Data from FDA - Curated by EPG Health - Last updated 30 August 2017

Indication(s)

INDICATIONS AND USAGE: Supplementation of the diet with vitamins A, D, and C. TRI-VIT with FLUORIDE 0.5 mg drops also provide fluoride for caries prophylaxis. TRI-VIT with FLUORIDE 0.5 mg (vitamins A, D, C and fluoride) drops provide fluoride in drop form for children ages 3 to 6 years in areas where the drinking water contains less than 0.3 ppm of fluoride and for children 6 years of age and older in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride.2 Each 1 mL supplies sodium fluoride (0.5 mg fluoride) plus three basic vitamins. TRI-VIT with FLUORIDE 0.5 mg drops supply significant amounts of vitamins A, D, and C 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, infants and children obtain three essential vitamins plus fluoride. A comprehensive 5 1/2 year series of studies of the effectiveness of vitamin-fluoride products in caries protection has been published.3-6 Children in this continuing study lived in an area where the water supply contained only 0.05 ppm fluoride. The subjects were divided into two groups, one which used only non-fluoridated vitamin products and other vitamin-fluoride products. The three-year interim report showed 63% fewer carious surfaces in primary teeth and 43% fewer carious surfaces in permanent teeth of the children taking vitamin-fluoride products.3 After four years the studies continued to support the effectiveness of vitamin-fluoride products, showing a reduction in carious surfaces of 68% in primary teeth and 46% in permanent teeth.4 Results at the end of 5 1/2 years further confirmed the previous findings and indicated that significant reductions in dental caries are apparent with the continued use of vitamin-fluoride products.5

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Advisory information

Special warnings and precautions
PRECAUTIONS: The suggested dose should not be exceeded since dental fluorosis may result from continued ingestion of large amounts of fluoride. When prescribing TRI-VIT with FLUORIDE 0.5 mg drops: 1) Determine the fluoride content of the drinking water from all major sources. 2) Make sure the child is not receiving significant amounts of fluoride from other sources such as medications and swallowed toothpaste. 3) Periodically check to make sure that the child does not develop significant dental fluorosis. TRI-VIT with FLUORIDE 0.5 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 a 50-mL size is well below the maximum to be dispensed at one time according to recommendations of the American Dental Association.)
Adverse reactions
ADVERSE REACTIONS: Allergic rash and other idiosyncrasies have been rarely reported.

Usage information

Dosing and administration
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.

More information

Category Value
Agency product number 1D1K0N0VVC
Orphan designation No
Product NDC 0603-1786
Date Last Revised 01-08-2016
Type HUMAN PRESCRIPTION DRUG
RXCUI 1365984
List of excipients Other ingredients: ascorbic acid (Vitamin C), caramel color, cholecalciferol (Vitamin D3), flavor, glycerin, polysorbate 80, purified water, sodium hydroxide, vitamin A palmitate
Storage and handling Occasional deepening of color has no significant effect on vitamin potency. After opening, store away from direct light. Your doctor or dentist is the best source of counsel and guidance in your child’s fluoride supplementation.
Marketing authorisation holder Qualitest Pharmaceuticals