{"active_ingredient":["Drug Facts Active ingredient (in each 5 mL) Loratadine USP 5 mg"],"ask_doctor":["Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose."],"dosage_and_administration":["Directions use only with enclosed dosing cup mL= milliliter adults and children 6 years and over 10mL daily; do not take more than 10mL in 24 hours children 2 to under 6 years of age 5mL daily; do not take more than 5mL in 24 hours children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor"],"dosage_and_administration_table":["<table border=\"0\" cellpadding=\"0\" cellspacing=\"0\" width=\"100%\"><colgroup><col width=\"50%\"/><col width=\"50%\"/></colgroup><tbody><tr styleCode=\"Botrule\"><td align=\"center\" styleCode=\"Lrule Rrule\" valign=\"top\">adults and children 6 years and over</td><td align=\"center\" styleCode=\"Rrule\" valign=\"top\">10mL daily; do not take more than 10mL in 24 hours</td></tr><tr styleCode=\"Botrule\"><td align=\"center\" styleCode=\"Lrule Rrule\" valign=\"top\">children 2 to under 6 years of age</td><td align=\"center\" styleCode=\"Rrule\" valign=\"top\">5mL daily; do not take more than 5mL in 24 hours</td></tr><tr styleCode=\"Botrule\"><td align=\"center\" styleCode=\"Lrule Rrule\" valign=\"top\">children under 2 years of age</td><td align=\"center\" styleCode=\"Rrule\" valign=\"top\">ask a doctor</td></tr><tr><td align=\"center\" styleCode=\"Lrule Rrule\" valign=\"top\">consumers with liver or kidney disease</td><td align=\"center\" styleCode=\"Rrule\" valign=\"top\">ask a doctor</td></tr></tbody></table>"],"effective_time":"20250515","id":"352cf9e6-9f6c-b81e-e063-6394a90a397f","inactive_ingredient":["Inactive ingredients artificial flavors, ascorbic acid, glycerin, maltitol, monobasic sodium phosphate monohydrate, phosphoric acid, propylene glycol, purified water, sodium benzoate, sodium metabisulfite, sorbitol, sucralose."],"indications_and_usage":["Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat"],"keep_out_of_reach_of_children":["Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"openfda":{"application_number":["ANDA208931"],"brand_name":["Loratadine"],"generic_name":["LORATADINE ORAL"],"is_original_packager":[true],"manufacturer_name":["BluePoint Laboratories"],"package_ndc":["68001-449-98"],"product_ndc":["68001-449"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["692783"],"spl_id":["352cf9e6-9f6c-b81e-e063-6394a90a397f"],"spl_set_id":["ab820f80-b5fc-7896-e053-2995a90a4b1c"],"substance_name":["LORATADINE"],"unii":["7AJO3BO7QN"]},"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL (120 mL Bottle) NDC 68001-449-98 Ages 2 years and older Loratadine Oral Solution USP 5 mg/5 mL Antihistamine Non-Drowsy* 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Do not use if carton is opened, or if cap safety seal is broken or missing. Dye-Free Sugar-Free Alcohol Free Indoor & Outdoor Allergies Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions. * When taken as directed. See Drug Facts Panel. Grape Flavor 4FL OZ (120 mL) Loratadine OS 5mg/5ml Loratadine OS Label","PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Carton (120 mL) NDC 68001-449-98 #Compare to the active ingredient in children’s Claritin® Ages 2years and older Loratadine Oral Solution USP 5 mg/5 mL Antihistamine Non-Drowsy* 24 Hour Relief of: Sneezing Runny Nose Itchy,watery Eyes Itchy Throat or Nose Indoor & Outdoor Allergies Dosing Cup Included Dye-Free Sugar-Free Alcohol Free Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions. * When taken as directed. See Drug Facts Panel. Grape Flavor 4 FL OZ (120 mL) Loratadine OS 5mg/5ml carton Loratadine OS Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? Call 1-855-274-4122 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 090, India For BluePoint Laboratories Code:TS/DRUGS/19/1993 Revised: 04/2025"],"recent_major_changes":[""],"set_id":"ab820f80-b5fc-7896-e053-2995a90a4b1c","spl_product_data_elements":["Loratadine Loratadine Oral GRAPE ASCORBIC ACID GLYCERIN MALTITOL SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE PHOSPHORIC ACID PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM METABISULFITE SORBITOL SUCRALOSE LORATADINE LORATADINE colorless to light yellow"],"stop_use":["Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away."],"storage_and_handling":["Other information each 5mLcontains : sodium 6 mg do not use if carton is opened, or if cap safety seal is broken or missing. store at 20° to 25°C (68° to 77°F)"],"version":"2","warnings":["Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients."],"when_using":["When using this product do not take more than directed. Taking more than directed may cause drowsiness."]}