{"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 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=\"65%\" styleCode=\"Noautorules\"><col align=\"left\" valign=\"top\" width=\"45%\"/><col align=\"left\" valign=\"top\" width=\"55%\"/><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Rrule Toprule\">adults and children 6 years and over</td><td styleCode=\"Toprule\">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 styleCode=\"Botrule\"><td styleCode=\"Rrule\">adults 65 years and over</td><td>ask a doctor</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">children under 6 years of age</td><td>ask a doctor</td></tr><tr><td styleCode=\"Rrule\">consumers with liver or kidney disease</td><td>ask a doctor</td></tr></tbody></table>"],"effective_time":"20250923","id":"3f7dc523-2934-780a-e063-6294a90a837f","inactive_ingredient":["Inactive ingredients corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, 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, contact a doctor or Poison Control Center (1-800-222-1222) right away."],"openfda":{"application_number":["ANDA077498"],"brand_name":["Cetirizine Hydrochloride"],"generic_name":["CETIRIZINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Marlex Pharmaceuticals, Inc"],"package_ndc":["10135-762-30","10135-762-90","10135-762-03","10135-762-05","10135-762-01"],"product_ndc":["10135-762"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014678"],"spl_id":["3f7dc523-2934-780a-e063-6294a90a837f"],"spl_set_id":["eb917099-fecf-6b55-e053-2995a90aaafa"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label NDC 10135-0762-30 Allergy Relief Cetirizine HCl Tablets, USP 10 mg ANTIHISTAMINE 30 TABLETS label1","PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label NDC 10135-0762-90 Allergy Relief Cetirizine HCl Tablets, USP 10 mg ANTIHISTAMINE 90 TABLETS 762-90","PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label NDC 10135-0762-01 Allergy Relief Cetirizine HCl Tablets, USP 10 mg ANTIHISTAMINE 100 TABLETS 762-01","PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label NDC 10135-0762-03 Allergy Relief Cetirizine HCl Tablets, USP 10 mg ANTIHISTAMINE 300 TABLETS label3","PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label NDC 10135-0762-05 Allergy Relief Cetirizine HCl Tablets, USP 10 mg ANTIHISTAMINE 500 TABLETS 0762-05"],"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"],"set_id":"eb917099-fecf-6b55-e053-2995a90aaafa","spl_product_data_elements":["Cetirizine Hydrochloride Cetirizine Hydrochloride POVIDONE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN TALC TITANIUM DIOXIDE HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED CETIRIZINE HYDROCHLORIDE CETIRIZINE rounded-off RI52"],"spl_unclassified_section":["Drug Facts","Manufactured for/ Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE 19720 Rev. 10/22 SP"],"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° and 77° F) do not use if imprinted safety seal under cap is broken or missing."],"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 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, contact a doctor or 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"]}