TYLENOL EXTRA STRENGTH- acetaminophen tablet, film coated 
Kenvue Brands LLC

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TYLENOL® Extra Strength

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Purpose

Pain reliever/fever reducer

Uses

■ temporarily relieves minor aches and pains due to:

- the common col

- headache

- backache

- minor pain of arthritis

- toothach

- muscular aches

- premenstrual and menstrual cramps

■ temporarily reduces fever

Warnings

Liver warning

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

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.

■ 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 you have liver disease

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

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.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning

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

do not take more than directed (see overdose warning)

adults andchildren
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

■ 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

carnauba wax, crospovidone, FD&C red no. 40, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)

PRINICIPAL DISPALY PANEL

NDC 50580-108-25

TYLENOL ®

FOR ADULTS

Acetaminophen

Pain Reliever

Fever Reducer

Extra Strength

Actual Size

225 Caplets

500 mg each

tylenol-1.jpg

TYLENOL EXTRA STRENGTH 
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-108
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POVIDONE (UNII: FZ989GH94E)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
Colorwhite (with red print) Scoreno score
ShapeOVALSize18mm
FlavorImprint Code TYLENOL;500
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-108-251 in 1 CARTON10/13/2025
1225 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01310/13/2025
Labeler - Kenvue Brands LLC (118772437)

Revised: 9/2025
Document Id: 3f653262-b932-7d42-e063-6394a90adddd
Set id: 3f653262-b931-7d42-e063-6394a90adddd
Version: 1
Effective Time: 20250925
 
Kenvue Brands LLC