{ "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": 1 } }, "results": [ { "spl_product_data_elements": [ "Allery Relief 24HR Allery Relief 24HR LEVOCETIRIZINE DIHYDROCHLORIDE LEVOCETIRIZINE SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TITANIUM DIOXIDE H;LL" ], "active_ingredient": [ "Active ingredient(s) Levocetirizine dihydrochloride USP 5 mg" ], "purpose": [ "Purpose Antihistamine" ], "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" ], "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 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 breastfeeding, 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)." ], "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 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 breastfeeding, 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 right away (1-800-222-1222)." ], "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 ½ tablet (2.5 mg) once daily in the evening may be appropriate for less severe symptoms children 6 to 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 to 64 years of age take 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 to 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
" ], "spl_unclassified_section": [ "Other information store at room temperature 20°– 25°C (68°– 77°F) do not use if imprinted seal under safety cap is broken or missing" ], "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide" ], "questions": [ "Questions/Comments Call 1-888-952-0050 Monday through Friday 9AM - 5PM" ], "package_label_principal_display_panel": [ "Principal Display Panel Allergy Relief 24HR Allergy Relief 24HR" ], "set_id": "c523c210-b1c4-4049-9c72-2b31c9c93137", "id": "d6893dfa-1c05-4ce7-b360-91baa94d6a69", "effective_time": "20240402", "version": "3", "openfda": { "application_number": [ "ANDA213513" ], "brand_name": [ "Allery Relief 24HR" ], "generic_name": [ "ALLERY RELIEF 24HR" ], "manufacturer_name": [ "Allegiant Health" ], "product_ndc": [ "69168-451" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "LEVOCETIRIZINE DIHYDROCHLORIDE" ], "rxcui": [ "855172" ], "spl_id": [ "d6893dfa-1c05-4ce7-b360-91baa94d6a69" ], "spl_set_id": [ "c523c210-b1c4-4049-9c72-2b31c9c93137" ], "package_ndc": [ "69168-451-06", "69168-451-60", "69168-451-80" ], "is_original_packager": [ true ], "unii": [ "SOD6A38AGA" ] } } ] }