{"active_ingredient":["ACTIVE INGREDIENT (IN EACH TABLET) Cetirizine HCl, 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 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":"20220601","id":"c091c3f5-1961-49ad-b4d5-b82062d31e88","inactive_ingredient":["INACTIVE INGREDIENTS corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide"],"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 (1-800-222-1222)."],"openfda":{"application_number":["ANDA077498"],"brand_name":["Cetirizine Hydrochloride"],"generic_name":["CETIRIZINE HYDROCHLORIDE"],"manufacturer_name":["Proficient Rx LP"],"original_packager_product_ndc":["51660-939"],"package_ndc":["63187-110-30","63187-110-60","63187-110-90"],"product_ndc":["63187-110"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["1014678"],"spl_id":["c091c3f5-1961-49ad-b4d5-b82062d31e88"],"spl_set_id":["d14feb90-3ca2-4d5b-825c-25fc2252ca38"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"unii":["64O047KTOA"],"upc":["0363187110901"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL † Compare to the active ingredient of Zyrtec ® NDC 63187-110-90 Original Prescription Strength Cetirizine HCl Tablets, 10 mg Antihistamine Allergy Indoor & Outdoor Allergies 24 Hour Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose 90 TABLETS 10 mg EACH † This product is not manufactured or distributed by McNeil-PPC, Inc., distributor of Zyrtec ® . Zyrtec ® is a registered trademark of UCB Pharma, S.A. 63187-110-90"],"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? call 1-800-406-7984 KEEP THE CARTON. IT CONTAINS IMPORTANT INFORMATION. SEE END PANEL FOR EXPIRATION DATE. Distributed by: Ohm Laboratories Inc. 1385 Livingston Avenue North Brunswick, NJ 08902 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320"],"set_id":"d14feb90-3ca2-4d5b-825c-25fc2252ca38","spl_product_data_elements":["Cetirizine Hydrochloride Cetirizine Hydrochloride CETIRIZINE HYDROCHLORIDE CETIRIZINE POVIDONE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN TALC TITANIUM DIOXIDE HYPROMELLOSE, UNSPECIFIED POLYETHYLENE GLYCOL, UNSPECIFIED rounded-off RI52"],"spl_unclassified_section":["OTHER INFORMATION • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE. (for bottle cartons/stand-alone labels only) • TAMPER EVIDENT: DO NOT USE IF BLISTER UNITS ARE TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING. (for blister cartons only) • store between 20° to 25° C (68° to 77° F)"],"stop_use":["Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away."],"version":"5","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 (1-800-222-1222)."],"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"]}