{"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":"20251110","how_supplied":["HOW SUPPLIED Product: 50090-7752 NDC: 50090-7752-0 10 TABLET in a BOTTLE NDC: 50090-7752-4 30 TABLET in a BOTTLE NDC: 50090-7752-5 90 TABLET in a BOTTLE"],"id":"090d7586-b989-424e-adf0-85d1446f8a90","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"],"manufacturer_name":["A-S Medication Solutions"],"original_packager_product_ndc":["0904-7426"],"package_ndc":["50090-7752-5","50090-7752-0","50090-7752-4"],"product_ndc":["50090-7752"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["311372"],"spl_id":["090d7586-b989-424e-adf0-85d1446f8a90"],"spl_set_id":["26c19e5b-7288-41a2-baaf-b4af19630140"],"substance_name":["LORATADINE"],"unii":["7AJO3BO7QN"]},"package_label_principal_display_panel":["Loratadine Label Image"],"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: MAJOR ® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.majorpharmaceuticals.com Made in India"],"set_id":"26c19e5b-7288-41a2-baaf-b4af19630140","spl_product_data_elements":["Loratadine Loratadine LORATADINE LORATADINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE ZEA MAYS (CORN) STARCH 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 Tamper-evident: do not use if foil seal under cap, printed with \"SEALED for YOUR PROTECTION\" is missing, open or broken store at 20° to 25°C (68° to 77°F) protect from excessive moisture"],"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."]}