{"id":"pyrilamine-maleate","_fda":{"id":"285fd0a2-df05-22b1-e063-6394a90a6962","set_id":"048c4b03-1cf4-b724-e063-6294a90a1cad","openfda":{"nui":["N0000175739","N0000175729","N0000175790","M0023046"],"upc":["0810053181249"],"unii":["362O9ITL9D","3G6A5W338E","R35D29L3ZA"],"route":["ORAL"],"rxcui":["1597298"],"spl_id":["285fd0a2-df05-22b1-e063-6394a90a6962"],"brand_name":["Buscapina"],"spl_set_id":["048c4b03-1cf4-b724-e063-6294a90a1cad"],"package_ndc":["69729-132-06"],"product_ndc":["69729-132"],"generic_name":["ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE"],"product_type":["HUMAN OTC DRUG"],"pharm_class_cs":["Xanthines [CS]"],"pharm_class_pe":["Central Nervous System Stimulation [PE]"],"substance_name":["ACETAMINOPHEN","CAFFEINE","PYRILAMINE MALEATE"],"pharm_class_epc":["Central Nervous System Stimulant [EPC]","Methylxanthine [EPC]"],"manufacturer_name":["OPMX LLC"],"application_number":["M013"],"is_original_packager":[true]},"purpose":["Purpose Active Ingredients (in each caplet) Purpose Acetaminophen 500mg Pain reliever Caffeine 60mg Diuretic Pyrilamine maleate 15mg Antihistamine"],"version":"2","stop_use":["Stop use and ask a doctor if new symptoms appear redness or swelling is present pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days"],"warnings":["Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 6 caplets in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy alert Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include: • skin reddening blisters rash hives facial swelling asthma (wheezing) shock If a skin or general allergic reaction occurs, stop use and seek medical help right away. 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 have ever had an allertgic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease glaucoma difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product you may get drowsy avoid alcoholic drinks excitability may occur, especially in children alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability sleeplessness, and, occasionally rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee. Stop use and ask a doctor if new symptoms appear redness or swelling is present pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days If pregnant or breast-feeding ask a health professional before use. Keep out of reach of chlidren. In case of overdose, get medical help or contact a Poison Control Center right away. 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? Call toll free 619-600-5632 Monday through Friday 9AM - 5PM EST"],"ask_doctor":["Ask a doctor before use if you have liver disease glaucoma difficulty in urination due to enlargement of the prostate gland a breathing problem such as emphysema or chronic bronchitis"],"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 have ever had an allertgic reaction to this product or any of its ingredients"],"when_using":["When using this product you may get drowsy avoid alcoholic drinks excitability may occur, especially in children alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability sleeplessness, and, occasionally rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee."],"purpose_table":["
Active Ingredients (in each caplet)Purpose
Acetaminophen 500mgPain reliever
Caffeine 60mgDiuretic
Pyrilamine maleate 15mgAntihistamine
"],"effective_time":"20241203","active_ingredient":["Active ingredients Purpose Active Ingredients (in each caplet) Purpose Acetaminophen 500mg Pain reliever Caffeine 60mg Diuretic Pyrilamine maleate 15mg Antihistamine"],"inactive_ingredient":["Inactive ingredients colloidal silicon dioxide, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, pvp K-30, sodium starch glycolate, stearic acid, talc, titanium dioxide"],"storage_and_handling":["Other information store at room temperature 68-77°F (20-25°C) TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING"],"indications_and_usage":["Uses for the temporary relief of these symptoms associated with menstrual periods: cramps bloating water-weight gain headache backache muscle aches fatigue"],"active_ingredient_table":["
Active Ingredients (in each caplet)Purpose
Acetaminophen 500mgPain reliever
Caffeine 60mgDiuretic
Pyrilamine maleate 15mgAntihistamine
"],"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 exceed recommended dosage adults and children 12 years and over: take 2 caplets with water. Repeat every 6 hours as needed. Do not exceed 6 caplets per day. children under 12 years: consult a doctor"],"spl_product_data_elements":["Buscapina Acetaminophen, Caffeine, Pyrilamine Maleate SILICON DIOXIDE STARCH, CORN MAGNESIUM STEARATE POVIDONE K30 STEARIC ACID HYPROMELLOSE, UNSPECIFIED PYRILAMINE MALEATE PYRILAMINE TALC MICROCRYSTALLINE CELLULOSE ACETAMINOPHEN ACETAMINOPHEN SODIUM STARCH GLYCOLATE TYPE A CAFFEINE CAFFEINE POLYETHYLENE GLYCOL, UNSPECIFIED TITANIUM DIOXIDE V1"],"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 chlidren. