NDC | 44946-1012-4, 44946-1012-5, 44946-1012-6, 44946-1012-7, 44946-1013-4, 44946-1013-5, 44946-1013-6, 44946-1014-4, 44946-1014-5, 44946-1014-6 |
Set ID | 50b44fd6-8747-448f-b951-234e7e17df4f |
Category | DIETARY SUPPLEMENT |
Packager | Sancilio & Company Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
- HEALTH CLAIM
-
STATEMENT OF IDENTITY
Nutrition Facts
Serving Size 1 Chewable Tablet
Serving Per Container 30 or 90Amount Per Serving
(1 Chewable Tablet)1.0 mg 0.5 mg 0.25 mg %DV Adults & Children
4 Years or More- *
- Daily Value (%DV) not established
Vitamin A 2500 IU 2500 IU 2500 IU 50% Vitamin C 60 mg 60 mg 60 mg 100% Vitamin D 400 IU 400 IU 400 IU 100% Vitamin E 15 IU 15 IU 15 IU 50% Thiamin 1.05 mg 1.05 mg 1.05 mg 70% Riboflavin 1.2 mg 1.2 mg 1.2 mg 70% Niacin 13.5 mg 13.5 mg 13.5 mg 68% Vitamin B6 1.05 mg 1.05 mg 1.05 mg 53% Folate 0.3 mg 0.3 mg 0.3 mg 75% Vitamin B12 4.5 mcg 4.5 mcg 4.5 mcg 75% Fluoride 1.0 mg 0.5 mg 0.25 mg * -
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 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 forms to produce the more caries-resistant crystal, fluorapatite. The reaction may be expressed by the equation:
Three stages of fluoride deposition in tooth enamel can be distinguished:
- Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed.
- After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted.
- After eruption, the surface enamel acquires fluoride from the water, food, supplementary fluoride and smaller amounts from saliva.
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INDICATIONS AND USAGE
Supplementation of the diet with fluoride and ten essential vitamins.
Multivitamin with 1.0 mg Fluoride Chewable Tablets provide 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 0.5 mg Fluoride Chewable Tablets provide fluoride in tablet form for children 4-6 years of age where the water fluoride level is less than 0.3 ppm, and for children 6 years of age and above where the drinking water contains 0.3 through 0.6 ppm of fluoride.
Multivitamin with 0.25 mg Fluoride Chewable Tablets provide fluoride in tablet form for children 4-6 years of age where the drinking water contains 0.3 through 0.6 ppm of fluoride.
Multivitamin 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.
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 Multivitamin 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.
- WARNING
-
PRECAUTIONS
The suggested dose of Multivitamin with Fluoride Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.
Before prescribing Multivitamin with Fluoride Chewable Tablets:
- Determine the fluoride content of the drinking water from all major sources.
- Make sure the child is not receiving significant amounts of fluoride from other sources such as medications and swallowed toothpaste.
- Periodically check to make sure that the child does not develop significant dental fluorosis.
- ADVERSE REACTIONS
- DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- HEALTH CLAIM
- PRINCIPAL DISPLAY PANEL - 1.0 mg Bottle Label
- PRINCIPAL DISPLAY PANEL - 0.5mg Bottle Label
- PRINCIPAL DISPLAY PANEL - 0.25mg Bottle Label
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INGREDIENTS AND APPEARANCE
MVC
sodium fluoride, vitamin a palmitate, ascorbic acid, cholecalciferol, alpha-tocopherol acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid and cyanocobalamin tablet, chewableProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:44946-1014 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 1 mg Vitamin A Palmitate (UNII: 1D1K0N0VVC) (Vitamin A - UNII:81G40H8B0T, Retinol - UNII:G2SH0XKK91) Vitamin A 2500 [iU] Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid 60 mg Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol 400 [iU] .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) (.Alpha.-Tocopherol - UNII:H4N855PNZ1) .Alpha.-Tocopherol 15 [iU] Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine 1.05 mg Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin 1.2 mg Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide 13.5 mg Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride 1.05 mg Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 0.3 mg cyanocobalamin (UNII: P6YC3EG204) (cyanocobalamin - UNII:P6YC3EG204) cyanocobalamin 4.5 ug Inactive Ingredients Ingredient Name Strength Citric Acid Monohydrate (UNII: 2968PHW8QP) Malic Acid (UNII: 817L1N4CKP) Microcrystalline Cellulose (UNII: OP1R32D61U) Sucralose (UNII: 96K6UQ3ZD4) Xylitol (UNII: VCQ006KQ1E) Talc (UNII: 7SEV7J4R1U) Magnesium Stearate (UNII: 70097M6I30) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:44946-1014-4 4 in 1 BOX 1 24 in 1 BOX 1 30 in 1 BOTTLE 2 NHRIC:44946-1014-5 4 in 1 BOX 2 24 in 1 BOX 2 90 in 1 BOTTLE 3 NHRIC:44946-1014-6 30 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Dietary Supplement 12/20/2009 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color scoring 1 shape size (solid drugs) 12 mm imprint flavor MVC
