{"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 over 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 cellspacing=\"5\" cellpadding=\"5\"><tbody><tr><td styleCode=\"Botrule Rrule Toprule\" valign=\"top\">adults and children 6 years and over</td><td styleCode=\"Botrule Toprule\" valign=\"top\">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><td styleCode=\"Botrule Rrule Toprule\" valign=\"top\">adults 65 years and over</td><td styleCode=\"Botrule Toprule\" valign=\"top\"> 5 mL once daily; do not take more than 5 mL in 24 hours.</td></tr><tr><td styleCode=\"Botrule Rrule Toprule\" valign=\"top\">children 2 to under 6 years of age</td><td styleCode=\"Botrule Toprule\" valign=\"top\"> 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><td styleCode=\"Botrule Rrule Toprule\" valign=\"top\">children under 2 years of age</td><td styleCode=\"Botrule Toprule\" valign=\"top\"> ask a doctor</td></tr><tr><td styleCode=\"Botrule Rrule Toprule\" valign=\"top\">consumers with liver or kidney disease</td><td styleCode=\"Botrule Toprule\" valign=\"top\"> ask a doctor</td></tr></tbody></table>"],"effective_time":"20260320","how_supplied":["HOW SUPPLIED Cetirizine HCl 5 mg NDC: 72162-2073-2: 118 mL in a BOTTLE Store between 20° to 25°C (68° to 77°F) Protect from light Do not use if carton is opened or if carton tape or bottle wrap imprinted \"SEALED FOR YOUR PROTECTION\" is broken or missing Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504"],"id":"9028db40-d89a-477b-a528-7f1c2ed5de64","inactive_ingredient":["Inactive ingredients Bubble Gum Syrup: anhydrous citric acid, artificial bubble gum flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose Grape Syrup: anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, 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":["ANDA212266"],"brand_name":["CETIRIZINE HYDROCHLORIDE"],"generic_name":["CETIRIZINE HYDROCHLORIDE"],"manufacturer_name":["Bryant Ranch Prepack"],"original_packager_product_ndc":["70752-104"],"package_ndc":["72162-2073-2"],"product_ndc":["72162-2073"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014673"],"spl_id":["9028db40-d89a-477b-a528-7f1c2ed5de64"],"spl_set_id":["9c11dd22-cb17-4179-8c54-1d515bf662d2"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"]},"package_label_principal_display_panel":["Cetirizine Hcl 1mg/ml Oral Solution #118 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"],"questions":["Questions? Call 1-888-344-9603 (toll-free)"],"set_id":"9c11dd22-cb17-4179-8c54-1d515bf662d2","spl_product_data_elements":["CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE CETIRIZINE ANHYDROUS CITRIC ACID PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL SUCRALOSE"],"spl_unclassified_section":["Manufactured by: Quagen Pharmaceuticals LLC West Caldwell, NJ 07006 51001 & 51002 Rev. 10/18"],"stop_use":["Stop use and ask a doctor if: an allergic reaction to this product occurs. Seek medical help right away. Side effects occur: You may report side effects to FDA at 1-800-FDA-1088."],"storage_and_handling":["Other Information store between 20° to 25°C (68° to 77°F) Protect from light do not use if carton is opened or if carton tape or bottle wrap imprinted \"SEALED FOR YOUR PROTECTION\" is broken or missing see bottom panel for lot number and expiration date"],"version":"104","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. Side effects occur: You may report side effects to FDA at 1-800-FDA-1088. 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"]}