Dosage Form: tablet, chewable
Unknown Title
Multi-Vitamin With Fluoride Chewable Tablets
Rx Only
| *Daily Value not established | |
| Supplement Facts | |
| Serving Size: 1 Chewable Tablet | |
| Amount Per Tablet | % Daily Value Adults & children 4 years or more |
| Vitamin A .................................. 2500 IU | 50% |
| Vitamin C ..................................... 60 mg | 100% |
| Vitamin D .................................... 400 IU | 100% |
| Vitamin E ...................................... 15 IU | 50% |
| Thiamin (B1) ............................ 1.05 mg | 70% |
| Riboflavin (B2) ........................... 1.2 mg | 71% |
| Niacin ....................................... 13.5 mg | 68% |
| Vitamin (B6) ............................. 1.05 mg | 53% |
| Folate ......................................... 0.3 mg | 75% |
| Vitamin B12 .............................. 4.5 mcg | 75% |
| Fluoride (as sodium fluoride) ... 0.25 mg | * |
Active ingredient for Caries Prophylaxis: Fluoride as Sodium Fluoride.
Other ingredients: Ascorbic acid, butylated hydroxyl toluene, cholecalciferol, citric acid, compressible sugar, DL-alpha Tocopherol, FD&C yellow #6 aluminum lake, folic acid, gelatin, magnesium stearate, maltodextrin, mannitol, medium chain triglycerides, methyl cellulose, mono- and di-glycerides, niacinamide, orange flavor, povidone, pyridoxine, riboflavin, silicon dioxide, sodium ascorbate, sodium citrate, starches, sucralose, thiamine, vitamin A acetate, vitamin B12 and vitamin E acetate.
CLINICAL PHARMACOLOGY
It is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries.
Multi-vitamin with Fluoride Chewable Tablets provide sodium fluoride and ten essential vitamins in a chewable tablet. Because the tablets are chewable, they provide a topical as well as systemic source of fluoride.
Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with the hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite. The reaction may be expressed by the equation:
Ca10(PO4)6(OH)2 + 2F- —————> Ca10(PO4)6F2 + 2OH-
(Hydroxyapatite) (Fluorapatite)
Three stages of fluoride deposition in tooth enamel can be distinguished:
1. Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed.
2. After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted.
3. After eruption, the surface enamel acquires fluoride from the water, food, supplementary fluoride and smaller amounts from saliva.
INDICATIONS AND USAGE
Supplementation of the diet with ten essential vitamins.
Supplementation of the diet with fluoride for caries prophylaxis.
See Dosage and Administration.
Multi-vitamin with Fluoride Chewable Tablets supply significant amounts of Vitamins A, C, D, E, thiamin, riboflavin, niacin, vitamin B6, vitamin B12, and folate 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 ten essential vitamins and the important mineral, fluoride.
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.
Children using Multi-vitamin with fluoride Chewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential.
WARNINGS
As in the case of all medications, keep out of the reach of children.
Should be chewed. This product, as all chewable tablets, is not recommended for children under age 4 due to risk of choking.
PRECAUTIONS
The suggested dose of Multi-vitamin with Fluoride Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.
Before prescribing Multi-vitamin with Fluoride Chewable Tablets, read these Important Considerations When Using Dosage Schedule found in Dosage and Administration.
- 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
Allergic rash and other idiosyncrasies have been rarely reported.
DOSAGE AND ADMINISTRATION
| *1.0 ppm = 1 mg / liter | |||
| **2.2 mg Sodium Fluoride contains 1mg fluoride ion. | |||
| Fluoride Ion Level in Drinking Water (ppm)* | |||
| AGE | <0.3 ppm | 0.3-0.6 ppm | >0.6 ppm |
| 4-6 years | 0.50 mg / day**(2 tablets) | 0.25 mg / day(1 tablet) | None |
| 6-16 years | 1.0 mg / day(4 tablets) | 0.50 mg / day(2 tablets) | None |
HOW SUPPLIED
Multi-vitamin 1 mg Sodium Fluoride Tablets: grape flavored, round, purple, debossed “BP 815”, available in 100 ct. bottle, NDC 64376-815-01.
Multi-vitamin 0.5 mg Sodium Fluoride Tablets: cherry flavored, square, red, debossed “BP 814”, available in 100 ct. bottle, NDC 64376-814-01.
Multi-vitamin 0.25 mg Sodium Fluoride Tablets: orange flavored, round, orange, debossed “BP 813”, available in 100 ct. bottle, NDC 64376-813-01.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C -30°C (59°-86°F) [See USP Controlled Room Temperature].
Manufactured for: Boca Pharmacal, Inc.
Coral Springs, FL 33065 www.bocapharmacal.com
1-800-354-8460 Iss. 08/11
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
[Rev 18]
| MULTI-VITAMIN WITH FLUORIDE vitamin a, vitamin d, thiamine, riboflavin, niacin, pyridoxine, folic acid, fluoride ion, ascorbic acid, .alpha.-tocopherol-acetate-dl, cyanocobalamin tablet, chewable | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved drug other | 12/28/2011 | ||
| Labeler - Boca Pharmacal, Inc (170266089) |
| Registrant - Boca Pharmacal, Inc (170266089) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Cispharma, Inc | 833171445 | MANUFACTURE | |
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