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Childrens Tylenol by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

Dosage form: tablet, chewable
Ingredients: Acetaminophen 160mg
Labeler: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
NDC Code: 50580-522

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Children's Tylenol

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 160 mg


Pain reliever/fever reducer

  • 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

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.

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.

  • 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 24under 2 yearsask a doctor
24-352-3 years1 tablet
36-474-5 years1½ tablets
48-596-8 years2 tablets
60-719-10 years2½ tablets
72-9511 years3 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, D&C red no. 30 aluminum lake, dextrose, FD&C blue no. 1 aluminum lake, flavor, magnesium stearate, povidone, sucralose

Questions or comments?

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


NDC 50580-522-24


New Strength & Directions

Pain Reliever
Fever Reducer

Ages 2-11

Ibuprofen Free, Aspirin Free

160 mg
Per Tablet

Actual Size

24 Chewable Tablets
160 mg each

Grape Flavor

acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-522
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen160 mg
Inactive Ingredients
Ingredient NameStrength
anhydrous citric acid 
cellulose acetate 
crospovidone, unspecified 
D&C RED NO. 7 
D&C RED NO. 30 
Aluminum Oxide 
dextrose, unspecified form 
magnesium stearate 
povidone, unspecified 
Product Characteristics
ColorPURPLEScore2 pieces
FlavorGRAPEImprint CodeTY;160;HALF;HALF
#Item CodePackage Description
1NDC:50580-522-241 BOTTLE in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34302/27/2017
Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)

Revised: 01/2018
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.