{"adverse_reactions":["ADVERSE REACTIONS Allergic rash and other idiosyncrasies have been rarely reported. To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010."],"boxed_warning":["WARNINGS Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or Poison Control Center immediately."],"clinical_pharmacology":["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: 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 water, supplementary fluoride and smaller amounts from saliva. Image of equation"],"description":["DESCRIPTION Percentage of U.S. Recommended Daily Allowance Each 1.0 mL supplies: Infants Children Under 4 Vitamin A 1500 IU 100 60 Vitamin C 35 mg 100 88 Vitamin D 400 IU 100 100 Iron 10 mg 67 100 Fluoride 0.25 mg U.S. Recommended Daily Allowance has not been established. Active Ingredient for carles prophylaxis: Each 1 mL contains 0.25 mg fluoride as sodium fluoride. Other ingredients: Ascorbic acid, caramel color, cherry flavor, cholecalciferol, ferrous sulfate, glycerin, methylparaben, polysorbate 80, propylene glycol, purified water, sodium benzoate, sodium hydroxide, vitamin A palmitate. Citric Acid may be used to adjust pH."],"description_table":["
Percentage of U.S. Recommended Daily Allowance
Each 1.0 mL supplies: Infants Children Under 4
Vitamin A 1500 IU 100 60
Vitamin C 35 mg 100 88
Vitamin D 400 IU 100 100
Iron 10 mg 67 100
Fluoride 0.25 mg U.S. Recommended Daily Allowance has not been established.
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION 1.0 mL daily, or as prescribed. May be dropped directly into mouth with dropper, or mixed with cereal, fruit juice or other food. USE FULL DOSAGE."],"effective_time":"20120105","how_supplied":["HOW SUPPLIED Vitamins A, C, D, Iron and Fluoride Drops 0.25 mg are available in 50 mL bottles with accompanying calibrated dropper."],"id":"98b14f59-5bac-4f23-93ff-bb5a8847fc3f","indications_and_usage":["INDICATIONS AND USAGE Vitamins A, C, D, Iron and Fluoride Drops may be useful for infants and children whose diets are lacking in vitamins A, C, D and iron. Vitamins A, C, D, Iron and Fluoride Drops also provide fluoride for caries prophylaxis. Vitamins A, C, D, Iron and Fluoride Drops were developed to 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 containes 0.3 thru 0.6 ppm of fluoride. Each 1.0 mL supplies sodium fluoride (0.25 mg fluoride) plus three basic vitamins and iron."],"openfda":{},"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 50383-628-50 Tri-Vitamin Drops with iron 0.25 mg VITAMINS A, C, D IRON AND FLUORIDE Rx Only 1 2/3 FL. OZ. (50 mL) Image of Container Label - 50 mL"],"precautions":["PRECAUTIONS The suggested dose should not be exceeded since dental fluorosis may result from continued ingestion of large amounts of fluoride. When prescribing Vitamin A, C, D, Iron and Fluoride Drops: Determine the fluoride content of the drinking water. Make sure the child is not receiving significant amounts of fluoride from other medications and swallowed toothpaste. Periodically check to make sure that the child does not develop significant dental fluorosis. Vitamins A, C, D, Iron and Fluoride Drops should be dispensed in the original plastic container, since contact with glass leads to instability and precipitation. (The amount of sodium fluoride in the 50 mL size is well below the maximum to be dispensed at one time according to recommendations of the American Dental Association.)"],"set_id":"a5f3b6a2-c936-49db-84c7-24ccd741ad73","spl_product_data_elements":["Tri-Vitamin with iron and fluoride Vitamins A, C, D, Iron and Fluoride VITAMIN A PALMITATE VITAMIN A PALMITATE ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL FERROUS SULFATE IRON SODIUM FLUORIDE FLUORIDE ION GLYCERIN METHYLPARABEN POLYSORBATE 80 PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM HYDROXIDE ANHYDROUS CITRIC ACID"],"spl_unclassified_section":["Rx only"],"storage_and_handling":["RECOMMENDED STORAGE: Store at room temperature, protect from light. Dispense in original container. Manufactured By: HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 Rev. 628:05 4/09"],"version":"2","warnings":["WARNINGS WARNINGS Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or Poison Control Center immediately."]}