Multi-Vitamin Drops with Fluoride 0.25 mg

Precautions re: Children

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.

Precautions re: All Other

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.

Precautions re: Allergies

ADVERSE REACTIONS Allergic rash and other idiosyncrasies have been rarely reported.

Suggested/Recommended/Usage/Directions

DOSAGE AND ADMINISTRATION See following chart. May be dropped directly into mouth with dropper; or mixed with cereal, fruit juice or other food.

Suggested/Recommended/Usage/Directions

DOSAGE AND ADMINISTRATION - continued (chart) Fluoride Ion Level in Drinking Water (ppm) 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)/day None None 3 - 6 years 0.50 mg (2 mL)/day 0.25 mg (1mL)/day None 1.0 ppm = 1 mg/liter 2.2 mg sodium fluoride contains 1 mg fluoride ion.

General Statements: All Other Content

HOW SUPPLIED Multi-Vitamin and Fluoride 0.25 mg drops is available in 50 mL bottles with accomplanying calibrated dropper.

Storage

RECOMMENDED STORAGE Store at controlled room temperature, 15(0)-25(0)C (59(0)-77(0)F). Excursions permitted. After opening, store away from direct light. Close tightly after each use. Occasional deepening of color has no significant affect on vitamin potency. REFRIGERATION IS NOT REQUIRED.

Suggested/Recommended/Usage/Directions

SHAKE WELL

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

REFERENCES 1. Brudevoid F. McCann HG: Fluoride and caries control - Mechanism of action, in Nizel AE (ed): The Science of Nutrition and ibs Application in Clinical Dentistry, Philadelphia. WB Saunders Co, 1966, pp 331-347. 2. American Academy of Pediatrics Commitee on Nutrition: Fluoride supplementation, Pediatrics 1986; 77:758. 3. American Dental Association Council on Dental Therapeutics: Accepted Dental Therapeutics, ed 38, Chicago. 1979, p 321. 4. Hennon DK, Stookey GK, Muhler JC: The clinical anticariogenic effectiveness of supplementary fluoride-vitamin preparations - Results at the end of three years. J Dent Children 1966; 33 January; 3-12. 5. Hennon DK, Stookey GK, Muhler JC: The clinical anticarlogenic effectiveness of supplementary fluoride-vitamin preparations - Results at the end of four years. J Dent Children 1967; 34 November; 439-443. 6. Hennon DK, Stookey GK, Muhler JC: The clinical anticarlogenic effectiveness of supplementary fluoride-vitamin preparations - Results at the end of five and a half years. Phar and Ther in Dent 1970; 1:1. Hennon DK, Stookey GK, Belswanger BB: Fluoride-vitamin supplements: Effects on dental caries and fluorosis when used in areas with suboptimum fluoride in the water supply. J Am Dent Assoc 1977; 95-965.

General Statements: All Other Content

Rev. 05/11

General Statements: All Other Content

NDC 64376-820-50

FDA Statement of Identity

MULTI-VITAMIN AND FLUORIDE SUPPLEMENT DROPS

General Statements: All Other Content

Rx Only

Suggested/Recommended/Usage/Directions

DOSAGE AND ADMINISTRATION: See package insert for complete dosing information.

General Statements: All Other Content

Lift Here N

Precautions re: All Other

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

Suggested/Recommended/Usage/Directions

Multi-Vitamin and Fluoride Drops 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.)

Formula re: Contains

Multi-Vitamin Drops With Fluoride 0.25 mg