{"active_ingredient":["Active ingredient (in each capsule) 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."],"dosage_and_administration":["Directions adults and children 6 years and over one 10 mg capsule once daily; do not take more than one 10 mg capsule 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 cellspacing=\"0\" cellpadding=\"0\" border=\"0\" width=\"100%\"><colgroup><col width=\"58%\"/><col width=\"41%\"/></colgroup><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"top\">adults and children 6 years and over </td><td styleCode=\"Rrule\" valign=\"top\">one 10 mg capsule once daily; do not take more than one 10 mg capsule in 24 hours. A 5 mg product may be appropriate for less severe symptoms. </td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"top\">adults 65 years and over </td><td styleCode=\"Rrule\" valign=\"top\">ask a doctor </td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"top\">children under 6 years of age </td><td styleCode=\"Rrule\" valign=\"top\">ask a doctor </td></tr><tr><td styleCode=\"Lrule Rrule\" valign=\"top\">consumers with liver or kidney disease </td><td styleCode=\"Rrule\" valign=\"top\">ask a doctor </td></tr></tbody></table>"],"effective_time":"20260226","id":"a74bd49f-8718-4483-9019-b761138669c9","inactive_ingredient":["Inactive ingredients black iron oxide, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sodium hydroxide, sorbitol sorbitan solution"],"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":{"application_number":["ANDA209107"],"brand_name":["Cetirizine Hydrochloride (Allergy)"],"generic_name":["CETIRIZINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Aurohealth LLC"],"package_ndc":["58602-806-04","58602-806-53","58602-806-12","58602-806-16"],"product_ndc":["58602-806"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014675"],"spl_id":["a74bd49f-8718-4483-9019-b761138669c9"],"spl_set_id":["ffbca2a4-8df0-4c85-adf9-9414cd706fb2"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"],"upc":["0358602806040"]},"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (12's Capsule Container Label) NDC 58602-806-04 Cetirizine HCl Capsules 10 mg Antihistamine Indoor & Outdoor Allergies CZ10 (Actual size) KEEP CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION AUROHEALTH 12 SOFTGELS** (** Liquid-filled capsules) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (12's Capsule Container Label)","PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (12's Capsule Container Carton Label) NDC 58602-806-04 * Compare to the active ingredient in Zyrtec ® Cetirizine HCl Capsules 10 mg Antihistamine Indoor & Outdoor CZ10 Allergies (Actual size) 24 HOUR Relief of: Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose AUROHEALTH 12 SOFTGELS** (** Liquid-filled capsules) PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (12's Capsule Container Carton Label)"],"package_label_principal_display_panel_table":["<table cellspacing=\"0\" cellpadding=\"0\" border=\"0\"><tbody><tr><td styleCode=\"Lrule Rrule\" align=\"center\" valign=\"middle\"> <content styleCode=\"bold\">KEEP CARTON FOR COMPLETE WARNINGS  AND PRODUCT INFORMATION </content></td></tr></tbody></table>"],"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"],"questions":["Questions or comments? call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST) * This product is not manufactured or distributed by the owners of Zyrtec ® . Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India"],"set_id":"ffbca2a4-8df0-4c85-adf9-9414cd706fb2","spl_product_data_elements":["Cetirizine Hydrochloride (Allergy) Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE FERROSOFERRIC OXIDE GELATIN, UNSPECIFIED GLYCERIN HYPROMELLOSE 2910 (6 MPA.S) POLYETHYLENE GLYCOL 400 PROPYLENE GLYCOL WATER SODIUM HYDROXIDE SORBITOL Clear colourless to pale yellow viscous liquid CZ10"],"spl_unclassified_section":["Cetirizine HCl Capsules 10 mg (Allergy) 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 at 20°-25°C (68°-77°F) avoid high humidity and excessive heat above 40°C (104°F) protect from light"],"version":"4","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."],"when_using":["When using this product drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens."]}