{"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 10 mL daily; do not take more than 10 mL in 24 hours children 2 to under 6 years of age 5 mL daily; do not take more than 5 mL 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 cellspacing=\"0\" cellpadding=\"0\" border=\"0\" width=\"599.564\"><colgroup><col width=\"50%\"/><col width=\"50%\"/></colgroup><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" align=\"center\" valign=\"middle\">adults and children 6 years and over </td><td styleCode=\"Rrule\" align=\"center\" valign=\"middle\">10 mL daily; do not take more than 10 mL in 24 hours </td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" align=\"center\" valign=\"middle\">children 2 to under 6 years of age </td><td styleCode=\"Rrule\" align=\"center\" valign=\"middle\">5 mL daily; do not take more than 5 mL in 24 hours </td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" align=\"center\" valign=\"middle\">children under 2 years of age </td><td styleCode=\"Rrule\" align=\"center\" valign=\"middle\">ask a doctor </td></tr><tr><td styleCode=\"Lrule Rrule\" align=\"center\" valign=\"middle\">consumers with liver or kidney disease </td><td styleCode=\"Rrule\" align=\"center\" valign=\"middle\">ask a doctor </td></tr></tbody></table>"],"effective_time":"20250120","id":"78515214-94d8-4977-aff5-8b9beb60042e","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":["Aurohealth LLC"],"package_ndc":["58602-423-11","58602-423-24"],"product_ndc":["58602-423"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["692783"],"spl_id":["78515214-94d8-4977-aff5-8b9beb60042e"],"spl_set_id":["0b86a9fe-db7e-470a-a8fa-d7d4373116ba"],"substance_name":["LORATADINE"],"unii":["7AJO3BO7QN"]},"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL (60 mL Bottle) AUROHEALTH NDC 58602-423-11 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 2 FL OZ (60 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL (60 mL Bottle)","PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Carton (60 mL) AUROHEALTH NDC 58602-423-11 # Compare to the active ingredient in children’s Claritin ® 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 Indoor & Outdoor Allergies Dosing Cup Included Dye-Free Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions. * When taken as directed. See Drug Facts Panel. Grape Flavor 2 FL OZ (60 mL) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 5 mg/5 mL Carton (60 mL)"],"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 Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road, East Windsor, NJ 08520 Made in India"],"set_id":"0b86a9fe-db7e-470a-a8fa-d7d4373116ba","spl_product_data_elements":["Loratadine Loratadine Oral LORATADINE LORATADINE GRAPE ASCORBIC ACID GLYCERIN MALTITOL SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE PHOSPHORIC ACID PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM METABISULFITE SORBITOL SUCRALOSE 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 5 mL contains : 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":"6","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."]}