{"id":"cetirizine-hydrochloride","_fda":{"id":"322eb217-089d-e92d-e063-6394a90a6566","set_id":"013ce40e-37c9-4b84-b530-ed895f60ce0e","openfda":{"upc":["0300450239129"],"unii":["64O047KTOA"],"route":["ORAL"],"rxcui":["2558501","2558503"],"spl_id":["322eb217-089d-e92d-e063-6394a90a6566"],"brand_name":["Childrens Zyrtec"],"spl_set_id":["013ce40e-37c9-4b84-b530-ed895f60ce0e"],"package_ndc":["50580-790-01","50580-790-02","50580-790-03"],"product_ndc":["50580-790"],"generic_name":["CETIRIZINE HYDROCHLORIDE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["CETIRIZINE HYDROCHLORIDE"],"manufacturer_name":["Kenvue Brands LLC"],"application_number":["NDA021621"],"is_original_packager":[true]},"purpose":["Purpose Antihistamine"],"version":"8","stop_use":["Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away."],"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)"],"questions":["Questions? call 1-800-343-7805 (toll-free) or 215-273-8755 (collect)"],"ask_doctor":["Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose."],"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."],"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"],"effective_time":"20250407","active_ingredient":["Active ingredient (in each chewable tablet) Cetirizine HCl 2.5 mg"],"inactive_ingredient":["Inactive ingredients betadex, corn starch, flavor, lactose monohydrate, magnesium stearate, mannitol, silicified microcrystalline cellulose, sucralose"],"storage_and_handling":["Other information store between 20° to 25°C (68° to 77°F) do not use if blister unit is torn or broken"],"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"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives."],"spl_unclassified_section":["Drug Facts"],"dosage_and_administration":["Directions may be taken with or without water chew or crush tablets completely before swallowing children 2 to under 6 years of age Chew and swallow 1 tablet (2.5 mg) once daily; If needed, dose can be increased to a maximum of 2 tablets (5 mg) once daily or 1 tablet (2.5 mg) every 12 hours. Do not give more than 2 tablets (5 mg) in 24 hours. adults and children 6 years and over Chew and swallow 2 tablets (5 mg) or 4 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 4 tablets (10 mg) in 24 hours. adults 65 years and over Chew and swallow 2 tablets (5 mg) once daily; do not take more than 2 tablets (5 mg) in 24 hours. children under 2 years of age ask a doctor consumers with liver or kidney disease ask a doctor"],"spl_product_data_elements":["Childrens Zyrtec Cetirizine hydrochloride BETADEX STARCH, CORN LACTOSE MONOHYDRATE MAGNESIUM STEARATE MANNITOL SUCRALOSE CETIRIZINE HYDROCHLORIDE CETIRIZINE CTZ"],"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_table":["
children 2 to under 6 years of ageChew and swallow 1 tablet (2.5 mg) once daily; If needed, dose can be increased to a maximum of 2 tablets (5 mg) once daily or 1 tablet (2.5 mg) every 12 hours. Do not give more than 2 tablets (5 mg) in 24 hours.
adults and children 6 years and overChew and swallow 2 tablets (5 mg) or 4 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 4 tablets (10 mg) in 24 hours.
adults 65 years and overChew and swallow 2 tablets (5 mg) once daily; do not take more than 2 tablets (5 mg) in 24 hours.
children under 2 years of ageask a doctor
consumers with liver or kidney diseaseask a doctor
"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL New look Same relief NDC 50580-790-01 Children's ZYRTEC ® Cetirizine HCl chewable tablets 2.5 mg /antihistamine ALLERGY Indoor + Outdoor Allergies 2 yrs & older Dye-Free Chewables 24 Hour Relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Actual Size Grape Flavor Chew or crush tablets completely before swallowing 12 CHEWABLE TABLETS Zyrtec-1"]},"safety":{"boxedWarnings":[]},"_chembl":null,"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=CETIRIZINE HYDROCHLORIDE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T05:19:42.778963+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T05:20:07.116636+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T05:19:49.204646+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CETIRIZINE HYDROCHLORIDE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T05:19:49.537615+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:19:41.660272+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:20:02.307652+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:19:41.660292+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Histamine H1 receptor antagonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T05:19:51.366070+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1607273/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T05:19:51.028086+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"NDA021621","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:19:41.660296+00:00"}},"_dailymed":{"setId":"9c11dd22-cb17-4179-8c54-1d515bf662d2","title":"CETIRIZINE HYDROCHLORIDE SOLUTION [BRYANT RANCH PREPACK]"},"aiSummary":"Cetirizine Hydrochloride is a marketed antihistamine primarily indicated for the relief of hay fever symptoms. The drug maintains a strong market position with a key composition patent expiring in 2028, providing a significant period of exclusivity. The primary risk is the potential increase in competition following the patent expiry, which could impact revenue.","_scrapedAt":"2026-03-27T23:40:51.713Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T05:20:07.116721+00:00","fieldsConflicting":0,"overallConfidence":0.95},"indications":{"approved":[{"id":"cetirizine-hydrochloride-hay-fever-symptoms-relief","name":"Hay Fever Symptoms Relief","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Individuals experiencing symptoms due to hay fever","pivotalTrial":null,"restrictions":[],"patientPopulation":"Individuals experiencing symptoms due to hay fever","diagnosticRequired":null,"brandNameForIndication":""},{"id":"cetirizine-hydrochloride-upper-respiratory-allergies-sy","name":"Upper Respiratory Allergies Symptoms Relief","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Individuals experiencing symptoms due to other upper respiratory 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