{"active_ingredient":["Active ingredient (in each tablet) Loratadine USP 10 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 adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 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=\"100%\"><colgroup><col width=\"41%\"/><col width=\"58%\"/></colgroup><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"middle\">adults and children 6 years and over </td><td styleCode=\"Rrule\" valign=\"middle\">1 tablet daily; not more than 1 tablet in 24 hours </td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"middle\">children under 6 years of age </td><td styleCode=\"Rrule\" valign=\"middle\">ask a doctor </td></tr><tr><td styleCode=\"Lrule Rrule\" valign=\"middle\">consumers with liver or kidney disease </td><td styleCode=\"Rrule\" valign=\"middle\">ask a doctor </td></tr></tbody></table>"],"effective_time":"20251112","id":"4f4ffb72-f4e8-4617-8bc5-61e6de488a2d","inactive_ingredient":["Inactive ingredients lactose monohydrate, magnesium stearate, pregelatinized starch (maize), sodium starch glycolate."],"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":["ANDA208314"],"brand_name":["Loratadine"],"generic_name":["LORATADINE"],"is_original_packager":[true],"manufacturer_name":["Aurobindo Pharma Limited"],"package_ndc":["84386-119-78"],"product_ndc":["84386-119"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["311372"],"spl_id":["4f4ffb72-f4e8-4617-8bc5-61e6de488a2d"],"spl_set_id":["4f4ffb72-f4e8-4617-8bc5-61e6de488a2d"],"substance_name":["LORATADINE"],"unii":["7AJO3BO7QN"],"upc":["0384386119786"]},"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Blister Carton (100 Tablets) AUROBINDO NDC 84386-119-78 # Compare to the active ingredient in Claritin ® Non-Drowsy* Loratadine Tablets USP 10 mg Antihistamine Indoor & Outdoor Allergies 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose *When taken as directed. See Drug Facts Panel. 100 Tablets PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg Blister Carton (100 Tablets)"],"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: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India"],"set_id":"4f4ffb72-f4e8-4617-8bc5-61e6de488a2d","spl_product_data_elements":["Loratadine Loratadine LORATADINE LORATADINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN SODIUM STARCH GLYCOLATE TYPE A POTATO White to Off-white 39;L"],"spl_unclassified_section":["Drug Facts"],"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 safety sealed: do not use if the individual blister unit is open or torn store at 20° to 25°C (68° to 77°F) protect from excessive moisture"],"version":"1","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."]}