TYLENOL

Manufacturer: Kenvue Brands LLC
Effective date: 2025-02-18
Label type: HUMAN OTC DRUG LABEL
Version: 16
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 carton is opened or neck wrap or foil inner seal imprinted with "SAFETY SEAL®" is broken or missing

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-877-895-3665

PhoneLabel contact215-273-8755

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

OTC - DO NOT USE SECTION

Do not use

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

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)

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 carton is opened or neck wrap or foil inner seal imprinted with "SAFETY SEAL®" is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax ¹, castor oil ¹, corn starch, FD&C red no. 40 aluminum lake, hypromellose, magnesium stearate, polyethylene glycol ¹, powdered cellulose, pregelatinized starch, propylene glycol, shellac, sodium starch glycolate, titanium dioxide

1 contains one or more of these ingredients

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 50580-451-50

See New Warnings Information & Directions

TYLENOL ^®

Pain Reliever
Fever Reducer
Acetaminophen

EXTRA
STRENGTH
For Adults

50 CAPLETS
500 mg each

Caplets

For Hospital and Government Use Only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198440	acetaminophen 500 MG Oral Tablet	PSN	16
209459	Tylenol Extra Strength 500 MG Oral Tablet	PSN	16
209459	acetaminophen 500 MG Oral Tablet [Tylenol]	SBD	16
198440	acetaminophen 500 MG Oral Tablet	SCD	16
198440	APAP 500 MG Oral Tablet	SY	16
209459	APAP 500 MG Oral Tablet [Tylenol]	SY	16
209459	Tylenol 500 MG Oral Tablet	SY	16
209459	Tylenol Extra Strength 500 MG Oral Tablet	SY	16

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50580-451-03	TYLENOLExtra Strength	1 in 1 POUCH	TABLET, COATED	1	16
50580-451-03	TYLENOLExtra Strength	150 in 1 CARTON	TABLET, COATED	150	16
50580-451-10	TYLENOLExtra Strength	10 in 1 CARTON	TABLET, COATED	10	16
50580-451-10	TYLENOLExtra Strength	10 in 1 BLISTER PACK	TABLET, COATED	10	16
50580-451-50	TYLENOLExtra Strength	1 in 1 CARTON	TABLET, COATED	1	16
50580-451-50	TYLENOLExtra Strength	50 in 1 BOTTLE, PLASTIC	TABLET, COATED	50	16
50580-451-70	TYLENOLExtra Strength	700 in 1 BOTTLE, PLASTIC	TABLET, COATED	700	16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-451	TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [KENVUE BRANDS LLC]	16	Current NDC, Legacy NDC, 7 package rows	20250221_bb6533e5-e6a9-488c-b8ab-a6a06e87ede9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-451-03	EA - Each	50580-451	bf2d93f2-37e7-4940-95f0-3bbadd928c17	1	2012-07-24
50580-451-10	EA - Each	50580-451	ae3ddd38-7acf-4ba2-a13f-e679753e429a	1	2014-07-02
50580-451-50	EA - Each	50580-451	ad97324f-9fc5-437d-9fa7-a55ff960df73	1	2012-07-24
50580-451-70	EA - Each	50580-451	5b285dd0-2a68-4fbf-9f61-d7a31c6ec5bb	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	5
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	5
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	5
Carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	5
castor oil	INACTIVE INGREDIENT	D5340Y2I9G	5
FD&C red No. 40	INACTIVE INGREDIENT	WZB9127XOA	5
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	5
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	5
Polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	5
powdered cellulose	INACTIVE INGREDIENT	SMD1X3XO9M	5
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	5
shellac	INACTIVE INGREDIENT	46N107B71O	5
Sodium Starch Glycolate Type A Potato	INACTIVE INGREDIENT	5856J3G2A2	5
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	5
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	5

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

TYLENOL Extra Strength
Acetaminophen
PROPYLENE GLYCOL
SHELLAC
SODIUM STARCH GLYCOLATE TYPE A
TITANIUM DIOXIDE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL, UNSPECIFIED
POWDERED CELLULOSE
CARNAUBA WAX
CASTOR OIL
STARCH, CORN
FD&C RED NO. 40
ALUMINUM OXIDE
HYPROMELLOSE, UNSPECIFIED

