TYLENOL For Children Plus Adults

Manufacturer
Kenvue Brands LLC
Effective date
2025-05-21
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:01:23

Label at a glance#

ProductTYLENOL For Children Plus Adults
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 muscular aches backache minor pain of arthritis premenstrual and menstrual cramps

Storage and handling

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 (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
      • muscular aches
      • backache
      • minor pain of arthritis
      • premenstrual and menstrual cramps

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. Severe liver damage may occur if
■ adult takes more than 4,000 mg of acetaminophen in 24 hours
■ child takes more than 5 doses in 24 hours, which is the maximum daily amount
■ taken with other drugs containing acetaminophen
■ adult has 3 or more alcoholic drinks every day while using this product

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.

Sore throat warning

SPL UNCLASSIFIED SECTION

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 you are allergic to acetaminophen or any of the inactive ingredients in this product

OTC - ASK DOCTOR SECTION


Ask a doctor before use if the user
■ has liver disease
■ is a child with pain of arthritis

OTC - ASK DOCTOR/PHARMACIST SECTION


Ask a doctor or pharmacist before use if the user 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 10 days in adults
■ pain gets worse or lasts more than 5 days in children under 12 years
■ 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 - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

OVERDOSAGE 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


■ do not give more than directed (see overdose warning)
■ shake well before using

■ mL = milliliter
■ Children 2 years to under 12 years:
■ find right dose on chart below. If possible, use weight to dose; otherwise, use age.
■ remove the child protective cap and squeeze the dose into the dosing cup
■ repeat dose every 4 hours while symptoms last
■ do not take more than 5 times in 24 hours unless directed by a doctor
■ do not take for more than 5 days unless directed by a doctor

Weight (lb)Age (years)Dose (mL)*
under 24under 2 yearsask a doctor
24-35 lbs2-3 years5 mL
36-47 lbs4-5 years7.5 mL
48-59 lbs6-8 years10 mL
60-71 lbs9-10 years12.5 mL
72-95 lbs11 years15 mL

* or as directed by a doctor

■ Adults and children 12 years and over:
■ take 20 mL (2 x 10 mL) every 4 hours while symptoms last. For adult dosing,the dosing cup needs to be filled to 10 mL line twice.
■ do not take more than 5 doses (100 mL) in 24 hours unless directed by a doctor
■ do not take for more than 10 days unless directed by a doctor


Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Other information

STORAGE AND HANDLING SECTION

  • 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

Questions or comments?

OTC - QUESTIONS SECTION

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

RECENT MAJOR CHANGES SECTION

dsdsds

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50580-177-08

Same as Children's TYLENOL ®
with adult dosing

TYLENOL ®
FOR CHILDREN
+ ADULTS
FAMILY

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

DYE-FREE
Pain+Fever

Ages 2 Years – Adult

FREE OF:

Dyes

Alcohol

Ibuprofen

Aspirin

Parabens

High Fructose
Corn Syrup

8 fl oz (240 mL)
160 mg per 5 mL

Cherry

Flavor

tylenol-children-01tylenol-children-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN5
828555Tylenol 160 MG in 5 mL Oral SuspensionPSN5
828555acetaminophen 32 MG/ML Oral Suspension [Tylenol]SBD5
307668acetaminophen 32 MG/ML Oral SuspensionSCD5
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY5
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY5
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY5
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY5
307668APAP 32 MG/ML Oral SuspensionSY5
828555APAP 32 MG/ML Oral Suspension [Tylenol]SY5
828555Tylenol 160 MG per 5 ML Oral SuspensionSY5
828555Tylenol 32 MG/ML Oral SuspensionSY5
828555Tylenol Infants 160 MG in 5 mL Oral SuspensionSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-177-08TYLENOL For Children Plus Adults240 mL in 1 BOTTLESUSPENSION2405
50580-177-08TYLENOL For Children Plus Adults1 in 1 CARTONSUSPENSION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-177TYLENOL FOR CHILDREN PLUS ADULTS (ACETAMINOPHEN) SUSPENSION [KENVUE BRANDS LLC]5Current NDC, Legacy NDC, 2 package rows20250523_5bb8ef99-a94b-49f9-89f9-cd1ce0a47a42.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-177-08ML - Milliliter50580-177b7b1498c-76fc-4302-87c4-bd0db62d479912021-10-08

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
50580-17750580-177-08

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
TYLENOL For Children Plus AdultsACETAMINOPHENKenvue Brands LLC5bb8ef99-a94b-49f9-89f9-cd1ce0a47a422025-05-21WarningsExact identifier
ndc (package): 50580-177-08
ndc (product): 50580-177
ndc11 (package): 50580017708
spl id: 35a3c165-116d-b171-e063-6394a90a8abd
spl set id: 5bb8ef99-a94b-49f9-89f9-cd1ce0a47a42

Reported adverse events (FAERS/openFDA)#

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