TYLENOL

McNeil Consumer Healthcare Div. McNeil-PPC, Inc

Tylenol Regular Strength

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each caplet)
• 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 caplet)

Acetaminophen 325 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. The maximum daily dose of this product is 10 caplets (3,250 mg) in 24 hours for adults or 5 caplets (1,625 mg) in 24 hours for children. Severe liver damage may occur if

• adult takes more than 4,000 mg of acetaminophen in 24 hours
• child takes more than 5 doses in 24 hours, which is the maximum daily amount
• taken with other drugs containing acetaminophen
• adult has 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 the user 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 in adults
• pain gets worse or lasts more than 5 days in children under 12 years
• 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

Inactive ingredients

carnauba wax, castor oil, corn starch, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

See New Warnings Information & Directions
NDC 50580-501-50

TYLENOL^®

Pain Reliever
Fever Reducer
Acetaminophen

REGULAR
STRENGTH

Contains
no aspirin

50 CAPLETS - 325 mg each

Caplets

For Hospital and Government Use Only