{"id":"chlorpheniramine","rwe":[],"_fda":{"id":"43810cbb-1d34-d1ff-e063-6294a90a2b40","set_id":"01a1a91e-04ba-4526-8946-10483932b30c","openfda":{"unii":["V1Q0O9OJ9Z"],"route":["ORAL"],"rxcui":["1363309"],"spl_id":["43810cbb-1d34-d1ff-e063-6294a90a2b40"],"brand_name":["SPRINSOL"],"spl_set_id":["01a1a91e-04ba-4526-8946-10483932b30c"],"package_ndc":["51467-101-01","51467-101-02"],"product_ndc":["51467-101"],"generic_name":["CHLORPHENIRAMINE MALEATE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["CHLORPHENIRAMINE MALEATE"],"manufacturer_name":["FORTUNE PHARMACAL COMPANY LIMITED"],"application_number":["M012"],"is_original_packager":[true]},"purpose":["Purpose Antihistamine"],"version":"3","warnings":["Warnings Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland"],"questions":["Questions or comments? (888) 221-3496 M-F 9 am to 5 pm you may also report serious side effects to this phone number"],"when_using":["When using this product do not exceed recommended dosage unless directed by a physician may cause excitability especially in children use caution when driving or operating machinery avoid alcoholic beverages may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect"],"effective_time":"20251113","active_ingredient":["Active ingredients (in each tablet) Chlorpheniramine maleate 4 mg"],"inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, corn starch, FD C red no. 40 aluminum lake, lactose monohydrate, magnesium stearate, povidone K30, sodium starch glycolate"],"indications_and_usage":["Uses temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: sneezing runny nose 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"],"other_safety_information":["Other information keep tightly sealed protect from light store between 20 to 25 C (68 to 77 F)"],"dosage_and_administration":["Directions adults and children 12 years of age and over: take 1 tablet every 4 to 6 hours, not to exceed 6 tablets (24 mg) in 24 hours, or as directed by a doctor children under 12 years of age: consult a doctor"],"spl_product_data_elements":["SPRINSOL Chlorpheniramine maleate SILICON DIOXIDE STARCH, CORN FD&C RED NO. 40 LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE K30 SODIUM STARCH GLYCOLATE TYPE A POTATO CHLORPHENIRAMINE MALEATE CHLORPHENIRAMINE FORTUNE"],"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"],"package_label_principal_display_panel":["Sprinsol Safely Sealed NDC 51467-101-02 Chlorpheniramine maleate - Antihistamine temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: sneezing runny nose itching of the nose or throat itchy, watery eyes 36 Tablets In Individually Sealed Strip Respiratory Series IMAGE OF CARTON"]},"tags":[],"safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"5135 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"3826 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"3606 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"3454 reports"},{"date":"","signal":"DYSPNOEA","source":"FDA FAERS","actionTaken":"3393 reports"},{"date":"","signal":"DIARRHOEA","source":"FDA FAERS","actionTaken":"2993 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"2553 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"2530 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"2509 reports"},{"date":"","signal":"COUGH","source":"FDA FAERS","actionTaken":"2215 reports"}],"drugInteractions":[{"drug":"Alcohol","action":"Avoid","effect":"Increased drowsiness"},{"drug":"Sedatives","action":"Monitor","effect":"Increased sedation"},{"drug":"Monoamine oxidase inhibitors (MAOIs)","action":"Avoid","effect":"Increased risk of anticholinergic side effects"}],"commonSideEffects":[],"contraindications":[],"specialPopulations":{"Pregnancy":"Use only if clearly needed.","Geriatric use":"Use with caution; monitor for increased sensitivity.","Paediatric use":"Consult a doctor for children under 12 years of age.","Renal impairment":"Use with caution; adjust dose if necessary.","Hepatic impairment":"Use with caution; adjust dose if necessary."},"seriousAdverseEvents":[]},"trials":[],"_chembl":{"chemblId":"CHEMBL180454","moleculeType":"Small molecule","molecularWeight":"390.87"},"aliases":["chlorphenamine"],"patents":[],"pricing":[],"_fixedAt":"2026-03-30T14:17:33.427800","_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=CHLORPHENIRAMINE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:21:58.861736+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T00:22:23.709334+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:22:04.262575+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:21:57.990711+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=CHLORPHENIRAMINE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:22:04.550988+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:21:55.796685+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:22:17.164672+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:21:55.796709+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":"2026-04-20T00:22:06.069909+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL180454/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:22:05.253357+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"M012","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:21:55.796713+00:00"}},"allNames":"CHLORPHENIRAMINE, chlorphenamine, chlorpheniramine","offLabel":[],"timeline":[{"date":"1948-01-01","type":"positive","milestone":"First synthesis of chlorpheniramine","regulator":"none","description":"Chlorpheniramine was first synthesized."},{"date":"1949-01-01","type":"positive","milestone":"FDA approval for allergic rhinitis","regulator":"FDA","description":"Chlorpheniramine received FDA approval for the treatment of allergic rhinitis."},{"date":"1950-01-01","type":"positive","milestone":"Widespread market availability","regulator":"none","description":"Chlorpheniramine became widely available in the market."},{"date":"2000-01-01","type":"negative","milestone":"Generic competition begins","regulator":"none","description":"Generic versions of chlorpheniramine began to enter the market."}],"_dailymed":{"setId":"7d1b3418-85a8-4ca0-bca7-261b2b58032a","title":"FLU HBP MAXIMUM STRENGTH (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [CHAIN DRUG MARKETING ASSOCIATION INC]"},"aiSummary":"Chlorpheniramine is a marketed antihistamine used primarily for relieving hay fever symptoms, with a key composition patent expiring in 2028. Its key strength lies in its well-established mechanism of selectively blocking histamine H1 receptors, effectively reducing allergy symptoms. However, it faces significant competition from less sedating and longer-lasting alternatives such as Cetirizine (Pfizer), Loratadine (Schering-Plough), and Fexofenadine (Sanofi).","ecosystem":[],"mechanism":{"target":"Histamine H1 receptor","novelty":"me-too","modality":"small molecule","drugClass":"Antihistamine","explanation":"","oneSentence":"","technicalDetail":"Chlorpheniramine is a small molecule that selectively binds to histamine H1 receptors with high affinity. It is rapidly absorbed orally and has a relatively short half-life, requiring multiple doses throughout the day. Its antihistaminic properties are well-characterized, and it is effective in reducing both immediate and delayed allergic responses."},"_scrapedAt":"2026-03-28T00:33:06.188Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"notes":"","yoyGrowth":"","launchDate":"","marketShare":"","revenueYear":"","annualCostUS":"$10/year (2023 WAC)","currentRevenue":"","percentOfCompany":"","patientPopulation":"~30M globally","peakSalesEstimate":"","genericCompetition":"yes"},"references":[],"_validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T00:22:23.709434+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"name":"Cetirizine","slug":"cetirizine","company":"Pfizer","advantage":"Less sedating, longer-lasting"},{"name":"Loratadine","slug":"loratadine","company":"Schering-Plough","advantage":"Non-sedating, once-daily dosing"},{"name":"Fexofenadine","slug":"fexofenadine","company":"Sanofi","advantage":"Non-sedating, effective for seasonal 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