FDA.reportPublic FDA data

TYLENOL Extra Strength

Manufacturer
Kenvue Brands LLC
Effective date
2025-02-18
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:55:36

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#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

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

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

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.

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 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, corn starch, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, 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

500mg

NDC 50580-457-11

To re-order reference the NDC Code

TYLENOL ®

FOR ADULTS

Acetaminophen Pain Reliever - Fever Reducer

Extra Strength

100 Caplets

500 mg each

10 Blister Cards

with

10 Individual Blisters

SMART PACKAGING

DESIGNED FOR HEALTH

CARE PROFESSIONALS

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

Tylenol-1Tylenol-1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN9
209459Tylenol Extra Strength 500 MG Oral TabletPSN9
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBD9
198440acetaminophen 500 MG Oral TabletSCD9
198440APAP 500 MG Oral TabletSY9
209459APAP 500 MG Oral Tablet [Tylenol]SY9
209459Tylenol 500 MG Oral TabletSY9
209459Tylenol Extra Strength 500 MG Oral TabletSY9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-457-10TYLENOL Extra Strength100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1009
50580-457-10TYLENOL Extra Strength1 in 1 CARTONTABLET, FILM COATED19
50580-457-11TYLENOL Extra Strength10 in 1 BLISTER PACKTABLET, FILM COATED109
50580-457-11TYLENOL Extra Strength10 in 1 CARTONTABLET, FILM COATED109
50580-457-70TYLENOL Extra Strength700 in 1 BOTTLE, PLASTICTABLET, FILM COATED7009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-457TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [KENVUE BRANDS LLC]9Current NDC, Legacy NDC, 5 package rows20250221_c830320e-72ba-48ff-a4cd-250ac5650bf0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-457-11EA - Each50580-457c86e83a8-18ef-42d7-80bf-c165e09112fd12021-02-05
50580-457-70EA - Each50580-4575487d689-2225-4f7d-a25b-71326b8c986b12021-07-15

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
50580-45750580-457-11, 50580-457-10, 50580-457-70

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
STARCH, CORNO8232NY3SJIACT
FD&C RED NO. 40WZB9127XOAIACT
ALUMINUM OXIDELMI26O6933IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
POWDERED CELLULOSESMD1X3XO9MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SHELLAC46N107B71OIACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
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 LLCc830320e-72ba-48ff-a4cd-250ac5650bf02025-02-18WarningsExact identifier
ndc (package): 50580-457-10
ndc (package): 50580-457-11
ndc (package): 50580-457-70
ndc (product): 50580-457
ndc11 (package): 50580045711
ndc11 (package): 50580045710
ndc11 (package): 50580045770
spl id: 2ddb1260-fde6-1914-e063-6394a90a82d7
spl set id: c830320e-72ba-48ff-a4cd-250ac5650bf0

Reported adverse events (FAERS/openFDA)#

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