Cold and Flu Severe 325 mg/1

Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl · TABLET, FILM COATED · Meijer Distribution, Inc.

No Recall HistoryCurrently in Shortage

Plain English

Cold and Flu Severe is a tablet, film coated containing acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl at 325 mg/1, taken oral. Manufactured by Meijer Distribution, Inc..

Key Facts

Brand Name: Cold and Flu Severe
Generic Name: Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
NDC Code (Product): 79481-5030
Manufacturer: Meijer Distribution, Inc.
Strength: 325 mg/1
Dosage Form: TABLET, FILM COATED
Route: ORAL
Marketing Status
Application #: M012
Drug Class: Expectorant [EPC]
Marketing Start: 08/21/2024

Recall History

No Recall History

Side Effects Reported to FDA

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

toxicity to various agents2 reports

anaphylactic reaction1 reports

choking1 reports

device difficult to use1 reports

disease progression1 reports

drug ineffective1 reports

erythema1 reports

eye pain1 reports

heart rate increased1 reports

intentional product misuse1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Uses temporarily relieves common cold and flu symptoms: minor aches and pains sinus congestion and pressure sore throat fever headache nasal congestion cough due to minor throat and bronchial irritation 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 Directions do not take more than directed do not take more than 8 caplets in 24 hours adults and children 12 years and over: take 2 caplets with water every 4 hours children under 12 years: ask a doctor

Warnings

Warnings Warnings Liver warning 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 Alergy alert Alergy 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 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 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 ha…

Frequently Asked Questions

What is Cold and Flu Severe used for?

Cold and Flu Severe contains Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Cold and Flu Severe a controlled substance?

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

What is the generic name for Cold and Flu Severe?

The generic name for Cold and Flu Severe is Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl. There are 11 other brand versions of Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl.

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

The NDC (National Drug Code) for Cold and Flu Severe 325 mg/1 is 79481-5030, listed by Meijer Distribution, Inc..

Product NDC

79481-5030

Package NDC

79481-5030-8

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)