Severe Cold 325 mg/1

Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl · TABLET, FILM COATED · United Natural Foods, Inc. dba UNFI

No Recall HistoryCurrently in Shortage

Plain English

Severe Cold is an over-the-counter tablet that combines acetaminophen (pain reliever/fever reducer), dextromethorphan (cough suppressant), guaifenesin (expectorant to help clear mucus), and phenylephrine (decongestant) to help relieve multiple cold symptoms. It is taken by mouth and is designed to address cough, congestion, aches, and fever associated with the common cold.

Key Facts

Brand Name: Severe Cold
Generic Name: Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
NDC Code (Product): 41163-053
Manufacturer: United Natural Foods, Inc. dba UNFI
Strength: 325 mg/1
Dosage Form: TABLET, FILM COATED
Route: ORAL
Marketing Status
Application #: M012
Drug Class: Expectorant [EPC]
Marketing Start: 01/27/2023

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion and pressure • cough due to minor throat and bronchial irritation • minor aches and pains • headache • fever • sore throat • reduces swelling of nasal passages • temporarily restores freer breathing through the nose • promotes nasal and/or sinus drainage • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

Dosage & Administration

Directions • take only as directed – see Overdose warning • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 6 to under 12 yrs 15 mL every 4 hrs children 4 to under 6 yrs ask a doctor children under 4 yrs do not use Other information • each 15 mL contains: sodium 6 mg • store at 20-25 ° C (68-77 ° F). Do not refrigerate.

Warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if • adult takes more than 4,000 mg of acetaminophen in 24 hours • child takes more than 5 doses in 24 hours • taken with other drugs containing acetaminophen • adult has 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 produc…

Frequently Asked Questions

What is Severe Cold used for?

Is Severe Cold a controlled substance?

Severe Cold is not classified as a controlled substance by the DEA.

What is the generic name for Severe Cold?

The generic name for Severe Cold is Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl. There are 12 other brand versions of Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl.

What is the NDC code for Severe Cold 325 mg/1?

The NDC (National Drug Code) for Severe Cold 325 mg/1 is 41163-053, listed by United Natural Foods, Inc. dba UNFI.

Product NDC

41163-053

Package NDC

41163-053-08

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)