TYLENOL Cold Sore Throat

McNeil Consumer Healthcare Div McNeil-PPC, Inc

Extra Strength TYLENOL COLD SORE THROAT

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each 15 mL = 1 tablespoon)
• Purpose
• TYLENOL Cold Sore Throat Uses
• Warnings
  • Liver warning
  • Sore throat warning
  • Do not use
  • Stop use and ask a doctor if
  • Overdose warning
• Directions
• TYLENOL Cold Sore Throat Other information
• Inactive ingredients
• Questions or comments?
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each 15 mL = 1 tablespoon)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

TYLENOL Cold Sore Throat Uses

• temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • sore throat
• 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

Sore throat warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

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)
• mL = milliliter; TBSP = tablespoon; FL OZ = fluid ounce
• use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.

TYLENOL Cold Sore Throat Other information

• each 15 mL (1 TBSP) (½ FL OZ) contains: sodium 11 mg
• store between 20-25°C (68-77°F)
• do not use if neck wrap imprinted with "COLD SORE THROAT" or foil inner seal imprinted with "SAFETY SEAL®" is broken or missing

Inactive ingredients

anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, sucrose

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NDC 50580-404-08

See New Warnings Information & Directions

Extra Strength
TYLENOL^®
COLD
SORE THROAT

For Adults

Acetaminophen, Pain Reliever/Fever Reducer

Relieves Sore Throat
Reduces Fever
Relieves Body Aches

8 fl oz
(240 ml)
Liquid

Cool Burst^®

500 mg per 15 ml