5004-Cardinal

Drug Facts

Active ingredients (in each caplet) Acetaminophen 250 mg Aspirin 250 mg (NSAID*) Caffeine 65 mg *nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

Purposes Pain reliever

Pain reliever aid

Uses

■ temporarily relieves minor aches and pains due to: ■ headache

■ muscular aches

■ a cold

■ arthritis ■ toothache

■ premenstrual and menstrual cramps

WARNINGS SECTION

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 ■ shock ■ asthma (wheezing) 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: ■ with other drugs containing acetaminophen ■ more than 8 caplets in 24 hours, which is the maximum daily amount ■ 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 ■ take more or for a longer time than directed ■ 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 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 have asthma

■ you are taking a diuretic

Ask a doctor or pharmacist before use if you are

■ taking a prescription drug for diabetes, gout, or arthritis

■ taking any other drug or are under a doctor’s care for any serious condition

Stop use and ask a doctor if

■ 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. ■ 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 ■ any new symptoms appear. These could be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

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.

Directions

■ 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

Other information

■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

■ use by expiration date on package

INACTIVE INGREDIENT SECTION

hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylpyrrolidone, pregelatinized starch, silica, starch, stearic acid, talc, titanium dioxide, triglycerides

SPL UNCLASSIFIED SECTION

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

RETAIN THIS CARTON FOR COMPLETE PRODUCT INFORMATION

†This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark Excedrin® Extra Strength.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader

NDC 70000-0066-1

Extra Strength

Headache Relief

Acetaminophen

Aspirin (NSAID)*/Caffeine

Pain Reliever/Pain Reliever Aid

COMPARE TO EXCEDRIN® EXTRA STRENGTH active ingredients†

100 Caplets

NOT FOR HOUSEHOLDS WITH YOUNG CHILDREN

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