Infants’ TYLENOL

Manufacturer
Kenvue Brands LLC
Effective date
2026-02-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:53:31

Label at a glance#

ProductInfants TYLENOL
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and uses

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

Dosage and administration

Directions ■ 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 below. 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 ■ d...

Storage and handling

Other information ■ each 5 mL contains: potassium 5 mg ■ store between 20-25°C (68-77°F) ■ do not use if carton is opened ■ do not use if bottle wrap imprinted with “TYLENOL” is broken or missing

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

Uses temporarily:

■ reduces fever

■ relieves minor aches and pains due to:


-the common cold

-flu

-headache

-sore throat

-toothache

Warnings

WARNINGS SECTION

Warnings

Liver warning

SPL UNCLASSIFIED SECTION

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.

OTC - DO NOT USE SECTION

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 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)

OTC - STOP USE SECTION

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 SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions
■ 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 below. 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


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

Other information

■ each 5 mL contains: potassium 5 mg
■ store between 20-25°C (68-77°F)

■ do not use if carton is opened

■ do not use if 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

OTC - QUESTIONS SECTION


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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

NDC 50580-154-02

Infant's TYLENOL ®

For children

Acetaminophen (160 mg per 5 mL)

Oral Suspension

Pain Reliever-Fever Reducer

Pain+Fever

Infants

DYE-FREE

Free Of:

• Dyes
• Alcohol
• Ibuprofen
• Aspirin
• Parabens
• High Fructose Corn Syrup
• Artificial Flavoring

Natural Apple
Flavor with Other
Natural Flavors

2 fl oz (60 mL) 160 mg per 5 mL*

*Same as Children’s TYLENOL®

SimpleMeasure®

Specially designed for younger children
Use Only Enclosed Syringe

Tylenol-1Tylenol-1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN1
828555Tylenol 160 MG in 5 mL Oral SuspensionPSN1
828555acetaminophen 32 MG/ML Oral Suspension [Tylenol]SBD1
307668acetaminophen 32 MG/ML Oral SuspensionSCD1
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY1
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY1
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY1
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY1
307668APAP 32 MG/ML Oral SuspensionSY1
828555APAP 32 MG/ML Oral Suspension [Tylenol]SY1
828555Tylenol 160 MG per 5 ML Oral SuspensionSY1
828555Tylenol 32 MG/ML Oral SuspensionSY1
828555Tylenol Infants 160 MG in 5 mL Oral SuspensionSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130300450146021GTIN-13: 0300450146021
EAN-13: 0300450146021
GTIN-12: 300450146021
UPC-A: 300450146021
GTIN storage (14 digits): 00300450146021
Tylenol-1.jpg
QR code linkQR Code2d.kenvue.com/01/00300450146021Tylenol-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-154-02Infants TYLENOL60 mL in 1 BOTTLESUSPENSION601
50580-154-02Infants TYLENOL1 in 1 CARTONSUSPENSION11

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
50580-15450580-154-02

Ingredients#

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

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

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Infants TYLENOLACETAMINOPHENKenvue Brands LLC4a121a53-dbae-05c7-e063-6294a90aed892026-02-13WarningsExact identifier
ndc (package): 50580-154-02
ndc (product): 50580-154
ndc11 (package): 50580015402
spl id: 4a121ba1-d91e-0039-e063-6294a90a5445
spl set id: 4a121a53-dbae-05c7-e063-6294a90aed89

Reported adverse events (FAERS/openFDA)#

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