{"id":"meclizine","rwe":[],"_fda":{"id":"2b4cfbd3-496d-100d-e063-6294a90aba52","set_id":"02d1af4d-d97d-4019-a5bf-3ec391238676","openfda":{"unii":["HDP7W44CIO"],"route":["ORAL"],"rxcui":["995632"],"spl_id":["2b4cfbd3-496d-100d-e063-6294a90aba52"],"brand_name":["Meclizine HCL"],"spl_set_id":["02d1af4d-d97d-4019-a5bf-3ec391238676"],"package_ndc":["71610-528-30","71610-528-60"],"product_ndc":["71610-528"],"generic_name":["MECLIZINE HCL 25MG CHEWABLE TABLETS"],"product_type":["HUMAN OTC DRUG"],"substance_name":["MECLIZINE HYDROCHLORIDE"],"manufacturer_name":["Aphena Pharma Solutions - Tennessee, LLC"],"application_number":["M012"],"original_packager_product_ndc":["54738-025"]},"purpose":["Purpose Antiemetic"],"version":"2","warnings":["Warnings Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to an elarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product you may get drowsy avoid alcoholic drinks alcohol, sedatives and tranquilizers may increse drowsiness be careful when driving a moor vehicle or operating machinery"],"questions":["Questions or Comments Call 804-270-4498, 8.30 am-4.30 pm ET, Monday - Friday TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING"],"effective_time":"20250109","active_ingredient":["Active ingredient Meclizine Hydrochloride 25 mg"],"inactive_ingredient":["Inactive ingredients Aspartame, compressible sugar, croscarmellose sodium, dextrose, FD&C red 40 (al-lake), magnesium stearate, microcrystalline cellulose, raspberry flavor"],"indications_and_usage":["Uses For the prevention and treatment of nausea, vomiting or dizziness associated with motion sickness. For other uses consult your doctor"],"other_safety_information":["OTHER INFORMATION Phenylketonurics: each tablet contains: phenylalanine 0.28 mg store at room temparature 15 - 30 °C"],"spl_unclassified_section":["Repackaging Information Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: Count 25 mg 30 71610-0528-30 90 71610-0528-60 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20210415JH Aphena Pharma Solutions - TN"],"dosage_and_administration":["Directions take dose one hour before travel starts tablets can be chewed or swallowed whole with water adults & children 12 years and over: take 1-2 tablets once daily children under 12 years: ask a doctor"],"spl_product_data_elements":["Meclizine HCL Meclizine HCl 25mg Chewable Tablets ASPARTAME CROSCARMELLOSE SODIUM DEXTROSE FD&C RED NO. 40 RASPBERRY MAGNESIUM STEARATE MICROCRYSTALLINE CELLULOSE SUCROSE MECLIZINE HYDROCHLORIDE MECLIZINE AP;115"],"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."],"spl_unclassified_section_table":["
Count25 mg
3071610-0528-30
9071610-0528-60
"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 25 mg NDC 71610-528 - Meclizine HCl 25 mg Chewable Tablets Bottle Label 25 mg"]},"tags":[],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"1884 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"1669 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"1585 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"1223 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"1181 reports"},{"date":"","signal":"FALL","source":"FDA FAERS","actionTaken":"1161 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"1147 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"976 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"944 reports"},{"date":"","signal":"ASTHENIA","source":"FDA FAERS","actionTaken":"942 reports"}],"drugInteractions":[],"commonSideEffects":[],"contraindications":["Angle-closure glaucoma","Benign prostatic hyperplasia","Bladder outflow obstruction","Chronic idiopathic constipation","Pyloric obstruction","Retention of urine"],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"approved","trials":["NCT00641797","NCT01537471","NCT03253289","NCT05852730","NCT02625181","NCT01443858","NCT04564144","NCT03270839","NCT04482985","NCT02112578"],"aliases":["Antivert","Bonine","Dramamine Less Drowsy"],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=meclizine","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:06:33.922731+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:06:41.386944+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T01:06:32.557201+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=meclizine","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:06:42.195554+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:06:31.261293+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:06:31.261349+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-20T01:06:43.796678+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1623/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:06:42.660622+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"M012","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T01:06:31.261360+00:00"}},"allNames":"antivert","offLabel":[],"timeline":[],"aiSummary":"Meclizine, also known as Antivert, is a small molecule antihistamine used to treat motion sickness and dizziness (vertigo). It is taken by mouth and its effects typically begin within an hour, lasting for up to a day.","brandName":"Antivert","companyId":"unknown","ecosystem":[],"mechanism":{"target":"Nuclear receptor subfamily 1 group I member 3, Serine protease hepsin, Histamine H1 receptor","novelty":"","modality":"Small molecule","drugClass":"Antihistamine/Antiemetic (vestibular suppressant)","explanation":"","oneSentence":"","technicalDetail":""},"commercial":null,"references":[],"_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:06:45.491955+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"companyName":"Generic (originally Pfizer/UCB)","competitors":[],"dataSources":[{"url":"https://clinicaltrials.gov","name":"ClinicalTrials.gov","fields":["trialDetails","trials"],"retrievedDate":"2026-04-07"},{"url":"https://drugcentral.org","name":"DrugCentral","fields":["indications","contraindications","safety","target","drugInteractions"],"retrievedDate":"2026-04-07"}],"genericName":"meclizine","indications":{"approved":[{"name":"Motion sickness","diseaseId":"motion-sickness","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Prevention of Motion Sickness","diseaseId":"prevention-of-motion-sickness","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"},{"name":"Vertigo","diseaseId":"vertigo","approvalDate":"","lineOfTherapy":"","approvalCountry":"United States"}],"offLabel":[],"pipeline":[]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT00641797","phase":"NA","title":"A Randomized Trial to Evaluate Resolution of Symptoms Using Vestibular Rehab Versus Conventional Therapy in Patients Presenting to the Emergency Department (ED) With Diagnosis of Benign Paroxysmal Pos","status":"COMPLETED","sponsor":"Lehigh Valley Hospital","isPivotal":false,"enrollment":26,"indication":"Benign Paroxysmal Positional Vertigo","completionDate":"2013-11"},{"nctId":"NCT01537471","phase":"Phase 1","title":"A Pilot Study of the Effects of Meclizine on Pre-Pulse Inhibition","status":"COMPLETED","sponsor":"Duke University","isPivotal":false,"enrollment":117,"indication":"Healthy","completionDate":"2012-09"},{"nctId":"NCT03253289","phase":"Phase 1","title":"A Window of Opportunity Trial with Meclizine in Hepatocellular Carcinoma","status":"COMPLETED","sponsor":"Tannaz Armaghnay","isPivotal":false,"enrollment":13,"indication":"Carcinoma, Hepatocellular","completionDate":"2023-03-28"},{"nctId":"NCT05852730","phase":"Phase 2","title":"Optimizing the Combination of Intranasal Scopolamine and Sensory Augmentation to Mitigate G-transition Induced Motion Sickness and Enhance Sensorimotor Performance. Motion Sickness Countermeasures Fie","status":"RECRUITING","sponsor":"Repurposed Therapeutics, Inc.","isPivotal":false,"enrollment":80,"indication":"Motion Sickness, Space, Motion Simulation","completionDate":"2026-09"},{"nctId":"NCT02625181","phase":"NA","title":"Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis","status":"COMPLETED","sponsor":"Vanderbilt University","isPivotal":false,"enrollment":27034,"indication":"Postoperative Nausea and Vomiting","completionDate":"2017-11-30"},{"nctId":"NCT01443858","phase":"Phase 2","title":"Meclizine as a Potential Smoking Cessation Treatment","status":"COMPLETED","sponsor":"Duke University","isPivotal":false,"enrollment":146,"indication":"Smoking Cessation","completionDate":"2013-07"},{"nctId":"NCT04564144","phase":"Phase 1","title":"A New Dual Function Oro-Dissolvable/Dispersible Meclizine HCL Tablet to Challenge Patient Inconvenience: In-Vitro Evaluation and In-Vivo Assessment in Human Volunteers","status":"UNKNOWN","sponsor":"Mansoura University","isPivotal":false,"enrollment":6,"indication":"Emesis","completionDate":"2020-12-01"},{"nctId":"NCT03270839","phase":"Phase 4","title":"Motion Sickness Medications and Vestibular Time Constant","status":"COMPLETED","sponsor":"Medical Corps, Israel Defense Force","isPivotal":false,"enrollment":54,"indication":"Drug Reaction","completionDate":"2020-01-01"},{"nctId":"NCT04482985","phase":"Phase 4","title":"Meclizine Plasma Levels in Responders and Non-responders","status":"UNKNOWN","sponsor":"Medical Corps, Israel Defense Force","isPivotal":false,"enrollment":50,"indication":"Seasickness, Meclizine","completionDate":"2021-09-01"},{"nctId":"NCT02112578","phase":"Phase 3","title":"\" National, Phase III, Radomized, Double-Blind, Double -Dummy, Controlled, Parallel to Evaluate Non Inferiority of Meclin® (Meclizine Chlorhydrate) Versus Dramin® (Dimenhydrinate) Soft Gel Capsules in","status":"COMPLETED","sponsor":"Apsen Farmaceutica S.A.","isPivotal":true,"enrollment":292,"indication":"Vertigo, Peripheral","completionDate":"2017-12-01"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"Oral","frequency":"Once to three times daily","formulation":"Tablet, Chewable tablet"},"crossReferences":{"chemblId":"CHEMBL1623"},"formularyStatus":[],"apiManufacturers":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":313,"therapeuticAreas":["Other"],"biosimilarFilings":[],"firstApprovalDate":"1957-01-01","companionDiagnostics":[],"firstApprovalCountry":"United States","genericManufacturerList":[],"modality":"Small molecule","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"1999-11-10T00:00:00.000Z","mah":"CASPER PHARMA LLC","brand_name_local":null,"application_number":"NDA010721"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2013-08-15T00:00:00.000Z","mah":"AMNEAL PHARMS","brand_name_local":null,"application_number":"ANDA201451"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2019-12-23T00:00:00.000Z","mah":"AUROBINDO PHARMA USA","brand_name_local":null,"application_number":"ANDA202640"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2019-12-23T00:00:00.000Z","mah":"EPIC PHARMA LLC","brand_name_local":null,"application_number":"ANDA200294"},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2022-08-11T00:00:00.000Z","mah":"CHARTWELL RX","brand_name_local":null,"application_number":"ANDA203003"},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":1,"withResults":0},"validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T01:06:45.491955+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}