FDA.reportPublic FDA data

Children's Tylenol

Manufacturer
Kenvue Brands LLC
Effective date
2026-04-16
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:54:01

Label at a glance#

ProductChildrens Tylenol
Active ingredientACETAMINOPHEN
Label structure11 sections

Indications and uses

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

Dosage and administration

this product does not contain directions or complete warnings for adult use. do not give more than directed (see overdose warning ) chew or crush tablets completely before swallowing; do not swallow tablets whole find right dose on chart below. If possible, use weight to dose; otherwise, use age. repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (tabl...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each chewable tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

  • 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 SECTION

Ask a doctor before use if your child has liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

When using this product do not exceed recommended dose (see overdose warning)

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 SECTION

Keep out of reach of children.

Overdose warning

SPL UNCLASSIFIED SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • this product does not contain directions or complete warnings for adult use.
  • do not give more than directed (see overdose warning)
  • chew or crush tablets completely before swallowing; do not swallow tablets whole
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
Weight (lb)Age (yr)Dose (tablets) *
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

* or as directed by a doctor

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50580-522-24

Children's
TYLENOL ®

Acetaminophen

Pain Reliever
Fever Reducer

Pain+Fever

Ages 2-11

Chewables

Chew or crush tablets completely

before swallowing

Ibuprofen Free

Aspirin Free

160 mg
Per Tablet

24 Chewable Tablets
160 mg each

Actual Size

Grape Flavor

tylenol-1.jpgtylenol-1.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313820acetaminophen 160 MG Chewable TabletPSN11
828557Tylenol Junior 160 MG Chewable TabletPSN11
828557acetaminophen 160 MG Chewable Tablet [Tylenol]SBD11
313820acetaminophen 160 MG Chewable TabletSCD11
313820APAP 160 MG Chewable TabletSY11
828557APAP 160 MG Chewable Tablet [Tylenol]SY11
828557Tylenol 160 MG Chewable TabletSY11

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130300450518248GTIN-13: 0300450518248
EAN-13: 0300450518248
GTIN-12: 300450518248
UPC-A: 300450518248
GTIN storage (14 digits): 00300450518248		tylenol-1.jpg
QR code linkQR Code2d.kenvue.com/01/00300450518248tylenol-1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-522-24Childrens Tylenol24 in 1 BOTTLETABLET, CHEWABLE2411
50580-522-24Childrens Tylenol1 in 1 CARTONTABLET, CHEWABLE111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-522-24EA - Each50580-522a99a0921-a62e-4e36-aeb5-b56dbc87f6ca12017-11-06

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50580-52250580-522-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSPOVIDONE2S7830E561IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CELLULOSE ACETATE3J2P07GVB6IACT
D&C RED NO. 7ECW0LZ41X8IACT
D&C RED NO. 302S42T2808BIACT
ALUMINUM OXIDELMI26O6933IACT
DEXTROSE, UNSPECIFIED FORMIY9XDZ35W2IACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
MAGNESIUM STEARATE70097M6I30IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SUCRALOSE96K6UQ3ZD4IACT
ACETAMINOPHEN362O9ITL9DACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens TylenolACETAMINOPHENKenvue Brands LLC9782fe86-d72a-4231-b1ba-d3f3b4ee49e32026-04-16WarningsExact identifier
ndc (package): 50580-522-24
ndc (product): 50580-522
ndc11 (package): 50580052224
spl id: 4f9105c9-c419-3cf0-e063-6394a90ad430
spl set id: 9782fe86-d72a-4231-b1ba-d3f3b4ee49e3
Childrens TylenolACETAMINOPHENKenvue Brands LLCbabcb210-6a47-46ef-b4ea-bdde80411cd32024-11-08WarningsExact identifier
ndc (package): 50580-522-24
ndc11 (package): 50580052224

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.