{"description":["Supplemental Facts Serving Size: 1.0 mL Amount Per Serving Percentage of U.S. Recommended Daily Allowance Each 1.0 mL supplies: Children 6 mos - 4 years old Vitamin A (as Vitamin A Palmitate) 1500 IU 60% Vitamin C (as Ascorbic Acid) 35 mg 88% Vitamin D (as Cholecalciferol) 400 IU 100% Vitamin E (as d-alpha-tocopheryl acid succinate) 5 IU 50% Vitamin B1 (as Thiamine HCI) 0.5 mg 71% Vitamin B2 (as Riboflavin Phosphate Sodium) 0.6 mg 75% Vitamin B12 (as Cyanocobalamin) 2 mcg 67% Niacin (as Niacinamide) 8 mg 89% Vitamin B6 (as Pyridoxine HCl) 0.4 mg 57% Fluoride (as Sodium Fluoride) 0.25 mg U.S. Recommended Daily Allowance has not been established."],"description_table":["
Supplemental Facts
Serving Size: 1.0 mL
Amount Per Serving Percentage of U.S. Recommended Daily Allowance
Each 1.0 mL supplies: Children 6 mos - 4 years old
Vitamin A (as Vitamin A Palmitate) 1500 IU 60%
Vitamin C (as Ascorbic Acid) 35 mg 88%
Vitamin D (as Cholecalciferol) 400 IU 100%
Vitamin E (as d-alpha-tocopheryl acid succinate) 5 IU 50%
Vitamin B1 (as Thiamine HCI) 0.5 mg 71%
Vitamin B2 (as Riboflavin Phosphate Sodium) 0.6 mg 75%
Vitamin B12 (as Cyanocobalamin) 2 mcg 67%
Niacin (as Niacinamide) 8 mg 89%
Vitamin B6 (as Pyridoxine HCl) 0.4 mg 57%
Fluoride (as Sodium Fluoride) 0.25 mg U.S. Recommended Daily Allowance has not been established.
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: See package insert for complete prescribing and dosing information."],"effective_time":"20160811","how_supplied":["HOW SUPPLIED Multi-Vitamin and Fluoride 0.25 mg drops is available in 50 mL bottles with accompanying calibrated dropper. a0b3108e-figure-03 RECOMMENDED STORAGE Store at controlled room temperature 15°-25°C (between 59°F and 77°F). Excursions Permitted. After opening store away from direct light. Close tightly after each use. Occasional deepening of color has no significant effect on vitamin potency. REFRIGERATION IS NOT REQUIRED. SHAKE WELL. Manufactured for: Seton Pharmaceuticals, LLC Manasquan, NJ 08736 1-800-510-3401 Rev. 02/14 Made in the USA"],"id":"5705cc02-e7ea-4f82-beb8-1cff60dbcee0","inactive_ingredient":["Other Ingredients: Caramel color, cherry flavor, ferrous sulfate, oil of orange, glycerin, methylparaben, polysorbate 80, purified water, sodium benzoate and sodium hydroxide."],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 0.25 mg label NDC 13925-167-50 Multi-Vitamin Drops With Fluoride 0.25 mg MULTI-VITAMIN AND FLUORIDE SUPPLEMENT DROPS R x Only 1.69 FL. OZ. (50 mL) SETON PHARMACEUTICALS container label"],"set_id":"32130bf3-cb1c-4c45-95f9-48b47fa2462c","spl_product_data_elements":["Multi Vitamin Drops with Fluoride vitamin a palmitate, ascorbic acid, cholecalciferol, alpha-tocopherol succinate, d-thiamine hydrochloride, riboflavin 5-phosphate sodium, cyanocobalamin, niacinamide, pyridoxine hydrochloride and sodium fluoride VITAMIN A PALMITATE VITAMIN A ASCORBIC ACID ASCORBIC ACID CHOLECALCIFEROL CHOLECALCIFEROL .ALPHA.-TOCOPHEROL SUCCINATE, D- .ALPHA.-TOCOPHEROL, D- THIAMINE HYDROCHLORIDE THIAMINE ION THIAMINE RIBOFLAVIN 5'-PHOSPHATE SODIUM FLAVIN MONONUCLEOTIDE CYANOCOBALAMIN CYANOCOBALAMIN NIACINAMIDE NIACINAMIDE PYRIDOXINE HYDROCHLORIDE PYRIDOXINE SODIUM FLUORIDE FLUORIDE ION FERROUS SULFATE ORANGE OIL GLYCERIN METHYLPARABEN POLYSORBATE 80 WATER SODIUM BENZOATE SODIUM HYDROXIDE caramel"],"spl_unclassified_section":["Active ingredient for caries prophylaxis: Fluoride as sodium fluoride. This product does not contain Folic Acid.","Fluoride Ion Level in Drinking Water (ppm) 1.0 ppm = 1 mg/liter Age <0.3 ppm 0.3-0.6 ppm >0.6 ppm Birth - 6 months None None None 6 mos - 3 years 0.25 mg (1 mL) / day 2.2 mg sodium fluoride contains 1 mg fluoride ion. None None 3 - 6 years 0.50 mg (2 mL) / day 0.25 mg (1 mL) / day None"],"spl_unclassified_section_table":["
Fluoride Ion Level in Drinking Water (ppm)1.0 ppm = 1 mg/liter
Age <0.3 ppm 0.3-0.6 ppm >0.6 ppm
Birth - 6 months None None None
6 mos - 3 years 0.25 mg (1 mL) / day2.2 mg sodium fluoride contains 1 mg fluoride ion. None None
3 - 6 years 0.50 mg (2 mL) / day 0.25 mg (1 mL) / day None
"],"storage_and_handling":["RECOMMENDED STORAGE Store at controlled room temperature 15°-25°C (between 59°F and 77°F). Excursions Permitted. After opening store away from direct light. Close tightly after each use. Occasional deepening of color has no significant effect on vitamin potency. REFRIGERATION IS NOT REQUIRED. SHAKE WELL. Manufactured for: Seton Pharmaceuticals, LLC Manasquan, NJ 08736 1-800-510-3401 Rev. 02/14 Made in the USA"],"version":"5"}