Drugplain

Cold and Flu 650 mg/20mL

Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl · SOLUTION · Walgreen Company

4 Recalls on RecordCurrently in Shortage
Plain English

This oral solution contains a combination of acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), guaifenesin (an expectorant that helps thin mucus), and phenylephrine (a decongestant) to help relieve multiple cold and flu symptoms. It is available over-the-counter without a prescription.

Key Facts

Brand Name
Cold and Flu
Generic Name
Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
NDC Code (Product)
0363-9042
Manufacturer
Walgreen Company
Strength
650 mg/20mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
10/21/2023

Recall History

4 Recalls on Record
Class II06/18/2013

Novartis Consumer Health

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

TerminatedVoluntary: Firm initiated
Class II06/18/2013

Novartis Consumer Health

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

TerminatedVoluntary: Firm initiated
Class II08/29/2013

Procter & Gamble Co

Incorrect/ Undeclared Excipients: NyQuil Liquid Original bottles were inadvertently overwrapped with NyQuil Liquid Cherry information as a result the outer wrap does not correctly identify color additives, particularly FD&C Yellow No. 6 and FD&C Yellow 10.

TerminatedVoluntary: Firm initiated
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

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

off label use22,651 reports
fatigue20,878 reports
drug ineffective18,677 reports
pain18,427 reports
nausea18,055 reports
headache17,092 reports
toxicity to various agents15,605 reports
dyspnoea14,931 reports
pyrexia14,586 reports
arthralgia14,527 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily relieves these symptoms due to a cold minor aches and pains headache nasal and sinus congestion sore throat cough due to minor throat and bronchial irritation temporarily reduces fever

Dosage & Administration

Directions do not take more than directed (see overdose warning ) do not take more than 6 doses (180 mL) in any 24-hour period measure only with dosing cup provided. Do not use any other dosing device. mL= milliliter keep dosing cup with product adults and children 12 years and over 30 mL every 4 hours chlldren under 12 years of age: do not use

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 inclide: 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 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. with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if you have liver disease heart disease diabetes hig

Frequently Asked Questions

What is Cold and Flu used for?

This oral solution contains a combination of acetaminophen (a pain reliever and fever reducer), dextromethorphan (a cough suppressant), guaifenesin (an expectorant that helps thin mucus), and phenylephrine (a decongestant) to help relieve multiple cold and flu symptoms. It is available over-the-counter without a prescription.

Is Cold and Flu a controlled substance?

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

What is the generic name for Cold and Flu?

The generic name for Cold and Flu 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 650 mg/20mL?

The NDC (National Drug Code) for Cold and Flu 650 mg/20mL is 0363-9042, listed by Walgreen Company.