TYLENOL Cold Plus Flu Severe 325 mg/1

Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride · TABLET, FILM COATED · Kenvue Brands LLC

No Recall HistoryCurrently in Shortage

Plain English

TYLENOL Cold Plus Flu Severe is a tablet, film coated containing acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride at 325 mg/1, taken oral. Manufactured by Kenvue Brands LLC.

Key Facts

Brand Name: TYLENOL Cold Plus Flu Severe
Generic Name: Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
NDC Code (Product): 50580-402
Manufacturer: Kenvue Brands LLC
Strength: 325 mg/1
Dosage Form: TABLET, FILM COATED
Route: ORAL
Marketing Status
Application #: M012
Drug Class: Expectorant [EPC]
Marketing Start: 09/01/2011

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses for the temporary relief of the following cold/flu symptoms: minor aches and pains headache sore throat nasal congestion cough sinus congestion and pressure sneezing and runny nose helps clear nasal passages relieves cough to help you sleep 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 4 hours swallow whole; do not crush, chew or dissolve do not take more than 10 caplets in 24 hours children under 12 years ask a doctor

Warnings

Warnings Liver warning This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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 th…

Frequently Asked Questions

What is TYLENOL Cold Plus Flu Severe used for?

TYLENOL Cold Plus Flu Severe contains Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is TYLENOL Cold Plus Flu Severe a controlled substance?

TYLENOL Cold Plus Flu Severe is not classified as a controlled substance by the DEA.

What is the generic name for TYLENOL Cold Plus Flu Severe?

The generic name for TYLENOL Cold Plus Flu Severe is Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride. There are 12 other brand versions of Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride.

What is the NDC code for TYLENOL Cold Plus Flu Severe 325 mg/1?

The NDC (National Drug Code) for TYLENOL Cold Plus Flu Severe 325 mg/1 is 50580-402, listed by Kenvue Brands LLC.

Product NDC

50580-402

Package NDC

50580-402-01

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

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