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Seek medical help right away. you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better ringing in the ears or loss of hearing occurs painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days any new symptoms occur These could be signs of a serious condition."],"warnings":["Warnings Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. 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. Allergy alert: Aspirin may cause a severe allergic reaction which may include: hives facial swelling asthma (wheezing) shock Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you are age 60 or older have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat. Do not use if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis any other drug, or are under a doctor’s care for any serious condition Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better ringing in the ears or loss of hearing occurs painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days any new symptoms occur These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. 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? 1-800-468-7746"],"ask_doctor":["Ask a doctor before use if you have liver disease stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you are taking a diuretic you have asthma"],"do_not_use":["Do not use if you have ever had an allergic reaction to acetaminophen, aspirin or any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist."],"effective_time":"20240405","active_ingredient":["Active ingredients (in each caplet) Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg *nonsteroidal anti-inflammatory drug"],"inactive_ingredient":["Inactive ingredients corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide"],"indications_and_usage":["Uses temporarily relieves minor aches and pains due to: headache a cold arthritis muscular aches toothache premenstrual and menstrual cramps"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis any other drug, or are under a doctor’s care for any serious condition"],"spl_unclassified_section":["Other information store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) close cap tightly after use read all product information before using. Keep this box for important information."],"dosage_and_administration":["Directions do not use more than directed drink a full glass of water with each dose adults and children 12 years of age and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours children under 12 years: ask a doctor"],"spl_product_data_elements":["Excedrin Extra Strength Pain Reliever Acetaminophen, Aspirin (NSAID), and Caffeine STARCH, CORN CROSPOVIDONE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED PROPYLENE GLYCOL SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A POTATO STEARIC ACID TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN ASPIRIN ASPIRIN CAFFEINE CAFFEINE White ES"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery."],"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. 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":["Principal Display Panel NDC 0067-8203-04 EXCEDRIN EXTRA STRENGTH Acetaminophen, Aspirin (NSAID) and Caffeine Pain Reliever/Pain Reliever Aid 300 CAPLETS TAMPER-EVIDENT BOTTLE DO NOT USE IF PRINTED INNER SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Distributed by: GSK Consumer Healthcare Warren, NJ 07059 ©2020 GSK group of companies or its licensor. Trademarks are owned by or licensed to the GSK group of companies. B-0630-763-17 – Front Carton B-0630-763-17 Excedrin ES Caplets Carton 300 ct"]},"tags":[{"label":"Nonsteroidal Anti-inflammatory Drug [EPC]","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Cyclooxygenase","category":"target"},{"label":"Oral","category":"route"},{"label":"Tablet","category":"form"},{"label":"Active","category":"status"},{"label":"headache","category":"indication"},{"label":"cold","category":"indication"},{"label":"arthritis","category":"indication"},{"label":"muscular aches","category":"indication"},{"label":"toothache","category":"indication"},{"label":"premenstrual cramps","category":"indication"},{"label":"Haleon Us Holdings","category":"company"},{"label":"Approved 2000s","category":"decade"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"3783 reports"},{"date":"","signal":"PRODUCT USE IN UNAPPROVED INDICATION","source":"FDA FAERS","actionTaken":"2049 reports"},{"date":"","signal":"DRUG EFFECTIVE FOR UNAPPROVED INDICATION","source":"FDA FAERS","actionTaken":"1574 reports"},{"date":"","signal":"HEADACHE","source":"FDA FAERS","actionTaken":"1114 reports"},{"date":"","signal":"NAUSEA","source":"FDA FAERS","actionTaken":"1026 