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TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief

Dosage form
KIT
Labeler
Kenvue Brands LLC
Label updated
2024-11-26
Retrieved
2026-09-07
Active ingredients
ACETAMINOPHEN · LIDOCAINE · MENTHOL, UNSPECIFIED FORM
View original label and images on DailyMed ↗
Drug Facts

Drug Facts

Active ingredient (in each gelcap)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

■ temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • 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

Label information

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

Label information

Ask a doctor before use if you have liver disease

Label information

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.

Label information

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

Label information

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 gelcaps every 6 hours while symptoms last
■ do not take more than 6 gelcaps 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). Avoid high humidity.
■ do not use if carton is opened. Do not use if foil inner seal imprinted with “TYLENOL” is broken or missing.​

Inactive ingredients

benzyl alcohol, butylparaben, carboxymethylcellulose sodium, D&C yellow no. 10, edetate calcium disodium, FD&C blue no. 1, FD&C red no. 40, gelatin, hypromellose, iron oxide, magnesium stearate, methylparaben, modified starch, polyethylene glycol, polysorbate 80, powdered cellulose, pregelatinized starch, propylene glycol, propylparaben, red iron oxide, sodium lauryl sulfate, sodium propionate, sodium starch glycolate, titanium dioxide, yellow iron oxide

Questions or comments?

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

Active Ingredient

Lidocaine 4%

Menthol 1%

Purpose

Topical analgesic

Topical analgesic

Uses

For the temporary relief of pain

Warnings

For external use only.

Do not use

▪ in large quantities, particularly over raw surfaces or blistered areas

When using this product

▪ avoid contact with eyes

Stop use and ask a doctor if

▪ condition worsens or symptoms persist for more than 7 days

▪ symptoms clear up and occur again within a few days

Label information

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

■ use only as directed
■ adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
■ children under 12 years of age: ask a doctor

Other Information

store at 15 to 30 C (59 to 86 F)

Inactive Ingredients

carbomer copolymer, cetearyl olivate, cetyl alcohol, fragrance, glycerin, isopropyl palmitate, phenoxyethanol, sodium polyacrylate, sorbitan olivate, water

Questions?

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

PRINCIPAL DISPLAY PANEL

NDC 50580-142-01

Extra Strength

TYLENOL ®


FOR ADULTS

Acetaminophen
Pain Reliever
Fever Reducer

RAPID RELEASE GELS


Actual Size

225 Gelcaps*
500 mg each

*Gelatin-Coated Tablets

+ FREE BONUS ITEM

TYLENOL ®

PRECISE TM

Cooling

Pain Relieving Cream

Lidocaine 4% Menthol 1%

Fast acting

Targeted penetrating

pain relief

Maximum Strength Lidocaine

without a prescription

LIGHTLY SCENTED

For external use only

NET WT. 0.5 OZ (14.2 g)

[Image in the official label — see DailyMed source]

DailyMed Set ID: 2611e984-0dd5-bda1-e063-6394a90a559a · Version 1
NDC: 50580-142