FDA.reportPublic FDA data

TYLENOL Extra Strength

Manufacturer
Select Consumer Group LLC
Effective date
2026-06-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-07-17 21:36:40

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 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 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 haveliver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you aretaking 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 yearsask 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

carnauba wax 1, corn starch 1, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, modified starch 1, polyethylene glycol 1, 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

Tylenol Extra -2Tylenol Extra -2Tylenol Extra StrengthTylenol Extra StrengthTYLENOL ®
FOR ADULTS

Acetaminophen
Pain Reliever
Fever Reducer

Extra Strength

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130655708119464GTIN-13: 0655708119464
EAN-13: 0655708119464
GTIN-12: 655708119464
UPC-A: 655708119464
GTIN storage (14 digits): 00655708119464		2611946009 - Tylenol Extra Strength - 1946-1.jpg
BarcodeEAN-130655708219461GTIN-13: 0655708219461
EAN-13: 0655708219461
GTIN-12: 655708219461
UPC-A: 655708219461
GTIN storage (14 digits): 00655708219461		2621946020 - Tylenol Extra Strength - 1946-2.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-449-00EA - Each50580-4496d4b05b4-6ad3-4928-8e25-c8b959463b2d12012-07-24
50580-449-05EA - Each50580-44988acde81-d037-4e5c-bb0c-84fb4f0c8a8712012-07-24
50580-449-07EA - Each50580-44920279d46-6713-4547-84fb-9a08de2e2d1512012-07-24
50580-449-09EA - Each50580-449c71a951e-137e-45aa-9cf4-fcf45d883ade12012-07-24
50580-449-10EA - Each50580-4493e2a7f0e-aa78-48c7-ad46-b671d85aa97912012-07-24
50580-449-12EA - Each50580-449241c2584-6250-4617-9d2b-bea53196e24512014-11-05
50580-449-13EA - Each50580-449e9e4683d-f503-45ba-935a-cfc8788a114a12015-10-02
50580-449-15EA - Each50580-44972f946f0-efd3-40f2-a3f4-b5bb480bb2f512012-07-24
50580-449-23EA - Each50580-449eb924eae-392e-408d-99ad-5b9ccf2f4b1e12012-07-24
50580-449-35EA - Each50580-449ccc5e685-e933-4c54-9a29-4f520edd3cf212013-03-03
50580-449-36EA - Each50580-449fe30c11b-8a2f-49f0-b4f9-7e2c03350a3612013-03-03
50580-449-37EA - Each50580-449d5cb5c35-153e-4f83-b28f-be9370e40ddd12026-04-20
50580-449-61EA - Each50580-449690e1cfe-fa00-469e-9039-75db9bb6375b12023-05-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85237-194685237-1946-0, 85237-1946-1, 85237-1946-2, 85237-1946-3, 85237-1946-4, 85237-1946-5, 85237-1946-6, 85237-1946-7
50580-449

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARNAUBA WAXR12CBM0EIZIACT
STARCH, CORNO8232NY3SJIACT
FD&C RED NO. 40WZB9127XOAIACT
ALUMINUM OXIDELMI26O6933IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TYLENOL Extra StrengthACETAMINOPHENSelect Consumer Group LLC529d3a51-a248-7c02-e063-6294a90a10ae2026-06-27WarningsExact identifier
ndc (package): 85237-1946-6
ndc (package): 85237-1946-7
ndc (package): 85237-1946-4
ndc (package): 85237-1946-0
ndc (package): 85237-1946-1
ndc (package): 85237-1946-2
ndc (package): 85237-1946-3
ndc (package): 85237-1946-5
ndc (product): 85237-1946
ndc11 (package): 85237194601
ndc11 (package): 85237194604
ndc11 (package): 85237194600
ndc11 (package): 85237194606
ndc11 (package): 85237194607
ndc11 (package): 85237194602
ndc11 (package): 85237194605
ndc11 (package): 85237194603
spl id: 5543ed1a-4081-afdd-e063-6394a90aa77b
spl set id: 529d3a51-a248-7c02-e063-6294a90a10ae
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC59773893-09a8-47a2-943a-e9ea9da4458a2026-06-15WarningsExact identifier
ndc (product): 50580-449

Reported adverse events (FAERS/openFDA)#

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