{"active_ingredient":["Active Ingredient (in each tablet) Cetirizine HCl 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":["<table><col/><col/><tbody><tr><td valign=\"top\" styleCode=\" Lrule Rrule\">adults and children 6 years and over</td><td valign=\"top\" styleCode=\" Rrule\">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.</td></tr><tr><td valign=\"top\" styleCode=\" Lrule Rrule\">adults 65 years and over</td><td valign=\"top\" styleCode=\" Rrule\">ask a doctor</td></tr><tr><td valign=\"top\" styleCode=\" Lrule Rrule\">children under 6 years of age</td><td valign=\"top\" styleCode=\" Rrule\">ask a doctor</td></tr><tr><td valign=\"top\" styleCode=\" Lrule Rrule\">consumers with liver or kidney disease</td><td valign=\"top\" styleCode=\" Rrule\">ask a doctor</td></tr></tbody></table>"],"effective_time":"20240624","id":"1125df7c-ba82-46fe-a411-05322146a3b9","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"],"generic_name":["CETIRIZINE HYDROCHLORIDE"],"manufacturer_name":["NCS HealthCare of KY, LLC dba Vangard Labs"],"original_packager_product_ndc":["70010-163"],"package_ndc":["0615-8479-39"],"product_ndc":["0615-8479"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014678"],"spl_id":["1125df7c-ba82-46fe-a411-05322146a3b9"],"spl_set_id":["b53d5e8a-a30c-4025-aa72-d2776a112e3e"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL PRINCIPAL DISPLAY PANEL"],"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":"b53d5e8a-a30c-4025-aa72-d2776a112e3e","spl_product_data_elements":["Cetirizine hydrochloride Cetirizine hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE LACTOSE MONOHYDRATE CROSCARMELLOSE SODIUM SILICON DIOXIDE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSE, UNSPECIFIED TITANIUM DIOXIDE POLYETHYLENE GLYCOL, UNSPECIFIED white to off white G;4 rounded off rectangualr"],"spl_unclassified_section":["Cetirizine Hydrochloride Tablets Drug Facts","QUESTIONS? call 1-877-770-3183: Mon-Fri 8:00 AM EST to 5:00 PM PST"],"stop_use":["STOP USE AND ASK 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) contains no ingredient made from a gluten-containing grain (Wheat, barley or rye)."],"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."],"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"]}