Headache Relief Tablet, Film Coated
FDA Label NDC 70000-0146

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:
• a cold
• headache
• 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: Aspirin may cause a severe allergic reaction, which may include:

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

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

• rash
• blisters
• skin reddening

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 4,000 mg in 24 hours, which is the maximum daily amount
• 3 or more alcoholic drinks every day while using this product
• with other drugs containing acetaminophen

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.

• 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 are taking a diuretic
• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
• 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

• you experience any of the following signs of stomach bleeding:
• feel faint
• have bloody or black stools
• vomit blood
• have stomach pain that does not get better
• an allergic reaction occurs. Seek medical help right away.
• any new symptoms appear
• ringing in the ears or loss of hearing occurs
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days
• painful area is red or swollen

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.

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

• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• see end flap for expiration date and lot number

corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

1-800-426-9391

LEADER_™

NDC 70000-0146-1

Extra Strength

Headache Relief
Acetaminophen | Aspirin (NSAID) | Caffeine
Pain Reliever | Pain Reliever Aid

COMPARE TO EXCEDRIN®
EXTRA STRENGTH
active ingredients†

100% Money Back Guarantee

24 CAPLETS

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

^†This product is not manufactured or distributed by Novartis AG,
owner of the registered trademark Excedrin^® Extra Strength.
50844      REV0117A33408

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com          1-800-200-6313

CARDINAL HEALTH, the Cardinal
Health LOGO, LEADER, and the Leader
LOGO are trademarks or registered
trademarks of Cardinal Health.

Leader 44-334b (Leader 44 334b 1)