{"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 over1 tablet daily; not more than 1 tablet in 24 hours
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor
"],"effective_time":"20240409","id":"15aaaeb4-fda5-f5e2-e063-6394a90a47ee","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 antihistamine"],"generic_name":["LORATADINE"],"manufacturer_name":["Aphena Pharma Solutions - Tennessee, LLC"],"original_packager_product_ndc":["45802-650"],"package_ndc":["43353-259-60","43353-259-18","43353-259-09"],"product_ndc":["43353-259"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["311372"],"spl_id":["15aaaeb4-fda5-f5e2-e063-6394a90a47ee"],"spl_set_id":["a2c92766-df4e-4414-9c42-e18bcf9db6b4"],"substance_name":["LORATADINE"],"unii":["7AJO3BO7QN"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 10 mg NDC 43353-259 - Loratadine 10 mg Tablets Bottle Label 10 mg"],"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":"a2c92766-df4e-4414-9c42-e18bcf9db6b4","spl_product_data_elements":["Loratadine antihistamine Loratadine LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE, UNSPECIFIED LORATADINE LORATADINE L612"],"spl_unclassified_section":["Repackaging Information Please reference the HOW SUPPLIED section listed above for a description of individual drug products listed below. This drug product has been received by Aphena Pharma Solutions - Tennessee, LLC in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: 10mg NDC 43353-259-60, Bottles of 90 Tablets NDC 43353-259-18, Bottles of 3000 Tablets NDC 43353-259-09, Bottles of 9000 Tablets Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20240409AMH Aphena Pharma Solutions - TN"],"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":"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. (1-800-222-1222)"],"when_using":["When using this product do not take more than directed. Taking more than directed may cause drowsiness."]}