{"active_ingredient":["Active ingredient (in each tablet) For 5 mg: Cetirizine HCl USP 5 mg For 10 mg: Cetirizine HCl USP 10 mg For 10 mg (Oval Shape): Cetirizine HCl USP 10 mg"],"dosage_and_administration":["Directions For 5 mg: adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours adults 65 years and ove r 1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours. children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor For 10 mg: 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":["
adults and children 6 years and over1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours
adults 65 years and over1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours.
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor
","
adults and children 6 years and overone 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 overask a doctor
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor
"],"effective_time":"20260710","id":"172d56b9-ba90-4e1b-934a-f75307564ea3","inactive_ingredient":["Inactive ingredients corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide Questions or comments? Call 1-877-376-4271 (weekdays 9 AM to 5 PM)"],"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":["ANDA078933"],"brand_name":["Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape)","Cetirizine Hydrochloride Tablets, 5 mg","Cetirizine Hydrochloride Tablets, 10 mg"],"generic_name":["CETIRIZINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["MARKSANS PHARMA LIMITED"],"package_ndc":["25000-219-03","25000-219-08","25000-219-14","25000-220-03","25000-220-08","25000-220-14","25000-220-78","25000-220-81","25000-160-81","25000-160-03","25000-160-14"],"product_ndc":["25000-160","25000-219","25000-220"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014676","1014678"],"spl_id":["172d56b9-ba90-4e1b-934a-f75307564ea3"],"spl_set_id":["652b0c65-a3f2-4454-9cf2-51a3389282cc"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"],"upc":["0325000160814","0325000219147","0325000219086","0325000160036","0325000160142","0325000220785","0325000220037","0325000220082","0325000219031","0325000220143","0325000220815"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 25000-219-03 Cetirizine Hydrochloride Tablets USP, 5 mg 30s count bottle label NDC 25000-219-03 Cetirizine Hydrochloride Tablets USP, 5 mg 30s count carton label NDC 25000-219-08 Cetirizine Hydrochloride Tablets USP, 5 mg 100s count bottle label NDC 25000-219-08 Cetirizine Hydrochloride Tablets USP, 5 mg 100s count carton label NDC 25000-219-14 Cetirizine Hydrochloride Tablets USP, 5 mg 1000s count bottle label NDC 25000-220-03 Cetirizine Hydrochloride Tablets USP, 10 mg 30s count bottle label NDC 25000-220-03 Cetirizine Hydrochloride Tablets USP, 10 mg 30s count carton label NDC 25000-220-08 Cetirizine Hydrochloride Tablets USP, 10 mg 100s count bottle label NDC 25000-220-08 Cetirizine Hydrochloride Tablets USP, 10 mg 100s count carton label NDC 25000-220-14 Cetirizine Hydrochloride Tablets USP, 10 mg 1000s count bottle label NDC 25000-220-78 Cetirizine Hydrochloride Tablets USP, 10 mg 7s count carton label NDC 25000-220-81 Cetirizine Hydrochloride Tablets USP, 10 mg 14s count carton label NDC 25000-160-81 Cetirizine Hydrochloride Tablets USP, 10 mg (Oval Shape) 14s count carton label NDC 25000-160-03 Cetirizine Hydrochloride Tablets USP, 10 mg (Oval Shape) 30s count carton label NDC 25000-160-03 (Oval Shape) Cetirizine Hydrochloride Tablets USP, 10 mg 30s count bottle label NDC 25000-160-14 Cetirizine Hydrochloride Tablets USP, 10 mg (Oval Shape) 1000s count bottle label cetirizine-hcl-5-mg-30ct-bottle cetirizine-hcl-5-mg-30ct-ifc cetirizine-hcl-5-mg-100ct-bottle cetirizine-hcl-5-mg-100ct-ifc cetirizine-hcl-5-mg-1000ct-bottle cetirizine-hcl-10-mg-30s-bottle cetirizine-hcl-10-mg-30s-ifc cetirizine-hcl-10-mg-100s-bottle cetirizine-hcl-10-mg-100ct-ifc cetirizine-hcl-10-mg-1000s-label cetirizine-hcl-10-mg-7s-ifc cetirizine-hcl-10-mg-14s-ifc cetirizine-hcl-10-mg-oval-14s-carton-label cetirizine-hcl-10-mg-oval-30s-carton cetirizine-hcl-10-mg-oval-30s-label cetirizine-hcl-10-mg-oval-1000s-label"],"purpose":["Purpose Antihistamine"],"set_id":"652b0c65-a3f2-4454-9cf2-51a3389282cc","spl_product_data_elements":["Cetirizine Hydrochloride Tablets, 5 mg Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE LACTOSE MONOHYDRATE STARCH, CORN POVIDONE K30 MAGNESIUM STEARATE HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE white to off white Rounded-off rectangular shaped J219 Cetirizine Hydrochloride Tablets, 10 mg Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE LACTOSE MONOHYDRATE STARCH, CORN POVIDONE K30 MAGNESIUM STEARATE HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE white to off white Rounded-off rectangular shaped J220 Cetirizine Hydrochloride Tablets, 10 mg (Oval Shape) Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE LACTOSE MONOHYDRATE STARCH, CORN POVIDONE K30 MAGNESIUM STEARATE HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE 160"],"spl_unclassified_section":["Other information •store between 20° to 25°C (68° to 77°F) •do not use if foil seal under cap is broken or missing"],"version":"14","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 in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens. 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."]}