TYLENOL

McNeil Consumer Healthcare Div. McNeil-PPC, Inc

TYLENOL Extra Strength

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each tablet)
• Purpose
• TYLENOL Uses
• Warnings
  • Liver warning
  • Do not use
  • Stop use and ask a doctor if
  • Keep out of reach of children.
  • Overdose warning
• Directions
• TYLENOL Other information
• Inactive ingredients
• Questions or comments?
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

TYLENOL Uses

• temporarily relieves 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 8 tablets 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

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

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)

TYLENOL Other information

• store between 20-25°C (68-77°F)
• do not use if carton is opened or neck wrap or foil inner seal imprinted with "Safety Seal®" is broken or missing
• see end panel for lot number and expiration date

Inactive ingredients

corn starch, magnesium stearate, powdered cellulose, pregelatinized starch, sodium starch glycolate

Questions or comments?

call 1-877-895-3665

PRINCIPAL DISPLAY PANEL

NDC 50580-499-68

See New Warnings Information

TYLENOL^®

Pain Reliever
Fever Reducer
Acetaminophen

EXTRA
STRENGTH

60 TABLETS
500 mg each

Tablets
Crushable•Dye Free

Contains
no aspirin