País: Estados Unidos
Língua: inglês
Origem: 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), SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)
Mayne Pharma Inc.
VITAMIN A PALMITATE
VITAMIN A 1500 [iU] in 1 mL
ORAL
PRESCRIPTION DRUG
Supplementation of the diet with Vitamins A, C, D and Fluoride 0.25 mg Drops also provides 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. Vitamins A, C, D and Fluoride 0.25 mg 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 children ages 2-3 years where the drinking water contains less than 0.3 ppm of fluoride and for children over 3 years, in areas where the drinking water contains 0.3 through 0.7 ppm of fluoride. Each 1.0 mL provides sodium fluoride (0.25 mg fluoride) plus eight essential vitamins and iron. The American Academy of Pediatrics recommends that infants and young children under 6 months to 3 years of age, in areas where drinking water contains less than 0.3 ppm of fluoride, and; and for children ages 3-6 years, in areas where the dri
Vitamins A, C, D and Fluoride 0.25 mg Drops are available in 50 mL bottles with accompanying calibrated dropper, NDC 51862-164-50. 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. TAMPER EVIDENT: Do not use if printed bottle seal around bottle cap is broken or missing. Manufactured for: Libertas Pharma, Inc. Lawrenceville, GA 30043 Iss. 03/11 164-50 743629
unapproved drug other
VITAMINS A, C, D AND FLUORIDE- VITAMINS A, C, D 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._ ---------- VITAMINS A, C, D AND FLUORIDE 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 (Ascorbic Acid) 35 mg 100 88 Vitamin D 400 IU 100 100 Fluoride 0.25 mg 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, ferrous sulfate, flavor, glycerin, methylparaben, niacinamide, polysorbate 80, purified water, sodium benzoate, sodium hydroxide, sucralose, 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. 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 Vitamins A, C, D and Fluoride 0.25 mg Dro Leia o documento completo