Drugplain

TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief

Acetaminophen, Lidocaine, Menthol · KIT · Kenvue Brands LLC

No Recall HistoryCurrently in Shortage
Plain English

TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief is a kit containing acetaminophen, lidocaine, menthol. Manufactured by Kenvue Brands LLC.

Key Facts

Brand Name
TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief
Generic Name
Acetaminophen, Lidocaine, Menthol
NDC Code (Product)
50580-142
Manufacturer
Kenvue Brands LLC
Dosage Form
KIT
Marketing Status
Application #
M013
Marketing Start
11/25/2024

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

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

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 o

Frequently Asked Questions

What is TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief used for?

TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief contains Acetaminophen, Lidocaine, Menthol. It is a kit taken as directed. Consult your doctor for specific uses.

Is TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief a controlled substance?

TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief is not classified as a controlled substance by the DEA.

What is the generic name for TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief?

The generic name for TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief is Acetaminophen, Lidocaine, Menthol. There are no other listed brand versions of Acetaminophen, Lidocaine, Menthol.

What is the NDC code for TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief ?

The NDC (National Drug Code) for TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief is 50580-142, listed by Kenvue Brands LLC.

Product NDC

50580-142

Package NDC

50580-142-01

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)