{"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":["
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
"],"effective_time":"20260129","how_supplied":["HOW SUPPLIED Product: 50090-6950 NDC: 50090-6950-0 30 TABLET in a BOTTLE NDC: 50090-6950-1 90 TABLET in a BOTTLE"],"id":"3df742ce-46f4-48d5-b07a-49bf1d6787fc","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"],"manufacturer_name":["A-S Medication Solutions"],"original_packager_product_ndc":["16714-799"],"package_ndc":["50090-6950-0","50090-6950-1"],"product_ndc":["50090-6950"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014678"],"spl_id":["3df742ce-46f4-48d5-b07a-49bf1d6787fc"],"spl_set_id":["ae02b16b-77dc-4bd6-8c07-e734fb448492"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"]},"package_label_principal_display_panel":["Cetirizine Hydrochloride Label Image"],"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":"ae02b16b-77dc-4bd6-8c07-e734fb448492","spl_product_data_elements":["Cetirizine Hydrochloride (Allergy) Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE SILICA CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (5 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE PEG-8 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"]}