Drugplain

Extra Strength TYLENOL Severe Cough Plus Sore Throat Night 1000 mg/30mL

Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate. · LIQUID · Kenvue Brands LLC

No Recall HistoryCurrently in Shortage
Plain English

Extra Strength TYLENOL Severe Cough Plus Sore Throat Night is a liquid containing acetaminophen, dextromethorphan hydrobromide and doxylamine succinate. at 1000 mg/30mL, taken oral. Manufactured by Kenvue Brands LLC.

Key Facts

Brand Name
Extra Strength TYLENOL Severe Cough Plus Sore Throat Night
Generic Name
Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate.
NDC Code (Product)
50580-243
Manufacturer
Kenvue Brands LLC
Strength
1000 mg/30mL
Dosage Form
LIQUID
Route
ORAL
Marketing Status
Application #
M012
Marketing Start
06/19/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

adverse drug reaction2 reports
dizziness2 reports
abdominal pain upper1 reports
adverse event1 reports
cold sweat1 reports
death1 reports
decreased appetite1 reports
drug screen positive1 reports
dyspnoea1 reports
expired product administered1 reports

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 cough sneezing and runny nose temporarily reduces fever

Dosage & Administration

Directions do not take more than directed (see overdose warning ) shake well before using mL = milliliter use only enclosed dosing cup designed for use with this product. Do not use any other dosing device. adults and children 12 years and over take 30 mL in the dosing cup provided every 6 hours while symptoms last do not take more than 90 mL 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 Severe Cough Plus Sore Throat Night used for?

Extra Strength TYLENOL Severe Cough Plus Sore Throat Night contains Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate.. It is a liquid taken oral. Consult your doctor for specific uses.

Is Extra Strength TYLENOL Severe Cough Plus Sore Throat Night a controlled substance?

Extra Strength TYLENOL Severe Cough Plus Sore Throat Night is not classified as a controlled substance by the DEA.

What is the generic name for Extra Strength TYLENOL Severe Cough Plus Sore Throat Night?

The generic name for Extra Strength TYLENOL Severe Cough Plus Sore Throat Night is Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate.. There are no other listed brand versions of Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate..

What is the NDC code for Extra Strength TYLENOL Severe Cough Plus Sore Throat Night 1000 mg/30mL?

The NDC (National Drug Code) for Extra Strength TYLENOL Severe Cough Plus Sore Throat Night 1000 mg/30mL is 50580-243, listed by Kenvue Brands LLC.

Product NDC

50580-243

Package NDC

50580-243-01

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

Data from openFDA · Public domain (CC0 1.0)