{"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 place 1 tablet on tongue; tablet disintegrates, with or without water 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=\"42.76%\"/><col width=\"57.24%\"/></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":"20260807","id":"e4fff55f-aace-428a-b474-e85cfd1fe6f5","inactive_ingredient":["Inactive ingredients aspartame, crospovidone, mannitol, microcrystalline cellulose, peppermint, pregelatinized starch (maize), sodium stearyl fumarate"],"indications_and_usage":["Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes 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":["ANDA208477"],"brand_name":["Loratadine ODT"],"generic_name":["LORATADINE"],"is_original_packager":[true],"manufacturer_name":["Rugby Laboratories"],"package_ndc":["0536-1367-07"],"product_ndc":["0536-1367"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["311373"],"spl_id":["e4fff55f-aace-428a-b474-e85cfd1fe6f5"],"spl_set_id":["f59f3400-da77-4eb7-be02-842071d87fae"],"substance_name":["LORATADINE"],"unii":["7AJO3BO7QN"]},"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 30 (3 X 10) Orally Disintegrating Tablets Rugby ® NDC 0536-1367-07 compare to the active ingredient in Claritin ® RediTabs ®** original prescription strength non-drowsy* loratadine orally disintegrating tablets USP loratadine 10 mg orally disintegrating tablets antihistamine indoor & outdoor allergies 24 hour relief of: • sneezing • runny nose • itchy, watery eyes • itchy throat or nose 30 (3 X 10) orally disintegrating tablets *when taken as directed. see Drug Facts panel. NO WATER NEEDED MELTS IN YOUR MOUTH actual size PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg, Blister Carton 30 (3 X 10) Orally Disintegrating 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: RUGBY ® LABORATORIES Indianapolis, IN 46268 www.major-rugby.com Made in India"],"set_id":"f59f3400-da77-4eb7-be02-842071d87fae","spl_product_data_elements":["Loratadine ODT Loratadine LORATADINE LORATADINE ASPARTAME CROSPOVIDONE (120 .MU.M) MANNITOL MICROCRYSTALLINE CELLULOSE PEPPERMINT STARCH, CORN SODIUM STEARYL FUMARATE White to Off-white Biconvex K;9"],"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 Phenylketonurics: Contains phenylalanine 2.25 mg per tablet do not use if the individual blister unit is open or torn store at 20° to 25°C (68° to 77°F) use tablet immediately after opening individual blister Complies with USP test 2 for Disintegration"],"version":"2","warnings":["Warnings"],"when_using":["When using this product do not take more than directed. Taking more than directed may cause drowsiness."]}