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

acetaminophen and dextromethorphan hydrobromide · LIQUID · Kenvue Brands LLC

No Recall HistoryCurrently in Shortage

Plain English

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

Key Facts

Brand Name: Extra Strength TYLENOL Severe Cough Plus Sore Throat Day
Generic Name: acetaminophen and dextromethorphan hydrobromide
NDC Code (Product): 50580-140
Manufacturer: Kenvue Brands LLC
Strength: 1000 mg/30mL
Dosage Form: LIQUID
Route: ORAL
Marketing Status
Application #: M012
Marketing Start: 06/06/2025

Recall History

No Recall History

Side Effects Reported to FDA

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

nausea8 reports

therapeutic product effect incomplete8 reports

abdominal pain7 reports

anaemia7 reports

chronic sinusitis7 reports

colitis7 reports

constipation7 reports

drug ineffective7 reports

dyspepsia7 reports

erythema7 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 ■ 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 …

Frequently Asked Questions

What is Extra Strength TYLENOL Severe Cough Plus Sore Throat Day used for?

Extra Strength TYLENOL Severe Cough Plus Sore Throat Day contains acetaminophen and dextromethorphan hydrobromide. It is a liquid taken oral. Consult your doctor for specific uses.

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

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

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

The generic name for Extra Strength TYLENOL Severe Cough Plus Sore Throat Day is acetaminophen and dextromethorphan hydrobromide. There are 7 other brand versions of acetaminophen and dextromethorphan hydrobromide.

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

The NDC (National Drug Code) for Extra Strength TYLENOL Severe Cough Plus Sore Throat Day 1000 mg/30mL is 50580-140, listed by Kenvue Brands LLC.

Product NDC

50580-140

Package NDC

50580-140-08

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

Data from openFDA · Public domain (CC0 1.0)