{"id":"triprolidine","rwe":[],"_fda":{"id":"42d6699c-dcfd-859b-e063-6294a90a0433","set_id":"05e944d5-3473-4d8c-8df4-2ffc7474e9fa","openfda":{"unii":["362O9ITL9D","9D2RTI9KYH","YAN7R5L890"],"route":["ORAL"],"rxcui":["2173667"],"spl_id":["42d6699c-dcfd-859b-e063-6294a90a0433"],"brand_name":["Target Overnight Cold and Flu"],"spl_set_id":["05e944d5-3473-4d8c-8df4-2ffc7474e9fa"],"package_ndc":["11673-698-06"],"product_ndc":["11673-698"],"generic_name":["ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL"],"product_type":["HUMAN OTC DRUG"],"substance_name":["ACETAMINOPHEN","DEXTROMETHORPHAN HYDROBROMIDE","TRIPROLIDINE HYDROCHLORIDE"],"manufacturer_name":["TARGET CORPORATION"],"application_number":["M012"],"is_original_packager":[true]},"purpose":["Active ingredients (in each 20 mL) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Triprolidine HCl 2.5 mg Antihistamine"],"version":"8","stop_use":["Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition."],"warnings":["Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take: more than 4000 mg in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Allergy alert Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have liver disease glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks use caution when driving a motor vehicle or operating machinery Stop use and ask a doctor if pain or cough gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur cough comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"questions":["Questions or comments? 1-866-467-2748"],"ask_doctor":["Ask a doctor before use if you have liver disease glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis persistent or chronic cough such as occurs with smoking, asthma, or emphysema cough that occurs with too much phlegm (mucus)"],"do_not_use":["Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product."],"when_using":["When using this product do not use more than directed excitability may occur, especially in children marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness avoid alcoholic drinks use caution when driving a motor vehicle or operating machinery"],"purpose_table":["<table width=\"55%\"><col width=\"32%\"/><col width=\"23%\"/><thead><tr><th align=\"left\" styleCode=\"Botrule Toprule \" valign=\"top\"><content styleCode=\"bold\"><content styleCode=\"italics\">Active ingredients (in each 20 mL)</content></content></th><th align=\"left\" styleCode=\"Botrule Toprule \" valign=\"top\"><content styleCode=\"bold\"><content styleCode=\"italics\">Purposes</content></content></th></tr></thead><tbody><tr><td styleCode=\"Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Acetaminophen 650 mg</content></paragraph></td><td styleCode=\"Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Pain reliever/fever reducer</content></paragraph></td></tr><tr><td valign=\"top\"><paragraph>Dextromethorphan HBr 20 mg</paragraph></td><td valign=\"top\"><paragraph>Cough suppressant</paragraph></td></tr><tr><td styleCode=\"Botrule \" valign=\"top\"><paragraph>Triprolidine HCl 2.5 mg</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>Antihistamine</paragraph></td></tr></tbody></table>"],"effective_time":"20251105","active_ingredient":["Active ingredients (in each 20 mL) Purposes Acetaminophen 650 mg Pain reliever/fever reducer Dextromethorphan HBr 20 mg Cough suppressant Triprolidine HCl 2.5 mg Antihistamine"],"inactive_ingredient":["Inactive ingredients anhydrous citric acid, ascorbic acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, flavors, glycerin, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum"],"storage_and_handling":["Other information each 20 mL contains: sodium 10 mg low sodium store at room temperature do not refrigerate"],"indications_and_usage":["Uses temporarily relieves these common cold and flu symptoms: cough minor aches and pains sore throat headache runny nose sneezing itching of the nose or throat itchy, watery eyes due to hay fever temporarily reduces fever controls cough to help you get to sleep"],"active_ingredient_table":["<table width=\"55%\"><col width=\"32%\"/><col width=\"23%\"/><thead><tr><th align=\"left\" styleCode=\"Botrule Toprule \" valign=\"top\"><content styleCode=\"bold\"><content styleCode=\"italics\">Active ingredients (in each 20 mL)</content></content></th><th align=\"left\" styleCode=\"Botrule Toprule \" valign=\"top\"><content styleCode=\"bold\"><content styleCode=\"italics\">Purposes</content></content></th></tr></thead><tbody><tr><td styleCode=\"Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Acetaminophen 650 mg</content></paragraph></td><td styleCode=\"Toprule \" valign=\"top\"><paragraph><content styleCode=\"bold\">Pain reliever/fever reducer</content></paragraph></td></tr><tr><td valign=\"top\"><paragraph>Dextromethorphan HBr 20 mg</paragraph></td><td valign=\"top\"><paragraph>Cough suppressant</paragraph></td></tr><tr><td styleCode=\"Botrule \" valign=\"top\"><paragraph>Triprolidine HCl 2.5 mg</paragraph></td><td styleCode=\"Botrule \" valign=\"top\"><paragraph>Antihistamine</paragraph></td></tr></tbody></table>"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers"],"spl_unclassified_section":["Drug