINGS

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

PRECAUTIONS

The suggested dose should not be exceeded since dental fluorosis may result from continued ingestion of large amounts of fluoride. When recommending vitamin fluoride products:

• Determine the fluoride content of the drinking water.
• Make sure the child is not receiving significant amounts of fluoride from other medications and swallowed toothpaste.
• Periodically check to make sure that the child does not develop significant dental fluorosis.

ADVERSE REACTIONS

Allergic rash or other idiosyncrasies have been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact H2-Pharma at 1-866-592-6438 or FDA at 1-800-FDA-1088 or via the web at www.fda.gov/medwatch for voluntary reporting of adverse reactions.

DOSAGE AND ADMINISTRATION

As directed by a physician. See American Dental Association (ADA) recommended supplement schedule below. May be dropped directly into the mouth with the enclosed dropper or mixed with cereal, fruit juice or other food.

SHAKE WELL BEFORE USE.

HOW SUPPLIED

Vitamins A, C, D and Fluoride Drops 0.5 mg are available in 50 mL bottles with accompanying calibrated dropper.

Dispense in original container.

RECOMMENDED STORAGE

Store at controlled room temperature, 20°-25°C (66°-77°F) [See USP Controlled Room Temperature]. After opening, store away from direct sunlight. Close tightly after each use. REFRIGERATION IS NOT REQUIRED.

TAMPER EVIDENT: Do not use if seal under cap is torn, broken or missing.

HEALTH CLAIM SECTION

Distributed by: H2-Pharma, LLCMontgomery, AL 36117