{"active_ingredient":["Active ingredient (in each tablet) Loratadine 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."],"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 place 1 tablet on tongue; tablet disintegrates, with or without water adults and children 6 years and over 1 tablet every 12 hours; not more than 2 tablets 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=\"459px\"><col width=\"230\"/><col width=\"229\"/><tbody><tr><td align=\"left\" styleCode=\"Botrule Rrule\" valign=\"top\">adults and children 6 years and over</td><td align=\"left\" styleCode=\"Botrule\" valign=\"top\">1 tablet every 12 hours; not more than 2 tablets in 24 hours</td></tr><tr><td align=\"left\" styleCode=\"Botrule Rrule\" valign=\"top\">children under 6 years of age</td><td align=\"left\" styleCode=\"Botrule\" valign=\"top\">ask a doctor</td></tr><tr><td align=\"left\" styleCode=\"Rrule\" valign=\"top\">consumers with liver or kidney disease</td><td align=\"left\" valign=\"top\">ask a doctor</td></tr></tbody></table>"],"effective_time":"20240102","id":"0df0dfde-1f52-4769-e063-6394a90a2f92","inactive_ingredient":["Inactive ingredients anhydrous citric acid, mannitol, peppermint flavor, polysorbate 80, pullulan"],"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":["ANDA212795"],"brand_name":["Loratadine"],"generic_name":["LORATADINE"],"is_original_packager":[true],"manufacturer_name":["Tenshi Kaizen Pvt Ltd"],"package_ndc":["72983-500-01"],"product_ndc":["72983-500"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["672558"],"spl_id":["0df0dfde-1f52-4769-e063-6394a90a2f92"],"spl_set_id":["c20b91e0-ef92-6f2f-e053-2a95a90a2a36"],"substance_name":["LORATADINE"],"unii":["7AJO3BO7QN"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding , ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? 1-877-244-9825 - Our Medical Information center shall operate between 9:00 AM to 5:00 PM EST from Monday through Friday (business hours). Queries received outside business hours shall reach voice mail and shall be attended on next business day."],"set_id":"c20b91e0-ef92-6f2f-e053-2a95a90a2a36","spl_product_data_elements":["Loratadine Loratadine ANHYDROUS CITRIC ACID PULLULAN POLYSORBATE 80 MANNITOL LORATADINE LORATADINE T5"],"spl_unclassified_section":["Drug Facts","Manufactured by: Tenshi Kaizen Private Limited Bengaluru Rural – 562112, India Revised: 01/2023"],"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 imprinted with Loratadine Orally disintegrating Tablet, USP is open or torn store between 20° to 25°C (68° to 77°F) use tablet immediately after opening individual blister complies with USP Procedure 2 for Assay and Organic Impurities and Test 2 for Disintegration"],"version":"5","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."]}