{"active_ingredient":["Active i ngredient (in each 5 mL ) Levocetirizine dihydrochloride 2.5 mg"],"ask_doctor":["Ask a doctor before use if you have ■ ever had trouble urinating or emptying your bladder"],"do_not_use":["Do not use ■ if you have kidney disease ■ if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine"],"dosage_and_administration":["Directions ■ use only with enclosed dosing cup adults 65 years of age and older ■ ask a doctor adults and children 12-64 years of age ■ take 5 mL or 10 mL once daily in the evening depending upon severity of symptoms ■ do not take more than 10 mL in 24 hours children 6-11 years of age ■ take 5 mL once daily in the evening ■ do not take more than 5 mL in 24 hours children 2-5 years of age ■ take 2.5 mL once daily in the evening ■ do not take more than 2.5 mL in 24 hours children under 2 years of age ■ do not use consumers with kidney disease ■ do not use Note: mL=milliliters"],"dosage_and_administration_table":["
adults 65 years of age and older■ ask a doctor
adults and children 12-64 years of age ■ take 5 mL or 10 mL once daily in the evening depending upon severity of symptoms ■ do not take more than 10 mL in 24 hours
children 6-11 years of age■ take 5 mL once daily in the evening ■ do not take more than 5 mL in 24 hours
children 2-5 years of age■ take 2.5 mL once daily in the evening ■ do not take more than 2.5 mL in 24 hours
children under 2 years of age■ do not use
consumers with kidney disease■ do not use
Note: mL=milliliters
"],"effective_time":"20260205","id":"3ce97c09-ae27-48cf-9413-0c7190a1fb94","inactive_ingredient":["Inactive ingredients flavor, glacial acetic acid, glycerin, maltitol solution, methylparaben, propylparaben, purified water, saccharin sodium, sodium acetate trihydrate"],"indications_and_usage":["Use s temporarily relieves these symptoms due to hay fever or other 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":["NDA209090"],"brand_name":["Childrens Xyzal Allergy"],"generic_name":["LEVOCETIRIZINE DIHYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Chattem, Inc."],"package_ndc":["41167-3535-0","41167-3535-1","41167-3530-1","41167-3533-0","41167-3533-1"],"product_ndc":["41167-3533","41167-3535","41167-3530"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["855168","855170"],"spl_id":["3ce97c09-ae27-48cf-9413-0c7190a1fb94"],"spl_set_id":["a33f2704-d350-428b-b467-91f4775ce17f"],"substance_name":["LEVOCETIRIZINE DIHYDROCHLORIDE"],"unii":["SOD6A38AGA"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL Children’s Xyzal Allergy 24HR Liquid Grape Flavor PRINCIPAL DISPLAY PANEL Children’s Xyzal Allergy 24HR Liquid Grape Flavor","PRINCIPAL DISPLAY PANEL Children’s Xyzal Allergy 24HR Liquid Tutti Frutti Flavor PRINCIPAL DISPLAY PANEL Children’s Xyzal Allergy 24HR Liquid Tutti Frutti Flavor","PRINCIPAL DISPLAY PANEL Children’s Xyzal Allergy 24HR Liquid Bubble Gum Flavor PRINCIPAL DISPLAY PANEL Children’s Xyzal Allergy 24HR Liquid Bubble Gum Flavor"],"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 1-8 66 - 844 - 2798"],"set_id":"a33f2704-d350-428b-b467-91f4775ce17f","spl_product_data_elements":["Childrens Xyzal Allergy Levocetirizine dihydrochloride LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE ACETIC ACID GLYCERIN MALTITOL METHYLPARABEN PROPYLPARABEN WATER SACCHARIN SODIUM SODIUM ACETATE Childrens Xyzal Allergy Levocetirizine dihydrochloride LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE ACETIC ACID GLYCERIN MALTITOL METHYLPARABEN PROPYLPARABEN WATER SACCHARIN SODIUM SODIUM ACETATE Childrens Xyzal Allergy Levocetirizine dihydrochloride LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE ACETIC ACID GLYCERIN MALTITOL METHYLPARABEN PROPYLPARABEN WATER SACCHARIN SODIUM SODIUM ACETATE"],"spl_unclassified_section":["Children’s Xyzal ® Allergy 24HR Drug Facts","Other information ■ each 5 mL contains: sodium 3 mg ■ store between 20° and 25°C (68° and 77°F) ■ safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing"],"stop_use":["Stop use and ask a doctor if ■ you have trouble urinating or emptying your bladder ■ an allergic reaction to this product occurs. Seek medical help right away."],"version":"23","warnings":["Warnings Do not use ■ if you have kidney disease ■ if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine Ask a doctor before use if you have ■ ever had trouble urinating or emptying your bladder 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 ■ in rare cases, you may experience itching after stopping levocetirizine. Consult your healthcare provider if this happens. Stop use and ask a doctor if ■ you have trouble urinating or emptying your bladder ■ 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 ■ in rare cases, you may experience itching after stopping levocetirizine. Consult your healthcare provider if this happens."]}