{"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."],"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 with a dosing cup find right dose on chart below mL = milliliter 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 ½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ 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"],"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 2 to under 6 years of age½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours.
children under 2 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor
"],"effective_time":"20251007","id":"36fee17d-2444-41d2-aca7-2f22d3f87cc0","inactive_ingredient":["Inactive ingredients glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, and sucrose"],"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 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":["Rising Pharma Holdings, Inc."],"package_ndc":["57237-357-12","57237-357-24"],"product_ndc":["57237-357"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014673"],"spl_id":["36fee17d-2444-41d2-aca7-2f22d3f87cc0"],"spl_set_id":["c6f08e78-10fc-48d0-a3e1-e227081548eb"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"],"upc":["0357237357248"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL: 4 fl. oz. (120 mL) - NDC 57237-357-12 NDC 57237-357-12 Children’s 2 yrs. & older Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL Antihistamine Grape Flavored ALLERGY Indoor and Outdoor Allergies 24 Hour Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose 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. Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Issued: 09/2025 cetirizine-hcl-os-120mL-1 cetirizine-hcl-os-120mL-2 cetirizine-hcl-os-120mL-3","PRINCIPAL DISPLAY PANEL: 8 fl. oz. (240 mL) - NDC 57237-357-24 NDC 57237-357-24 Children’s 2 yrs. & older Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL Antihistamine Grape Flavored ALLERGY Indoor and Outdoor Allergies 24 Hour Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose 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. Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Issued: 09/2025 cetirizine-hcl-os-240mL-1 cetirizine-hcl-os-240mL-2 cetirizine-hcl-os-240mL-3"],"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 1-844-474-7464"],"set_id":"c6f08e78-10fc-48d0-a3e1-e227081548eb","spl_product_data_elements":["CETIRIZINE HYDROCHLORIDE CETIRIZINE HYDROCHLORIDE SUCROSE SODIUM ACETATE WATER GLYCERIN ACETIC ACID METHYLPARABEN PROPYLENE GLYCOL PROPYLPARABEN CETIRIZINE HYDROCHLORIDE CETIRIZINE"],"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."],"storage_and_handling":["Other information Store between 20 to 25ºC (68 to 77ºF) or store refrigerated, 2 to 8ºC (36 to 46ºF)"],"version":"1","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 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"]}