Drug Facts
Active ingredients (in each caplet)
Acetaminophen 250mg
Aspirin 250 mg (NSAID*)
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Purposes
Pain reliever
Pain reliever
Pain reliever aid
Use
• treats migraine
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 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
Medication overuse headache warning:Headaches may worsen if this product is used for 10 or more days per month.
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 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 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. • 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 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.
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
Other information
• store at controlled room temperature 20°-25°C (68°-77°F) • close cap tightly after use • read all product information before using.
Keep this box for important information.
Inactive ingredients
benzoic acid, carnauba wax, FD&C blue no. 1, hypromellose, light mineral oil, low-substituted hydroxypropyl cellulose, microcrystalline cellulose, polysorbate 20, povidone, propylene glycol, simethicone, sorbitan monolaurate, stearic acid, titanium dioxide