{"active_ingredient":["Active ingredient (in each caplet) Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg *nonsteroidal anti-inflammatory drug"],"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"],"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"],"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."],"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"],"effective_time":"20240128","id":"1005a911-f3ad-23c9-e063-6294a90abb9f","inactive_ingredient":["Inactive ingredients (24 ct)","Inactive ingredients (100 ct) 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"],"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."],"openfda":{"application_number":["M013"],"brand_name":["Excedrin Extra Strength Headache"],"generic_name":["ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE"],"is_original_packager":[true],"manufacturer_name":["Haleon US Holdings LLC"],"nui":["N0000175739","N0000175729","N0000175790","M0023046","N0000000160","N0000008836","M0001335","N0000175722","N0000175578","N0000008832"],"package_ndc":["0067-2002-01","0067-2002-02","0067-2002-03","0067-2002-04","0067-2002-05","0067-2002-06","0067-2002-07","0067-2002-08","0067-2003-01","0067-2003-02"],"pharm_class_cs":["Xanthines [CS]","Anti-Inflammatory Agents, Non-Steroidal [CS]"],"pharm_class_epc":["Central Nervous System Stimulant [EPC]","Methylxanthine [EPC]","Nonsteroidal Anti-inflammatory Drug [EPC]","Platelet Aggregation Inhibitor [EPC]"],"pharm_class_moa":["Cyclooxygenase Inhibitors [MoA]"],"pharm_class_pe":["Central Nervous System Stimulation [PE]","Decreased Prostaglandin Production [PE]","Decreased Platelet Aggregation [PE]"],"product_ndc":["0067-2002","0067-2003"],"product_type":["HUMAN OTC DRUG"],"route":["ORAL"],"rxcui":["209468","308297"],"spl_id":["1005a911-f3ad-23c9-e063-6294a90abb9f"],"spl_set_id":["61802b27-c9ec-4386-9d44-45e8b1e558b7"],"substance_name":["ACETAMINOPHEN","ASPIRIN","CAFFEINE"],"unii":["3G6A5W338E","R16CO5Y76E","362O9ITL9D"]},"package_label_principal_display_panel":["Package/Label Principal Display Panel (24 ct.) EXCEDRIN EXTRA STRENTH HEADACHE Acetaminophen 250 mg, Aspirin 250 mg (NSAID) and Caffeine 65 mg Pain Reliever / Pain Reliever Aid ACTUAL SIZE 24 CAPLETS TAMPER-EVIDENT BOTTLE DO NOT USE IF INNER SAFETY SEAL IMPRINTED WITH “SEALED for YOUR PROTECTION” IS BROKEN OR MISSING Distributed by: Haleon, Warren, NJ 07059 ©2023 Haleon or licensor. Trademarks are owned by or licensed to the Haleon group of companies. 62000000201911 Excedrin Extra Strength Headache 24 ct","Package/Label Principal Display Panel (100 ct.) EXCEDRIN EXTRA STRENGTH HEADACHE Acetaminophen 250 mg, Aspirin 250 mg (NSAID) and Caffeine 65 mg Pain Reliever / Pain Reliever Aid ACTUAL SIZE 100 CAPLETS TAMPER-EVIDENT BOTTLE DO NOT IF USE PRINTED INNER SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. Distributed by: Haleon, Warren, NJ 07059 ©2023 Haleon or licensor. Trademarks are owned by or licensed to the Haleon group of companies. Excedrin Extra Strength Headache 100 ct"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery."],"purpose":["Purposes Pain reliever Pain reliever Pain reliever aid"],"questions":["Questions or comments? 1-800-468-7746"],"set_id":"61802b27-c9ec-4386-9d44-45e8b1e558b7","spl_product_data_elements":["Excedrin Extra Strength Headache Acetaminophen, Aspirin (NSAID), Caffeine BENZOIC ACID CARNAUBA WAX FD&C BLUE NO. 1 HYPROMELLOSE, UNSPECIFIED LIGHT MINERAL OIL LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE POLYSORBATE 20 POVIDONE, UNSPECIFIED PROPYLENE GLYCOL SORBITAN MONOLAURATE STEARIC ACID TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN ASPIRIN ASPIRIN CAFFEINE CAFFEINE E Excedrin Extra Strength Headache Acetaminophen, Aspirin (NSAID), Caffeine STARCH, CORN CROSPOVIDONE, UNSPECIFIED HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE POVIDONE, UNSPECIFIED PROPYLENE GLYCOL SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A STEARIC ACID TITANIUM DIOXIDE ACETAMINOPHEN ACETAMINOPHEN ASPIRIN ASPIRIN CAFFEINE CAFFEINE ES"],"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."],"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 occur These could be signs of a serious condition."],"version":"2","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 at 20 weeks or later in 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."]}