Childrens Tylenol Powder
FDA Label NDC 50580-555

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Childrens Tylenol (NDC 50580-555). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient (in each powder), purpose, uses, liver warning, do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.