Active Ingredients (in each Caplet): Acetaminophen (250 mg), Aspirin (250 mg), Caffeine (65 mg). Inactive Ingredients: Benzoic Acid, Carnauba Wax, FD&C Blue No. 1 (May Contain These Ingredients), Hydroxypropylcellulose, Hypromellose, Microcrystalline Cellulose, Mineral Oil, Polysorbate 20, Povidone, Propylene Glycol, Simethicone Emulsion, Sorbitan Monolaurate, Stearic Acid, Titanium Dioxide (May Contain These Ingredients).
Do not use more than directed (see overdose warning). 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. Store at 20-25 degrees C (68-77 degrees F). Read all product information before using. Keep this box for important information.
Novartis Consumer Health, Inc.
Parsippany, NJ 07054-0622
Drug Interactions & Precautions
Do not use with any other products containing acetaminophen.
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: Aspirin may cause a severe allergic reaction which may include hives; facial swelling; asthma (wheezing); shock. Alcohol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen and aspirin or other pain relievers/fever reducers. Acetaminophen and aspirin may cause liver damage and stomach bleeding. 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 any other pain reliever/fever reducer. Ask a doctor before use if you have never had migraines diagnosed by a health professional; a headache that is different from your usual migraines; the worst headache of your life; fever and stiff neck; headaches beginning after or caused by head injury, exertion, coughing or bending; experienced your first headache after the age of 50; daily headaches; a migraine so severe as to require bed rest; asthma; bleeding problems; ulcers; stomach problems such as heartburn, upset stomach, or stomach pain that do not go away or recur; problems or serious side effects from taking pain relievers or fever reducers; vomiting with your migraine headache. Ask a doctor or pharmacist before use if you are taking a prescription drug for anticoagulation (thinning of the blood); diabetes; gout; arthritis; under a doctor's 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; your migraine is not relieved or worsens after first dose; new or unexpected symptoms occur; stomach pain or upset gets worse or lasts; 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. Overdose Warning: Taking more than the recommended dose can cause serious health problems, including serious liver damage. 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. Tamper-Evident Bottle: Do not use if inner foil seal imprinted with sealed for your protection is broken or missing.