{"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."],"do_not_use":["Do not use if you have ever had an allergic reaction to this product or any of its ingredients."],"dosage_and_administration":["Directions (24 Hour Relief) 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 width=\"100%\"><col width=\"54%\"/><col width=\"46%\"/><tbody><tr><td styleCode=\"Rrule Botrule Toprule \" valign=\"top\"><paragraph>adults and children   6 years and over </paragraph></td><td styleCode=\"Botrule Lrule Toprule \" valign=\"top\"><paragraph>1 tablet daily; not more   than 1 tablet in 24 hours </paragraph></td></tr><tr><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>children under 6 years of age</paragraph></td><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph>ask a doctor</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>consumers with liver   or kidney disease </paragraph></td><td styleCode=\"Botrule Lrule \" valign=\"top\"><paragraph>ask a doctor</paragraph></td></tr></tbody></table>"],"effective_time":"20250722","id":"3a865b90-4189-3e83-e063-6394a90aba53","inactive_ingredient":["Inactive Ingredients Corn starch, lactose monohydrate and magnesium stearate."],"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 right away."],"openfda":{"application_number":["ANDA076154"],"brand_name":["Loratadine"],"generic_name":["LORATADINE"],"manufacturer_name":["Mylan Institutional Inc."],"original_packager_product_ndc":["0378-8880"],"package_ndc":["51079-246-01","51079-246-20"],"product_ndc":["51079-246"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["311372"],"spl_id":["3a865b90-4189-3e83-e063-6394a90aba53"],"spl_set_id":["1fc9ddd1-393d-4fe2-a9e0-d192df7331db"],"substance_name":["LORATADINE"],"unii":["7AJO3BO7QN"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL – 10 mg NDC 51079-246-20 Loratadine Tablets, USP 10 mg Antihistamine Original Prescription Strength Non-Drowsy* Indoor and Outdoor Allergies 24 Hour Relief (See Uses section of enclosed leaflet) *When taken as directed. See enclosed leaflet. TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. Loratadine Tablets 10 mg Carton Label Outer Carton Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use"],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? 1-800-848-0462 Serious side effects associated with use of this product may be reported to this number. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Made in India Code No.: MH/DRUGS/25/NKD/89 Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. S-11333 R3 1/21"],"set_id":"1fc9ddd1-393d-4fe2-a9e0-d192df7331db","spl_product_data_elements":["Loratadine loratadine STARCH, CORN LACTOSE MONOHYDRATE MAGNESIUM STEARATE LORATADINE LORATADINE white to off-white G;L;10"],"spl_unclassified_section":["Original Prescription Strength Non-Drowsy* Indoor and Outdoor Allergies *When taken as directed. See Drug Facts Panel. TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.","Other information TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] protect from excessive moisture"],"stop_use":["Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away."],"version":"11","warnings":["Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness. Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away."],"when_using":["When using this product do not take more than directed. Taking more than directed may cause drowsiness."]}