reports"},{"date":"","signal":"FATIGUE","source":"FDA FAERS","actionTaken":"616 reports"},{"date":"","signal":"DIZZINESS","source":"FDA FAERS","actionTaken":"596 reports"},{"date":"","signal":"MIGRAINE","source":"FDA FAERS","actionTaken":"586 reports"},{"date":"","signal":"PAIN","source":"FDA FAERS","actionTaken":"529 reports"},{"date":"","signal":"VOMITING","source":"FDA FAERS","actionTaken":"518 reports"}]},"trials":[],"aliases":["non-steroidal anti-inflammatory drugs","Isolated non-steroid anti-inflammatory group","ibuprofen","CaiFen","Meloxicam/Mobic (NDC 68382-000-01; manufacturer: Zydus; encapsulated in size AA"],"company":"Haleon Us Holdings","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=NSAID","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T00:46:16.427134+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Nsaid","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T00:46:23.568958+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T00:46:22.052690+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-20T00:46:15.543153+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=NSAID","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T00:46:22.398781+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":"2026-04-20T00:46:12.816238+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:46:12.816269+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:46:12.816276+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":"2026-04-20T00:46:24.142234+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Cyclooxygenase inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:46:23.568889+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL139/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T00:46:23.234813+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"M013","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T00:46:12.816279+00:00"}},"allNames":"excedrin extra strength pain reliever","offLabel":[],"synonyms":["Excedrin Extra Strength Pain Reliever","ACETAMINOPHEN"],"timeline":[{"date":"20040827","type":"positive","source":"OpenFDA","milestone":"FDA approval (Haleon Us Holdings)"}],"aiSummary":"Excedrin Extra Strength Pain Reliever is a nonsteroidal anti-inflammatory drug (NSAID) developed by Haleon US Holdings, targeting cyclooxygenase. It is a small molecule modality, approved by the FDA in 2004 for various pain conditions, including headache, arthritis, and menstrual cramps. The commercial status of Excedrin Extra Strength Pain Reliever is owned by Haleon US Holdings, with approved indications for headache, cold, arthritis, muscular aches, toothache, premenstrual cramps, and menstrual cramps. Key safety considerations include potential gastrointestinal and cardiovascular risks. Excedrin Extra Strength Pain Reliever is a widely used over-the-counter medication.","approvals":[{"date":"20040827","orphan":false,"company":"HALEON US HOLDINGS","regulator":"FDA"}],"brandName":"Excedrin Extra Strength Pain Reliever","ecosystem":[],"mechanism":{"target":"Cyclooxygenase","moaClass":"Cyclooxygenase Inhibitors [MoA]","modality":"Small Molecule","drugClass":"Nonsteroidal Anti-inflammatory Drug [EPC]","explanation":"","oneSentence":"","technicalDetail":"Excedrin Extra Strength Pain Reliever targets cyclooxygenase (COX) enzymes, specifically COX-1 and COX-2, to inhibit the conversion of arachidonic acid to prostaglandins, thereby reducing pain and inflammation."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Nonsteroidal_anti-inflammatory_drug","title":"Nonsteroidal anti-inflammatory drug","extract":"Nonsteroidal anti-inflammatory drugs (NSAID) are members of a therapeutic drug class which reduces pain, decreases inflammation, decreases fever, and prevents blood clots. Side effects depend on the specific drug, its dose and duration of use, but largely include an increased risk of gastrointestinal ulcers and bleeds, heart attack, and kidney disease. The most prominent NSAIDs are aspirin, ibuprofen, diclofenac and naproxen, all available over the counter (OTC) in most countries. Paracetamol (acetaminophen) is generally not considered an NSAID because it has only minor anti-inflammatory activity.","wiki_history":"==History==\nthumb|200px|right|One of the first advertisements for Bayer Aspirin, published in [[The New York Times in 1917]]\nIt is widely believed that naturally occurring salicin in willow trees and other plants was used by the ancients as a form of analgesic or anti-inflammatory drug, but this story, although compelling, is not entirely true. Hippocrates does not mention willow at all. Dioscorides's De materia medica was arguably the most influential herbal from Roman to Medieval times but, if he mentions willow at all (there is doubt about the identity of 'Itea'), then he used the ashes, steeped in vinegar, as a treatment for corns, which corresponds well with modern uses of salicylic acid.