Drugplain

Codeine-Guaifenesin 10 mg/5mL

Codeine Phosphate and Guaifenesin · SOLUTION · NuCare Pharmaceuticals,Inc.

1 Recall on Record
Plain English

Codeine-Guaifenesin is a solution containing codeine phosphate and guaifenesin at 10 mg/5mL, taken oral. Manufactured by NuCare Pharmaceuticals,Inc..

Key Facts

Brand Name
Codeine-Guaifenesin
Generic Name
Codeine Phosphate and Guaifenesin
NDC Code (Product)
68071-5173
Manufacturer
NuCare Pharmaceuticals,Inc.
Strength
10 mg/5mL
Dosage Form
SOLUTION
Route
ORAL
Marketing Status
DEA Schedule
Schedule V (Controlled)
Application #
M013
Drug Class
Expectorant [EPC]
Marketing Start
04/01/2014

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 contains Codeine Phosphate and Guaifenesin. It is a solution taken oral. Consult your doctor for specific uses.

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 68071-5173, listed by NuCare Pharmaceuticals,Inc..

Product NDC

68071-5173

Package NDC

68071-5173-4

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

Data from openFDA · Public domain (CC0 1.0)