{"active_ingredient":["Active ingredient (in each tablet) Levocetirizine dihydrochloride 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 adults 65 years of age and older ■ ask a doctor adults and children 12-64 years of age ■ take 1 tablet (5 mg) once daily in the evening ■ do not take more than 1 tablet (5 mg) in 24 hours ■ ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms children 6-11 years of age ■ take ½ tablet (2.5 mg) once daily in the evening ■ do not take more than ½ tablet (2.5 mg) in 24 hours children under 6 years of age ■ do not use consumers with kidney disease ■ do not use"],"dosage_and_administration_table":["<table><col width=\"288\"/><col width=\"425\"/><tbody><tr><td styleCode=\"Toprule Rrule \">adults 65 years of age and older</td><td styleCode=\"Toprule Lrule \">&#x25A0; ask a doctor</td></tr><tr><td styleCode=\"Toprule Rrule \">adults and children 12-64 years of age </td><td styleCode=\"Toprule Lrule \">&#x25A0; take 1 tablet (5 mg) once daily in the evening &#x25A0; do not take more than 1 tablet (5 mg) in 24 hours &#x25A0; &#xBD; tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms</td></tr><tr><td styleCode=\"Toprule Rrule \">children 6-11 years of age</td><td styleCode=\"Toprule Lrule \">&#x25A0; take &#xBD; tablet (2.5 mg) once daily in the evening &#x25A0; do not take more than &#xBD; tablet (2.5 mg) in 24 hours</td></tr><tr><td styleCode=\"Toprule Rrule \">children under 6 years of age</td><td styleCode=\"Toprule Lrule \">&#x25A0; do not use</td></tr><tr><td styleCode=\"Toprule Rrule \">consumers with kidney disease</td><td styleCode=\"Toprule Lrule \">&#x25A0; do not use</td></tr></tbody></table>"],"effective_time":"20260311","id":"f43bc46c-c507-4ccf-9b93-17eaeebf4ed5","inactive_ingredient":["Inactive ingredients Colloidal anhydrous silica, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, titanium dioxide"],"indications_and_usage":["Uses 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":["NDA209089"],"brand_name":["Xyzal Allergy 24HR"],"generic_name":["LEVOCETIRIZINE DIHYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Chattem, Inc."],"package_ndc":["41167-3510-0","41167-3510-1","41167-3510-2","41167-3510-3","41167-3510-4","41167-3510-5","41167-3510-6","41167-3511-2","41167-3511-8","41167-3511-9","41167-3513-4"],"product_ndc":["41167-3510","41167-3511","41167-3513"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["855172","855174"],"spl_id":["f43bc46c-c507-4ccf-9b93-17eaeebf4ed5"],"spl_set_id":["8be45c2a-1eca-4a00-81b9-f7babdbdcd41"],"substance_name":["LEVOCETIRIZINE DIHYDROCHLORIDE"],"unii":["SOD6A38AGA"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL ORIGINAL PRESCIPTION STRENGTH XYZAL ALLERGY 24HR 5 mg/ antihistamine 10 Tablets ORIGINAL PRESCIPTION STRENGTH XYZAL ALLERGY 24HR 5 mg/ antihistamine 10 Tablets","PRINCIPAL DISPLAY PANEL NDC 41167-3510-1 XYZAL Allergy 24HR 5 mg 35 Tablets NDC 41167-3510-1 XYZAL Allergy 24HR 5 mg 35 Tablets","PRINCIPAL DISPLAY PANEL NDC 41167-3511-2 XYZAL Allergy 24HR 5 mg 20 Tablets PRINCIPAL DISPLAY PANEL NDC 41167-3511-2 XYZAL Allergy 24HR 5 mg 20 Tablets"],"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 1-800- 633-1610"],"set_id":"8be45c2a-1eca-4a00-81b9-f7babdbdcd41","spl_product_data_elements":["Xyzal Allergy 24HR Levocetirizine dihydrochloride LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE SILICON DIOXIDE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE X;X Xyzal Allergy 24HR Levocetirizine dihydrochloride LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE SILICON DIOXIDE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE x;x Xyzal Allergy 24HR Levocetirizine dihydrochloride LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE SILICON DIOXIDE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE x;x"],"spl_unclassified_section":["X y z al Allergy 24HR Tablet Drug Facts","Other information store between 20° and 25°C (68° and 77°F) (if blister) safety sealed: do not use if carton was opened or if individual blister unit is open or torn (if bottled) safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing (if stretch card ) safety sealed: do not use if sealed package was torn or 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":"14","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 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"]}