TYLENOL Extra Strength

McNeil Consumer Healthcare Div. McNeil-PPC, Inc

TYLENOL Extra Strength

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each caplet)
• Purpose
• TYLENOL Extra Strength Uses
• Warnings
  • Liver warning
  • Do not use
  • Stop use and ask a doctor if
  • Overdose warning
• Directions
• TYLENOL Extra Strength Other information
• Inactive ingredients
• Questions or comments?
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

TYLENOL Extra Strength Uses

• temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • 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
• 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

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 Extra Strength 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 waxcontains one or more of these ingredients, castor oilcontains one or more of these ingredients, corn starch, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, polyethylene glycolcontains one or more of these ingredients, 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

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SEE
ABOVE

See New Warnings Information & Directions

NDC 50580-449-09

TYLENOL ^®

Pain Reliever
Fever Reducer
Acetaminophen

EXTRA
STRENGTH
For Adults

100 CAPLETS
500 mg each

Caplets