Facts"],"dosage_and_administration":["Directions do not take more than directed (see Overdose warning ) do not take more than 4 doses in any 24-hour period measure only with dosing cup provided do not use dosing cup with other products dose as follows or as directed by a doctor adults and children 12 years of age and older: 20 mL in dosing cup provided every 4 hours children under 12 years of age: do not use"],"spl_product_data_elements":["Target Overnight Cold and Flu Acetaminophen, Dextromethorphan HBr, Triprolidine HCl XANTHAN GUM ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN TRIPROLIDINE HYDROCHLORIDE TRIPROLIDINE ANHYDROUS CITRIC ACID ASCORBIC ACID EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GLYCERIN PROPYL GALLATE PROPYLENE GLYCOL WATER SODIUM BENZOATE SODIUM CITRATE, UNSPECIFIED FORM SORBITOL SUCRALOSE"],"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."],"package_label_principal_display_panel":["Principal Display Panel - 180 mL Bottle Label Compare to active ingredients Mucinex ® Nightshift Cold & Flu* NDC 11673-698-06 maximum strength Overnight Cold & Flu Acetaminophen – Pain Reliever/Fever Reducer Dextromethorphan HBr – Cough Suppressant Triprolidine HCl – Antihistamine Support better sleep for a better morning Cough Fever Sore throat Runny nose Sneezing Per 4-hours dose up &up AGES 12+ YEARS 6 FL OZ (180 mL) Tamper evident: do not use if printed seal under cap is broken or missing Maximum Strength per 4-hour dose Distributed by: Target Corp. Mpls., MN 55403 TM & ©2020 target Brands Inc. *This product is not manufactured or distributed by RB Health, the distributor of Mucinex® Nightshift Cold & Flu. Target maximum strength overnight cold and flu"]},"tags":[{"label":"triprolidine","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Histamine H1 receptor","category":"target"},{"label":"HRH1","category":"gene"},{"label":"R06AX07","category":"atc"},{"label":"Oral","category":"route"},{"label":"Capsule","category":"form"},{"label":"Liquid","category":"form"},{"label":"Solution","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":"Common cold","category":"indication"},{"label":"Dermatographic urticaria","category":"indication"},{"label":"Itching of skin","category":"indication"},{"label":"Nasal discharge","category":"indication"},{"label":"Sandoz","category":"company"},{"label":"Approved 1980s","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":"PSORIATIC ARTHROPATHY","source":"FDA FAERS","actionTaken":"118 reports"},{"date":"","signal":"TYPE 2 DIABETES MELLITUS","source":"FDA FAERS","actionTaken":"118 reports"},{"date":"","signal":"OEDEMA","source":"FDA FAERS","actionTaken":"117 reports"},{"date":"","signal":"PERICARDITIS","source":"FDA FAERS","actionTaken":"117 reports"},{"date":"","signal":"SINUSITIS","source":"FDA FAERS","actionTaken":"117 reports"},{"date":"","signal":"PEMPHIGUS","source":"FDA FAERS","actionTaken":"116 reports"},{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"116 reports"},{"date":"","signal":"URTICARIA","source":"FDA FAERS","actionTaken":"116 reports"},{"date":"","signal":"JOINT SWELLING","source":"FDA FAERS","actionTaken":"115 reports"},{"date":"","signal":"INJURY","source":"FDA FAERS","actionTaken":"112 reports"}],"commonSideEffects":[],"contraindications":["Acidosis","Acute abdominal pain","Acute exacerbation of asthma","Acute hepatitis","Acute pancreatitis","Angle-closure glaucoma","Arterial thrombosis","Arteriosclerotic vascular disease","Asthenia","Benign intracranial hypertension","Benign prostatic hyperplasia","Bladder outflow obstruction","Bradycardia","Central nervous system depression","Chronic disease of respiratory system","Chronic heart failure","Chronic idiopathic constipation","Conduction disorder of the heart","Coronary arteriosclerosis","Decreased respiratory function","Dependent drug abuse","Diabetes mellitus","Disease of liver","Disorder of coronary artery","Disorder of gallbladder"]},"trials":[],"aliases":[],"company":"Novartis","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.5485/ML","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$197","description":"TRIPROLIDINE 0.938 MG/ML DROPS","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=TRIPROLIDINE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:29:45.865671+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Triprolidine","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T03:29:58.808027+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:29:57.361762+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=TRIPROLIDINE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:29:58.242306+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:29:43.644834+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:30:34.018708+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:29:43.644883+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":"2026-04-20T03:29:59.718462+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200450/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:29:58.700684+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"M012","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:29:43.644889+00:00"}},"allNames":"actidil","offLabel":[],"synonyms":["actidil","triprolidine","triprolidin","tripyrolidine","triprolidine