{"active_ingredient":["Cetirizine HCl 10 mg"],"dosage_and_administration":["adults & 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: Ask a doctor consumers with liver or kidney disease: Ask a doctor"],"effective_time":"20240517","id":"18ab8b3c-80f1-72ea-e063-6394a90ac0d1","inactive_ingredient":["colloidal silicon dioxide, croscarmellose sodium, Hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide"],"indications_and_usage":[""],"keep_out_of_reach_of_children":["Keep out of reach of children. OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms."],"openfda":{"application_number":["ANDA209274"],"brand_name":["Cetirizine hydrochloride"],"generic_name":["CETIRIZINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["OPMX LLC"],"package_ndc":["69729-139-14"],"product_ndc":["69729-139"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014678"],"spl_id":["18ab8b3c-80f1-72ea-e063-6394a90ac0d1"],"spl_set_id":["b452bca6-2c51-d0a1-e053-2995a90aff67"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"]},"other_safety_information":["■ store at room temperature between 20-25°C (68-77°F). ■ close cap tightly after use. ■ contains no ingredient made from a gluten-containing grain (wheat, barley or rye). TAMPER EVIDENT: Do not use if imprinted safety seal is broken or missing."],"package_label_principal_display_panel":["139 L 139 C"],"purpose":["Antihistamine"],"set_id":"b452bca6-2c51-d0a1-e053-2995a90aff67","spl_product_data_elements":["Cetirizine hydrochloride Cetirizine hydrochloride POLYETHYLENE GLYCOL, UNSPECIFIED LACTOSE MONOHYDRATE ANHYDROUS LACTOSE CROSCARMELLOSE SODIUM CROSCARMELLOSE HYPROMELLOSE, UNSPECIFIED CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE SILICON DIOXIDE TITANIUM DIOXIDE CETIRIZINE HYDROCHLORIDE CETIRIZINE G;4"],"version":"3","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 sedatives or tranquilizers. 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 Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children."]}