{"active_ingredient":["Active ingredient (in each tablet) Cetirizine HCl, 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."],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives."],"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 1 tablets (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than one 10 mg tablet in 24 hours. adults 65 years and over 1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) 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 width=\"80%\"><col align=\"left\" span=\"1\" valign=\"top\" width=\"50%\"/><col align=\"left\" span=\"1\" valign=\"top\" width=\"50%\"/><tbody><tr styleCode=\"Botrule\"><td colspan=\"1\" rowspan=\"1\" styleCode=\"Rrule\">adults and children 6 years and over</td><td colspan=\"1\" rowspan=\"1\">1 tablets (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than one 10 mg tablet in 24 hours.</td></tr><tr styleCode=\"Botrule\"><td colspan=\"1\" rowspan=\"1\" styleCode=\"Rrule\">adults 65 years and over</td><td colspan=\"1\" rowspan=\"1\">1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours.</td></tr><tr styleCode=\"Botrule\"><td colspan=\"1\" rowspan=\"1\" styleCode=\"Rrule\">children under 6 years of age</td><td colspan=\"1\" rowspan=\"1\">ask a doctor</td></tr><tr><td colspan=\"1\" styleCode=\"Rrule\">consumers with liver or kidney disease</td><td colspan=\"1\">ask a doctor</td></tr></tbody></table>"],"effective_time":"20260706","id":"d3e49827-fd28-7341-e817-d4d74da15aa5","inactive_ingredient":["Inactive ingredients Lactose monohydrate, microcrystalline cellulose, starch (corn), magnesium stearate, hypromellose, polydextrose, polyethylene glycol and 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 right away."],"openfda":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 5 mg APOTEX CORP. NDC 60505-2632-1 Cetirizine 5 mg Cetirizine Hydrochloride Tablets Antihistamine /Original Prescription Strength Indoor & Outdoor Allergies 24 hour Relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 100 count","PRINCIPAL DISPLAY PANEL - 10 mg APOTEX CORP. NDC 60505-2633-1 Cetirizine 10 mg Cetirizine Hydrochloride Tablets Antihistamine/ Original Prescription Strength Indoor & Outdoor Allergies 24 hour Relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 100 count"],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? call 1-800-706-5575 , weekdays, 8:30am - 5:00pm Eastern Standard Time Manufactured by: Manufactured for: Apotex Inc. Apotex Corp. Toronto, Ontario Weston, Florida Canada M9L 1T9 33326"],"questions_table":["<table width=\"40%\"><col span=\"1\" width=\"20%\"/><col span=\"1\" width=\"20%\"/><tbody><tr styleCode=\"toprule\"><td colspan=\"1\" rowspan=\"1\">Manufactured by:</td><td colspan=\"1\" rowspan=\"1\">Manufactured for:</td></tr><tr><td colspan=\"1\" rowspan=\"1\">Apotex Inc.</td><td colspan=\"1\" rowspan=\"1\">Apotex Corp.</td></tr><tr><td colspan=\"1\" rowspan=\"1\">Toronto, Ontario</td><td colspan=\"1\" rowspan=\"1\">Weston, Florida</td></tr><tr><td colspan=\"1\" rowspan=\"1\">Canada M9L 1T9</td><td colspan=\"1\" rowspan=\"1\">33326</td></tr></tbody></table>"],"set_id":"d4bdcbf7-d848-6a91-b93e-1bdaef11d946","spl_product_data_elements":["Cetirizine Hydrochloride Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE LACTOSE MONOHYDRATE MICROCRYSTALLINE CELLULOSE STARCH, CORN MAGNESIUM STEARATE HYPROMELLOSE, UNSPECIFIED POLYDEXTROSE POLYETHYLENE GLYCOL 3350 TITANIUM DIOXIDE pillow-shaped 5MG;APO Cetirizine Hydrochloride Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE LACTOSE MONOHYDRATE MICROCRYSTALLINE CELLULOSE STARCH, CORN MAGNESIUM STEARATE HYPROMELLOSE, UNSPECIFIED POLYDEXTROSE POLYETHYLENE GLYCOL 3350 TITANIUM DIOXIDE pillow-shaped 10MG;APO 10mg-100btl 5mg-100btl"],"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 store between 20C° to 25°C (68F° to 77°F) do not use if seal under bottle cap is broken or missing USP Dissolution Test 3"],"version":"5","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 tranquilizers or sedatives. 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 in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens. 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 right away.","If pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use"],"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 in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens."]}