Label: MULTIVITAMIN WITH FLUORIDE- vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, and sodium fluoride tablet, chewable
- NHRIC Code(s): 61269-153-01
- Packager: H2-Pharma, LLC
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Updated February 3, 2020
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- DOSAGE AND ADMINISTRATION
STATEMENT OF IDENTITY
Supplement Facts Serving Size 1 Tablet
Servings Per Container 100
Amount Per Serving % Daily Value
- Daily Value not established
Vitamin A 2500 IU 50% Vitamin C 60 mg 100% Vitamin D 400 IU 100% Vitamin E 15 IU 50% Thiamine 1.05 mg 70% Riboflavin 1.2 mg 70% Niacinamide 13.5 mg 68% Vitamin B6 1.05 mg 53% Folic Acid 0.3 mg 75% Vitamin B12 4.5 mcg 75% Fluoride 1.0 mg *
Other Ingredients: Artificial cherry flavor, artificial grape flavor, ascorbic acid, cholecalciferol, compressible sugar, D&C Red #7 calcium lake, FD&C Blue #1 aluminum lake, FD&C Yellow #6 aluminum lake, folic acid, magnesium stearate, microcrystalline cellulose, natural and artificial orange flavor, niacinamide, polyethylene glycol, pyridoxine HCI, riboflavin, sodium ascorbate, sodium fluoride, stearic acid, sucralose, thiamine HCI, vitamin A acetate, vitamin B12 and vitamin E acetate.
Active ingredient for caries prophylaxis: Fluoride as sodium fluoride.
Significant decrease in the incidence of dental caries can be linked to the fluoridation of the water supply (1ppm fluoride) during the period of tooth development.
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 is formed to produce the more caries-resistant crystal, fluorapatite.
The reaction may be expressed by the equation:
Ca10(PO4)6(OH2) + 2F- Ca10 (PO4)6F2 + 2OH- (Hydroxyapatite) (Fluorapatite)
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 of saliva.
- DIETARY SUPPLEMENTATION
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 recommending 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
MultiVitamin with Fluoride Chewable Tablets 0.25 mg are available as orange, red and purple chewable tablets imprinted with "151" in 100 tablet bottles.
MultiVitamin with Fluoride Chewable Tablets 0.5 mg are available as orange, red and purple chewable tablets imprinted with "152" in 100 tablet bottles.
MultiVitamin with Fluoride Chewable Tablets 1.0 mg are available as orange, red and purple chewable tablets imprinted with "153" in 100 tablet bottles.
- HEALTH CLAIM
- PRINCIPAL DISPLAY PANEL - 1 mg Tablet Bottle Label
INGREDIENTS AND APPEARANCE
MULTIVITAMIN WITH FLUORIDE
vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, thiamine hydrochloride, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, and sodium fluoride tablet, chewable
Product Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:61269-153 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) 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 ACETATE 15 [iU] THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE 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 SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1 mg Inactive Ingredients Ingredient Name Strength CHERRY (UNII: BUC5I9595W) GRAPE (UNII: 6X543N684K) SUCROSE (UNII: C151H8M554) D&C RED NO. 7 (UNII: ECW0LZ41X8) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) ORANGE (UNII: 5EVU04N5QU) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SODIUM ASCORBATE (UNII: S033EH8359) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:61269-153-01 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 12/05/2016 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color color color scoring 1 shape size (solid drugs) 13 mm imprint flavor flavor flavor Labeler - H2-Pharma, LLC (028473634)