{"id":"brompheniramine","rwe":[{"pmid":"41635965","year":"2026","title":"Capillary Electrophoretic Chiral Separation of Antihistamines: Enantiomers Recognition Mechanism by Isothermal Titration Calorimetry and Simulation Studies.","finding":"","journal":"Chirality","studyType":"Clinical Study"},{"pmid":"41282384","year":"2025","title":"Serotonin syndrome induced by Bromfed DM in a patient on sertraline.","finding":"","journal":"SAGE open medical case reports","studyType":"Clinical Study"},{"pmid":"30000263","year":"2006","title":"Brompheniramine.","finding":"","journal":"","studyType":"Clinical Study"},{"pmid":"39192218","year":"2024","title":"Identification of RCAN1's role in hepatocellular carcinoma using single-cell analysis.","finding":"","journal":"BMC cancer","studyType":"Clinical Study"},{"pmid":"39113544","year":"2024","title":"Dithiocarbamate-based novel anti-histaminic agents: synthesis, characterization, crystal structure and thermal study.","finding":"","journal":"Dalton transactions (Cambridge, England : 2003)","studyType":"Clinical Study"}],"_fda":{"id":"36a84a46-7142-f5e6-e063-6294a90a5f3b","set_id":"004e104b-d6ff-48d5-8685-cd1bff45399a","openfda":{"unii":["IXA7C9ZN03"],"route":["ORAL"],"rxcui":["2685263"],"spl_id":["36a84a46-7142-f5e6-e063-6294a90a5f3b"],"brand_name":["CVS PHARMACY Childrens Cold and Allergy"],"spl_set_id":["004e104b-d6ff-48d5-8685-cd1bff45399a"],"package_ndc":["51316-693-04"],"product_ndc":["51316-693"],"generic_name":["BROMPHENIRAMINE MALEATE"],"product_type":["HUMAN OTC DRUG"],"substance_name":["BROMPHENIRAMINE MALEATE"],"manufacturer_name":["CVS PHARMACY, INC."],"application_number":["M012"],"is_original_packager":[true]},"purpose":["Purposes Antihistamine"],"version":"2","warnings":["Warnings Do not use to sedate a child or to make a child sleepy Ask a doctor before use if you have trouble urinating due to an enlarged prostate gland glaucoma a breathing problem such as emphysema, or chronic bronchitis. Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers When using this product do not use more than directed drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children 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 at 1-800-222-1222."],"questions":["Questions or comments? 1-866-467-2748"],"ask_doctor":["Ask a doctor before use if you have trouble urinating due to an enlarged prostate gland glaucoma a breathing problem such as emphysema, or chronic bronchitis."],"do_not_use":["Do not use to sedate a child or to make a child sleepy"],"when_using":["When using this product do not use more than directed drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children"],"effective_time":"20250603","active_ingredient":["Active Ingredients (in each 10 mL) Brompheniramine maleate, USP 2 mg"],"inactive_ingredient":["Inactive ingredients citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sodium citrate, sorbitol liquid, sucralose"],"indications_and_usage":["Uses temporarily relieves: runny nose sneezing itchy, watery eyes due to hay fever itching of the nose or throat"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers"],"spl_unclassified_section":["Drug Facts","Other information each 10 ml contains: sodium 6 mg store at room temperature"],"dosage_and_administration":["Directions do not take more than 6 doses in any 24-hour period measure only with dosage cup provided keep dosage cup with product ml = milliliter age Dose adults and children 12 years and over 20 ml every 4 hours children 6 to under 12 years 10 ml every 4 hours children under 6 years do not use"],"spl_product_data_elements":["CVS PHARMACY Childrens Cold and Allergy Brompheniramine maleate ANHYDROUS CITRIC ACID FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYL GALLATE PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE BROMPHENIRAMINE MALEATE BROMPHENIRAMINE purple liquid"],"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 at 1-800-222-1222."],"dosage_and_administration_table":["<table width=\"100%\" styleCode=\"Noautorules\"><col width=\"40%\"/><col width=\"43%\"/><thead><tr><th align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"bottom\"><content styleCode=\"bold\">age</content></th><th