{"active_ingredient":["Active ingredient (in each tablet) Cetirizine Hydrochloride 10 mg"],"dosage_and_administration":["Directions adults and children 6 years of age and over One 10 mg tablet once daily; do not take more than one 10mg tablet in 24 hours. A 5mg product may be appropriate for less severe symptoms. adults 65 years and older 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 width=\"100%\"><caption/><tbody><tr><td><content styleCode=\"bold\">adults and children 6 years of age and over</content></td><td><paragraph/><paragraph>One 10 mg tablet once daily; do not take more than one 10mg tablet in 24 hours. A 5mg product may be appropriate for less severe symptoms.</paragraph></td></tr><tr><td><content styleCode=\"bold\">adults 65 years and older </content></td><td>ask a doctor</td></tr><tr><td><content styleCode=\"bold\">children under 6 years of age </content></td><td>ask a doctor</td></tr><tr><td><content styleCode=\"bold\">consumers with liver or kidney disease</content></td><td>ask a doctor</td></tr></tbody></table>"],"effective_time":"20240103","id":"0e12b3c6-357a-b0dc-e063-6394a90a8ea4","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":["ANDA209274"],"brand_name":["CETIRIZINE HYDROCHLORIDE 10 MG"],"generic_name":["CETIRIZINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["TWIN MED, LLC"],"package_ndc":["55681-302-03"],"product_ndc":["55681-302"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014678"],"spl_id":["0e12b3c6-357a-b0dc-e063-6394a90a8ea4"],"spl_set_id":["d9437d88-da59-5567-e053-2995a90a362b"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"]},"other_safety_information":["Other information store between 20° and 25°C (68° and 77°F)"],"package_label_principal_display_panel":["PDP DF1 DF2"],"purpose":["PURPOSE ANTIHISTAMINE"],"questions":["Questions? call toll-free 1-800-935-6737"],"set_id":"d9437d88-da59-5567-e053-2995a90a362b","spl_product_data_elements":["CETIRIZINE HYDROCHLORIDE 10 MG CETIRIZINE HYDROCHLORIDE SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSE 2208 (100 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 1000 TITANIUM DIOXIDE CETIRIZINE HYDROCHLORIDE CETIRIZINE ROUNDED G4"],"version":"3","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 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"]}