{"active_ingredient":["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"],"ask_doctor_or_pharmacist":["ASK A DOCTOR OR PHARMACIST BEFORE USE IF"],"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","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 than1 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":["
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 eveningdo not take more than1 tablet (5 mg) in 24 hours½ 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 eveningdo 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
"],"effective_time":"20250216","id":"2e504864-a08d-48e1-e063-6394a90a92ed","inactive_ingredient":["Inactive ingredients hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, silicon dioxide, and 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).","KEEP OUT OF REACH OF CHILDREN"],"openfda":{"application_number":["ANDA211551"],"brand_name":["Levocetirizine Dihydrochloride"],"generic_name":["LEVOCETIRIZINE DIHYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Micro Labs Limited"],"package_ndc":["42571-312-53","42571-312-90","42571-312-32","42571-312-11","42571-312-18"],"product_ndc":["42571-312"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["855172"],"spl_id":["2e504864-a08d-48e1-e063-6394a90a92ed"],"spl_set_id":["78ff8e86-ee5b-4626-aa81-49e974febf1d"],"substance_name":["LEVOCETIRIZINE DIHYDROCHLORIDE"],"unii":["SOD6A38AGA"],"upc":["0342571312909"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL MICRO LABS LIMITED Container NDC- 42571-312-90 Levocetirizine dihydrochloride Tablets USP 5mg Antihistamine 90 Tablets MICRO LABS Container-Carton NDC- 42571-312-90 Levocetirizine dihydrochloride Tablets USP 5mg Antihistamine 90 Tablets MICRO LABS INVATECH PHARMA SOLUTIONS LLC Container NDC- 42571-312-90 Levocetirizine dihydrochloride Tablets USP 5mg Antihistamine 90 Tablets MICRO LABS Container-Carton NDC- 42571-312-90 Levocetirizine dihydrochloride Tablets USP 5mg Antihistamine 90 Tablets MICRO LABS micro container label micro carton label invatech container label invatech carton label"],"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"],"set_id":"78ff8e86-ee5b-4626-aa81-49e974febf1d","spl_product_data_elements":["Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE MAGNESIUM STEARATE HYPROMELLOSE 2910 (5 MPA.S) TITANIUM DIOXIDE POLYETHYLENE GLYCOL 400 LACTOSE MONOHYDRATE LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE White to off-white LI"],"spl_unclassified_section":["Questions or comments? call 1-855-839-8195"],"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."],"storage_and_handling":["STORAGE store between 20° and 25°C (68° and 77°F) safety sealed: do not use if carton was opened or torn"],"version":"6","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"]}