Active Ingredients (in each Caplet): Acetaminophen (250 mg); Aspirin (250 mg); Caffeine (65 mg). Inactive Ingredients: Benzoic Acid, Camauba Wax, FD&C Blue No. 1 (May Contain this Ingredient), Hydroxypropylcellulose, Hypromellose, Microcrystalline Cellulose, Mineral Oil, Polysorbate 20, Povidone, Propylene Glycol, Simethicone Emulsion, Sorbitan Monolaurate, Stearic Acid, Titanium Dioxide (May Contain this Ingredient).
Do not use more than directed (see Overdose Warning). 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. Tamper-evident bottle. Do not use if inner foil seal imprinted with Sealed For Your Protection is broken or missing. Store at room temperature. Read all product information before using. Keep this box for important information.
Novartis Consumer Health, Inc.
Parsippany, NJ 07054-0622
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; with any other products containing acetaminophen, (see Overdose Warning). Ask a doctor before use if you have asthma; ulcers; bleeding problems; stomach problems such as heartburn, upset stomach, or stomach pain that do not go away or return. Ask a doctor or pharmacist before use if you are taking a prescription drug for: anticoagulation (thinning of the blood); diabetes; gout; arthritis. Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away; new symptoms occur; symptoms do not get better or worsen; 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. 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.