EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/NIGHT
Acetaminophen, Dextromethorphan hydrobromide, Chlorpheniramine Maleate · KIT · Kenvue Brands LLC
Extra Strength Tylenol Severe Cough Plus Sore Throat Day/Night is an over-the-counter combination medicine that contains acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), and chlorpheniramine (an antihistamine) to relieve cough, sore throat, and cold symptoms. This product comes as a day and night kit with different formulations designed for daytime and nighttime use.
Key Facts
- Brand Name
- EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/NIGHT
- Generic Name
- Acetaminophen, Dextromethorphan hydrobromide, Chlorpheniramine Maleate
- NDC Code (Product)
50580-551- Manufacturer
- Kenvue Brands LLC
- Dosage Form
- KIT
- Route
- ORAL
- Marketing Status
- Application #
- M012
- Marketing Start
- 08/26/2024
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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/NIGHT used for?
Extra Strength Tylenol Severe Cough Plus Sore Throat Day/Night is an over-the-counter combination medicine that contains acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), and chlorpheniramine (an antihistamine) to relieve cough, sore throat, and cold symptoms. This product comes as a day and night kit with different formulations designed for daytime and nighttime use.
Is EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/NIGHT a controlled substance?
EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/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 DAY/NIGHT?
The generic name for EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/NIGHT is Acetaminophen, Dextromethorphan hydrobromide, Chlorpheniramine Maleate. There are no other listed brand versions of Acetaminophen, Dextromethorphan hydrobromide, Chlorpheniramine Maleate.
What is the NDC code for EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/NIGHT ?
The NDC (National Drug Code) for EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY/NIGHT is 50580-551, listed by Kenvue Brands LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)