\n\nWillow bark (from trees of the Salix genus) was widely known to be used as a medicine by multiple First Nations communities. The bark would be chewed or steeped in water for its pain relieving and antipyretic effects. The effects are a result of the bark's salicin content. Meadowsweet, another plant to contain salicin, has strong roots in British folk medicine for the same maladies. Willow bark was first reported in Western science by Edward Stone in 1763 as a treatment for ague (fever) according to the pseudoscientific doctrine of signatures.\n\nIn the body, salicin is turned into salicylic acid, which produces the antipyretic and analgesic effects that the plants are known for.\n\nSalicin was first isolated by Johann Andreas Buchner in 1827. By 1829, French chemist Henri Leroux had improved the extraction process to obtain about 30g of purified salicin from 1.5kg of willow bark. By hydrolysis, salicin releases glucose and salicyl alcohol which can be converted into salicylic acid, both in vivo and through chemical methods. In 1869, Hermann Kolbe synthesised salicylic acid, although it was too acidic for the gastric mucosa.\n700px|center|Kolbe–Schmitt reaction mechanism\n\nBy 1897, the German chemist Felix Hoffmann and the Bayer company prompted a new age of pharmacology by convert"},"commercial":{"launchDate":"2004","_launchSource":"OpenFDA (20040827, HALEON US HOLDINGS)"},"references":[{"id":1,"url":"https://api.fda.gov/drug/label.json?search=openfda.generic_name:\"NSAID\"","fields":["mechanism","indications","adverse_reactions","contraindications","warnings","dosage"],"source":"OpenFDA Label"},{"id":2,"url":"https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:\"NSAID\"","fields":["approvals","company"],"source":"OpenFDA Drugs@FDA"},{"id":3,"url":"https://clinicaltrials.gov/search?intr=nsaid","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":4,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=nsaid","fields":["publications"],"source":"PubMed/NCBI"},{"id":5,"url":"https://en.wikipedia.org/wiki/Nonsteroidal_anti-inflammatory_drug","fields":["history","overview"],"source":"Wikipedia"}],"_enrichedAt":"2026-03-31T10:21:37.534638","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T00:46:25.447635+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[],"genericName":"nsaid","indications":{"approved":[{"name":"headache","source":"OpenFDA Label","regulator":"FDA"},{"name":"cold","source":"OpenFDA Label","regulator":"FDA"},{"name":"arthritis","source":"OpenFDA Label","regulator":"FDA"},{"name":"muscular aches","source":"OpenFDA Label","regulator":"FDA"},{"name":"toothache","source":"OpenFDA Label","regulator":"FDA"},{"name":"premenstrual cramps","source":"OpenFDA Label","regulator":"FDA"},{"name":"menstrual cramps","source":"OpenFDA Label","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06574191","phase":"NA","title":"The Effects of Patient and Visit Characteristics on Health Outcomes in Knee Osteoarthritis","status":"RECRUITING","sponsor":"University of California, Davis","startDate":"2025-01-29","conditions":["Knee Osteoarthritis"],"enrollment":220,"completionDate":"2028-01-27"},{"nctId":"NCT04976387","phase":"","title":"Post Operative Analgesia and Patient Satisfaction","status":"COMPLETED","sponsor":"Loma Linda University","startDate":"2021-07-02","conditions":["Postoperative Pain","Patient Satisfaction","Analgesia"],"enrollment":160,"completionDate":"2023-05-11"},{"nctId":"NCT07493226","phase":"NA","title":"Efficacy of Chemically Distinct Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and Pain Phenotypes in Adhesive Capsulitis","status":"RECRUITING","sponsor":"Konya Beyhekim Training and Research Hospital","startDate":"2026-04-01","conditions":["Frozen Shoulder","Adhesive Capsulitis","Shoulder Pain","NSAID (Non-Steroidal Anti-Inflammatory Drug)","Nociplastic Pain","Neuropathic Pain"],"enrollment":120,"completionDate":"2027-03-30"},{"nctId":"NCT05430230","phase":"PHASE4","title":"Study of Nonsteroidal Anti-inflammatory Drugs in People With Painful Knee Osteoarthritis","status":"ACTIVE_NOT_RECRUITING","sponsor":"Northwestern University","startDate":"2022-08-24","conditions":["Osteoarthritis, Knee"],"enrollment":20,"completionDate":"2027-09-01"},{"nctId":"NCT07487610","phase":"","title":"Relationship Between Neuropathic Pain and Geriatric Assessment Parameters in Patients Aged 80 Years and Older","status":"RECRUITING","sponsor":"Sultan 1. 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