{"active_ingredient":["Active ingredient (in each tablet) Cetirizine hydrochloride 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 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 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 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=\"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":"20240626","id":"31542c85-db9e-4225-bd25-d231710595b0","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, 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":{"application_number":["ANDA090760"],"brand_name":["Cetirizine Hydrochloride (Allergy)"],"generic_name":["CETIRIZINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["NorthStar Rx LLC"],"package_ndc":["16714-799-01","16714-799-02","16714-799-03","16714-799-04"],"product_ndc":["16714-799"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014678"],"spl_id":["31542c85-db9e-4225-bd25-d231710595b0"],"spl_set_id":["c9d1e26f-c95a-4991-95fa-9ed6ed484fe2"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"],"upc":["0316714799049"]},"package_label_principal_display_panel":["PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (500's Tablets Container Label) NDC 16714-799-04 Cetirizine Hydrochloride Tablets USP 10 mg Antihistamine ALLERGY RELIEF Original Prescription Strength Indoor & Outdoor Allergies 10 mg Strength Tablets 24 Hour Relief of : • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose 500 Tablets 10 mg each NORTHSTAR ™ PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (500's Tablets Container Label)"],"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? call 1-800-206-7821 Manufactured for: Northstar Rx LLC Memphis, TN 38141 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 090, India Code: TS/DRUGS/19/1993 Issued: 05/2024"],"set_id":"c9d1e26f-c95a-4991-95fa-9ed6ed484fe2","spl_product_data_elements":["Cetirizine Hydrochloride (Allergy) Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (5 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE White to Off-white X;36"],"spl_unclassified_section":["Cetirizine Hydrochloride Tablets USP 10 mg (ALLERGY RELIEF) 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° to 25°C (68° to 77°F) TAMPER EVIDENT: DO NOT USE IF SEAL OVER BOTTLE OPENING IS BROKEN OR MISSING"],"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 avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery"]}