{"active_ingredient":["Active ingredient (in each 5 mL teaspoonful) Purpose Cetirizine HCl 5 mg----------------------------------Antihistamine"],"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 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 2 to under 6 years of age: 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours. children under 2 years of age: ask a doctor consumers with liver or kidney disease: ask a doctor"],"effective_time":"20260518","id":"6b714ab7-ee3a-4b6a-ab4b-de3c2b2b2499","inactive_ingredient":["Inactive ingredients glacial acetic acid, glycerine, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, sucrose"],"indications_and_usage":["Uses temporarily relieves these symptoms due to hay fever or 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":["ANDA090474"],"brand_name":["Cetrizine Hydrochloride"],"generic_name":["CETIRIZINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["APOZEAL PHARMACEUTICALS INC"],"package_ndc":["83745-188-04","83745-188-08","83745-188-16","83745-188-12","83745-188-24","83745-188-48"],"product_ndc":["83745-188"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014673"],"spl_id":["6b714ab7-ee3a-4b6a-ab4b-de3c2b2b2499"],"spl_set_id":["9c0549cf-4c93-45d9-9eac-3948fa45554e"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"],"upc":["0383745188128","0383745188241"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 83745- 188 -12 Cetirizine Hydrochloride Oral Solution, USP 1mg/mL Grape Flavored Syrup 120 mL NDC 83745- 188 -24 Cetirizine Hydrochloride Oral Solution, USP 1mg/mL Grape Flavored Syrup 120 mL containerlabel240ml containerlabel120"],"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? 1-833-688-7848 *This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., distributor of Children’s Zyrtec ® ."],"set_id":"9c0549cf-4c93-45d9-9eac-3948fa45554e","spl_product_data_elements":["Cetrizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE CETIRIZINE METHYLPARABEN PROPYLPARABEN GLYCERIN PROPYLENE GLYCOL SODIUM ACETATE GRAPE ACETIC ACID SUCROSE WATER Colorless to slightly yellow"],"spl_unclassified_section":["Drug Facts","Distributed by: Apozeal Pharmaceuticals Inc. Hartel St, Levittown PA 19057"],"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 Store between 20° to 25°C (68° to 77°F). Excursions permitted to 15°–30°C (59°–86°F) [see USP Controlled Room Temperature]. Tamper Evident Do not use if foil seal over mouth of the bottle is torn, broken or missing Dosing cup should be washed and left to air dry after each use."],"version":"5","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"]}