PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


Principal Display Panel NDC 0067-8103-50 EXCEDRIN MIGRAINE Acetaminophen, Aspirin (NSAID) and Caffeine Tablets Pain Reliever / Pain Reliever Aid 50 COATED CAPLETS** **CAPSULE-SHAPED TABLETS 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 12041

OTC - ACTIVE INGREDIENT SECTION.


Active ingredient Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg *nonsteroidal anti-inflammatory drug

INDICATIONS & USAGE SECTION.


Uses treats migraines

DOSAGE & ADMINISTRATION SECTION.


Directions do not use more than directed adults: take 2 caplets with a glass of water if symptoms persist or worsen, ask your doctor do not take more than 2 caplets in 24 hours, unless directed by a doctor under 18 years of age: ask a doctor

SPL UNCLASSIFIED SECTION.


Other information store at 20-25C (68-77F) close cap tightly after use read all product information before using. Keep this box for important information.

INACTIVE INGREDIENT SECTION.


Inactive ingredients carnauba wax, crospovidone, FD&C blue #1 aluminum lake, hypromellose, microcrystalline cellulose, povidone, pregeletanized starch, propylene glycol, saccharin sodium, stearic acid, titanium dioxide

OTC - QUESTIONS SECTION.


Questions or comments? 1-800-468-7746

WARNINGS SECTION.


Warnings Reyes 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 Reyes 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 2 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 never had migraines diagnosed by a health professional you have a headache that is different from your usual migraines you have the worst headache of your life you have fever and stiff neck you have headaches beginning after or caused by head injury, exertion, coughing or bending you experienced your first headache after the age of 50 you have daily headaches you have a migraine so severe as to require bed rest 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 you have problems or serious side effects from taking pain relievers or fever reducers you have vomiting with your migraine headache Ask a doctor or pharmacist before use if you are taking a prescription drug for: diabetes gout arthritis under a doctors care for any serious condition taking any other drug taking any other product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer 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 your migraine is not relieved or worsens after first dose new or unexpected symptoms occur ringing in the ears or loss of hearing occurs 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.

OTC - PURPOSE SECTION.


Purpose Pain reliever Pain reliever Pain reliever aid