{"id":"dexbrompheniramine-maleate","_fda":{"id":"4513db4f-e8f2-ecc6-e063-6294a90a1b17","set_id":"0d203b5c-8b10-428b-8703-17be6b4ce6eb","openfda":{"upc":["0350991783605"],"unii":["BPA9UT29BS"],"route":["ORAL"],"rxcui":["2262293","2262295"],"spl_id":["4513db4f-e8f2-ecc6-e063-6294a90a1b17"],"brand_name":["ALA-HIST IR"],"spl_set_id":["0d203b5c-8b10-428b-8703-17be6b4ce6eb"],"package_ndc":["50991-783-02","50991-783-60"],"product_ndc":["50991-783"],"generic_name":["DEXBROMPHENIRAMINE MALEATE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["DEXBROMPHENIRAMINE MALEATE"],"manufacturer_name":["Poly Pharmaceuticals, Inc."],"application_number":["M012"],"is_original_packager":[true]},"purpose":["Purpose Antihistamine"],"version":"11","warnings":["Warnings Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma trouble urinating due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product excitability may occur, especially in children may cause drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery If pregnant or breast-feeding, 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."],"questions":["Questions? Call 1-800-882-1041 Manufactured for: Poly Pharmaceuticals Quitman, MS 39355 Rev. 02/12"],"when_using":["When using this product excitability may occur, especially in children may cause drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery If pregnant or breast-feeding, ask a health professional before use."],"effective_time":"20251203","active_ingredient":["Drug Facts Active ingredients (in each tablet) Dexbrompheniramine Maleate 2 mg Purpose Antihistamine"],"inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C Blue #1 aluminum lake, FD&C Yellow #5 aluminum lake, magnesium stearate, and silicified microcrystalline cellulose."],"storage_and_handling":["Other information Store at 15° - 30°C (59° - 86°F). Supplied in a tight, light-resistant container with a child-resistant cap. Contains color additives including FD&C Yellow No. 5 (tartrazine). Ala-Hist IR Tablets are dark green caplet shaped, scored tablets, debossed \"Poly\" bisect \"783\" on one side and plain on the other."],"indications_and_usage":["Uses Temporarily relieves these symptoms due to hay fever (allergic rhinitis) or upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product excitability may occur, especially in children may cause drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase the drowsiness effect use caution when driving a motor vehicle or operating machinery If pregnant or breast-feeding, ask a health professional before use."],"dosage_and_administration":["Directions Adults and children 12 years of age and over: 1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours. Children 6 to under 12 years of age: 1/2 tablet every 4 to 6 hours, not to exceed 3 tablets in 24 hours. Children under 6 years of age: Consult a doctor."],"spl_product_data_elements":["ALA-HIST IR Dexbrompheniramine Maleate CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE SILICON DIOXIDE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE DEXBROMPHENIRAMINE MALEATE DEXBROMPHENIRAMINE dark green Poly;783"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, 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."],"dosage_and_administration_table":["<table width=\"500px\"><col/><col/><tbody><tr><td valign=\"top\">Adults and children  12 years of age and  over: </td><td valign=\"top\">1 tablet every 4 to 6  hours, not to exceed  6 tablets in 24 hours. </td></tr><tr><td valign=\"top\">Children 6 to under  12 years of age: </td><td valign=\"top\">1/2 tablet every 4 to 6  hours, not to exceed  3 tablets in 24 hours. </td></tr><tr><td valign=\"top\">Children under 6  years of age: </td><td valign=\"top\">Consult a doctor. </td></tr></tbody></table>"],"package_label_principal_display_panel":["Product Packaging The packaging below represents the labeling currently used. Principal display panel and side panel for 60 tablets label: NDC 50991-783-60 ALA-HIST IR 2 mg Tablets Antihistamine Each tablet contains: Dexbrompheniramine Maleate.........2 mg 60 Tablets Usual Dosage: See product foldout for full prescribing information Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing. KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN. Store at controlled room temperature 15°-30°C (59°-86°F). Manufactured for: Poly Pharmaceuticals Rev. 02/12 label insert"]},"safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"34 reports"},{"date":"","signal":"ANXIETY","source":"FDA FAERS","actionTaken":"29 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"23 reports"},{"date":"","signal":"ARTHRALGIA","source":"FDA FAERS","actionTaken":"16 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"16 reports"},{"date":"","signal":"DEPRESSION","source":"FDA FAERS","actionTaken":"15 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"15 reports"},{"date":"","signal":"PAIN IN EXTREMITY","source":"FDA FAERS","actionTaken":"15 reports"},{"date":"","signal":"BRONCHITIS","source":"FDA FAERS","actionTaken":"14 reports"},{"date":"","signal":"COUGH","source":"FDA FAERS","actionTaken":"14 reports"}]},"_chembl":null,"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=DEXBROMPHENIRAMINE MALEATE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T04:46:41.074969+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T04:47:06.151720+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T04:46:47.838423+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DEXBROMPHENIRAMINE MALEATE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T04:46:48.520502+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T04:46:38.834196+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T04:47:00.937924+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T04:46:38.834246+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":"2026-04-20T04:46:50.315254+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Histamine H1 receptor antagonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T04:46:49.377199+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200638/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T04:46:49.277878+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"M012","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T04:46:38.834252+00:00"}},"_dailymed":{"setId":"2a343656-ac6d-8b20-e063-6294a90ab319","title":"CONEX (DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL) LIQUID [LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION]"},"aiSummary":"Dexbrompheniramine Maleate is a marketed antihistamine primarily indicated for the relief of hay fever symptoms. The drug's key composition patent is set to expire in 2028, providing a period of market exclusivity and potential revenue stability. The primary risk is the loss of patent protection in 2028, which could lead to increased competition from generic alternatives.","_scrapedAt":"2026-03-28T00:39:19.379Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T04:47:06.152218+00:00","fieldsConflicting":0,"overallConfidence":0.95},"indications":{"approved":[{"id":"dexbrompheniramine-maleate-hay-fever-symptoms-relief","name":"Hay Fever Symptoms Relief","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Individuals with hay fever (allergic rhinitis)","pivotalTrial":null,"restrictions":[],"patientPopulation":"Individuals with hay fever (allergic rhinitis)","diagnosticRequired":null,"brandNameForIndication":""},{"id":"dexbrompheniramine-maleate-upper-respiratory-allergies-sy","name":"Upper Respiratory Allergies Symptoms Relief","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Individuals with upper respiratory allergies","pivotalTrial":null,"restrictions":[],"patientPopulation":"Individuals with upper respiratory allergies","diagnosticRequired":null,"brandNameForIndication":""}]},"trialDetails":[],"_emaApprovals":[],"_faersSignals":[],"administration":{"route":"Oral"},"crossReferences":{"chemblId":"CHEMBL1200638"},"_approvalHistory":[],"publicationCount":11,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"approved","brandName":"DEXBROMPHENIRAMINE MALEATE","genericName":"DEXBROMPHENIRAMINE MALEATE","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"1963","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":0,"withResults":0},"validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T04:47:06.152218+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"enriching","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":false,"score":1}}