Drugplain

Multi-Symptom Cold Relief 325 mg/1

Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl , Guaifenesin, , · TABLET, FILM COATED · Unifirst First Aid Corporation

1 Recall on RecordCurrently in Shortage
Plain English

Multi-Symptom Cold Relief is an over-the-counter tablet that combines a pain reliever (acetaminophen), a cough suppressant (dextromethorphan), a decongestant (phenylephrine), and an expectorant (guaifenesin) to help relieve multiple cold symptoms. This combination medicine works to reduce fever and pain, suppress coughs, clear nasal congestion, and help thin mucus so you can cough it up more easily.

Key Facts

Brand Name
Multi-Symptom Cold Relief
Generic Name
Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl , Guaifenesin, ,
NDC Code (Product)
47682-047
Manufacturer
Unifirst First Aid Corporation
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
09/26/2022

Recall History

1 Recall on Record
Class II01/24/2022

Ultra Seal Corporation

cGMP deviations

TerminatedVoluntary: Firm initiated

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Temporarily relieves these symptoms due to the common cold headache nasal congestion cough minor aches and pains sore throat sinus congestion and pressure helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough 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 not to 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.

Frequently Asked Questions

What is Multi-Symptom Cold Relief used for?

Multi-Symptom Cold Relief is an over-the-counter tablet that combines a pain reliever (acetaminophen), a cough suppressant (dextromethorphan), a decongestant (phenylephrine), and an expectorant (guaifenesin) to help relieve multiple cold symptoms. This combination medicine works to reduce fever and pain, suppress coughs, clear nasal congestion, and help thin mucus so you can cough it up more easily.

Is Multi-Symptom Cold Relief a controlled substance?

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

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

The generic name for Multi-Symptom Cold Relief is Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl , Guaifenesin, ,. There are 1 other brand versions of Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl , Guaifenesin, ,.

What is the NDC code for Multi-Symptom Cold Relief 325 mg/1?

The NDC (National Drug Code) for Multi-Symptom Cold Relief 325 mg/1 is 47682-047, listed by Unifirst First Aid Corporation.

Product NDC

47682-047

Package NDC

47682-047-47

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)