Infants TYLENOL

McNeil Consumer Healthcare Div. McNeil-PPC, Inc

Infants' TYLENOL

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient (in each 5 mL)
• Purpose
• Infants TYLENOL Uses
• Warnings
  • Liver warning
  • Sore throat warning
  • Do not use
  • Stop use and ask a doctor if
  • Overdose warning
• Directions
• Infants TYLENOL Other information
• Inactive ingredients
• Questions or comments?
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Infants TYLENOL Uses

temporarily:

• reduces fever
• relieves minor aches and pains due to:
  • the common cold
  • flu
  • headache
  • sore throat
  • toothache

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if your child takes

• more than 5 doses in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen

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 your child is allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if your child has liver disease

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin

When using this product do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if

• pain gets worse or lasts more than 5 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.

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

• this product does not contain directions or complete warnings for adult use.
• do not give more than directed (see overdose warning)
• shake well before using
• mL = milliliter
• find right dose on chart. If possible, use weight to dose; otherwise, use age.
• push air out of syringe. Insert syringe tip into bottle opening
• flip bottle upside down. Pull yellow part of syringe to correct dose
• dispense liquid slowly into child's mouth, toward inner cheek
• repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours
• replace cap tightly to maintain child resistance

Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

Infants TYLENOL Other information

• store between 20-25°C (68-77°F)
• do not use if carton tape imprinted "SAFETY SEAL®" or bottle wrap imprinted "SAFETY SEAL®" and "USE WITH ENCLOSED DOSING DEVICE ONLY" is broken or missing

Inactive ingredients

anhydrous citric acid, butylparaben, D&C red no. 33, FD&C blue no. 1, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

See New Dosage & Directions

NDC 50580-191-01

Infants'
TYLENOL^®
For Children

Acetaminophen
Oral Suspension
Pain Reliever-Fever Reducer

INFANTS

NEW!
Dosage
& Directions

Ibuprofen Free
Alcohol Free
Aspirin Free

Use Only Enclosed Syringe

SimpleMeasure™
See side panel for more information

Grape
FLAVOR

1 fl oz (30 ml)
160 mg per 5 ml