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms."],"package_label_principal_display_panel":["Buscapina 6 caplets Buscapina Acetaminophen, Caffeine, Pyrilamine Maleate Tablets NDC 69729-132-06 Cramps Bloating Fatigue Heacache Backache 6 Caplets 3 packs of 2 Caplets Buscapina w6"]},"safety":{"boxedWarnings":[]},"_chembl":{"chemblId":"CHEMBL1201006","moleculeType":"Small molecule","molecularWeight":"401.46"},"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=PYRILAMINE MALEATE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T05:38:02.324707+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T05:38:42.258951+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T05:38:07.859040+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=PYRILAMINE MALEATE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T05:38:08.179627+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:38:01.206056+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:38:01.206093+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:38:35.509026+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:38:01.206098+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Histamine H1 receptor antagonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T05:38:09.660731+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1201006/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T05:38:09.312271+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"M013","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T05:38:01.206101+00:00"}},"_dailymed":{"setId":"4cc4b39a-39d5-a2bb-e063-6394a90a2e95","title":"BUSCAPINA (ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE) TABLET, COATED [OPMX LLC]"},"aiSummary":"Pyrilamine Maleate is a marketed drug primarily indicated for menstrual cramps, with a key composition patent expiring in 2028. Its market position is bolstered by its established presence and specific indication, which may offer a niche advantage. The primary risk is the patent expiry in 2028, which could lead to increased competition from generics.","mechanism":{"drugClass":"Central Nervous System Stimulant [EPC]"},"_scrapedAt":"2026-03-28T00:38:04.020Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_validation":{"fieldsValidated":2,"lastValidatedAt":"2026-04-20T05:38:42.259027+00:00","fieldsConflicting":0,"overallConfidence":0.95},"indications":{"approved":[{"id":"pyrilamine-maleate-menstrual-cramps","name":"Menstrual Cramps","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Individuals experiencing menstrual cramps","pivotalTrial":null,"restrictions":[],"patientPopulation":"Individuals experiencing menstrual cramps","diagnosticRequired":null,"brandNameForIndication":""},{"id":"pyrilamine-maleate-bloating","name":"Bloating","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Individuals experiencing bloating during menstrual periods","pivotalTrial":null,"restrictions":[],"patientPopulation":"Individuals experiencing bloating during menstrual periods","diagnosticRequired":null,"brandNameForIndication":""},{"id":"pyrilamine-maleate-water-weight-gain","name":"Water Weight Gain","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Individuals experiencing water-weight gain during menstrual periods","pivotalTrial":null,"restrictions":[],"patientPopulation":"Individuals experiencing water-weight gain during menstrual periods","diagnosticRequired":null,"brandNameForIndication":""},{"id":"pyrilamine-maleate-headache","name":"Headache","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Individuals experiencing headaches during menstrual periods","pivotalTrial":null,"restrictions":[],"patientPopulation":"Individuals experiencing headaches during menstrual periods","diagnosticRequired":null,"brandNameForIndication":""},{"id":"pyrilamine-maleate-backache","name":"Backache","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Individuals experiencing backaches during menstrual periods","pivotalTrial":null,"restrictions":[],"patientPopulation":"Individuals experiencing backaches during menstrual periods","diagnosticRequired":null,"brandNameForIndication":""},{"id":"pyrilamine-maleate-muscle-aches","name":"Muscle Aches","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Individuals experiencing muscle aches during menstrual periods","pivotalTrial":null,"restrictions":[],"patientPopulation":"Individuals experiencing muscle aches during menstrual periods","diagnosticRequired":null,"brandNameForIndication":""},{"id":"pyrilamine-maleate-fatigue","name":"Fatigue","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Individuals experiencing fatigue during menstrual periods","pivotalTrial":null,"restrictions":[],"patientPopulation":"Individuals experiencing fatigue during menstrual periods","diagnosticRequired":null,"brandNameForIndication":""}]},"trialDetails":[{"nctId":"NCT02601235","phase":"PHASE3","title":"Efficacy and Safety of Pediatric Drugs in Nasal Congestion","status":"COMPLETED","sponsor":"EMS","startDate":"2018-01-16","conditions":"Nasal Congestion","enrollment":292}],"_emaApprovals":[],"_faersSignals":[],"administration":{"route":"Oral"},"crossReferences":{"chemblId":"CHEMBL1201006"},"_approvalHistory":[],"publicationCount":78,"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":"PYRILAMINE MALEATE","genericName":"PYRILAMINE MALEATE","companyName":"","companyId":"","modality":"Small molecule","firstApprovalDate":"1973","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":"2026-04-20T05:38:42.259027+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"partial","dataCompleteness":{"mechanism":false,"indications":true,"safety":false,"trials":true,"score":2}}