Acetaminophen, Aspirin and Caffeine Tablets USP, 250 mg, 250 mg and 65 mg

ACTIVE INGREDIENT(S)

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

PURPOSE

Pain reliever Pain reliever Pain reliever aid

USE(S)

• 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 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

• taking a prescription drug for: o diabetes o gout o 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 DOCTOR IF

• an allergic reaction occurs. Seek medical help right away. • you experience any of the following signs of stomach bleeding : o feel faint o vomit blood o have bloody or black stools o 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.

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° to 25°C (68° to 77°F) • close cap tightly after use • read all product information before using. Keep this box for important information.

• Tamper Evident : Do not use if foil inner seal under the cap is opened or missing

INACTIVE INGREDIENTS

Carnauba wax, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, propylene glycol, sodium stearyl fumarate and titanium dioxide