FDA.reportPublic FDA data

TYLENOL Extra Strength

Manufacturer
Kenvue Brands LLC
Effective date
2026-01-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:35:13

Label at a glance#

ProductTYLENOL Extra Strength
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and uses

temporarily relieves minor aches and pains due to: ■ the common cold ■ headache ■ backache ■ minor pain of arthritis ■ toothache ■ muscular aches ■ premenstrual and menstrual cramps temporarily reduces fever

Dosage and administration

■ do not take more than directed (see overdose warning) adults and children 12 years and over ■ take 2 caplets every 6 hours while symptoms last ■ do not take more than 6 caplets in 24 hours, unless directed by a doctor ■ do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor

Storage and handling

■ store between 20-25°C (68-77°F) ■ do not use if blister unit is torn or broken

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

Acetaminophen 500 mg

OTC - PURPOSE SECTION

Purpose
Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains due to:

■ the common cold

■ headache
■ backache

■ minor pain of arthritis
■ toothache

■ muscular aches
■ premenstrual and menstrual cramps

  • temporarily reduces fever

Warnings

WARNINGS SECTION

Warnings

Liver warning:

WARNINGS SECTION

This product contains acetaminophen. Severe liver damage may occur if you take
■ more than 4,000 mg of acetaminophen in 24 hours
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks every day while using this product

Allergy alert

WARNINGS SECTION

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.

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 you have liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

OTC - STOP USE SECTION

Stop use and ask a doctor if
■ pain gets worse or lasts more than 10 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 - 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.

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

■ do not take more than directed (see overdose warning)

adults and children
12 years and over 		■ take 2 caplets every 6 hours while symptoms last
■ do not take more than 6 caplets in 24 hours, unless directed by a doctor
■ do not use for more than 10 days unless directed by a doctor
children under
12 years 		ask a doctor

Other information

STORAGE AND HANDLING SECTION

■ store between 20-25°C (68-77°F)
■ do not use if blister unit is torn or broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, modified starch, polyethylene glycol, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50580-491-10

To re-order reference the NDC Code

TYLENOL ®
FOR ADULTS

Acetaminophen Pain Reliever - Fever Reducer

Extra Strength

FOR HOSPITAL USE ONLY. NOT FOR HOUSEHOLD USE. PACKAGE IS NOT CHILD-RESISTANT.

100 Caplets
500 mg each

10 Blister Cards with 10 Individual Blisters

tylenol-1tylenol-1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN1
209459Tylenol Extra Strength 500 MG Oral TabletPSN1
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBD1
198440acetaminophen 500 MG Oral TabletSCD1
198440APAP 500 MG Oral TabletSY1
209459APAP 500 MG Oral Tablet [Tylenol]SY1
209459Tylenol 500 MG Oral TabletSY1
209459Tylenol Extra Strength 500 MG Oral TabletSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeITF30060804tylenol-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
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aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-491-01TYLENOL Extra Strength1 in 1 CARTONTABLET, FILM COATED11
50580-491-01TYLENOL Extra Strength100 in 1 BOTTLETABLET, FILM COATED1001
50580-491-10TYLENOL Extra Strength10 in 1 CARTONTABLET, FILM COATED101
50580-491-10TYLENOL Extra Strength10 in 1 BLISTER PACKTABLET, FILM COATED101
50580-491-70TYLENOL Extra Strength1 in 1 CARTONTABLET, FILM COATED11
50580-491-70TYLENOL Extra Strength700 in 1 BOTTLETABLET, FILM COATED7001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-491-10EA - Each50580-491f4b28b30-a8e4-4cd0-bf0c-331aa5eb7c6d12026-03-17

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
50580-49150580-491-70, 50580-491-01, 50580-491-10

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
CARNAUBA WAXR12CBM0EIZIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ACETAMINOPHEN362O9ITL9DACTIB
POWDERED CELLULOSESMD1X3XO9MIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
SHELLAC46N107B71OIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C RED NO. 40WZB9127XOAIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
ALUMINUM OXIDELMI26O6933IACT

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 Extra StrengthACETAMINOPHENKenvue Brands LLC4961695d-72f3-533a-e063-6294a90a5a292026-01-27WarningsExact identifier
ndc (package): 50580-491-10
ndc (package): 50580-491-70
ndc (package): 50580-491-01
ndc (product): 50580-491
ndc11 (package): 50580049170
ndc11 (package): 50580049110
ndc11 (package): 50580049101
spl id: 4961695d-72f4-533a-e063-6294a90a5a29
spl set id: 4961695d-72f3-533a-e063-6294a90a5a29

Reported adverse events (FAERS/openFDA)#

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