{"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 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=\"80%\"><col width=\"40%\"/><col width=\"40%\"/><tbody><tr><td styleCode=\"Rrule Botrule Toprule \" valign=\"top\"><paragraph>adults and children 6 years and over</paragraph></td><td styleCode=\"Botrule Toprule \" valign=\"top\"><paragraph>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</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>adults 65 years and over</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>ask a doctor</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>children under 6 years of age</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>ask a doctor</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule \" valign=\"top\"><paragraph>consumers with liver or kidney disease</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>ask a doctor</paragraph></td></tr></tbody></table>"],"effective_time":"20250601","id":"486667d6-e84e-457e-812c-80cb1d23ec57","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 - 10 mg APOTEX CORP. NDC 63187-932-15 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 15 count 63187-932-15"],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? call 1-800-706-5575 , weekdays, 8:30am - 5:00pm Eastern Standard Time Manufactured by: Manufactured for: Repackaged by: Apotex Inc. Apotex Corp. Proficient Rx LP Toronto, Ontario Weston, Florida Thousand Oaks, CA 91320 Canada M9L 1T9 33326"],"questions_table":["<table width=\"60%\"><col width=\"20%\"/><col width=\"20%\"/><col width=\"20%\"/><tbody><tr><td styleCode=\"Toprule \" valign=\"top\"><paragraph>Manufactured by:</paragraph></td><td styleCode=\"Toprule \" valign=\"top\"><paragraph>Manufactured for:</paragraph></td><td styleCode=\"Toprule \" valign=\"top\"><paragraph>Repackaged by:</paragraph></td></tr><tr><td valign=\"top\"><paragraph>Apotex Inc.</paragraph></td><td valign=\"top\"><paragraph>Apotex Corp.</paragraph></td><td valign=\"top\"><paragraph>Proficient Rx LP</paragraph></td></tr><tr><td valign=\"top\"><paragraph>Toronto, Ontario</paragraph></td><td valign=\"top\"><paragraph>Weston, Florida</paragraph></td><td valign=\"top\"><paragraph>Thousand Oaks, CA 91320</paragraph></td></tr><tr><td styleCode=\"Botrule \" valign=\"top\"><paragraph>Canada M9L 1T9</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>33326</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"/></tr></tbody></table>"],"set_id":"06e0ddde-cd4c-47b0-80eb-d9bc853e0d4f","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 10MG;APO"],"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 20° and 25°C (68° - 77°F) • 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 1. drowsiness may occur 2. avoid alcoholic drinks 3. alcohol, sedatives, and tranquilizers may increase drowsiness 4. 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 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 1. drowsiness may occur 2. avoid alcoholic drinks 3. alcohol, sedatives, and tranquilizers may increase drowsiness 4. be careful when driving a motor vehicle or operating machinery"]}