{"active_ingredient":["Drug Facts Active ingredient (in each tablet) Levocetirizine dihydrochloride USP 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 to 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 ■ 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms children 6 to 11 years of age ■ take 1/2 tablet (2.5 mg) once daily in the evening ■ do not take more than 1/2 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 border=\"0\" width=\"40%\"><tbody><tr><td>adults 65 years of age and older</td><td>&#x25A0; ask a doctor</td></tr><tr><td>adults and children 12 to 64 years of age</td><td>&#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; 1/2 tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms </td></tr><tr><td>children 6 to 11 years of age</td><td>&#x25A0; take 1/2 tablet (2.5 mg) once daily in the evening   &#x25A0; do not take more than 1/2 tablet (2.5 mg) in 24 hours </td></tr><tr><td>children under 6 years of age</td><td>&#x25A0; do not use</td></tr><tr><td>consumers with kidney disease</td><td>&#x25A0; do not use</td></tr></tbody></table>"],"effective_time":"20260406","id":"4ed17484-560a-d993-e063-6294a90a82a2","inactive_ingredient":["Inactive ingredients Colloidal silicone dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, 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":["ANDA213513"],"brand_name":["Levocetirizine Dihydrochloride"],"generic_name":["LEVOCETIRIZINE DIHYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Farmacias De Similares TX LLC"],"package_ndc":["85786-206-30"],"product_ndc":["85786-206"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["855172"],"spl_id":["4ed17484-560a-d993-e063-6294a90a82a2"],"spl_set_id":["4ed17484-5609-d993-e063-6294a90a82a2"],"substance_name":["LEVOCETIRIZINE DIHYDROCHLORIDE"],"unii":["SOD6A38AGA"],"upc":["0199961000331"]},"other_safety_information":["Other information ■ store between 20° and 25°C (68° and 77°F) ■ safety sealed: do not use if carton was opened or if individual blister unit is open or torn"],"package_label_principal_display_panel":["Carton labeling Carton labeling"],"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? (855)-280-1079"],"set_id":"4ed17484-5609-d993-e063-6294a90a82a2","spl_product_data_elements":["Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride SILICON DIOXIDE POLYETHYLENE GLYCOL 400 LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE LACTOSE MONOHYDRATE HYPROMELLOSE 2910 (3 MPA.S) MAGNESIUM STEARATE TITANIUM DIOXIDE HYPROMELLOSE 2910 (6 MPA.S) MICROCRYSTALLINE CELLULOSE POLYSORBATE 80 H;LL"],"spl_unclassified_section":["Principal Display Panel NDC: 85786-206-30 DR. SIMI Allergy Relief Levocetirizine Dihydrochloride Tablets, USP 5 mg Antihistamine 24 HOUR Relief of: • Sneezing • Runny Nose • Itchy Nose or Throat • Itchy, Watery Eyes 30 Tablets Compare to XYZAL® 24 HR Active Ingredient* *This product is not manufactured or distributed by Chattem, Inc. owner of the registered trademark XYZAL® Allergy 24HR. Read directions and warnings before use. Keep this carton. It has important information. Distributed by: FARMACIAS DE SIMILARES TX LLC 800 Brazos St Ste 260, Austin, TX, 78701, USA customerservice@drsimi.com www.drsimi.com"],"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":"1","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"]}