sodium fluoride, vitamin a palmitate, ascorbic acid, cholecalciferol, alpha-tocopherol acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid and cyanocobalamin tablet, chewableProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:44946-1013 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 0.5 mg Vitamin A Palmitate (UNII: 1D1K0N0VVC) (Vitamin A - UNII:81G40H8B0T, Retinol - UNII:G2SH0XKK91) Vitamin A 2500 [iU] Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid 60 mg Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol 400 [iU] .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) (.Alpha.-Tocopherol - UNII:H4N855PNZ1) .Alpha.-Tocopherol 15 [iU] Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine 1.05 mg Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin 1.2 mg Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide 13.5 mg Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride 1.05 mg Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 0.3 mg cyanocobalamin (UNII: P6YC3EG204) (cyanocobalamin - UNII:P6YC3EG204) cyanocobalamin 4.5 ug Inactive Ingredients Ingredient Name Strength Citric Acid Monohydrate (UNII: 2968PHW8QP) Malic Acid (UNII: 817L1N4CKP) Microcrystalline Cellulose (UNII: OP1R32D61U) Sucralose (UNII: 96K6UQ3ZD4) Xylitol (UNII: VCQ006KQ1E) Talc (UNII: 7SEV7J4R1U) Magnesium Stearate (UNII: 70097M6I30) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:44946-1013-4 4 in 1 BOX 1 24 in 1 BOX 1 30 in 1 BOTTLE 2 NHRIC:44946-1013-5 4 in 1 BOX 2 24 in 1 BOX 2 90 in 1 BOTTLE 3 NHRIC:44946-1013-6 30 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Dietary Supplement 12/20/2009 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color scoring 1 shape size (solid drugs) 12 mm imprint flavor MVC
sodium fluoride, vitamin a palmitate, ascorbic acid, cholecalciferol, alpha-tocopherol acetate, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid and cyanocobalamin tablet, chewableProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:44946-1012 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 0.25 mg Vitamin A Palmitate (UNII: 1D1K0N0VVC) (Vitamin A - UNII:81G40H8B0T, Retinol - UNII:G2SH0XKK91) Vitamin A 2500 [iU] Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid 60 mg Cholecalciferol (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41) Cholecalciferol 400 [iU] .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) (.Alpha.-Tocopherol - UNII:H4N855PNZ1) .Alpha.-Tocopherol 15 [iU] Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine 1.05 mg Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin 1.2 mg Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide 13.5 mg Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride 1.05 mg Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 0.3 mg cyanocobalamin (UNII: P6YC3EG204) (cyanocobalamin - UNII:P6YC3EG204) cyanocobalamin 4.5 ug Inactive Ingredients Ingredient Name Strength Citric Acid Monohydrate (UNII: 2968PHW8QP) Malic Acid (UNII: 817L1N4CKP) Microcrystalline Cellulose (UNII: OP1R32D61U) Sucralose (UNII: 96K6UQ3ZD4) Xylitol (UNII: VCQ006KQ1E) Talc (UNII: 7SEV7J4R1U) Magnesium Stearate (UNII: 70097M6I30) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:44946-1012-7 7 in 1 BOTTLE, PLASTIC 2 NHRIC:44946-1012-4 4 in 1 BOX 2 24 in 1 BOX 2 30 in 1 BOTTLE 3 NHRIC:44946-1012-5 4 in 1 BOX 3 24 in 1 BOX 3 90 in 1 BOTTLE 4 NHRIC:44946-1012-6 30 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Dietary Supplement 12/20/2009 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color scoring 1 shape size (solid drugs) 13 mm imprint flavor Labeler - Sancilio & Company Inc (176681257) Establishment Name Address ID/FEI Business Operations Sancilio & Company Inc 080018491 MANUFACTURE, RELABEL, REPACK