Label: MULTIVITAMIN WITH FLUORIDE- .alpha.-tocopherol acetate, dl-, ascorbic acid, cyanocobalamin, folic acid, niacin, pyridoxine, riboflavin, sodium fluoride, thiamine mononitrate, vitamin a and vitamin d tablet, chewable
- NDC Code(s): 58657-163-01, 58657-163-90
- Packager: Method Pharmaceuticals, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated February 22, 2021
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SPL UNCLASSIFIED SECTION
MULTIVITAMIN WITH FLUORIDE
Disclaimer: This drug has not been found by FDA to be safeand effective, and this labeling has not been approved by FDA.
Each Fluoride Chewable Tablet Contains:
Dosage Size 1 Chewable Tablet
Amount per Tablet % DV Adults and Children 4 years or More Vitamin A (as Vitamin A acetate) 2500 IU 50% Vitamin C (as ascorbic acid) 60 mg 100% Vitamin D (as cholecalciferol) 400 IU 100% Vitamin E (dl-alpha tocopherol acetate
15 IU 50% Thiamine (as thiamine) 1.05 mg 70% Riboflavin (as riboflavin) 1.2 mg 71% Niacin (as niacinamide) 13.5 mg 68% Vitamin B6 (as pyridoxine HCl) 1.05 mg 53% Folate (as folic acid) 300 mcg 75% Vitamin B12 (as cyanocobalamin) 4.5 mcg 75% Fluoride (as sodium fluoride) 0.25 mg *
*Daily value (DV) not established
Multivitamin with Fluoride 0.25 mg Chewable Tabletsactive ingredient for caries prophylaxis: Fluoride as sodium fluoride
Multivitamin with Fluoride 0.25 mg Chewable Tabletsprovide sodium fluoride and ten essential vitamins in a chewable tablet.
Other ingredients: citric acid, magnesium stearate, mannitol, microcrystalline cellulose, orange flavor, sucralose, talc, xylitol.
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 0.25 mg 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-
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 0.25 mg Chewable Tablets provide 0.25 mg fluoride in tablet form for children 4-6years of age in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride.
Multivitamin with Fluoride 0.25 mg Chewable Tablets supply 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 0.25 mg Chewable 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.
Keep out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
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.
The suggested dose of Multivitamin with Fluoride 0.25 mg Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.
Before prescribing Multivitamin with Fluoride 0.25 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
- DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
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.
Fort Worth, TX 76118
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
MULTIVITAMIN WITH FLUORIDE
.alpha.-tocopherol acetate, dl-, ascorbic acid, cyanocobalamin, folic acid, niacin, pyridoxine, riboflavin, sodium fluoride, thiamine mononitrate, vitamin a and vitamin d tablet, chewable
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58657-163 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A 2500 [iU] ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 60 mg VITAMIN D (UNII: 9VU1KI44GP) (VITAMIN D - UNII:9VU1KI44GP) VITAMIN D 400 [iU] .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL- 15 [iU] THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 1.05 mg RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN 1.2 mg NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN 13.5 mg PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 1.05 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 300 ug CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 4.5 ug SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.25 mg Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SUCRALOSE (UNII: 96K6UQ3ZD4) TALC (UNII: 7SEV7J4R1U) XYLITOL (UNII: VCQ006KQ1E) Product Characteristics Color yellow (yellowish/cream) Score no score Shape ROUND Size 9mm Flavor ORANGE Imprint Code M163 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58657-163-90 90 in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2018 2 NDC:58657-163-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/20/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 07/20/2018 Labeler - Method Pharmaceuticals, LLC (060216698) Establishment Name Address ID/FEI Business Operations Monarch PCM, LLC 080000294 manufacture(58657-163)