Multi-Vitamin Drops with Fluoride 0.25 mg
Product Overview
Brand: Boca Pharmacal
Barcode: 3 64376 82050 2
Net Contents: 1.69 fl. Oz.; 50 mL
Serving Size (Overview): 1 mL [Age 6 mos - 3 years take 1 mL / day]; 2 mL [Age 3 - 6 years take 2 mL / day]
Product Type: Other Combinations [A1325]
Form: Liquid [E0165]
Date Entered: Aug 24, 2012
Market Status: Off Market
Suggested Use (Overview): DOSAGE AND ADMINISTRATIONSee following chart. May be dropped directly into mouth with dropper; or mixed with cereal; fruit juice or other food. DOSAGE AND ADMINISTRATION - continued(chart)Fluoride Ion Level in Drinking Water (ppm)Age <0.3 ppm 0.3-0.6 ppm >0.6 ppmBirth-6 months None None None6 mos - 3 years 0.25 mg (1 mL)/day None None3 - 6 years 0.50 mg (2 mL)/day 0.25 mg (1mL)/day None1.0 ppm = 1 mg/liter2.2 mg sodium fluoride contains 1 mg fluoride ion. SHAKE WELL DOSAGE AND ADMINISTRATION: See package insert for complete dosing information. 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.)
Product Self-Roles:
- No specific self-roles defined.
Dietary Supplement Facts
| Ingredient | Category | Amount Per Serving | Unit | % Daily Value | Target Group | Serving Size (Fact) |
|---|---|---|---|---|---|---|
| Vitamin A | vitamin | 1500 | IU | 60 | Children less than 4 years of age | 1 mL |
| Vitamin C | vitamin | 35 | mg | 88 | Children less than 4 years of age | 1 mL |
| Vitamin D | vitamin | 400 | IU | 100 | Children less than 4 years of age | 1 mL |
| Vitamin E | vitamin | 5 | IU | 50 | Children less than 4 years of age | 1 mL |
| Vitamin B1 | vitamin | 0.5 | mg | 71 | Children less than 4 years of age | 1 mL |
| Vitamin B2 | vitamin | 0.6 | mg | 75 | Children less than 4 years of age | 1 mL |
| Vitamin B12 | vitamin | 2 | mcg | 67 | Children less than 4 years of age | 1 mL |
| Niacin | vitamin | 8 | mg | 89 | Children less than 4 years of age | 1 mL |
| Vitamin B6 | vitamin | 0.4 | mg | 57 | Children less than 4 years of age | 1 mL |
| Fluoride | mineral | 0.25 | mg | N/A | Children less than 4 years of age | 1 mL |
Label Statements
Precautions
- 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. 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 REACTIONSAllergic rash and other idiosyncrasies have been rarely reported. PRECAUTIONSThe suggested dose should not be exceeded since dental fluorosis may result from continued ingestion of large amounts of fluoride.
Suggested Use
- DOSAGE AND ADMINISTRATIONSee following chart. May be dropped directly into mouth with dropper; or mixed with cereal fruit juice or other food. DOSAGE AND ADMINISTRATION; continued(chart)Fluoride Ion Level in Drinking Water (ppm)Age <0.3 ppm 0.3-0.6 ppm >0.6 ppmBirth-6 months None None None6 mos; 3 years 0.25 mg (1 mL)/day None None3; 6 years 0.50 mg (2 mL)/day 0.25 mg (1mL)/day None1.0 ppm = 1 mg/liter2.2 mg sodium fluoride contains 1 mg fluoride ion. SHAKE WELL DOSAGE AND ADMINISTRATION: See package insert for complete dosing information. 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.)
Other
- HOW SUPPLIEDMulti-Vitamin and Fluoride 0.25 mg drops is available in 50 mL bottles with accomplanying calibrated dropper. Rev. 05/11 NDC 64376-820-50 Rx Only Lift HereN
Product Specific Information
- RECOMMENDED STORAGEStore 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.
Branding Statement(s)
- REFERENCES1. 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.
Statement of Identity
- MULTI-VITAMIN AND FLUORIDE SUPPLEMENT DROPS
Formulation
- Multi-Vitamin Drops With Fluoride 0.25 mg
Associated Company Information & Roles
Boca Pharmacal Inc.
Coral Springs,
FL
33065
Roles for this Product:
- Distributor