Tri-Vitamin Drops with Fluoride

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 

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.)

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. 

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.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child's doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Change in look of teeth or gums.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child's doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:

• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your child's doctor. Call your child's doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of Tri-Vitamin with Fluoride may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.