FDA Label for Tylenol Extra Strength

Active Ingredient (In Each Caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

■ temporarily relieves minor aches and pains due to:

■ the common cold ■ headache

■ backache ■ minor pain of arthritis

■ toothache ■ muscular aches

■ premenstrual and menstual cramps

■ temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

■ more than 4,000 mg of acetaminophen in 24 hours

■ with other drugs containing acetaminophen

■ 3 or more alcoholic drinks every day while using this product.

Allergy alert: acetaminophen may cause severe skin reactions.symptoms may include:

■ skin reddening ■ blisters ■ rash

Ifa skin reaction occurs, stop use and seek medical help right away.

Do Not Use

■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen. ask a doctor or pharmacist.

■ if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Ask A Doctor Before Use If You Have

liver disease.

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin

Stop Use And Ask A Doctor If

■ pain gets worse or lasts more than 10 days

■ fever gets worse or lasts more than 3 days

■ new symptoms occur

■ redness or swelling is present.

These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

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 take more than directed (see overdose warning).

adults and children ■ take 2 capletes every 6 hours while symptoms

12 years and over: last
■ do not take more than 6 capletes in 24 hours,

unless directed by a doctor
■ do not use for more than 10 days unless

directed by a doctor

children under 12 years ask a doctor

Other Information

■ store between 20-25C (68-77F)

■ do not use if pouch is torn or damaged.

Inactive Ingredients

carnauba wax*, corn starch*, FD&C red no.40 aluminum lake, hypromellose, magnesium stearate, modified starch*, polyethylene glycol*, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide

* contains one or more of these ingredients

Questions Or Comments?

Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

Package Labeling

Package Label - TylenolExtraStrength 25