{"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":"20250424","id":"5a891a5c-794e-47e1-831a-7762414aab74","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":{},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL LEADER ® NDC 37205-0825-74 Indoor & Outdoor Allergies Compare to Zyrtec ® active ingredient † ORIGINAL PRESCRIPTION STRENGTH AllDayAllergy Cetirizine HCl Tablets, 10 mg/Antihistamine 24 Hour Relief of: • Sneezing • Runny Nose • Itchy, Watery Eyes • Itchy Throat or Nose 14TABLETS 10 mg EACH † This product is not manufactured or distributed by McNeil-PPC, Inc.,distributor ofZyrtec ® . Zyrtec ® is a registered trademark of UCB Pharma, S.A. This is the 14 count blister carton label for Leader Cetirizine. This is the 120 count bottle carton label for Leader Cetirizine HCl tablets."],"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."],"set_id":"38e7396c-223a-4df6-9d39-fb4de5214269","spl_product_data_elements":["LEADER ALL DAY ALLERGY cetirizine CETIRIZINE HYDROCHLORIDE CETIRIZINE STARCH, CORN HYPROMELLOSE, UNSPECIFIED LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE, UNSPECIFIED TALC TITANIUM DIOXIDE 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/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":"3","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"]}