{ "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": 1 } }, "results": [ { "spl_product_data_elements": [ "Cetirizine Hydrochloride Cetirizine Hydrochloride Allergy CETIRIZINE HYDROCHLORIDE CETIRIZINE SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSE 2910 (5 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL 400 TITANIUM DIOXIDE White to Off-white X;36" ], "spl_unclassified_section": [ "Drug Facts" ], "active_ingredient": [ "Active ingredient (in each tablet) Cetirizine hydrochloride USP 10 mg" ], "purpose": [ "Purpose Antihistamine" ], "indications_and_usage": [ "Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itchy, watery eyes itching of the nose or throat" ], "warnings": [ "Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine." ], "ask_doctor": [ "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 taking tranquilizers or sedatives." ], "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 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 right away. [1-800-222-1222]" ], "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 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
" ], "storage_and_handling": [ "Other information store between 20° to 25°C (68° to 77°F) TAMPER EVIDENT: DO NOT USE IF SEAL OVER BOTTLE OPENING IS BROKEN OR MISSING." ], "inactive_ingredient": [ "Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide." ], "questions": [ "Questions? call 1-855-274-4122 DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Made in India Code: TS/DRUGS/19/1993" ], "package_label_principal_display_panel": [ "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (365's Tablets Bottle) LEADER TM NDC 70000-0047-1 Original Prescription Strength All Day Allergy Cetirizine Hydrochloride Tablets USP, 10 mg | Antihistamine COMPARE TO ZYRTEC ® active ingredient * Indoor and Outdoor Allergies 24-Hour Relief of: Sneezing; Runny Nose; Itchy, Watery Eyes; Itchy Throat or Nose 365 TABLETS 10 mg EACH PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 10 mg (14's Tablet Blister Pack Label)" ], "set_id": "0cab7aa8-ded3-46f1-b801-2663cc9b0173", "id": "5c5725c9-4879-424d-829c-44017284977a", "effective_time": "20251003", "version": "4", "openfda": { "application_number": [ "ANDA090760" ], "brand_name": [ "Cetirizine Hydrochloride" ], "generic_name": [ "CETIRIZINE HYDROCHLORIDE ALLERGY" ], "manufacturer_name": [ "LEADER/ CARDINAL HEALTH 110, INC." ], "product_ndc": [ "70000-0047" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "CETIRIZINE HYDROCHLORIDE" ], "rxcui": [ "1014678" ], "spl_id": [ "5c5725c9-4879-424d-829c-44017284977a" ], "spl_set_id": [ "0cab7aa8-ded3-46f1-b801-2663cc9b0173" ], "package_ndc": [ "70000-0047-1" ], "is_original_packager": [ true ], "unii": [ "64O047KTOA" ] } } ] }