{"active_ingredient":["ALLERGY Active ingredient (in each film-coated tablet) Fexofenadine HCl USP 60 mg Fexofenadine HCl USP 180 mg"],"ask_doctor":["Ask a doctor before use if you have 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 Directions (for 60mg) adults and children 12 years of age and over take one 60mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor Directions (for 180mg) adults and children 12 years of age and over take one 180mg tablet with water once a day; do not take more than 1 tablet in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor"],"dosage_and_administration_table":["
adults and children 12 years of age and overtake one 60mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours
children under 12 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor
","
adults and children 12 years of age and overtake one 180mg tablet with water once a day; do not take more than 1 tablet in 24 hours
children under 12 years of agedo not use
adults 65 years of age and olderask a doctor
consumers with kidney diseaseask a doctor
"],"effective_time":"20250403","id":"31e71ef2-159c-8273-e063-6294a90aaa08","inactive_ingredient":["Inactive ingredients anhydrous lactose, colloidal silicon dioxide, corn starch, croscarmellose sodium, hypromellose, lactose monohydrate, polyethylene glycol, pregelatinized starch (maize), red iron oxide, stearic acid, titanium dioxide, and yellow iron oxide"],"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 right away (1-800-222-1222)."],"openfda":{"application_number":["ANDA204507"],"brand_name":["fexofenadine hcl"],"generic_name":["FEXOFENADINE HCL"],"manufacturer_name":["Aphena Pharma Solutions - Tennessee, LLC"],"original_packager_product_ndc":["0904-7486"],"package_ndc":["71610-893-53","71610-893-60","71610-893-70"],"product_ndc":["71610-893"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["997420"],"spl_id":["31e71ef2-159c-8273-e063-6294a90aaa08"],"spl_set_id":["31e71ee7-c4b5-6c1c-e063-6294a90a1513"],"substance_name":["FEXOFENADINE HYDROCHLORIDE"],"unii":["2S068B75ZU"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 180mg NDC 71610-893 - Fexofenadine HCl, USP 180mg Tablets Label"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? Call toll-free 1-888-588-1418 Monday-Friday 9AM-7PM EST Distributed by: MAJOR ® PHARMACEUTICALS Indianapolis, IN 46268 (800) 616-2471 www.majorpharmaceuticals.com"],"set_id":"31e71ee7-c4b5-6c1c-e063-6294a90a1513","spl_product_data_elements":["fexofenadine hcl fexofenadine hcl ANHYDROUS LACTOSE SILICON DIOXIDE STARCH, CORN CROSCARMELLOSE SODIUM LACTOSE MONOHYDRATE STEARIC ACID HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED FERRIC OXIDE RED TITANIUM DIOXIDE FERRIC OXIDE YELLOW FEXOFENADINE HYDROCHLORIDE FEXOFENADINE SG;202"],"spl_unclassified_section":["REPACKAGING INFORMATION Please reference the HOW SUPPLIED section listed above (if available) 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: 180mg NDC 71610-893-53, Bottles of 60 Tablets NDC 71610-893-60, Bottles of 90 Tablets NDC 71610-893-70, Bottles of 120 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 20250403AMH Aphena"],"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 store between 20° and 25°C (68° and 77°F) protect from excessive moisture each tablet contains: sodium 2.7 mg (for 60 mg), sodium 8.2 mg (for 180 mg) this product meets the requirements of USP Dissolution Test 2"],"version":"1","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 kidney disease. Your doctor should determine if you need a different dose. When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) 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 do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions)"]}