{"active_ingredient":["Active ingredient (in each tablet) Cetirizine Hydrochloride, USP 10 mg"],"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."],"do_not_use":["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."],"dosage_and_administration":["Directions (24 Hour Relief) 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
"],"effective_time":"20260730","id":"4c6a67e4-53a4-417c-b960-e25464bc0954","inactive_ingredient":["Inactive ingredients Anhydrous lactose, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin"],"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"],"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."],"openfda":{"application_number":["ANDA076677"],"brand_name":["Cetirizine Hydrochloride"],"generic_name":["CETIRIZINE HYDROCHLORIDE"],"manufacturer_name":["Cardinal Health 107, LLC"],"original_packager_product_ndc":["51079-597"],"package_ndc":["55154-5399-0"],"product_ndc":["55154-5399"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014678"],"spl_id":["4c6a67e4-53a4-417c-b960-e25464bc0954"],"spl_set_id":["0b0190c7-acfd-4140-bcaf-9fe835ebaf49"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"],"upc":["0055154539906"]},"package_label_principal_display_panel":["Principal Display Panel NDC 55154-5399-0 CETIRIZINE HCl TABLETS, USP 10 mg 10 TABLETS 10mg bag 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"],"questions":["Questions? 1-800-848-0462 • Serious side effects associated with use of this product may be reported to this number."],"set_id":"0b0190c7-acfd-4140-bcaf-9fe835ebaf49","spl_product_data_elements":["Cetirizine Hydrochloride cetirizine hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE ANHYDROUS LACTOSE SILICON DIOXIDE HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE POLYDEXTROSE POLYETHYLENE GLYCOL, UNSPECIFIED SODIUM LAURYL SULFATE TITANIUM DIOXIDE TRIACETIN M;C37"],"spl_unclassified_section":["CETIRIZINE HCl 10 mg TABLETS, USP Antihistamine Indoor & Outdoor Allergies TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.","Other information • Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]","HOW SUPPLIED Cetirizine Hydrochloride Tablets, USP are available as follows: 10 mg - White, film-coated, round, biconvex, beveled edge, unscored tablets debossed with M on one side of the tablet and C37 on the other side. Overbagged with 10 film-coated tablets per bag, NDC 55154-5399-0 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Made in India Code No.: MH/DRUGS/25/NKD/89 Distributed by: Mylan Institutional Inc. Rockford, IL 61103 U.S.A. Distributed By: Cardinal Health Dublin, OH 43017 L48853561223 S-12769 10/21"],"stop_use":["Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away."],"version":"15","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 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 taking tranquilizers or sedatives. 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 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."],"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"]}