Data from FDA - Curated by EPG Health - Last updated 31 August 2017

Indication(s)

INDICATIONS AND USAGE Supplementation of the diet with vitamins A, C and D. Triple-Vitamin Drops with Fluoride 0.25 mg also provides fluoride for caries prophylaxis. The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. The American Academy of Pediatrics recommend that infants and young children 6 months to 3 years of age, in areas where the drinking water contains less than 0.3 ppm of fluoride, and children 3-6 years of age, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride, receive 0.25 mg of supplemental fluoride daily which is provided in a dose of 1 mL of Triple-Vitamin Drops with Fluoride 0.25 mg (See Dosage and Administration). Triple-Vitamin Drops with Fluoride 0.25 mg supply significant amounts of vitamins A, C and D 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, children obtain essential vitamins and fluoride.

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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 vitamin fluoride products: 1. Determine the fluoride content of the drinking water. 2. Make sure the child is not receiving significant amounts of fluoride from other medications and swallowed toothpaste. 3. Periodically check to make sure that the child does not develop significant dental fluorosis. Triple-Vitamin Drops with Fluoride 0.25 mg 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.) Important Considerations When Using Dosage Schedule: If fluoride level is unknown, drinking water should be tested for fluoride content before supplements are prescribed. For testing of fluoride content, contact the local or state health department. All sources of fluoride should be evaluated with a thorough fluoride history. Patient exposure to multiple water sources can make proper prescribing complex. Ingestion of higher than recommended levels of fluoride by children has been associated with an increase in mild dental fluorosis in developing, unerupted teeth. Fluoride supplements require long-term compliance on a daily basis.
Adverse reactions
ADVERSE REACTIONS Allergic rash and other idiosyncrasies have been rarely reported.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION See following chart. May be dropped directly into the mouth with dropper; or mixed with cereal, fruit juice or other food. Fluoride Ion Level in Drinking Water (ppm)1.0 ppm = 1 mg/liter Age <0.3 ppm 0.3 - 0.6 ppm >0.6 ppm Birth - 6 months None None None 6 mos - 3 years 0.25 mg (1 mL) / day2.2 mg sodium fluoride contains 1 mg fluoride ion. None None 3 - 6 years 0.50 mg (2 mL) / day 0.25 mg (1 mL) / day None Dropper Image

More information

Category Value
Agency product number 1C6V77QF41
Orphan designation No
Product NDC 58980-504
Date Last Revised 02-09-2014
Type HUMAN PRESCRIPTION DRUG
RXCUI 1365980
Storage and handling RECOMMENDED STORAGE Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). After opening, store away from direct light. Close tightly after each use. Occasional deepening of color has no significant effect on vitamin potency. REFRIGERATION IS NOT REQUIRED. SHAKE WELL.
Marketing authorisation holder Stratus Pharmaceuticals