FDA.reportPublic FDA data

Infants TYLENOL

Manufacturer
Kenvue Brands LLC
Effective date
2025-02-20
Label type
HUMAN OTC DRUG LABEL
Version
15
Source
full-release
Hydrated at
2026-06-01 00:55:59

Label at a glance#

ProductInfants TYLENOL
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and uses

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

Dosage and administration

this product does not contain directions or complete warnings for adult use. do not give more than directed (see overdose warning ) shake well before using mL = milliliter find right dose on chart. If possible, use weight to dose; otherwise, use age. push air out of syringe. Insert syringe tip into bottle opening flip bottle upside down. Pull yellow part of syringe to correct dose dispense liquid slowly into child...

Storage and handling

store between 20-25°C (68-77°F) do not use if carton tape or bottle wrap imprinted with "TYLENOL" is broken or missing

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

temporarily:

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

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)
  • shake well before using
  • mL = milliliter
  • find right dose on chart. If possible, use weight to dose; otherwise, use age.
  • push air out of syringe. Insert syringe tip into bottle opening
  • flip bottle upside down. Pull yellow part of syringe to correct dose
  • dispense liquid slowly into child's mouth, toward inner cheek
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • replace cap tightly to maintain child resistance
Dosing Chart
Weight (lb)Age (yr)Dose (mL) *
under 24under 2 yearsask a doctor
24-35 lbs2-3 years5 mL

* or as directed by a doctor

SPL UNCLASSIFIED SECTION

Attention: use only enclosed syringe specifically designed for use with this product.

Do not use any other dosing device.

Other information

STORAGE AND HANDLING SECTION

  • store between 20-25°C (68-77°F)
  • do not use if carton tape or bottle wrap imprinted with "TYLENOL" is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, flavors, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, potassium sorbate, purified water, sorbitol solution, sucralose, sucrose, xanthan gum

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 50580-599-03

Infants'
TYLENOL ®
For Children

Acetaminophen 160 mg per 5 mL Oral Suspension
Pain Reliever-Fever Reducer

DYE-FREE

Pain+Fever

Infants

Free Of:

  • Dyes
  • Alcohol
  • Ibuprofen
  • Aspirin
  • Parabens
  • High Fructose

Corn Syrup

SimpleMeasure ®
Specially designed for younger children

Use Only Enclosed Syringe

*Same as Children's TYLENOL

1 fl oz ( 30 mL)
160 mg per 5 mL*

Cherry
Flavor

tylenol-01tylenol-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN15
828555Tylenol 160 MG in 5 mL Oral SuspensionPSN15
828555acetaminophen 32 MG/ML Oral Suspension [Tylenol]SBD15
307668acetaminophen 32 MG/ML Oral SuspensionSCD15
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY15
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY15
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY15
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY15
307668APAP 32 MG/ML Oral SuspensionSY15
828555APAP 32 MG/ML Oral Suspension [Tylenol]SY15
828555Tylenol 160 MG per 5 ML Oral SuspensionSY15
828555Tylenol 32 MG/ML Oral SuspensionSY15
828555Tylenol Infants 160 MG in 5 mL Oral SuspensionSY15

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50580-599-012024-02-06C16284748780-11030e365-1a04-111a-e063-dadaa90a10e2Infants' TYLENOL ®
50580-599-022024-02-06C16284748780-11030e365-1a04-111a-e063-dadaa90a10e2Infants' TYLENOL ®
50580-599-032024-02-06C16284748780-11030e365-1a04-111a-e063-dadaa90a10e2Infants' TYLENOL ®
50580-599-012024-01-30C16284748780-11030e365-1a04-111a-e063-dadaa90a10e2Infants' TYLENOL ®
50580-599-022024-01-30C16284748780-11030e365-1a04-111a-e063-dadaa90a10e2Infants' TYLENOL ®
50580-599-032024-01-30C16284748780-11030e365-1a04-111a-e063-dadaa90a10e2Infants' TYLENOL ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-599-01Infants TYLENOL1 in 1 CARTONSUSPENSION115
50580-599-01Infants TYLENOL60 mL in 1 BOTTLESUSPENSION6015
50580-599-02Infants TYLENOL60 mL in 1 BOTTLESUSPENSION6015
50580-599-02Infants TYLENOL2 in 1 CARTONSUSPENSION215
50580-599-03Infants TYLENOL1 in 1 CARTONSUSPENSION115
50580-599-03Infants TYLENOL30 mL in 1 BOTTLESUSPENSION3015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-599INFANTS TYLENOL (ACETAMINOPHEN) SUSPENSION [KENVUE BRANDS LLC]15Current NDC, Legacy NDC, 6 package rows20250226_f9de7c2f-016b-4f40-8b5e-141ad194be97.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-599-01ML - Milliliter50580-599f23bdcb2-a6bf-4c37-b48f-ef996e84244012020-05-08

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50580-59950580-599-01, 50580-599-03, 50580-599-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
XANTHAN GUMTTV12P4NEEIACT
ACETAMINOPHEN362O9ITL9DACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
SORBITOL SOLUTION8KW3E207O2IACT
SUCRALOSE96K6UQ3ZD4IACT
SUCROSEC151H8M554IACT

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
Gentle Care KitZINC OXIDEKenvue Brands LLC4b8f7a5a-2fc4-ea00-e063-6294a90ab95b2026-02-24WarningsExact identifier
ndc (package): 50580-599-03
ndc11 (package): 50580059903
Infants TYLENOLACETAMINOPHENKenvue Brands LLCf9de7c2f-016b-4f40-8b5e-141ad194be972025-02-20WarningsExact identifier
ndc (package): 50580-599-01
ndc (package): 50580-599-03
ndc (package): 50580-599-02
ndc (product): 50580-599
ndc11 (package): 50580059903
ndc11 (package): 50580059901
ndc11 (package): 50580059902
spl id: 2e8d9ab2-5131-8810-e063-6394a90aba9c
spl set id: f9de7c2f-016b-4f40-8b5e-141ad194be97

Reported adverse events (FAERS/openFDA)#

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