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]

SPL UNCLASSIFIED SECTION

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 col

- headache

- backache

- minor pain of arthritis

- toothach

- 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.

■ 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 years: ask 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

INGREDIENTS AND APPEARANCE

TYLENOL EXTRA STRENGTH 
acetaminophen tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50580-108
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
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
Color	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: 50580-108-25	1 in 1 CARTON	10/13/2025
1		225 in 1 BOTTLE; 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	10/13/2025

Labeler - Kenvue Brands LLC (118772437)