FDA Label for Infants Tylenol

Other

Drug Facts

Allergy alert: acetaminophen may cause severe skin reactions.

Symptoms may include:

• skin reddening
• blisters
• rash

If a skin reaction occurs, stop use and seek medical help right away.

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.

Attention: use only enclosed syringe specifically designed for use with this product.

Do not use any other dosing device.

Active Ingredient (In Each 5 Ml)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily:

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

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

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

Otc - Ask Doctor

Ask a doctor before use if your child has liver disease

Otc - Ask Doctor/Pharmacist

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

Otc - When Using

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.

Otc - Keep Out Of Reach Of Children

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

Dosing Chart

Weight (lb)	Age (yr)	Dose (mL) or as directed by a doctor
under 24	under 2 years	ask a doctor
24-35 lbs	2-3 years	5 mL

Other Information

• store between 20-25°C (68-77°F)
• do not use if carton tape or bottle wrap imprinted with "TYLENOL" is broken or missing

Inactive Ingredients

anhydrous citric acid, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol solution, sucralose, sucrose, xanthan gum

Questions Or Comments?

call 1-800-458-1635 (toll-free) or 215-273-8755 (collect)

Principal Display Panel

NDC 50580-599-03

Infants'
TYLENOL^®
For Children

Acetaminophen 160 mg per 5 mL Oral Suspension
Pain Reliever-Fever Reducer

Pain+Fever

Infants

Dye-Free

Alcohol Free
Ibuprofen Free
Aspirin Free
No Parabens

Cherry
Flavor

SimpleMeasure^®
Specially designed for younger children

Use Only Enclosed Syringe
*Same as Children's TYLENOL

1 fl oz (30 mL)
160 mg per 5 mL*

DYE-FREE