TYLENOL EXTRA STRENGTH- acetaminophen tablet, film coated

TYLENOL Extra Strength by

Drug Labeling and Warnings

TYLENOL Extra Strength by is a Otc medication manufactured, distributed, or labeled by Kenvue Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Drug Facts

ACTIVE INGREDIENT

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 cold

■ headache
■ backache

■ minor pain of arthritis
■ toothache

■ muscular aches
■ premenstrual and menstrual cramps

• temporarily reduces fever

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

INGREDIENTS AND APPEARANCE

TYLENOL EXTRA STRENGTH 
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-491
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (white with red print)	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	TYLENOL;500
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50580-491-70	1 in 1 CARTON	08/30/2025
1		700 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 50580-491-01	1 in 1 CARTON	08/30/2025
2		100 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 50580-491-10	10 in 1 CARTON	08/30/2025
3		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	08/30/2025

Labeler - Kenvue Brands LLC (118772437)