hydrochloride","triprolidine HCl"],"timeline":[{"date":"1983-05-17","type":"positive","source":"DrugCentral","milestone":"FDA approval (Sandoz)"},{"date":"1983-07-01","type":"positive","source":"FDA Orange Book","milestone":"Actidil approved — 2.5MG"}],"aiSummary":"Actidil (triprolidine) is a small molecule histamine H1 receptor antagonist developed by SANDOZ, targeting allergic conditions such as conjunctivitis, rhinitis, and urticaria. It was FDA approved in 1983 and is currently off-patent with multiple generic manufacturers. Actidil works by blocking the histamine H1 receptor, reducing symptoms associated with allergic reactions. The commercial status of Actidil is generic, with no active Orange Book patents. Key safety considerations include its low bioavailability of 4%.","approvals":[{"date":"1983-05-17","orphan":false,"company":"SANDOZ","regulator":"FDA"}],"brandName":"Actidil","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":"Common cold","otherDrugs":[{"name":"acetylsalicylic acid","slug":"acetylsalicylic-acid","company":"Endo Pharms"},{"name":"acrivastine","slug":"acrivastine","company":"Auxilium Pharms Inc"},{"name":"ammonium chloride","slug":"ammonium-chloride","company":"B Braun"},{"name":"azatadine","slug":"azatadine","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":"brompheniramine","slug":"brompheniramine","company":""}],"globalPrevalence":68000000},{"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":"brompheniramine","slug":"brompheniramine","company":""}],"globalPrevalence":null},{"indication":"Urticaria","otherDrugs":[{"name":"alimemazine","slug":"alimemazine","company":"Allergan Herbert"},{"name":"antazoline","slug":"antazoline","company":"Novartis"},{"name":"azatadine","slug":"azatadine","company":""},{"name":"brompheniramine","slug":"brompheniramine","company":""}],"globalPrevalence":68000000}],"mechanism":{"target":"Histamine H1 receptor","novelty":"Follow-on","targets":[{"gene":"HRH1","source":"DrugCentral","target":"Histamine H1 receptor","protein":"Histamine H1 receptor"}],"modality":"Small Molecule","drugClass":"triprolidine","explanation":"","oneSentence":"","technicalDetail":"Actidil (triprolidine) is a competitive antagonist of the histamine H1 receptor, exhibiting a high affinity for the receptor and inhibiting histamine-induced responses in vitro."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Triprolidine","title":"Triprolidine","extract":"Triprolidine is an over-the-counter antihistamine with anticholinergic properties. It is used to combat the symptoms associated with allergies and is sometimes combined with other cold medications designed to provide general relief for flu-like symptoms. As with many antihistamines, the most common side effect is drowsiness."},"commercial":{"launchDate":"1983","_launchSource":"DrugCentral (FDA 1983-05-17, SANDOZ)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/2763","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=TRIPROLIDINE","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://en.wikipedia.org/wiki/Triprolidine","fields":["history","overview"],"source":"Wikipedia"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T16:09:28.568337","_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T03:30:34.284140+00:00","fieldsConflicting":2,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"cyproheptadine","drugSlug":"cyproheptadine","fdaApproval":"1961-10-17","genericCount":31,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"antazoline","drugSlug":"antazoline","fdaApproval":"1990-04-30","relationship":"same-class"},{"drugName":"azatadine","drugSlug":"azatadine","fdaApproval":"1977-03-29","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"astemizole","drugSlug":"astemizole","fdaApproval":"1988-12-31","relationship":"same-class"},{"drugName":"terfenadine","drugSlug":"terfenadine","fdaApproval":"","relationship":"same-class"},{"drugName":"loratadine","drugSlug":"loratadine","fdaApproval":"1993-04-12","genericCount":29,"patentStatus":"Off-patent — generic 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available","relationship":"same-class"}],"dataSources":[{"url":"https://data.medicaid.gov/dataset/4j6z-xnwq","name":"CMS National Average Drug Acquisition Cost (NADAC)","fields":["pricing"],"retrievedDate":"2026-04-07"}],"genericName":"triprolidine","indications":{"approved":[{"id":"triprolidine-cough-relief","name":"Cough relief","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Individuals with common cold or flu","pivotalTrial":null,"restrictions":[],"patientPopulation":"Individuals with common cold or flu","diagnosticRequired":null,"brandNameForIndication":"Actidil"},{"id":"triprolidine-minor-aches-and-pains-relief","name":"Minor aches and pains relief","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Individuals with common cold or flu","pivotalTrial":null,"restrictions":[],"patientPopulation":"Individuals with common cold or flu","diagnosticRequired":null,"brandNameForIndication":"Actidil"},{"id":"triprolidine-sore-throat-relief","name":"Sore throat 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