Label: MULTIVITAMIN WITH FLUORIDE DROPS- vitamin a palmitate, ascorbic acid, cholecalciferol, .alpha.-tocopherol, thiamine hydrochloride, riboflavin 5-phosphate sodium, niacinamide, pyridoxine hydrochloride, cyanocobalamin, and sodium fluoride solution/ drops
- NHRIC Code(s): 61269-162-50
- Packager: H2-Pharma, LLC
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Updated August 30, 2022
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STATEMENT OF IDENTITY
Supplement Facts Serving Size 1.0 mL
Servings Per Container 50
Amount Per Serving % Daily Value Children over 4 & Adults
- Daily Value not established
Vitamin A 450 mcg 50% Vitamin C 35 mg 39% Vitamin D 10 mcg (400 IU) 50% Vitamin E 3.35 mg 22% Thiamin 0.5 mg 42% Riboflavin 0.6 mg 46% Niacin 8 mg 50% Vitamin B6 0.4 mg 24% Vitamin B12 2 mcg 83% Fluoride 0.5 mg *
*U.S. Recommended Daily Allowance not established.
Consult your physician for use by infants and young children 6 months to 3 years of age.
Active ingredient for caries prophylaxis: Fluoride as sodium fluoride.
Other ingredients: Ascorbic acid, caramel color, cherry flavor, cholecalciferol, citric acid, cyanocobalamin, d-alpha-tocopheryl acetate, ferrous sulfate, glycerin, methyl paraben, niacinamide, polysorbate 80, purified water, pyridoxine HCL, riboflavin-5-phosphate sodium, sodium benzoate, sodium fluoride, sodium hydroxide, sucralose, thiamine HCL, vitamin A palmitate.
It is well established that fluoridation of the water supply (0.7 mg/L fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries. 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 water, food, supplementary fluoride and small amounts from saliva.
MultiVitamin with Fluoride Supplement Drops provide supplementation of the diet with nine essential vitamins, and with fluoride for caries prophylaxis. The American Academy of Pediatrics recommends that children up to the age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation. MultiVitamin with Fluoride Supplement Drops provide fluoride in drop form for infants and young children 6 months to 3 years of age in areas where the drinking water contains less than 0.3 ppm of fluoride and for children ages 3 to 6 years in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride.
Each 1.0 mL dose of MultiVitamin with Fluoride Supplement Drops 0.5 mg supplies sodium fluoride (0.5 mg fluoride) plus nine essential vitamins. A half dose (0.5 mL) of MultiVitamin with Fluoride Supplement Drops 0.5 mg could also provides a daily fluoride intake of 0.25 mg; however, the dosage reduces vitamin supplementation by half. MultiVitamin with Fluoride Supplement Drops 0.5 mg supply significant amounts of vitamins A, C, D, E, thiamine, riboflavin, niacinamide, pyridoxine and cyanocobalamin to supplement the diet, and to help ensure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, infants and children obtain nine essential vitamins and fluoride.
The suggested dose should not be exceeded since dental fluorosis may result from continued ingestion of large amounts of fluoride. When prescribing vitamin fluoride products:
1. Determine the fluoride content of the drinking water.
2. Make sure the child is not receiving significant amounts of fluoride from other medications and swallowed toothpaste.
3. Periodically check to make sure that the child does not develop significant dental fluorosis.
- ADVERSE REACTIONS
DOSAGE AND ADMINISTRATION
As directed by a physician. See American Dental Association (ADA) recommended supplement schedule below. May be dropped directly into the mouth with the enclosed dropper or mixed with cereal, fruit juice, or other food.
ADA Dietary Fluoride Supplement Schedule for Children at High Caries Risk Age Fluoride ion level in drinking water (ppm)* <0.3 ppm 0.3-0.6 ppm >0.6 ppm Birth - 6 months None None None 6 months - 3 years 0.25 mg/day† None None 3-6 years 0.50 mg/day 0.25 mg/day None 6-16 years 1.0 mg/day 0.50 mg/day None
SHAKE WELL BEFORE USE.
- HOW SUPPLIED
- RECOMMENDED STORAGE
- HEALTH CLAIM
- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
INGREDIENTS AND APPEARANCE
MULTIVITAMIN WITH FLUORIDE DROPS
vitamin a palmitate, ascorbic acid, cholecalciferol, .alpha.-tocopherol, thiamine hydrochloride, riboflavin 5-phosphate sodium, niacinamide, pyridoxine hydrochloride, cyanocobalamin, and sodium fluoride solution/ drops
Product Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:61269-162 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A 450 ug in 1 mL ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 35 mg in 1 mL CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL 10 ug in 1 mL .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL 3.35 mg in 1 mL THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE 0.5 mg in 1 mL RIBOFLAVIN 5'-PHOSPHATE SODIUM DIHYDRATE (UNII: 20RD1DZH99) (RIBOFLAVIN 5'-PHOSPHATE - UNII:7N464URE7E) RIBOFLAVIN 5'-PHOSPHATE 0.6 mg in 1 mL NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 8 mg in 1 mL PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE 0.4 mg in 1 mL CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 2 ug in 1 mL SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength CARAMEL (UNII: T9D99G2B1R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FERROUS SULFATE (UNII: 39R4TAN1VT) CHERRY (UNII: BUC5I9595W) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM HYDROXIDE (UNII: 55X04QC32I) SUCRALOSE (UNII: 96K6UQ3ZD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:61269-162-50 1 in 1 CARTON 1 50 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 01/04/2017 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color flavor Labeler - H2-Pharma, LLC (028473634)