align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"bottom\"><content styleCode=\"bold\">Dose</content></th></tr></thead><tbody><tr><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>adults and children 12 years and over</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"middle\"><paragraph>20 ml every 4 hours</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Lrule Botrule \" valign=\"middle\"><paragraph>children 6 to under 12 years</paragraph></td><td align=\"center\" styleCode=\"Rrule Lrule Toprule Botrule \" valign=\"middle\"><paragraph>10 ml every 4 hours</paragraph></td></tr><tr><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph>children under 6 years</paragraph></td><td align=\"center\" styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"middle\"><paragraph>do not use</paragraph></td></tr></tbody></table>"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 118 ml Bottle Label Compare to the active ingredients in Children’s Dimetapp® Cold & Allergy* NDC# 51316-693-04 Children's Cold & Allergy Brompheniramine Maleate USP (Antihistamine) Relieves + comforts: Runny Nose Itchy, Watery Eyes Sneezing Itchy throat For Ages 6 Years and Over Grape Flavor Naturally and Artificially Flavored No Added Alcohol No Added Sugar 4 FL OZ (118 ml) IMPORTANT: Keep this carton for future reference on full labeling. Distributed by: *This product is not manufactured or distributed by Foundation Consumer Healthcare, LLC, the distributor of Children’s Dimetapp® Cold & Allergy. CVS Childrens Cold and Allergy Relief 4 FL OZ 118 ml"],"package_label_principal_display_panel_table":["<table width=\"100%\" styleCode=\"Noautorules\"><col width=\"100%\"/><tbody><tr><td styleCode=\"Rrule Botrule Lrule Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">IMPORTANT:</content>Keep this carton for future reference on full labeling. </paragraph></td></tr></tbody></table>"]},"tags":[{"label":"brompheniramine","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Histamine H1 receptor","category":"target"},{"label":"HRH1","category":"gene"},{"label":"KCNH2","category":"gene"},{"label":"SCN1A","category":"gene"},{"label":"R06AB01","category":"atc"},{"label":"Oral","category":"route"},{"label":"Elixir","category":"form"},{"label":"Liquid","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Allergic conjunctivitis","category":"indication"},{"label":"Allergic rhinitis","category":"indication"},{"label":"Dermatographic urticaria","category":"indication"},{"label":"Influenza-like symptoms","category":"indication"},{"label":"Itching of skin","category":"indication"},{"label":"Nasal discharge","category":"indication"},{"label":"Approved 1950s","category":"decade"},{"label":"Anti-Allergic Agents","category":"pharmacology"},{"label":"Histamine Agents","category":"pharmacology"},{"label":"Histamine Antagonists","category":"pharmacology"},{"label":"Histamine H1 Antagonists","category":"pharmacology"},{"label":"Neurotransmitter Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"CEREBROVASCULAR ACCIDENT","source":"FDA FAERS","actionTaken":"124 reports"},{"date":"","signal":"HAEMORRHAGIC STROKE","source":"FDA FAERS","actionTaken":"31 reports"},{"date":"","signal":"CONVULSION","source":"FDA FAERS","actionTaken":"25 reports"},{"date":"","signal":"DRUG HYPERSENSITIVITY","source":"FDA FAERS","actionTaken":"18 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"17 reports"},{"date":"","signal":"INJURY","source":"FDA FAERS","actionTaken":"16 reports"},{"date":"","signal":"HEMIPARESIS","source":"FDA FAERS","actionTaken":"15 reports"},{"date":"","signal":"HYPERTENSION","source":"FDA FAERS","actionTaken":"15 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"13 reports"},{"date":"","signal":"FALL","source":"FDA FAERS","actionTaken":"13 reports"}],"commonSideEffects":[],"contraindications":["Achalasia of esophagus","Acidosis","Acute abdominal pain","Acute exacerbation of asthma","Acute hepatitis","Acute pancreatitis","Alcohol intoxication","Alcohol withdrawal delirium","Alcoholism","Angle-closure glaucoma","Arterial thrombosis","Arteriosclerotic vascular disease","Asthenia","Atony of colon","Autonomic dysreflexia","Benign intracranial hypertension","Benign prostatic hyperplasia","Bladder