FDA.reportPublic FDA data

TYLENOL Extra Strength

Manufacturer
Kenvue Brands LLC
Effective date
2025-08-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:40:00

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 capsules every 6 hours while symptoms last do not take more than 6 capsules 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 carton is opened. 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 capsule)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

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

SPL UNCLASSIFIED 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

SPL UNCLASSIFIED 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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

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

adults and children 12 years and over
  • take 2 capsules every 6 hours while symptoms last
  • do not take more than 6 capsules 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 carton is opened. Do not use if foil inner seal imprinted with “TYLENOL” is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, hypromellose, lecithin, medium chain triglycerides, polyethylene glycol, povidone, propylene glycol, sorbitol, 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 50580-469-18

NEW

Extra Strength

TYLENOL ®
FOR ADULTS

Acetaminophen

Pain Reliever - Fever Reducer

LIQUID GELS

Actual Size

18 Liquid Gels*

500 mg each

*Liquid Filled Capsules

tylenol-1tylenol-1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198439acetaminophen 500 MG Oral CapsulePSN1
351580Tylenol Gelcap Extra Strength 500 MG Oral CapsulePSN1
351580acetaminophen 500 MG Oral Capsule [Tylenol Gelcap Extra Strength]SBD1
198439acetaminophen 500 MG Oral CapsuleSCD1
198439APAP 500 MG Oral CapsuleSY1
351580APAP 500 MG Oral Capsule [Tylenol Gelcap Extra Strength]SY1
351580Tylenol Gelcap Extra Strength 500 MG Oral CapsuleSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130300450439185GTIN-13: 0300450439185
EAN-13: 0300450439185
GTIN-12: 300450439185
UPC-A: 300450439185
GTIN storage (14 digits): 00300450439185		tylenol-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
50580-469-18TYLENOL Extra Strength1 in 1 CARTONCAPSULE, LIQUID FILLED11
50580-469-18TYLENOL Extra Strength18 in 1 BOTTLECAPSULE, LIQUID FILLED181
50580-469-40TYLENOL Extra Strength40 in 1 BOTTLECAPSULE, LIQUID FILLED401
50580-469-40TYLENOL Extra Strength1 in 1 CARTONCAPSULE, LIQUID FILLED11
50580-469-75TYLENOL Extra Strength1 in 1 CARTONCAPSULE, LIQUID FILLED11
50580-469-75TYLENOL Extra Strength75 in 1 BOTTLECAPSULE, LIQUID FILLED751

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
50580-46950580-469-18, 50580-469-40, 50580-469-75

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
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GLYCERINPDC6A3C0OXIACT
GELATIN2G86QN327LIACT
HYPROMELLOSES3NXW29V3WOIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC3bb7dc60-97b2-1291-e063-6294a90a26d92025-08-12WarningsExact identifier
ndc (package): 50580-469-75
ndc (package): 50580-469-40
ndc (package): 50580-469-18
ndc (product): 50580-469
ndc11 (package): 50580046940
ndc11 (package): 50580046918
ndc11 (package): 50580046975
spl id: 3bb7dcea-736b-343c-e063-6394a90a89e0
spl set id: 3bb7dc60-97b2-1291-e063-6294a90a26d9

Reported adverse events (FAERS/openFDA)#

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