Headache ReliefExtra Strength

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 and 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 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

• adult takes more than 8 tablets in 24 hours, which is the maximum daily amount
• taken with other drugs containing acetaminophen
• adult has 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, occasionally, rapid heart beat.

Do not use

• if you have ever had an allergic reaction to
  acetaminophen, aspirin or 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 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

Ask a doctor or pharmacist before use if

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

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
• 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
• ever gets worse or lasts for more than 3 days
• any new symptoms occur
  These could be signs of a serious condition

If pregnant or breastfeeding,

ask a health professional before use. It is especially important not to use aspirin
during the last 3 months of pregnancy unless specifically
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
(1-800-222-1222) right away. Quick medical attention is
critical for adults as well as for children even if you do not
notice the 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 tablets every 6 hours; not more than 8 tablets in 24 hours

children under 12 years: ask a doctor

store at 20°-25°C (68°-77°F)

corn starch, croscarmellose sodium, crospovidone, hypromellose, microcrystalline
cellulose, polyethylene glycol, povidone, pregelatinized
starch, silicon dioxide, stearic acid, titanium dioxide

Call 1-877-290-4008

[Image in the official label — see DailyMed source]

[Image in the official label — see DailyMed source]