FDA.reportPublic FDA data

TYLENOL Extra Strength

Manufacturer
Kenvue Brands LLC
Effective date
2025-09-17
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:14:19

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 ) tear packet and pour powder directly on tongue adults and children 12 years and over take 2 powders every 6 hours, while symptoms last do not take more than 6 powders 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

each powder contains: sodium 4 mg store between 20-25°C (68-77°F) do not use if packet is torn or damaged

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each powder)

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

  • do not take more than directed (see overdose warning)
  • tear packet and pour powder directly on tongue
    adults and children 12 years and over
    • take 2 powders every 6 hours, while symptoms last
    • do not take more than 6 powders 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

  • each powder contains: sodium 4 mg
  • store between 20-25°C (68-77°F)
  • do not use if packet is torn or damaged

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, ethylcellulose, flavor, magnesium stearate, maltodextrin, sodium bicarbonate, sucralose, xylitol

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 50580-209-04

Extra Strength
TYLENOL ®
FOR ADULTS

Acetaminophen
Pain Reliever-Fever Reducer

DISSOLVE PACKS

  • NO WATER NEEDED
  • DISSOLVES IN SECONDS

32 Packets*
500 mg
each packet

Berry
Flavor
*Packets of Powder

PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2374360acetaminophen 500 MG Oral PowderPSN7
2374361Tylenol DISSOLVE PACKS 500 MG Oral PowderPSN7
2374361acetaminophen 500 MG Oral Powder [Tylenol]SBD7
2374360acetaminophen 500 MG Oral PowderSCD7
2374360APAP 500 MG Oral PowderSY7
2374361APAP 500 MG Oral Powder [Tylenol]SY7
2374361Tylenol 500 MG Oral PowderSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-209-02TYLENOL Extra Strength12 in 1 CARTONPOWDER127
50580-209-02TYLENOL Extra Strength0.95 g in 1 PACKETPOWDER0.957
50580-209-04TYLENOL Extra Strength32 in 1 CARTONPOWDER327
50580-209-04TYLENOL Extra Strength0.95 g in 1 PACKETPOWDER0.957

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-209-02EA - Each50580-209efe66416-47ae-407a-92a8-7561b45e7a3112022-07-06
50580-209-04EA - Each50580-2092a4b1688-45e3-456c-90cf-9e36a2d011c212022-07-06

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50580-20950580-209-02, 50580-209-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
ETHYLCELLULOSE, UNSPECIFIED7Z8S9VYZ4BIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SUCRALOSE96K6UQ3ZD4IACT
XYLITOLVCQ006KQ1EIACT
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 LLCab02080a-c903-4e4a-a9f3-2b8197ed2f2b2025-09-17WarningsExact identifier
ndc (package): 50580-209-02
ndc (package): 50580-209-04
ndc (product): 50580-209
ndc11 (package): 50580020904
ndc11 (package): 50580020902
spl id: 3efe12ef-7f94-9548-e063-6294a90aba91
spl set id: ab02080a-c903-4e4a-a9f3-2b8197ed2f2b

Reported adverse events (FAERS/openFDA)#

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