{"active_ingredient":["ACTIVE INGREDIENT (IN EACH TABLET) Cetirizine HCl, 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."],"do_not_use":["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."],"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 width=\"100%\"> <col width=\"50%\"/> <col width=\"50%\"/> <tbody> <tr> <td styleCode=\"Toprule \" valign=\"top\"> <paragraph>adults and children 6 years and over</paragraph> </td> <td styleCode=\"Toprule \" valign=\"top\"> <paragraph>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. </paragraph> </td> </tr> <tr> <td valign=\"top\"> <paragraph>adults 65 years and over</paragraph> </td> <td valign=\"top\"> <paragraph>ask a doctor</paragraph> </td> </tr> <tr> <td valign=\"top\"> <paragraph>children under 6 years of age</paragraph> </td> <td valign=\"top\"> <paragraph>ask a doctor</paragraph> </td> </tr> <tr> <td styleCode=\"Botrule \" valign=\"top\"> <paragraph>consumers with liver or kidney disease</paragraph> </td> <td styleCode=\"Botrule \" valign=\"top\"> <paragraph>ask a doctor</paragraph> </td> </tr> </tbody> </table>"],"effective_time":"20190819","id":"acd5c107-c9fc-42fd-baf2-714888f59bd4","inactive_ingredient":["INACTIVE INGREDIENTS Corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, 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":["ANDA077498"],"brand_name":["Cetirizine Hydrochloride"],"generic_name":["CETIRIZINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Publix Super Markets Inc"],"package_ndc":["56062-939-54","56062-939-30","56062-939-60"],"product_ndc":["56062-939"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014678"],"spl_id":["acd5c107-c9fc-42fd-baf2-714888f59bd4"],"spl_set_id":["a0a063a1-e067-480e-afab-7f01165025f4"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Carton NDC 56062-939-60 INDOOR & OUTDOOR ALLERGIES ORIGINAL PRESCRIPTION STRENGTH 24-HOUR allergyrelief CETIRIZINE HYDROCHLORIDE TABLETS USP, 10 mg ANTIHISTAMINE 24-hour relief of: • Sneezing • Runny nose • Itchy, watery eyes • Itchy throat or nose ACTUAL SIZE 60 TABLETS 10 mg EACH † Compare to Active Ingredient in Zyrtec ® spl-publix-cetirizine-10mg-60ct-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"],"set_id":"a0a063a1-e067-480e-afab-7f01165025f4","spl_product_data_elements":["Cetirizine Hydrochloride Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE STARCH, CORN HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE, UNSPECIFIED TALC TITANIUM DIOXIDE Rounded-Off R152"],"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 • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. • store between 68° to 77° F (20° to 25° C)"],"version":"2","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. 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)."],"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"]}