{"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 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 Take 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%\"> <col width=\"13%\"/> <col width=\"13%\"/> <tbody> <tr> <td styleCode=\"Rrule Toprule \" valign=\"top\"> <paragraph> adults and children 6 years and over</paragraph> </td> <td styleCode=\"Botrule Toprule \" valign=\"top\"> <paragraph>Take 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 \" 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 \" 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":"20190910","id":"2befc0ab-dc50-42d2-9e84-8102961035b8","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":["Cetirizine Hydrochloride Tablets, 10mg Cetirizine Hydrochloride Tablets, 10mg"],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? 1-800-645-2158 *This product is not manufactured or distributed by McNeil-PPC, Inc., distributor of Zyrtec®. Zyrtec® is a registered trademark of UCB Pharma, S.A. Distributed by: Rugby Laboratories 31778 Enterprise Drive Livonia, MI 48150 www.rugbylaboratories.com Re-order No. 255553 R-126 Rev. 06/14"],"questions_table":["<table width=\"100%\"> <col width=\"29%\"/> <tbody> <tr> <td styleCode=\"Toprule \" valign=\"top\"> <paragraph>Distributed by:</paragraph> </td> </tr> <tr> <td valign=\"top\"> <paragraph> Rugby Laboratories</paragraph> </td> </tr> <tr> <td valign=\"top\"> <paragraph> 31778 Enterprise Drive</paragraph> </td> </tr> <tr> <td valign=\"top\"> <paragraph> Livonia, MI 48150</paragraph> </td> </tr> <tr> <td valign=\"top\"> <paragraph> <linkHtml href=\"#_Ref\">www.rugbylaboratories.com</linkHtml> </paragraph> </td> </tr> <tr> <td valign=\"top\"> <paragraph> Re-order No. 255553</paragraph> </td> </tr> <tr> <td valign=\"top\"> <paragraph> R-126</paragraph> </td> </tr> <tr> <td styleCode=\"Botrule \" valign=\"top\"> <paragraph> Rev. 06/14</paragraph> </td> </tr> </tbody> </table>"],"set_id":"690f7f04-3fc1-4a55-86f5-28e05b02fb66","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)"],"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 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"]}