FDA Label for Acetaminophen

Active Ingredient (In Each Tablet)

Acetaminophen 500 mg

Purpose

Pain Reliever/Fever Reducer

Uses

To reduce fever and for the temporary relief of minor aches and pains due to:

•headache

•muscular aches

•backache

•minor pain of arthritis

•the common cold

•toothache

•premenstrual and menstrual 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
• 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

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

Do not use

• with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if the user has ever had an allergic reaction to this product or any of its ingredients.

Ask a doctor before use if the user has

has liver disease

Ask a doctor or pharmacist before use if the user is 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:

Taking more than the recommended dose (overdose) may cause liver damage. 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)

Other Information

store at 20° to 25°C (68° to 77°F)

Inactive Ingredients:

Gelatinized starch, magnesium stearate, povidone

Questions Or Comments?

Call toll-free 1-877-225-6999

Manufactured for

AARNA USA INC.

Leland, NC 28451

* This product is not manufactured or distributed by Johnson and Johnson, consumer inc., distributor of regular Tylenol Tablets.

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