{"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 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=\"38%\"/><col width=\"62%\"/><tbody><tr><td styleCode=\"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=\"Lrule Botrule \" valign=\"top\"><paragraph>adults 65 years and over</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>ask a doctor</paragraph></td></tr><tr><td styleCode=\"Lrule Botrule \" valign=\"top\"><paragraph>children under 6 years of age</paragraph></td><td styleCode=\"Rrule Lrule Botrule \" valign=\"top\"><paragraph>ask a doctor</paragraph></td></tr><tr><td styleCode=\"Botrule Lrule \" valign=\"top\"><paragraph>consumers with liver or kidney disease</paragraph></td><td styleCode=\"Rrule Botrule Lrule \" valign=\"top\"><paragraph>ask a doctor</paragraph></td></tr></tbody></table>"],"effective_time":"20220401","id":"517ed467-a0d0-43ab-99ce-e6a4808800c4","inactive_ingredient":["Inactive ingredients corn starch, FD&C blue no. 1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, titanium dioxide, triacetin"],"indications_and_usage":["Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1. runny nose 2. sneezing 3. itchy, watery eyes 4. 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":{"application_number":["ANDA078336"],"brand_name":["cetirizine hydrochloride"],"generic_name":["CETIRIZINE HYDROCHLORIDE"],"manufacturer_name":["Proficient Rx LP"],"original_packager_product_ndc":["45802-919"],"package_ndc":["71205-207-06","71205-207-10","71205-207-15","71205-207-30","71205-207-60","71205-207-90"],"product_ndc":["71205-207"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014678"],"spl_id":["517ed467-a0d0-43ab-99ce-e6a4808800c4"],"spl_set_id":["198ca875-bb8a-49d5-8809-7121ba119381"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"],"upc":["0371205207304"]},"package_label_principal_display_panel":["Principal Display Panel Compare to Zyrtec® active ingredient Cetirizine Hydrochloride Tablets 10 mg Antihistamine Allergy 24 Hour Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Original Prescription Strength actual size 30 Tablets Indoor & Outdoor Allergies NDC 71205-207-30 Repackaged By: Proficient Rx LP Thousand Oaks, CA 91320 71205-207-30"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding: 1. if breast-feeding: not recommended 2. if pregnant: ask a health professional before use."],"purpose":["Purpose Antihistamine"],"questions":["Questions or comments? 1-800-719-9260"],"set_id":"198ca875-bb8a-49d5-8809-7121ba119381","spl_product_data_elements":["cetirizine hydrochloride Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE STARCH, CORN HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED TITANIUM DIOXIDE TRIACETIN FD&C BLUE NO. 1 4H2"],"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 1. store between 20 - 25°C (68 - 77°F) 2. do not use if printed foil under cap is broken or missing"],"version":"8","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: 1. if breast-feeding: not recommended 2. 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)"],"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"]}