Tri-Vit With Fluoride 0.25 mg Drops®

Suggested/Recommended/Usage/Directions

INDICATIONS AND USAGE: TRI-VIT with FLUORIDE 0.25 mg drops may be useful for infants whose diets are lacking in vitamins A, D and C. TRI-VIT with FLUORIDE 0.25 mg drops also provide fluoride for caries prophylaxis. TRI-VIT with FLUORIDE 0.25 mg (vitamins A, D, C, and fluoride) drops were developed to provide fluoride in drop form for infants and young children from 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.

Suggested/Recommended/Usage/Directions

TRI-VIT with FLUORIDE 0.25 mg drops should be dispensed in the original plastic 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.)

Suggested/Recommended/Usage/Directions

DOSAGE AND ADMINISTRATION: 1 mL daily, or as prescribed. May be dropped directly into mouth with dropper, or mixed with fruit juice, cereal or other food. USE FULL DOSAGE. DISPENSE in original container

Suggested/Recommended/Usage/Directions

See box for dosage information and complete listing of ingredients. Save box for future use.

Suggested/Recommended/Usage/Directions

DISPENSE in original container.

Storage

After opening, store away from direct light.

Formula re: Contains

Active ingredient for caries prophylaxis: Each 1 mL contains 0.25 mg fluoride as sodium fluoride.

Formula re: Contains

Each 1 mL supples sodium fluoride (0.25 mg fluoride) plus three basic vitamins.

FDA Statement of Identity

Vitamin A, D, C & Fluoride Supplement Drops

FDA Disclaimer Statement

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.

General Statements: All Other Content

Rx only

General Statements: All Other Content

Rev. 6/08 R5 8277530 1785

General Statements: All Other Content

REFERENCES 1. Brudevold 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 Co.; 1966;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.

General Statements: All Other Content

Occasional deepening of color has no significant effect on vitamin potency.

Brand IP Statement(s) re: (c), (TM), (SM)

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.

Brand IP Statement(s) re: (c), (TM), (SM)

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

General Statements: All Other Content

Your doctor or dentist is the best source of counsel and guidance in your child's fluoride supplementation.

General: Product/Version Code

Rev. 6/08 R5 8077500 1785

General Statements: All Other Content

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