FDA Label for Multivitamin With Fluoride
View Indications, Usage & Precautions
Multivitamin With Fluoride Product Label
The following document was submitted to the FDA by the labeler of this product Bryant Ranch Prepack. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.
Multivitamin with Fluoride 1.0 mg Chewable Tabletsprovide 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.
Multivitamin with Fluoride 1.0 mg Chewable Tabletsprovide 1.0 mg fluoride in tablet form for children 6-16 years of age in areas where the water fluoride level is less than 0.3 ppm.
Multivitamin with Fluoride 1.0 mg Chewable Tabletssupply significant amounts of Vitamins A, C, D, E, thiamine, 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 supplements.
Children using Multivitamin with Fluoride 1.0 mgChewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential. Multivitamin with Fluoride Chewable Tablets is a prescription product for the clinical dietary management of the metabolic processes of caries prophylaxis and provides supplementation of the diet with ten essential vitamins.
Warning
Keep out of the reach of children. In case of accidentaloverdose, seek professional assistance or contact aPoison Control Center immediately.
CAUTION
Do not eat or drink dairy products within one hour of fluoride administration.
Should be chewed. This product, as all chewable tablets, is not recommended for children under age 4 due to risk of choking.
Precaution
The suggested dose of Multivitamin with Fluoride 1.0 mgChewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.
Before prescribing Multivitamin with Fluoride 1.0 mg
Chewable Tablets:
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.
Adverse Reactions
Allergic rash and other idiosyncrasies have been rarely reported.
Dosage And Administration
One tablet daily, to be dissolved in the mouth or chewed before swallowing. Do not give a chewable tablet to a child younger than 4 years old.
How Supplied
NDC: 63629-1138-1 100 Chewable Tablets in a BOTTLE
Storage
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature.
Dispense in a tight, light resistant container with a child-resistant closure as defined in the USP/NF. All prescription substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.
Manufactured For:
Method Pharmaceuticals
Fort Worth, TX 76118
Rev. 06/2019
Package Label.Principal Display Panel
Multivitamin/Fluoride Oral Tablet Chewable
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