Cold and Flu severe 325 mg/1
Acetaminophen,Dextromethorphan HBr,Guaifenesin,Phenylephrine HCl · TABLET, FILM COATED · Wal-Mart Stores Inc
Cold and Flu Severe is an over-the-counter combination tablet that contains acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), guaifenesin (an expectorant to help thin mucus), and phenylephrine (a nasal decongestant) to help relieve multiple cold and flu symptoms. This medication is taken by mouth and is designed to address cough, congestion, aches, and fever associated with cold and flu.
Key Facts
- Brand Name
- Cold and Flu severe
- Generic Name
- Acetaminophen,Dextromethorphan HBr,Guaifenesin,Phenylephrine HCl
- NDC Code (Product)
49035-053- Manufacturer
- Wal-Mart Stores Inc
- Strength
- 325 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- M012
- Drug Class
- Expectorant [EPC]
- Marketing Start
- 08/04/2005
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 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 is an over-the-counter combination tablet that contains acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), guaifenesin (an expectorant to help thin mucus), and phenylephrine (a nasal decongestant) to help relieve multiple cold and flu symptoms. This medication is taken by mouth and is designed to address cough, congestion, aches, and fever associated with cold and flu.
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 no other listed 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 49035-053, listed by Wal-Mart Stores Inc.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)