Prescription Drugs

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. 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. 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.

Triple Vita Drops with Fluoride 0.25 mg (vitamin a, d, c, and fluoride) DESCRIPTION Each 1.0 mL supplies: Percentage of U. S. Recommended Daily Allowance Infants Children Under Age 4 Years Vitamin A, 1500 IU 100 60 Vitamin D, 400 IU 100 100 Vitamin C, 35 mg 100 88 Fluoride, 0.25 mg * * * U. S. Recommended Daily Allowance has not been established. Active ingredient for caries prophylaxis: Each 1 mL contains 0.25 mg fluoride as sodium fluoride. Inactive Ingredients: Caramel Color, NF; Edetate Disodium, USP; Fruit (Natural & Artificial) Flavor; Glycerin, USP; Methylparaben, NF; Polysorbate 80, NF; Propylene Glycol, USP; Propylparaben, NF; Purified Water, USP; Sodium Benzoate, NF and Sodium Hydroxide, NE. May also contain Hydrochloric Acid, NF.

INDICATIONS Triple Vita Drops with Fluoride 0.25 mg may be useful for infants whose diets are lacking in vitamins A, D and C. Triple Vita Drops with Fluoride 0.25 mg (vitamin a, d, c, and fluoride) also provide fluoride for caries prophylaxis. Triple Vita Drops with Fluoride 0.25 mg (vitamin a, d, c, and fluoride) (vitamins A, D, C and fluoride supplement) were developed to provide fluoride in drop form for infants and young children from birth to 2 years of age in areas where the drinking water contains less than 0.3 ppm of fluoride; and for children ages 2-3 years in areas where the drinking water contains 0.3 through 0.7 ppm of fluoride. Each 1.0 mL supplies sodium fluoride (0.25 mg fluoride) plus three basic vitamins. DOSAGE AND ADMINISTRATION 1.0 mL daily, or as prescribed by the physician. May be dropped directly into mouth with the enclosed dropper, or mixed with cereal, fruit juice or other food. USE FULL DOSAGE. HOW SUPPLIED Triple Vita Drops with Fluoride 0.25 mg (vitamin a, d, c, and fluoride) (vitamins A, D, C and fluoride) are available in bottles of 1 2/3 fl oz (50 mL). RECOMMENDED STORAGE: Store at controlled room temperature, 15° -30° C (59° -86 °F). After opening, store away from direct light. REFRIGERATION IS NOT REQUIRED. CAUTION: Federal law prohibits dispensing without prescription.

PATIENT INFORMATION See WARNINGS and PRECAUTIONS.

OVERDOSE No information provided. CONTRAINDICATIONS See WARNINGS and PRECAUTIONS.

SIDE EFFECTS Allergic rash and other idiosyncrasies have been rarely reported. DRUG INTERACTIONS No information provided.

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 prescribing Triple Vita Drops with Fluoride 0.25 mg (vitamin a, d, c, and fluoride) , the physician should: 1. Determine the fluoride content of the drinking water. 2. Make sure the child is not receiving significant amounts of fluoride from other medications 3. Periodically check to make sure that the child does not develop significant dental fluorosis. Triple Vita Drops with Fluoride 0.25 mg (vitamin a, d, c, and fluoride) should be dispensed in the original container, since contact with glass leads to instability and precipitation. (The amount of sodium fluoride in the 50- mL size is well below the maximum to be dispensed at one time according to recommendations of the American Dental Association.)