{"active_ingredient":["Active ingredient (in each tablet) Loratadine 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 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":["
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
"],"effective_time":"20260209","id":"9f222415-3471-459d-9401-6c73d09b0f4d","inactive_ingredient":["Inactive ingredients lactose monohydrate, magnesium stearate, povidone, pregelatinized starch"],"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. (1-800-222-1222)"],"openfda":{"application_number":["ANDA076301"],"brand_name":["Loratadine"],"generic_name":["LORATADINE"],"manufacturer_name":["Major Pharmaceuticals"],"original_packager_product_ndc":["0904-6852"],"package_ndc":["0904-7511-61"],"product_ndc":["0904-7511"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["311372"],"spl_id":["9f222415-3471-459d-9401-6c73d09b0f4d"],"spl_set_id":["60162446-4fa1-4ee3-ae20-19fadc2491ab"],"substance_name":["LORATADINE"],"unii":["7AJO3BO7QN"]},"package_label_principal_display_panel":["Principal Display Panel MAJOR® NDC 0904-7511-61 Unit Dose Original Prescription Strength Loratadine Tablets 10 mg Antihistamine 100 TABLETS (10 x 10) 10mg carton label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? 1-800-719-9260"],"set_id":"60162446-4fa1-4ee3-ae20-19fadc2491ab","spl_product_data_elements":["Loratadine Loratadine LORATADINE LORATADINE LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE, UNSPECIFIED L612"],"spl_unclassified_section":[". **This product is not manufactured or distributed by Bayer Healthcare LLC, distributor of Claritin® Tablets. Cartons of 100 tablets (10 tablets each blister pack x 10), NDC 0904-7511-61 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children. Distributed by MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.major-rugby.com Packaged and Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 USA Refer to package label for Distributor's NDC Number Rev. 04/25 M-05 Re-order No. 701027"],"spl_unclassified_section_table":["
Rev. 04/25
M-05
Re-order No. 701027
"],"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 • do not use if printed foil under cap is broken or missing • store between 20 ° to 25 ° C (68 ° to 77 ° F)"],"version":"2","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. (1-800-222-1222)"],"when_using":["When using this product do not take more than directed. Taking more than directed may cause drowsiness."]}