Drugplain

Cold Multi-Symptom Severe 325 mg/1

Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl · TABLET, FILM COATED · Valu Merchandisers Company

No Recall HistoryCurrently in Shortage
Plain English

Cold Multi-Symptom Severe is an over-the-counter tablet containing acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), guaifenesin (an expectorant that helps clear mucus), and phenylephrine (a decongestant) to relieve multiple cold and flu symptoms. This combination product is designed to address congestion, cough, aches, and fever associated with colds and upper respiratory infections.

Key Facts

Brand Name
Cold Multi-Symptom Severe
Generic Name
Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
NDC Code (Product)
63941-509
Manufacturer
Valu Merchandisers Company
Strength
325 mg/1
Dosage Form
TABLET, FILM COATED
Route
ORAL
Marketing Status
HUMAN OTC DRUG
Application #
M012
Drug Class
Adrenergic alpha1-Agonists [MoA]; Decreased Respiratory Secretion Viscosity [PE]
Marketing Start
08/04/2005

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
atrial fibrillation1 reports
cardiac disorder1 reports
choking1 reports
diarrhoea1 reports
dizziness1 reports
erythema1 reports
heart rate increased1 reports
intentional product misuse1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves these common cold and flu symptoms: sore throat cough nasal congestion headache minor aches and pains helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily reduces fever

Dosage & Administration

Directions do not take more than directed adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew, or dissolve 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. 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 this product. if you have ever had an allergic reaction to this product or any of its ingre…

Frequently Asked Questions

What is Cold Multi-Symptom Severe used for?

Cold Multi-Symptom Severe is an over-the-counter tablet containing acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), guaifenesin (an expectorant that helps clear mucus), and phenylephrine (a decongestant) to relieve multiple cold and flu symptoms. This combination product is designed to address congestion, cough, aches, and fever associated with colds and upper respiratory infections.

Is Cold Multi-Symptom Severe a controlled substance?

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

What is the generic name for Cold Multi-Symptom Severe?

The generic name for Cold Multi-Symptom Severe 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 Cold Multi-Symptom Severe 325 mg/1?

The NDC (National Drug Code) for Cold Multi-Symptom Severe 325 mg/1 is 63941-509, listed by Valu Merchandisers Company.

Product NDC

63941-509

Package NDC

63941-509-08

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)