Head Congestion plus Flu Severe 325 mg/1

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE · TABLET, COATED · United Natural Foods, Inc. dba UNFI

No Recall HistoryCurrently in Shortage

Plain English

Head Congestion plus Flu Severe is a tablet, coated containing acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride at 325 mg/1, taken oral. Manufactured by United Natural Foods, Inc. dba UNFI.

Key Facts

Brand Name: Head Congestion plus Flu Severe
Generic Name: ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE
NDC Code (Product): 41163-713
Manufacturer: United Natural Foods, Inc. dba UNFI
Strength: 325 mg/1
Dosage Form: TABLET, COATED
Route: ORAL
Marketing Status
Application #: M012
Drug Class: Expectorant [EPC]
Marketing Start: 08/19/2022

Recall History

No Recall History

Side Effects Reported to FDA

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

dizziness1 reports

drug abuse1 reports

hyperhidrosis1 reports

loss of consciousness1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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 take more than directed (see overdose warning ) adults and children 12 years and over take 2 caplets every 4 hours 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 Head Congestion plus Flu Severe used for?

Head Congestion plus Flu Severe contains ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE. It is a tablet, coated taken oral. Consult your doctor for specific uses.

Is Head Congestion plus Flu Severe a controlled substance?

Head Congestion plus Flu Severe is not classified as a controlled substance by the DEA.

What is the generic name for Head Congestion plus Flu Severe?

The generic name for 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 Head Congestion plus Flu Severe 325 mg/1?

The NDC (National Drug Code) for Head Congestion plus Flu Severe 325 mg/1 is 41163-713, listed by United Natural Foods, Inc. dba UNFI.

Product NDC

41163-713

Package NDC

41163-713-02

Other Acetaminophen, Brands

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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)