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, C, and iron. Supplementation of the diet with fluoride for caries prophylaxsis. TRI-VIT with FLUORIDE 0.25 mg and IRON (vitamins A, D, C, iron and fluoride) drops 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.2,3

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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 0.25 mg and IRON 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 0.25 mg and IRON 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.)
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 DISPENSE in original container

More information

Category Value
Agency product number 1D1K0N0VVC
Orphan designation No
Product NDC 0603-1787
Date Last Revised 01-08-2016
Type HUMAN PRESCRIPTION DRUG
RXCUI 1244008
List of excipients Other ingredients: ascorbic acid (Vitamin C), caramel color, cholecalciferol (Vitamin D3), ferrous sulfate, flavor, glycerin, polysorbate 80, purified water, vitamin A palmitate
Marketing authorisation holder Qualitest Pharmaceuticals
Warnings WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately.