{"active_ingredient":["Active ingredient (in each tablet) Cetirizine HCl 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."],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers"],"do_not_use":["Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine."],"dosage_and_administration":["Directions adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor"],"dosage_and_administration_table":["<table width=\"100%\"><tbody><tr><td>adults and children 6 years and over</td><td>one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours.   A 5 mg product may be appropriate for less severe symptoms. </td></tr><tr><td>adults 65 years and over</td><td>ask a doctor </td></tr><tr><td>children under 6 years of age </td><td>ask a doctor </td></tr><tr><td>consumers with liver or kidney disease</td><td>ask a doctor </td></tr></tbody></table>"],"effective_time":"20260318","id":"4d50d76d-12e9-17c0-e063-6394a90a4f6f","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide"],"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":["ANDA077829"],"brand_name":["Indoor and Outdoor Allergy Relief"],"generic_name":["CETIRIZINE HCL"],"is_original_packager":[true],"manufacturer_name":["Famora Inc."],"package_ndc":["87509-0002-3"],"product_ndc":["87509-0002"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"spl_id":["4d50d76d-12e9-17c0-e063-6394a90a4f6f"],"spl_set_id":["2a94d25c-aacf-4f5c-b406-815f0e1d0611"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"],"upc":["0860015529411"]},"other_safety_information":["Other information store between 20° to 25°C (68° to 77°F) do not use if pouch is torn or damaged meets USP Dissolution Test 2"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Allergy Relief Cetirizine 10 mg Label Cetirizine 10 mg front Cetirizine 10 mg Back"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, if breast-feeding: not recommended if pregnant: ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? 1-800-373-6981"],"set_id":"2a94d25c-aacf-4f5c-b406-815f0e1d0611","spl_product_data_elements":["Indoor and Outdoor Allergy Relief Cetirizine HCl HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN POVIDONE POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE CETIRIZINE HYDROCHLORIDE CETIRIZINE S4"],"spl_unclassified_section":["Drug Facts Active ingredient (in each tablet) Cetirizine HCl 10 mg Purpose Antihistamine","Distributed by: Famora Inc. Elk Grove Village, IL 60007"],"stop_use":["Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away."],"version":"1","warnings":["Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, if breast-feeding: not recommended if pregnant: 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 (1-800-222-1222) right away."],"when_using":["When using this product drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery"]}