{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-11", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "spl_product_data_elements": [ "Curist Allergy Relief Levocetirizine dihydrochloride 5 mg LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE TITANIUM DIOXIDE HYPROMELLOSE 2910 (3 MPA.S) POLYETHYLENE GLYCOL 400 POLYSORBATE 80 LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE HYPROMELLOSE 2910 (6 MPA.S) SILICON DIOXIDE LL;H" ], "spl_unclassified_section": [ "Drug Facts", "Distributed by: Little Pharma, Inc. New York, NY 10023 Made in India" ], "active_ingredient": [ "Active ingredient (in each tablet) Levocetirizine dihydrochloride USP 5 mg" ], "purpose": [ "Purpose Antihistamine" ], "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" ], "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 (1-800-222-1222) right away." ], "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" ], "ask_doctor": [ "Ask a doctor before use if you have ever had trouble urinating or emptying your bladder." ], "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" ], "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." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding, if breast-feeding: not recommended if pregnant: ask a health professional before use" ], "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 (1-800-222-1222) right away." ], "dosage_and_administration": [ "Directions adults 65 years and older ask a doctor adults and children 12-64 years 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 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 do not use consumers with kidney disease do not use" ], "dosage_and_administration_table": [ "
adults 65 years and olderask a doctor
adults and children 12-64 yearstake 1 tablet (5 mg) once daily in the eveningdo not take more than 1 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 yearstake 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 yearsdo not use
consumers with kidney diseasedo not use
" ], "storage_and_handling": [ "Other information ​store between 20° and 25°C (68° and 77°F)" ], "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide." ], "questions": [ "Questions? Call 1-844-243-1241 or email hi@curistrelief.com" ], "package_label_principal_display_panel": [ "curist Allergy Relief Levocetirizine Dihydrochloride Tablets, USP 5 mg Antihistamine 24 Hour Relief of Runny Nose; Sneezing; Itchy, Watery Eyes; Itchy Nose or Throat 180 Tablets curistrelief.com Tamper Evident: Do Not Use If Safety Seal Under Cap Is Broken Or Missing levocetirizine 180ct" ], "set_id": "f2a2a5bc-2efa-c550-e053-2a95a90a55ff", "id": "4c4b5fdc-122b-70cc-e063-6394a90a0b58", "effective_time": "20260305", "version": "5", "openfda": { "application_number": [ "ANDA213513" ], "brand_name": [ "Curist Allergy Relief" ], "generic_name": [ "LEVOCETIRIZINE DIHYDROCHLORIDE 5 MG" ], "manufacturer_name": [ "Little Pharma, Inc." ], "product_ndc": [ "72559-021" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LEVOCETIRIZINE DIHYDROCHLORIDE" ], "rxcui": [ "855172" ], "spl_id": [ "4c4b5fdc-122b-70cc-e063-6394a90a0b58" ], "spl_set_id": [ "f2a2a5bc-2efa-c550-e053-2a95a90a55ff" ], "package_ndc": [ "72559-021-05", "72559-021-56" ], "is_original_packager": [ true ], "upc": [ "0372559021561" ], "unii": [ "SOD6A38AGA" ] } } ] }