Drugplain

Extra Strength TYLENOL Cold Plus Flu Multi-Action Day 500 mg/1

acetaminophen, Pseudoephedrine hydrochloride, and Dextromethorphan Hydrobromide · TABLET, FILM COATED · Kenvue Brands LLC

No Recall HistoryCurrently in Shortage
Plain English

Extra Strength TYLENOL Cold Plus Flu Multi-Action Day is a prescription tablet, film coated containing acetaminophen, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide at 500 mg/1, taken oral. Manufactured by Kenvue Brands LLC.

Key Facts

Brand Name
Extra Strength TYLENOL Cold Plus Flu Multi-Action Day
Generic Name
acetaminophen, Pseudoephedrine hydrochloride, and Dextromethorphan Hydrobromide
NDC Code (Product)
50580-344
Manufacturer
Kenvue Brands LLC
Strength
500 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
HUMAN OTC DRUG
Application #
M012
Drug Class
Adrenergic alpha-Agonists [MoA]; Sigma-1 Agonist [EPC]
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 used for?

Extra Strength TYLENOL Cold Plus Flu Multi-Action Day contains acetaminophen, Pseudoephedrine hydrochloride, and Dextromethorphan Hydrobromide. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Extra Strength TYLENOL Cold Plus Flu Multi-Action Day a controlled substance?

Extra Strength TYLENOL Cold Plus Flu Multi-Action Day 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?

The generic name for Extra Strength TYLENOL Cold Plus Flu Multi-Action Day is acetaminophen, Pseudoephedrine hydrochloride, and Dextromethorphan Hydrobromide. There are no other listed brand versions of acetaminophen, Pseudoephedrine hydrochloride, and Dextromethorphan Hydrobromide.

What is the NDC code for Extra Strength TYLENOL Cold Plus Flu Multi-Action Day 500 mg/1?

The NDC (National Drug Code) for Extra Strength TYLENOL Cold Plus Flu Multi-Action Day 500 mg/1 is 50580-344, listed by Kenvue Brands LLC.

Product NDC

50580-344

Package NDC

50580-344-01

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

Data from openFDA · Public domain (CC0 1.0)