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50580-451	50580-451-03, 50580-451-10, 50580-451-50, 50580-451-70

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SHELLAC	46N107B71O	IACT
SODIUM STARCH GLYCOLATE TYPE A	H8AV0SQX4D	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
ACETAMINOPHEN	362O9ITL9D	ACTIB
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
POWDERED CELLULOSE	SMD1X3XO9M	IACT
CARNAUBA WAX	R12CBM0EIZ	IACT
CASTOR OIL	D5340Y2I9G	IACT
STARCH, CORN	O8232NY3SJ	IACT
FD&C RED NO. 40	WZB9127XOA	IACT
ALUMINUM OXIDE	LMI26O6933	IACT
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 55 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Carnauba wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, COATED / ORAL	207.5 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Carnauba wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, COATED / ORAL	207.5 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
shellac	SHELLAC	46N107B71O	TABLET, COATED / ORAL	30 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
FD&C red No. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, COATED / ORAL	0.1 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
FD&C red No. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, COATED / ORAL	0.1 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
FD&C red No. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, COATED / ORAL	0.1 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
powdered cellulose	POWDERED CELLULOSE	SMD1X3XO9M	TABLET, COATED / ORAL	40.2 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 5 equally ranked IID candidates
shellac	SHELLAC	46N107B71O	TABLET, COATED / ORAL	30 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
powdered cellulose	POWDERED CELLULOSE	SMD1X3XO9M	TABLET, COATED / ORAL	40.2 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
powdered cellulose	POWDERED CELLULOSE	SMD1X3XO9M	TABLET, COATED / ORAL	40.2 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 5 equally ranked IID candidates
shellac	SHELLAC	46N107B71O	TABLET, COATED / ORAL	30 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
FD&C red No. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, COATED / ORAL	0.1 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 5 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 5 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
castor oil	CASTOR OIL	D5340Y2I9G	TABLET, COATED / ORAL	0.9 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
castor oil	CASTOR OIL	D5340Y2I9G	TABLET, COATED / ORAL	0.9 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
FD&C red No. 40	FD&C RED NO. 40	WZB9127XOA	TABLET, COATED / ORAL	0.1 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
castor oil	CASTOR OIL	D5340Y2I9G	TABLET, COATED / ORAL	0.9 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
shellac	SHELLAC	46N107B71O	TABLET, COATED / ORAL	30 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Carnauba wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, COATED / ORAL	207.5 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
magnesium stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
powdered cellulose	POWDERED CELLULOSE	SMD1X3XO9M	TABLET, COATED / ORAL	40.2 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
Carnauba wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, COATED / ORAL	207.5 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, COATED / ORAL		16 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
castor oil	CASTOR OIL	D5340Y2I9G	TABLET, COATED / ORAL	0.9 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
powdered cellulose	POWDERED CELLULOSE	SMD1X3XO9M	TABLET, COATED / ORAL	40.2 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
titanium dioxide	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
starch, corn	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
aluminum oxide	ALUMINUM OXIDE	LMI26O6933	TABLET / ORAL	NA		Exact identifier — unii+route 5 equally ranked IID candidates
Carnauba wax	CARNAUBA WAX	R12CBM0EIZ	TABLET, COATED / ORAL	207.5 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
castor oil	CASTOR OIL	D5340Y2I9G	TABLET, COATED / ORAL	0.9 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
hypromelloses	HYPROMELLOSE	3NXW29V3WO	TABLET, COATED / ORAL		58 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
shellac	SHELLAC	46N107B71O	TABLET, COATED / ORAL	30 mg		Exact identifier — unii+route+dosage form 5 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TYLENOL Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	bb6533e5-e6a9-488c-b8ab-a6a06e87ede9	2025-02-18	Warnings	Exact identifier ndc (package): 50580-451-03 ndc (package): 50580-451-70 ndc (package): 50580-451-10 ndc (package): 50580-451-50 ndc (product): 50580-451 ndc11 (package): 50580045170 ndc11 (package): 50580045150 ndc11 (package): 50580045103 ndc11 (package): 50580045110 spl id: 2d87c8e1-e743-56cc-e063-6394a90aac79 spl set id: bb6533e5-e6a9-488c-b8ab-a6a06e87ede9

Reported adverse events (FAERS/openFDA)#

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