Drugplain

Extra Strength TYLENOL Cold plus Flu Multi-Action Day/Night

acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide, and chlorpheniramine maleate · KIT · Kenvue Brands LLC

No Recall HistoryCurrently in Shortage
Plain English

Extra Strength TYLENOL Cold plus Flu Multi-Action Day/Night is a kit containing acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide, and chlorpheniramine maleate. Manufactured by Kenvue Brands LLC.

Key Facts

Brand Name
Extra Strength TYLENOL Cold plus Flu Multi-Action Day/Night
Generic Name
acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide, and chlorpheniramine maleate
NDC Code (Product)
50580-374
Manufacturer
Kenvue Brands LLC
Dosage Form
KIT
Marketing Status
Application #
M012
Marketing Start
06/21/2021

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves these common cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough sinus congestion and pressure helps clear nasal passages promotes nasal and sinus drainage temporarily reduces fever

Dosage & Administration

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

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. Sore throat warning If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. 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 now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. if you have ever had an allergic reaction to this product or any of its ingredi

Frequently Asked Questions

What is Extra Strength TYLENOL Cold plus Flu Multi-Action Day/Night used for?

Extra Strength TYLENOL Cold plus Flu Multi-Action Day/Night contains acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide, and chlorpheniramine maleate. It is a kit taken as directed. Consult your doctor for specific uses.

Is Extra Strength TYLENOL Cold plus Flu Multi-Action Day/Night a controlled substance?

Extra Strength TYLENOL Cold plus Flu Multi-Action Day/Night is not classified as a controlled substance by the DEA.

What is the generic name for Extra Strength TYLENOL Cold plus Flu Multi-Action Day/Night?

The generic name for Extra Strength TYLENOL Cold plus Flu Multi-Action Day/Night is acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide, and chlorpheniramine maleate. There are no other listed brand versions of acetaminophen, pseudoephedrine hydrochloride, dextromethorphan hydrobromide, and chlorpheniramine maleate.

What is the NDC code for Extra Strength TYLENOL Cold plus Flu Multi-Action Day/Night ?

The NDC (National Drug Code) for Extra Strength TYLENOL Cold plus Flu Multi-Action Day/Night is 50580-374, listed by Kenvue Brands LLC.

Product NDC

50580-374

Package NDC

50580-374-01

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

Data from openFDA · Public domain (CC0 1.0)