{"active_ingredient":["Active Ingredient Cetirizine HCl 10 mg"],"ask_doctor":["ASK A DOCTOR BEFORE USE IF 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 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 cellspacing=\"0\" cellpadding=\"0\" border=\"0\" width=\"100%\"><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Lrule Rrule\" valign=\"top\">adults and children 6 years and over</td><td align=\"left\" styleCode=\"Rrule\" valign=\"top\">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 styleCode=\"Botrule\"><td align=\"left\" styleCode=\"Lrule Rrule\" valign=\"top\">adults 65 years and over</td><td align=\"left\" styleCode=\"Rrule\" valign=\"top\">ask a doctor</td></tr><tr styleCode=\"Botrule\"><td align=\"left\" styleCode=\"Lrule Rrule\" valign=\"top\">children under 6 years of age</td><td align=\"left\" styleCode=\"Rrule\" valign=\"top\">ask a doctor</td></tr><tr><td styleCode=\"Lrule Rrule\" valign=\"top\">consumers with liver or kidney disease</td><td align=\"left\" styleCode=\"Rrule\" valign=\"top\">ask a doctor</td></tr></tbody></table>"],"effective_time":"20251204","id":"451b5247-4660-9ebe-e063-6294a90a13c2","inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide."],"indications_and_usage":["USE(S) 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"],"is_original_packager":[true],"manufacturer_name":["Granules Pharmaceuticals Inc."],"package_ndc":["70010-163-05","70010-163-09"],"product_ndc":["70010-163"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014678"],"spl_id":["451b5247-4660-9ebe-e063-6294a90a13c2"],"spl_set_id":["d55dfce1-acef-3342-e053-2a95a90a4b83"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Cetirizine-HCl-tablets-500-ct Cetirizine-HCl-tablets-bulk-500-ct"],"pregnancy_or_breast_feeding":["PREGNANCY/BREASTFEEDING if breast-feeding: not recommended if pregnant: ask a health professional before use."],"purpose":["PURPOSE Antihistamine"],"set_id":"d55dfce1-acef-3342-e053-2a95a90a4b83","spl_product_data_elements":["Cetirizine hydrochloride Cetirizine hydrochloride CROSCARMELLOSE SODIUM SILICON DIOXIDE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE HYPROMELLOSE, UNSPECIFIED TITANIUM DIOXIDE POLYETHYLENE GLYCOL CETIRIZINE HYDROCHLORIDE CETIRIZINE LACTOSE MONOHYDRATE white to off white rounded off rectangualr G;4"],"spl_unclassified_section":["Cetirizine Hydrochloride Tablets Drug Facts","Other information ◾Contains no ingredient made from a gluten-containing grain (wheat, barley or rye)."],"stop_use":["STOP USE AND ASK DOCTOR IF an allergic reaction to this product occurs. Seek medical help right away."],"storage_and_handling":["STORAGE store between 20° to 25°C (68° to 77°F)"],"version":"5","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"]}