{ "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": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 9 } }, "results": [ { "spl_product_data_elements": [ "Cetirizine Hydrochloride Cetirizine Hydrochloride Tablets CETIRIZINE HYDROCHLORIDE CETIRIZINE HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL 400 POVIDONE, UNSPECIFIED STARCH, CORN TITANIUM DIOXIDE C" ], "spl_unclassified_section": [ "Drug Facts" ], "active_ingredient": [ "Active ingredient (in each tablet) Cetirizine HCl, 10mg" ], "purpose": [ "Purpose Antihistamine" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1. runny nose 2. sneezing 3. itchy, watery eyes 4. itching of the nose or throat ." ], "warnings": [ "Warnings Ask a doctor before use if you have Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistaminecontaining hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product 1. drowsiness may occur 2. avoid alcoholic drinks 3. alcohol, sedatives, and tranquilizers may increase drowsiness 4. be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding: 1. If breast-feeding: not recommended 2. 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." ], "ask_doctor": [ "Ask a doctor before use if you have Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistaminecontaining hydroxyzine. Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose." ], "ask_doctor_or_pharmacist": [ "Ask a doctor or pharmacist before use if you are Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives." ], "when_using": [ "When using this product 1. drowsiness may occur 2. avoid alcoholic drinks 3. alcohol, sedatives, and tranquilizers may increase drowsiness 4. be careful when driving a motor vehicle or operating machinery" ], "stop_use": [ "Stop use and ask a doctor if Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast-feeding: 1. If breast-feeding: not recommended 2. if pregnant: ask a health professional before use." ], "keep_out_of_reach_of_children": [ "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." ], "dosage_and_administration": [ "Directions adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor" ], "dosage_and_administration_table": [ "
adults and children 6 years and overone 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.
adults 65 years and overask a doctor
children under 6 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor
" ], "storage_and_handling": [ "Other information 1. store between 20° to 25°C (68° to 77°F) Repackaged By: Preferred Pharmaceuticals Inc." ], "inactive_ingredient": [ "Inactive ingredients hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, starch, titanium dioxide." ], "questions": [ "Questions? call 1-888-375-3784 . NDC 68788-8435" ], "package_label_principal_display_panel": [ "Bottle Label A close-up of a yellow and black text AI-generated content may be incorrect." ], "set_id": "14a885e5-5e75-4a18-b5bc-6aaa748712db", "id": "8efeffe6-f264-4a44-a348-63a33f9c6d25", "effective_time": "20260325", "version": "4", "openfda": { "application_number": [ "ANDA078343" ], "brand_name": [ "Cetirizine Hydrochloride" ], "generic_name": [ "CETIRIZINE HYDROCHLORIDE TABLETS" ], "manufacturer_name": [ "Preferred Pharmaceuticals Inc." ], "product_ndc": [ "68788-8435" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CETIRIZINE HYDROCHLORIDE" ], "rxcui": [ "1014678" ], "spl_id": [ "8efeffe6-f264-4a44-a348-63a33f9c6d25" ], "spl_set_id": [ "14a885e5-5e75-4a18-b5bc-6aaa748712db" ], "package_ndc": [ "68788-8435-3", "68788-8435-6", "68788-8435-9" ], "original_packager_product_ndc": [ "43598-811" ], "unii": [ "64O047KTOA" ] } } ] }