Label: MULTI-VIT WITH FLUORIDE- dl-alpha-tocopheryl acetate and ascorbic acid and cholecalciferol and cyanocobalamin and niacinamide and pyridoxine hydrochloride and riboflavin and fluoride and thiamine hydrochloride and vitamin a palmitate solution
- NDC Code(s): 0603-1449-47
- Packager: Par Pharmaceutical
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated November 11, 2019
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Supplement Facts Dosage Size 1 mL (Mark on Dropper) Amount Per
% Daily Value Infants Children Under
Age 4 Years
Vitamin A 1500 IU 100% 60% Vitamin C 35 mg 100% 88% Vitamin D 400 IU 100% 100% Vitamin E 5 IU 100% 50% Thiamin 0.5 mg 100% 71% Riboflavin 0.6 mg 100% 75% Niacin 8 mg 100% 89% Vitamin B6 0.4 mg 100% 57% Vitamin B12 2 mcg 100% 67% Fluoride 0.25 mg * * *Daily Value (DV) not established
Active ingredient for caries prophylaxis:
Each 1 mL contains 0.25 mg fluoride as sodium fluoride.
ascorbic acid (Vitamin C), caramel color, cholecalciferol (Vitamin D3), cyanocobalamin (Vitamin B12), dl-alpha-tocopheryl acetate (Vitamin E), ferrous sulfate, flavors, glycerin, niacinamide, polysorbate 80, purified water, pyridoxine hydrochloride (Vitamin B6), riboflavin 5’-phosphate sodium (Vitamin B2), sodium hydroxide, thiamine hydrochloride (Vitamin B1), vitamin A palmitate
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. 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. Three stages of fluoride deposition in tooth enamel can be distinguished:1 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 smaller amounts from saliva.
INDICATIONS AND USAGE:
Supplementation of the diet with nine essential vitamins. Supplementation of the diet with fluoride for caries prophylaxis. MULTI-VIT with FLUORIDE 0.25 mg drops were developed to provide fluoride in drop form for infants and young children from 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.2, 3 Each 1 mL supplies sodium fluoride (0.25 mg fluoride) plus nine essential vitamins. MULTI-VIT with FLUORIDE 0.25 mg drops supply significant amounts of vitamins A, C, D, E, thiamin, riboflavin, niacin, vitamin B6 and vitamin B12 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, infants and children obtain nine essential vitamins plus fluoride.
The suggested dose should not be exceeded since dental fluorosis may result from continued ingestion of large amounts of fluoride. When prescribing MULTI-VIT with FLUORIDE 0.25 mg drops: 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 sourcessuch as medications and swallowed toothpaste. 3) Periodically check to make sure that the child does not develop significant dental fluorosis. MULTI-VIT with FLUORIDE 0.25 mg drops should be dispensed in the original plastic container, since contact with glass leads to instability and precipitation. (The amount of sodium fluoride in a 50-mL size is well below the maximum to be dispensed at one time according to recommendations of the American Dental Association.)
- ADVERSE REACTIONS:
- DOSAGE AND ADMINISTRATION:
- STORAGE AND HANDLING
- Brudevold F, McCann HG. Fluoride and caries control - Mechanism of action. In: Nizel AE, ed. The Science of Nutrition and Its Application in Clinical Dentistry. Philadelphia: WB Saunders Co.; 1966;331-347.
- American Academy of Pediatrics, Committee on Nutrition: Fluoride Supplementation for Children: Interim Policy Recommendations. Pediatrics. 1995;95:777.
- American Dental Association Council on Dental Therapeutics. New Fluoride Schedule Adopted. ADA News. May 16, 1994;12-14.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - carton
- PRINCIPAL DISPLAY PANEL - label
INGREDIENTS AND APPEARANCE
MULTI-VIT WITH FLUORIDE
dl-alpha-tocopheryl acetate and ascorbic acid and cholecalciferol and cyanocobalamin and niacinamide and pyridoxine hydrochloride and riboflavin and fluoride and thiamine hydrochloride and vitamin a palmitate solution
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0603-1449 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 1500 [iU] 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 400 [iU] in 1 mL .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL- 5 [iU] in 1 mL THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (Thiamine ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE 0.5 mg in 1 mL RIBOFLAVIN 5'-PHOSPHATE SODIUM (UNII: 20RD1DZH99) (FLAVIN MONONUCLEOTIDE - UNII:7N464URE7E) FLAVIN MONONUCLEOTIDE 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 0.25 mg in 1 mL Inactive Ingredients Ingredient Name Strength FERROUS SULFATE (UNII: 39R4TAN1VT) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Product Characteristics Color BROWN Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0603-1449-47 1 in 1 CARTON 04/18/1997 03/31/2021 1 50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED DRUG OTHER 04/18/1997 03/31/2021 Labeler - Par Pharmaceutical (011103059)