{"active_ingredient":["Active ingredient (in each 5 mL) Cetirizine HCl 5 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 use only with enclosed dosing cup find right dose on chart below mL = milliliter adults and children 6 years and over 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.. adults 65 years and older 5 mL once daily; do not take more than 5 mL in 24 hours children 2 to under 6 years of age 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor"],"dosage_and_administration_table":["<table width=\"65%\"><col align=\"left\" valign=\"top\" width=\"30%\"/><col align=\"left\" valign=\"top\" width=\"70%\"/><tbody><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">adults and children 6 years and over</td><td>5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours..</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">adults 65 years and older</td><td>5 mL once daily; do not take more than 5 mL in 24 hours</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">children 2 to under 6 years of age</td><td>2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 5 mL in 24 hours.</td></tr><tr styleCode=\"Botrule\"><td styleCode=\"Rrule\">children under 2 years of age</td><td>ask a doctor</td></tr><tr><td styleCode=\"Rrule\">consumers with liver or kidney disease</td><td>ask a doctor</td></tr></tbody></table>"],"effective_time":"20260607","id":"53b5fbb1-4c70-0f2c-e063-6394a90a4f7b","inactive_ingredient":["Inactive ingredients artificial grape flavor, glacial acetic acid, glycerin, propylene glycol, purified water, sodium acetate anhydrous, sodium benzoate, sucralose"],"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":["ANDA090182"],"brand_name":["Childrens Cetirizine Hydrochloride"],"generic_name":["CETIRIZINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Sun Pharmaceutical Industries, Inc."],"package_ndc":["51672-2147-8","51672-2147-1"],"product_ndc":["51672-2147"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014673"],"spl_id":["53b5fbb1-4c70-0f2c-e063-6394a90a4f7b"],"spl_set_id":["30cbaa91-2216-efd2-e063-6294a90aaaed"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"],"upc":["0351672214784"]},"package_label_principal_display_panel":["120 mL Carton Carton","120 mL Carton Carton"],"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"],"questions":["Questions? Call 1-866-923-4914"],"set_id":"30cbaa91-2216-efd2-e063-6294a90aaaed","spl_product_data_elements":["Childrens Cetirizine Hydrochloride Cetirizine Hydrochloride PROPYLENE GLYCOL WATER SODIUM ACETATE ANHYDROUS SUCRALOSE SODIUM BENZOATE ACETIC ACID GLYCERIN CETIRIZINE HYDROCHLORIDE CETIRIZINE"],"spl_unclassified_section":["Drug Facts","Distributed by: Ohm Laboratories Inc. New Brunswick, NJ 08901"],"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 each 5mL contains: sodium 4 mg do not use if carton is opened or if imprinted safety seal is broken or missing see bottom panel for lot number and expiration date store between 20° to 25°C (68° to 77°F)"],"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. 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"]}