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

----------

TYLENOL Extra Strength

Drug Facts

Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose
Pain reliever/fever reducer

Uses

■ the common cold

■ headache
■ backache

■ minor pain of arthritis
■ toothache

■ muscular aches
■ premenstrual and menstrual cramps

Warnings

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.

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

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 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

■ store between 20-25°C (68-77°F)
do not use if blister unit is torn or broken

Inactive ingredients

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

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

NDC 50580-491-10

To re-order reference the NDC Code

TYLENOL ®
FOR ADULTS

Acetaminophen Pain Reliever - Fever Reducer

Extra Strength

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

100 Caplets
500 mg each

10 Blister Cards with 10 Individual Blisters

tylenol-1

TYLENOL EXTRA STRENGTH 
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-491
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
SHELLAC (UNII: 46N107B71O)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
Product Characteristics
Colorwhite (white with red print) Scoreno score
ShapeOVALSize18mm
FlavorImprint Code TYLENOL;500
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50580-491-701 in 1 CARTON08/30/2025
1700 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:50580-491-011 in 1 CARTON08/30/2025
2100 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:50580-491-1010 in 1 CARTON08/30/2025
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01308/30/2025
Labeler - Kenvue Brands LLC (118772437)

Revised: 1/2026
Document Id: 4961695d-72f4-533a-e063-6294a90a5a29
Set id: 4961695d-72f3-533a-e063-6294a90a5a29
Version: 1
Effective Time: 20260127
 
Kenvue Brands LLC