{"active_ingredient":["Active Ingredient (in each 5 mL teaspoonful) Cetirizine hydrochloride, USP 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. hives that are an unusual color, look bruised or blistered hives that do not itch"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives."],"do_not_use":["Do not use Do not use ■ to prevent hives from any known cause such as: foods insect stings medicines latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause. ■ 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 with a dosing cup adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours. adults 65 years and over 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours. children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor"],"dosage_and_administration_table":["
adults and children 6 years and over1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.
adults 65 years and over1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor
"],"effective_time":"20260826","id":"5a1df22c-40c4-6cf1-e063-6294a90ad7f7","inactive_ingredient":["Inactive ingredients glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, and sucrose"],"indications_and_usage":["Uses reduces hives and relieves itching due to hives (urticaria). This product will not prevent hives or an allergic skin reaction from occurring."],"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 toll-free number 1-800-222-1222."],"openfda":{"application_number":["ANDA091327"],"brand_name":["CETIRIZINE HYDROCHLORIDE"],"generic_name":["CETIRIZINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["BAJAJ MEDICAL, LLC"],"package_ndc":["61037-480-22","61037-480-23","61037-480-24","61037-480-26","61037-480-32"],"product_ndc":["61037-480"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014673"],"spl_id":["5a1df22c-40c4-6cf1-e063-6294a90ad7f7"],"spl_set_id":["36b6d0e4-8da5-9df5-e063-6294a90af326"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"],"upc":["0361037480327"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL: 4 fl. oz. (120 mL) - NDC 61037-480-22 NDC 61037-480-22 Children’s Cetirizine Hydrochloride 1 mg/mL Oral Solution, USP 6 yrs. & older Antihistamine Grape Flavored HIVES Relief 24 hour Relief of ITCHING Due to Hives 4 fl. oz. (120 mL) Dosing cup should be washed and left to air dry after each use. Do not use if seal on bottle is broken or missing. Manufactured by: Bajaj Medical, LLC Chicago IL 60609, USA Issued: 06/2025 4oz1 4oz2 4oz3","PRINCIPAL DISPLAY PANEL: 16 fl. oz. (480 mL) - NDC 61037-480-23 NDC 61037-480-23 Children’s Cetirizine Hydrochloride 1 mg/mL Oral Solution, USP 6 yrs. & older Antihistamine Grape Flavored HIVES Relief 24 hour Relief of ITCHING Due to Hives 16 fl. oz. (480 mL) Dosing cup should be washed and left to air dry after each use. Do not use if seal on bottle is broken or missing. Manufactured by: Bajaj Medical, LLC Chicago IL 60609, USA Issued: 06/2025 16oz1 16oz2","PRINCIPAL DISPLAY PANEL: 8 fl. oz. (240 mL) - NDC 61037-480-24 NDC 61037-480-24 Children’s Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL 6 yrs. & older Antihistamine Grape Flavored HIVES Relief 24 hour Relief of ITCHING Due to Hives 8 fl. oz. (240 mL) Dosing cup should be washed and left to air dry after each use. Do not use if seal on bottle is broken or missing. Manufactured by: Bajaj Medical, LLC Chicago IL 60609, USA Issued: 08/2025 8oz1 8oz2 8oz3","5 mL - NDC 61037-480-32 NDC 61037-480-32 Children's Cetirizine Hydrochloride Oral Solution, USP 5 mg/5 mL 5ml1 5ml2 5ml3 5ml4"],"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 or comments? call toll-free 1-800-581-2528 weekdays"],"set_id":"36b6d0e4-8da5-9df5-e063-6294a90af326","spl_product_data_elements":["CETIRIZINE HYDROCHLORIDE Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE SUCROSE SODIUM ACETATE WATER GLYCERIN ACETIC ACID METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN"],"spl_unclassified_section":["Drug Facts"],"stop_use":["Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve after 3 days of treatment the hives have lasted more than 6 weeks"],"storage_and_handling":["Other information Store between 20 to 25ºC (68 to 77ºF) or store refrigerated, 2 to 8ºC (36 to 46ºF)"],"version":"4","warnings":["Warnings Severe Allergy Warning Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms: trouble swallowing dizziness or loss of consciousness swelling of tongue swelling in or around mouth trouble speaking drooling wheezing or problems breathing These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later. Not a Substitute for Epinephrine . If your doctor has prescribed an epinephrine injector for \"anaphylaxis\" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times. Do not use Do not use ■ to prevent hives from any known cause such as: foods insect stings medicines latex or rubber gloves because this product will not stop hives from occurring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious. If you do not know the cause of your hives, see your doctor for a medical exam. Your doctor may be able to help you find a cause. ■ 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. hives that are an unusual color, look bruised or blistered hives that do not itch 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. symptoms do not improve after 3 days of treatment the hives have lasted more than 6 weeks 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 toll-free number 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"]}