{"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 styleCode=\"Noautorules\" width=\"100%\"><col width=\"50%\"/><col width=\"50%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph> adults and children 6 years and over</paragraph></td><td styleCode=\"Rrule Botrule Lrule 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 Lrule Botrule \" valign=\"top\"><paragraph> adults 65 years and over</paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph> ask a doctor</paragraph></td></tr><tr><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph> children under 6 years of age</paragraph></td><td styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"top\"><paragraph> ask a doctor</paragraph></td></tr><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph> consumers with liver or kidney disease</paragraph></td><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph> ask a doctor</paragraph></td></tr></tbody></table>"],"effective_time":"20241106","id":"271f33a5-0f77-4bec-a747-93a79ce5fc24","inactive_ingredient":["Inactive ingredients carnuaba wax, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, starch (corn), 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. (1-800-222-1222)"],"openfda":{},"package_label_principal_display_panel":["Principal Display Panel MAJOR® NDC 0904-5852-60 Compare to active ingredient In Zyrtec® Original Prescription Strength ALL DAY ALLERGY Cetirizine HCl Tablets, USP 10 mg Antihistamine INDOOR & OUTDOOR ALLERGIES 24 HOUR RELIEF OF: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose 100 TABLETS 10 mg EACH representative label"],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? call 1-800-706-5575 , weekdays, 8:30am - 5:00pm Eastern Standard Time *This product is not manufactured or distributed by McNeil-PPC, Inc. owner of the registered trademark Zyrtec® Manufactured by: Apotex In c. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 Distributed By: MAJOR® PHARMACEUTICALS 31778 Enterprise Drive Livonia, MI 48150"],"set_id":"93426a9b-e33a-40f7-8b38-7390a14d77da","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) • do not use if seal under bottle cap is broken or missing • meets USP Dissolution Test 3"],"version":"9","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. (1-800-222-1222)","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"]}