{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-06-02", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "spl_product_data_elements": [ "Excedrin Extra Strength Geltabs Acetaminophen, Asprin, Caffeine ACETAMINOPHEN ACETAMINOPHEN ASPIRIN ASPIRIN CAFFEINE CAFFEINE BENZOIC ACID D&C YELLOW NO. 10 EDETATE DISODIUM FD&C BLUE NO. 1 FD&C RED NO. 40 GELATIN, UNSPECIFIED GLYCERIN HYPROMELLOSE, UNSPECIFIED FERROSOFERRIC OXIDE ISOPROPYL ALCOHOL LACTOSE MONOHYDRATE LIGHT MINERAL OIL LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED MALTITOL MEDIUM-CHAIN TRIGLYCERIDES MICROCRYSTALLINE CELLULOSE PEPSIN POLYSORBATE 20 POVIDONE, UNSPECIFIED PROPYL GALLATE PROPYLENE GLYCOL DIMETHICONE SILICON DIOXIDE SORBITAN MONOLAURATE STEARIC ACID TITANIUM DIOXIDE dark green E" ], "active_ingredient": [ "Active ingredients (in each GelTab) Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Caffeine 65 mg *nonsteroidal anti-inflammatory drug" ], "purpose": [ "Purposes Pain reliever Pain reliever Pain reliever aid" ], "indications_and_usage": [ "Uses • temporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • toothache • premenstrual & menstrual cramps" ], "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 geltabs 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 appear 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." ], "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." ], "ask_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" ], "stop_use": [ "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 appear These could be signs of a serious condition." ], "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." ], "dosage_and_administration": [ "Directions • do not use more than directed • drink a full glass of water with each dose • adults and children 12 years and over: take 2 geltabs every 6 hours; not more than 8 geltabs in 24 hours • children under 12 years: ask a doctor" ], "spl_unclassified_section": [ "Other information • store at 20°-25°C (68°-77°F) • close cap tightly after use • read all product information before using. Keep this box for important information." ], "inactive_ingredient": [ "Inactive ingredients benzoic acid, D&C yellow #10 aluminum lake, edetate disodium, FD&C blue #1, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, gelatin, glycerin, hypromellose, iron oxide black, isopropyl alcohol, lactose monohydrate, light mineral oil, low-substituted hydroxypropyl cellulose, maltitol syrup, medium-chain triglycerides, microcrystalline cellulose, pepsin, polysorbate 20, povidone, propyl gallate, propylene glycol, simethicone, sorbitan monolaurate, stearic acid, titanium dioxide" ], "questions": [ "Questions? 1-800-452-0051" ], "package_label_principal_display_panel": [ "Principal Display Panel NDC 0067-2021-20 EXCEDRIN EXTRA STRENGTH Acetaminophen, Aspirin (NSAID) and Caffeine Pain Reliever/Pain Reliever Aid 20 GELTABS TAMPER-EVIDENT BOTTLE DO NOT USE IF INNER FOIL SELA IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING Distributed by: GSK Consumer Healthcare Warren, NJ 07059 ©2015 GSK or its licensor. Visit us at www.excedrin.com 46172149 Excedrin Extra Strength geltabs 20 count carton" ], "set_id": "11a8439b-0159-4351-b0f5-fe7fad6a33c0", "id": "09d7d5f9-c9f1-4942-8dc8-13ca8e164ce9", "effective_time": "20240305", "version": "6", "openfda": { "application_number": [ "M013" ], "brand_name": [ "Excedrin Extra Strength Geltabs" ], "generic_name": [ "ACETAMINOPHEN, ASPRIN, CAFFEINE" ], "manufacturer_name": [ "Haleon US Holdings LLC" ], "product_ndc": [ "0067-2021" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "ASPIRIN", "CAFFEINE" ], "rxcui": [ "209468", "308297" ], "spl_id": [ "09d7d5f9-c9f1-4942-8dc8-13ca8e164ce9" ], "spl_set_id": [ "11a8439b-0159-4351-b0f5-fe7fad6a33c0" ], "package_ndc": [ "0067-2021-20", "0067-2021-24", "0067-2021-80" ], "is_original_packager": [ true ], "nui": [ "N0000000160", "N0000008836", "M0001335", "N0000175722", "N0000175578", "N0000008832", "N0000175739", "N0000175729", "N0000175790", "M0023046" ], "pharm_class_moa": [ "Cyclooxygenase Inhibitors [MoA]" ], "pharm_class_pe": [ "Decreased Prostaglandin Production [PE]", "Decreased Platelet Aggregation [PE]", "Central Nervous System Stimulation [PE]" ], "pharm_class_cs": [ "Anti-Inflammatory Agents, Non-Steroidal [CS]", "Xanthines [CS]" ], "pharm_class_epc": [ "Nonsteroidal Anti-inflammatory Drug [EPC]", "Platelet Aggregation Inhibitor [EPC]", "Central Nervous System Stimulant [EPC]", "Methylxanthine [EPC]" ], "unii": [ "362O9ITL9D", "R16CO5Y76E", "3G6A5W338E" ] } } ] }