País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) (VITAMIN A - UNII:81G40H8B0T), ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R), CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41), .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1), THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J), RIBOFLAVIN 5'-PHOSPHATE SODIUM (UNII: 20RD1DZH99) (FLAVIN MONONUCLEOTIDE - UNII:7N464URE7E), NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X5
Mayne Pharma Inc
VITAMIN A PALMITATE
VITAMIN A 1500 [iU] in 1 mL
ORAL
PRESCRIPTION DRUG
Supplementation of the diet with nine essential vitamins. Supplementation of the diet with fluoride for caries prophylaxis. 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. Multivitamin and Fluoride Supplemental Drops 0.25 mg 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 3-6 years, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride. Each 1.0 mL supplies sodium fluoride (0.25 mg fluoride) plus nine essential vitamins. The American Academy of Pediatrics recommended that infants and young children 6 months to 3 years of age, in areas where drinking water contains less than 0.3 ppm of fluoride, and children 3-6, years of age, in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride, receive 0.2
Multivitamin and Fluoride Supplemental Drops 0.25 mg are available in 50 mL bottles with accompanying calibrated dropper, NDC 51862-161-50. Store at controlled room temperature, 20º-25ºC (68º-77ºF). [See USP Controlled Room Temperature]. After opening, store away from direct light. Close tightly after each use. REFRIGERATION IS NOT REQUIRED. Manufactured for: Libertas Pharma, Inc. Lawrenceville, GA 30043 Iss. 03/11 161-50 743623
unapproved drug other
MULTI VITAMIN AND FLUORIDE- MULTI VITAMIN AND FLUORIDE SOLUTION/ DROPS MAYNE PHARMA INC _Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been_ _approved by FDA. For further information about unapproved drugs, click here._ ---------- MULTI VITAMIN AND FLUORIDE SUPPLEMENTAL DROPS 0.25 MG DROPS DESCRIPTION * EACH 1.0 ML SUPPLIES: PERCENTAGE OF U.S. RECOMMENDED DAILY ALLOWANCE INFANTS CHILDREN UNDER 4 Vitamin A 1500 IU 100 60 Vitamin C 35 mg 100 88 Vitamin D 400 IU 100 100 Vitamin E 5 IU 100 50 Thiamine 0.5 mg 100 71 Riboflavin 0.6 mg 100 75 Niacin 8 mg 100 89 Vitamin B 0.4 mg 100 57 Vitamin B 2 mcg 100 67 Fluoride 0.25 mg This product does not contain the essential vitamin folic acid. See INDICATIONS AND USAGE section below 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, cholecalciferol, citric acid, cyanocobalamin, D- alpha tocopheryl acid succinate, ferrous sulfate, flavor, glycerin, methylparaben, niacinamide, polysorbate 80, purified water, pyridoxine HCL, riboflavin-5-phosphate sodium, sodium benzoate, sodium hydroxide, sucralose, thiamine HCL, vitamin A palmitate. 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. 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: 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. U.S. RDA not established 6 12 * * 2. After enamel has been laid down, fluoride de Leer el documento completo