Drugplain

Guaifenesin 400 400 mg/1

Guaifenesin Tablets 400 · TABLET · InvaTech Pharma Solutions LLC

4 Recalls on Record
Plain English

Guaifenesin 400 is a tablet containing guaifenesin tablets 400 at 400 mg/1, taken oral. Manufactured by InvaTech Pharma Solutions LLC.

Key Facts

Brand Name
Guaifenesin 400
Generic Name
Guaifenesin Tablets 400
NDC Code (Product)
57631-012
Manufacturer
InvaTech Pharma Solutions LLC
Strength
400 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
01/13/2021

Recall History

4 Recalls on Record
Class II01/26/2022

ULTRAtab Laboratories, Inc.

CGMP Deviations

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 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 III12/07/2012

Bayer Healthcare, LLC

Labeling: Label lacks warning or Rx legend; Certain information was inadvertently excluded from the product carton label.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

transaminases increased1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

cough, cold

Frequently Asked Questions

What is Guaifenesin 400 used for?

Guaifenesin 400 contains Guaifenesin Tablets 400. It is a tablet taken oral. Consult your doctor for specific uses.

Is Guaifenesin 400 a controlled substance?

Guaifenesin 400 is not classified as a controlled substance by the DEA.

What is the generic name for Guaifenesin 400?

The generic name for Guaifenesin 400 is Guaifenesin Tablets 400. There are no other listed brand versions of Guaifenesin Tablets 400.

What is the NDC code for Guaifenesin 400 400 mg/1?

The NDC (National Drug Code) for Guaifenesin 400 400 mg/1 is 57631-012, listed by InvaTech Pharma Solutions LLC.

Product NDC

57631-012

Package NDC

57631-012-00

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

Data from openFDA · Public domain (CC0 1.0)