FDA Label for Childrens 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.

Active Ingredient (In Each Tablet)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Uses

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

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)
• find right dose on chart below. If possible, use weight to dose; otherwise, use age.
• chew tablets completely before swallowing; do not swallow tablets whole
• repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hours

Weight (lb)	Age (yr)	Dose (tablets) or as directed by a doctor
under 24	under 2 years	ask a doctor
24-35	2-3 years	1 tablet
36-47	4-5 years	1½ tablets
48-59	6-8 years	2 tablets
60-71	9-10 years	2½ tablets
72-95	11 years	3 tablets

Other Information

• store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.
• do not use if neck band or foil inner seal imprinted with "TYLENOL" is broken or missing

Inactive Ingredients

anhydrous citric acid, cellulose acetate, crospovidone, D&C red no. 7 calcium lake, dextrose, flavor, magnesium stearate, povidone, sucralose

Questions Or Comments?

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

Principal Display Panel

NDC 50580-521-24

Children's
TYLENOL^®

New Strength & Directions

Acetaminophen
Pain Reliever
Fever Reducer

Pain+Fever Ages 2-11

Chewables

Ibuprofen Free, Aspirin Free

Now
160 mg
Per Tablet

24 Chewable Tablets
160 mg each

Actual Size

Bubble Gum Flavor