TYLENOL

Manufacturer
Kenvue Brands LLC
Effective date
2025-08-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:12:02

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 2...

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 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

Warnings

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

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

Ask a doctor before use if the user

OTC - ASK DOCTOR SECTION

■ has liver disease ■ is a child with pain of arthritis

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

■ 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 not use for more than 5 days unless directed by a doctor

children
under 6 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, hypromellose, magnesium stearate,powdered cellulose, pregelatinized starch, sodium starch glycolate

OTC - QUESTIONS SECTION

Questions or comments? Call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

325 mg

NDC 50580-475-11

To re-order reference the NDC Code

TYLENOL®

Acetaminophen Pain Reliever - Fever Reducer

Regular Strength

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

100 Caplets

325 mg each


10 Blister Cards

with

10 Individual Blisters

SMART PACKAGING
DESIGNED FOR HEALTH
CARE PROFESSIONALS

tylenol-1tylenol-1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313782acetaminophen 325 MG Oral TabletPSN1
209387Tylenol Regular Strength 325 MG Oral TabletPSN1
209387acetaminophen 325 MG Oral Tablet [Tylenol]SBD1
313782acetaminophen 325 MG Oral TabletSCD1
313782APAP 325 MG Oral TabletSY1
209387APAP 325 MG Oral Tablet [Tylenol]SY1
209387Tylenol 325 MG Oral TabletSY1

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
50580-475-10TYLENOLRegular Strength1 in 1 CARTONTABLET, FILM COATED11
50580-475-10TYLENOLRegular Strength1000 in 1 BOTTLETABLET, FILM COATED10001
50580-475-11TYLENOLRegular Strength10 in 1 CARTONTABLET, FILM COATED101
50580-475-11TYLENOLRegular Strength10 in 1 BLISTER PACKTABLET, FILM COATED101
50580-475-50TYLENOLRegular Strength50 in 1 BOTTLETABLET, FILM COATED501
50580-475-50TYLENOLRegular Strength1 in 1 CARTONTABLET, FILM COATED11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-475-11EA - Each50580-4758f4013b0-191a-4cea-b5f0-9eca1cdac68512025-12-16

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50580-47550580-475-11, 50580-475-50, 50580-475-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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 Regular StrengthACETAMINOPHENKenvue Brands LLC398d8996-b522-a3cd-e063-6394a90ac2c82025-08-06WarningsExact identifier
ndc (package): 50580-475-50
ndc (package): 50580-475-10
ndc (package): 50580-475-11
ndc (product): 50580-475
ndc11 (package): 50580047511
ndc11 (package): 50580047510
ndc11 (package): 50580047550
spl id: 398d8996-b523-a3cd-e063-6394a90ac2c8
spl set id: 398d8996-b522-a3cd-e063-6394a90ac2c8

Reported adverse events (FAERS/openFDA)#

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