{"active_ingredient":["Active ingredients (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 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":"20190305","id":"8f18ca02-4a4c-4658-90b6-838e2635d60b","inactive_ingredient":["Inactive ingredients carnauba wax, crospovidone, FD&C blue #1 aluminum lake, hypromellose, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, saccharin sodium, stearic acid, titanium dioxide"],"indications_and_usage":["Uses • temporarily relieves minor aches and pains due to: • headache • a cold • arthritis • muscular aches • toothache • premenstrual & 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":{},"package_label_principal_display_panel":["Principal Display Panel NDC 0067-8104-50 EXCEDRIN ® EXTRA STRENGTH Acetaminophen, Aspirin (NSAID) and Caffeine Pain Relieve/Pain Reliever Aid 50 CAPLETS DO NOT USE IF PRINTED FOIL SEAL UNDER CAP IS BROKEN OR MISSING KEEP BOX FOR REFERENCE Distributed by: Novartis Consumer Health, Inc. Parsippany, NJ 07054-0622 ©2014 Visit us at www.excedrin.com 12043 Excedrin Extra Strength 50 count carton"],"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."],"purpose":["Purposes Pain reliever Pain reliever Pain reliever aid"],"questions":["Questions or comments? 1-800-468-7746"],"set_id":"3c8aad15-970f-4de4-9714-6dbf5f6452c7","spl_product_data_elements":["Excedrin Extra Strength Caplets Acetaminophen, Aspirin (NSAID), and Caffeine ACETAMINOPHEN ACETAMINOPHEN ASPIRIN ASPIRIN CAFFEINE CAFFEINE CARNAUBA WAX FD&C BLUE NO. 1 HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE CROSPOVIDONE, UNSPECIFIED PROPYLENE GLYCOL SACCHARIN SODIUM STEARIC ACID TITANIUM DIOXIDE White Capsule-Shaped Tablet Ex"],"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 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":"6","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 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."]}