Drugplain

Mucus Relief 400 mg/1

Guaifenesin · TABLET · Bi-Mart

9 Recalls on Record
Plain English

Mucus Relief is a tablet containing guaifenesin at 400 mg/1, taken oral. Manufactured by Bi-Mart.

Key Facts

Brand Name
Mucus Relief
Generic Name
Guaifenesin
NDC Code (Product)
37835-401
Manufacturer
Bi-Mart
Strength
400 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
M012
Drug Class
Expectorant [EPC]
Marketing Start
05/01/2025

Recall History

9 Recalls on Record
Class III01/18/2013

Aaron Industries Inc

Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.

TerminatedVoluntary: Firm initiated
Class II01/08/2016

Perrigo Company PLC

Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.

TerminatedVoluntary: Firm initiated
Class III04/04/2013

Aaron Industries Inc

Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.

TerminatedVoluntary: Firm initiated
Class III01/18/2013

Aaron Industries Inc

Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.

TerminatedVoluntary: Firm initiated
Class II01/08/2016

Perrigo Company PLC

Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.

TerminatedVoluntary: Firm initiated
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated
Class III01/10/2022

Dr. Reddy's Laboratories, Inc.

Subpotent drug

TerminatedVoluntary: Firm initiated
Class II05/02/2019

Unipharma, Llc.

CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

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

dyspnoea585 reports
pneumonia549 reports
nausea505 reports
fatigue477 reports
drug ineffective476 reports
pain449 reports
diarrhoea438 reports
cough386 reports
headache384 reports
off label use378 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive temporarily relieves nasal congestion due to: common cold hay fever upper respiratory allergies temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage temporarily relieves sinus congestion and pressure

Dosage & Administration

Directions do not crush, chew, or break tablet take with a full glass of water this product can be administered without regard for timing of meals adults and children 12 years and older: 2 tablets every 12 hours; not more than 4 tablets in 24 hours children under 12 years of age: do not use

Warnings

Warnings 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. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate gland persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema cough accompanied by too much phlegm (mucus) When using this product do not use more than directed Stop use and ask doctor if you get nervous, dizzy, or sleepless symptoms do not get better within 7 days, come back or occur with a fever, rash, or persistent headache. These could be signs of a serious illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Frequently Asked Questions

What is Mucus Relief used for?

Mucus Relief contains Guaifenesin. It is a tablet taken oral. Consult your doctor for specific uses.

Is Mucus Relief a controlled substance?

Mucus Relief is not classified as a controlled substance by the DEA.

What is the generic name for Mucus Relief?

The generic name for Mucus Relief is Guaifenesin. There are 12 other brand versions of Guaifenesin.

What is the NDC code for Mucus Relief 400 mg/1?

The NDC (National Drug Code) for Mucus Relief 400 mg/1 is 37835-401, listed by Bi-Mart.