Extra Strength Headache Tablet
FDA Label NDC 66715-6922

Active ingredients (in each caplet)

Acetaminophen 250 mg

Aspirin 250 mg (NSAID)*

Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever

Pain reliever

Pain reliever aid

Uses

• temporarily relieves minor aches and pains due to:
• headache
• a cold
• arthritis
• muscular aches
• sinusitis
• 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:Aspirin may cause a severe allergic reaction,
which may include:

• hives
• facial swelling
• asthma (wheezing)
• shock

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.

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, occasionally, rapid heartbeat.

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 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 you are taking

• any other drug containing an NSAID (prescription or nonprescription)
• a prescription drug for diabetes, gout, or arthritis
• any other drug or are under a doctor’s care for any serious condition
• a blood thinning (anticoagulant) or steroid drug

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
• fever gets worse or lasts for more than 3 days
• any new symptoms appear

These could be signs of a serious condition.

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: In case of overdose, get medical help
or contact a Poison Control Center right away
(1-800-222-1222). 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 (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; do not take more than 8 caplets in 24 hours
• children under 12 years: ask a doctor

• store between 20°-25°C (68°-77°F)

Inactive ingredients

colloidal silicon dioxide, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone K30, pregelatinized starch, stearic acid, talc

Questions or comments?
Call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

[caduceus]

Compare to the Active
Ingredients in Excedrin®
Extra Strength**

Extra Strength
Headache

Acetaminophen 250 mg
Pain Reliever
Aspirin (NSAID) 250 mg Pain Reliever
Caffeine 65 mg Pain Reliever Aid

[caplets image]

ACTUAL SIZE

50

Caplets [Lil' Drug Store Logo]