FDA Label for Childrens Tylenol

View Indications, Usage & Precautions

Childrens Tylenol Product Label

The following document was submitted to the FDA by the labeler of this product Johnson & Johnson Consumer Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 Powder)



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)
  • find right dose on chart. If possible, use weight to dose; otherwise, use age.
  • tear packet and pour powder on your child's tongue
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • Weight (lb)Age (yr)Dose (powder)

    or as directed by a doctor

    under 48under 6 yearsdo not use
    48-596-8 years2 powders
    60-719-10 years2 powders
    72-9511 years3 powders

Other Information



  • store between 20-25°C (68-77°F)
  • do not use if packet is torn or damaged

Inactive Ingredients



citric acid, ethylcellulose, flavor, magnesium stearate, maltodextrin, sodium bicarbonate, sucralose, xylitol


Questions Or Comments?



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


Principal Display Panel



NDC 50580-555-05

NEW

Children's
TYLENOL®

Acetaminophen
Pain Reliever-Fever Reducer

Ibuprofen Free
Aspirin Free

Pain+Fever Ages 6-11

DISSOLVE PACKS

  • ✔NO WATER NEEDED
  • ✔DISSOLVES IN SECONDS
  • 18 Packets*
    160 mg
    each packet

    Wild Berry
    Flavor

    *Packets of Powder


* Please review the disclaimer below.