Drugplain

Codeine-Guaifenesin 10 mg/5mL

Codeine Phosphate and Guaifenesin · SOLUTION · Proficient Rx LP

1 Recall on Record
Plain English

Codeine-Guaifenesin is an over-the-counter oral solution that combines codeine, a cough suppressant, with guaifenesin, an expectorant that helps thin mucus to make coughs more productive. It is used to help relieve cough and congestion associated with colds and respiratory conditions.

Key Facts

Brand Name
Codeine-Guaifenesin
Generic Name
Codeine Phosphate and Guaifenesin
NDC Code (Product)
71205-624
Manufacturer
Proficient Rx LP
Strength
10 mg/5mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
DEA Schedule
Schedule V (Controlled)
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
07/15/2020

Recall History

1 Recall on Record
Class II12/12/2017

Woodfield Pharmaceutical, LLC

Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

death10 reports
fatigue10 reports
nausea10 reports
pain10 reports
pneumonia9 reports
vomiting9 reports
cough7 reports
diarrhoea7 reports
pyrexia7 reports
upper respiratory tract infection7 reports

Frequently Asked Questions

What is Codeine-Guaifenesin used for?

Codeine-Guaifenesin is an over-the-counter oral solution that combines codeine, a cough suppressant, with guaifenesin, an expectorant that helps thin mucus to make coughs more productive. It is used to help relieve cough and congestion associated with colds and respiratory conditions.

Is Codeine-Guaifenesin a controlled substance?

Yes, Codeine-Guaifenesin is classified as CV under the DEA Controlled Substances Act.

What is the generic name for Codeine-Guaifenesin?

The generic name for Codeine-Guaifenesin is Codeine Phosphate and Guaifenesin. There are 1 other brand versions of Codeine Phosphate and Guaifenesin.

What is the NDC code for Codeine-Guaifenesin 10 mg/5mL?

The NDC (National Drug Code) for Codeine-Guaifenesin 10 mg/5mL is 71205-624, listed by Proficient Rx LP.

Product NDC

71205-624

Package NDC

71205-624-04

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

Data from openFDA · Public domain (CC0 1.0)