outflow obstruction","Bleeding","Bradycardia","Brain damage","Breastfeeding (mother)","Central nervous system depression","Chronic disease of respiratory system","Chronic heart failure"],"specialPopulations":{"Pregnancy":"Pregnancy Category C: Animal reproduction studies have not been conducted with Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup. It is also not known whether Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide Syrup can cause fetal harm when administered to pregnant woman or can affect reproduction capacity. It should be given to pregnant woman only if clearly needed.","Geriatric use":"Clinical studies of brompheniramine maleate, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide syrup mg/30 mg/10 mg per mL did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, antihistamines are more likely to cause dizziness, sedation, and hypotension in elderly patients. The elderly are also more likely to experience adverse reactions to sympathomimetics.In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.","Paediatric use":"Safety and effectiveness in pediatric patients below the age of months have not been established (see DOSAGE AND ADMINISTRATION)."}},"trials":[],"aliases":[],"patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=BROMPHENIRAMINE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:56:30.776349+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:56:36.726808+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-19T23:56:29.886076+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BROMPHENIRAMINE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:56:37.080152+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:56:29.055638+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:56:29.055662+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":"2026-04-19T23:56:38.549368+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Histamine H1 receptor antagonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:56:38.139972+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200961/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:56:37.794518+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"M012","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:56:29.055666+00:00"}},"allNames":"dimetane-dx","offLabel":[],"synonyms":["brompheniramine","bromopheniramine","bromphen","parabromdylamine","parabromodylamine","brompheniramine maleate"],"timeline":[{"date":"1957-08-23","type":"positive","source":"DrugCentral","milestone":"FDA approval"}],"aiSummary":"Dimetane-Dx (BROMPHENIRAMINE) is a small molecule histamine H1 receptor antagonist developed by and currently owned by various generic manufacturers. It was first approved by the FDA in 1957 for the treatment of allergic conjunctivitis, allergic rhinitis, dermatographic urticaria, influenza-like symptoms, itching of the skin, nasal discharge, seasonal allergic rhinitis, and urticaria. As an off-patent medication, Dimetane-Dx is available from multiple generic manufacturers. Key safety considerations include potential drowsiness and anticholinergic side effects. Dimetane-Dx is a commercial option for patients seeking relief from allergic symptoms.","brandName":"Dimetane-Dx","ecosystem":[{"indication":"Allergic conjunctivitis","otherDrugs":[{"name":"acrivastine","slug":"acrivastine","company":"Auxilium Pharms Inc"},{"name":"alcaftadine","slug":"alcaftadine","company":"Allergan"},{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"antazoline","slug":"antazoline","company":"Novartis"}],"globalPrevalence":null},{"indication":"Allergic rhinitis","otherDrugs":[{"name":"acrivastine","slug":"acrivastine","company":"Auxilium Pharms Inc"},{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"antazoline","slug":"antazoline","company":"Novartis"},{"name":"astemizole","slug":"astemizole","company":""}],"globalPrevalence":null},{"indication":"Dermatographic urticaria","otherDrugs":[{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"antazoline","slug":"antazoline","company":"Novartis"},{"name":"azatadine","slug":"azatadine","company":""},{"name":"carbinoxamine","slug":"carbinoxamine","company":"Mcneil"}],"globalPrevalence":68000000},{"indication":"Influenza-like