SUDAFED PE Head Congestion Plus Flu Severe 325 mg/1
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride · TABLET, FILM COATED · Kenvue Brands LLC
SUDAFED PE Head Congestion 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
- SUDAFED PE Head Congestion Plus Flu Severe
- Generic Name
- Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
- NDC Code (Product)
50580-450- 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
- 06/17/2019
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 symptoms due to the common cold: nasal congestion headache minor aches and pains cough sore throat sinus congestion and pressure helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive temporarily reduces fever
Dosage & Administration
Directions do not use more than directed (see overdose warning ) adults and children 12 years and over take 2 tablets every 4 hours do not take more than 10 tablets 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 tablets (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 SUDAFED PE Head Congestion Plus Flu Severe used for?
SUDAFED PE Head Congestion 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 SUDAFED PE Head Congestion Plus Flu Severe a controlled substance?
SUDAFED PE Head Congestion Plus Flu Severe is not classified as a controlled substance by the DEA.
What is the generic name for SUDAFED PE Head Congestion Plus Flu Severe?
The generic name for SUDAFED PE Head Congestion 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 SUDAFED PE Head Congestion Plus Flu Severe 325 mg/1?
The NDC (National Drug Code) for SUDAFED PE Head Congestion Plus Flu Severe 325 mg/1 is 50580-450, listed by Kenvue Brands LLC.
Other Acetaminophen, Brands
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- Maximum Strength Mucinex Fast-Max Cold and Flu325 mg/163824-518
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- Mucinex Fast-Max Cold, Flu and Sore Throat325 mg/163824-591
- Sinus Relief Pressure, Pain and Cough325 mg/163941-399
- Tylenol Cold plus Flu Severe, TRAVEL BASIX325 mg/166715-7856
- head congestion plus flu severe PE325 mg/141250-574
- Cold Flu Severe325 mg/146122-418
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)