FDA.reportPublic FDA data

TYLENOL

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-07
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 20:50:00

Label at a glance#

ProductTYLENOL Regular Strength
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and uses

temporarily relieves minor aches and pains due to: headache muscular aches backache minor pain of arthritis the common cold toothache 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 4 to 6 hours while symptoms last do not take more than 10 caplets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children 6 years to under 12 years take 1 caplet every 4 to 6 hours while symptoms last do not take more than 5 caplets in 24 hours do ...

Storage and handling

store between 20-25°C (68-77°F). Avoid high humidity. Protect from light. do not use if any individual blister unit is open or torn

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg) in 24 hours for adults or 5 caplets (1,625 mg) in 24 hours for children. Severe liver damage may occur if

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 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 the user has liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if the user is 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 in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • 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 4 to 6 hours while symptoms last
  • do not take more than 10 caplets in 24 hours, unless directed by a doctor
  • do not use for more than 10 days unless directed by a doctor
children 6 years to under 12 years
  • take 1 caplet every 4 to 6 hours while symptoms last
  • do not take more than 5 caplets in 24 hours
  • do not use for more than 5 days unless directed by a doctor
children under 6 yearsask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store between 20-25°C (68-77°F). Avoid high humidity. Protect from light.
  • do not use if any individual blister unit is open or torn

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, crospovidone, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, medium chain triglycerides, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, shellac glaze, sodium starch glycolate, stearic acid, 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

325mg

NDC 50580-600-02
To re-order reference the NDC code

TYLENOL®
Acetaminophen Pain Reliever - Fever Reducer
Regular Strength

EZ DOSE™

100 Caplets
325 mg each

10 Blister Cards
with
10 Individual Blisters

SMART PACKAGING
DESIGNED FOR HEALTH
CARE PROFESSIONALS

FOR HOSPITAL AND GOVERNMENT USE ONLY

PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50580-600-012025-07-29C16284748780-13b156c62-2af5-fb37-e063-e6dba90a4e07TYLENOL Regular Strength
50580-600-022025-07-29C16284748780-13b156c62-2af5-fb37-e063-e6dba90a4e07TYLENOL Regular Strength
50580-600-032025-07-29C16284748780-13b156c62-2af5-fb37-e063-e6dba90a4e07TYLENOL Regular Strength

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-600TYLENOL REGULAR STRENGTH (ACETAMINOPHEN) TABLET, FILM COATED [KENVUE BRANDS LLC]8Legacy NDC20241109_511536b2-6cbd-463e-b2db-6feec474cf6b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-600-01EA - Each50580-6007c340e86-6387-4291-b519-c581723ba2a812018-02-20
50580-600-02EA - Each50580-600eb77fba1-7c36-4d7e-a5d8-3a10dded598912017-07-07
50580-600-03EA - Each50580-60031f77edc-3bb5-4e99-94f7-767c6a3b821e12018-01-12

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50580-60050580-600-01, 50580-600-02, 50580-600-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARNAUBA WAXR12CBM0EIZIACT
CROSPOVIDONE2S7830E561IACT
FD&C RED NO. 40WZB9127XOAIACT
ALUMINUM OXIDELMI26O6933IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM STARCH GLYCOLATE TYPE AH8AV0SQX4DIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB
SHELLAC46N107B71OIACT

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
5263666e-951d-4b03-e063-6294a90af88c511536b2-6cbd-463e-b2db-6feec474cf6b2026-05-22WarningsExact identifier
spl set id: 511536b2-6cbd-463e-b2db-6feec474cf6b

Reported adverse events (FAERS/openFDA)#

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