Extra Strength Headache Relief

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)**

Caffeine 65 mg

**nonsteroidal anti-inflammatory drug

Pain reliever

Pain reliever

Pain reliever aid

Temporarily relieves minor aches and pains due to:

• headache

• a cold

• arthritis

• muscular aches

• toothache

• premenstrual & menstrual cramps

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 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 8 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 occasional rapid heartbeat.

• 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.

• 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

• taking a prescription drug for diabetes, gout, or arthritis
• taking any other drug, or are under a doctor's care for any serious condition

• 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

• 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

• any new symptoms occur. These could be signs of a serious condition.

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.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

•  do not use more than directed

• 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

• store at 20°-25°C(68°-77°F)
• close cap tightly after use

Colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, PVP-K30, sodium starch glycolate, stearic acid, talc, titanium dioxide.

call toll-free 1-800-630-8895

[Image in the official label — see DailyMed source]