symptoms","otherDrugs":[{"name":"acetylsalicylic acid","slug":"acetylsalicylic-acid","company":"Endo Pharms"},{"name":"caffeine","slug":"caffeine","company":"Novartis"},{"name":"chlorphenamine","slug":"chlorphenamine","company":"Bayer Healthcare Llc"},{"name":"codeine","slug":"codeine","company":"Ani Pharms"}],"globalPrevalence":null},{"indication":"Itching of skin","otherDrugs":[{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"allantoin","slug":"allantoin","company":""},{"name":"ammonium lactate","slug":"ammonium-lactate","company":"Ranbaxy"},{"name":"antazoline","slug":"antazoline","company":"Novartis"}],"globalPrevalence":null},{"indication":"Nasal discharge","otherDrugs":[{"name":"acrivastine","slug":"acrivastine","company":"Auxilium Pharms Inc"},{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"ammonium chloride","slug":"ammonium-chloride","company":"B Braun"},{"name":"antazoline","slug":"antazoline","company":"Novartis"}],"globalPrevalence":30000000},{"indication":"Seasonal allergic rhinitis","otherDrugs":[{"name":"acrivastine","slug":"acrivastine","company":"Auxilium Pharms Inc"},{"name":"azatadine","slug":"azatadine","company":""},{"name":"azelastine","slug":"azelastine","company":"Meda Pharms"},{"name":"carbinoxamine","slug":"carbinoxamine","company":"Mcneil"}],"globalPrevalence":null},{"indication":"Urticaria","otherDrugs":[{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"antazoline","slug":"antazoline","company":"Novartis"},{"name":"azatadine","slug":"azatadine","company":""},{"name":"carbinoxamine","slug":"carbinoxamine","company":"Mcneil"}],"globalPrevalence":68000000}],"mechanism":{"target":"Histamine H1 receptor","novelty":"Follow-on","targets":[{"gene":"HRH1","source":"DrugCentral","target":"Histamine H1 receptor","protein":"Histamine H1 receptor"},{"gene":"KCNH2","source":"DrugCentral","target":"Potassium voltage-gated channel subfamily H member 2","protein":"Potassium voltage-gated channel subfamily H member 2"},{"gene":"SCN1A","source":"DrugCentral","target":"Sodium channel alpha subunits; brain (Types I, II, III)","protein":"Sodium channel protein type 1 subunit alpha"},{"gene":"SCN2A","source":"DrugCentral","target":"Sodium channel alpha subunits; brain (Types I, II, III)","protein":"Sodium channel protein type 2 subunit alpha"},{"gene":"SCN3A","source":"DrugCentral","target":"Sodium channel alpha subunits; brain (Types I, II, III)","protein":"Sodium channel protein type 3 subunit alpha"}],"modality":"Small Molecule","drugClass":"brompheniramine","explanation":"","oneSentence":"","technicalDetail":"Dimetane-Dx (BROMPHENIRAMINE) is a competitive antagonist of the histamine H1 receptor, with a bioavailability of 89% and an unknown half-life. It is a non-selective H1 receptor antagonist, meaning it blocks the action of histamine at all H1 receptors in the body."},"commercial":{"launchDate":"1957","_launchSource":"DrugCentral (FDA 1957-08-23, )"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/408","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=BROMPHENIRAMINE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BROMPHENIRAMINE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange 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Combination of Brompheniramine and Phenylephrine for the Symptoms Relief of Rhinitis","status":"COMPLETED","sponsor":"Ache Laboratorios Farmaceuticos S.A.","startDate":"2014-08","conditions":["Nasal Congestion and Inflammations","Rhinitis"],"enrollment":879,"completionDate":"2016-12"},{"nctId":"NCT01393561","phase":"PHASE3","title":"Efficacy and Safety of Combination of Brompheniramine and Phenylephrine for the Symptoms Relief of Rhinitis","status":"COMPLETED","sponsor":"Ache Laboratorios Farmaceuticos S.A.","startDate":"2014-07","conditions":["Nasal Congestion and Inflammations","Rhinitis"],"enrollment":167,"completionDate":"2014-12"},{"nctId":"NCT01177852","phase":"PHASE3","title":"Evaluation of Efficacy and Safety in Control Cough and the Relief of Nasal Symptoms in Children 2-12 Years Old,Suffering From Cough and Acute Rhinitis","status":"WITHDRAWN","sponsor":"Ache Laboratorios Farmaceuticos 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