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guaifenesin

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Brand names: Mucinex

Expectorant OTC

Guaifenesin (Mucinex) is a medicine that helps to loosen mucus in your lungs. It makes it easier to cough up.

Drug Pricing (NADAC)

Generic Price

$0.01/unit

Generic Available

Yes (17 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

This medicine helps with coughs caused by minor throat and lung irritation.

Common side effects

Nausea, Vomiting, Headache

Key warnings

Do not give to children under 4 years of age.

How It Works

Guaifenesin is an expectorant. It works by thinning the mucus in your airways. This makes the mucus easier to cough up and clear from your lungs.

How to Take It

Take this medicine every 4 hours as needed. Do not take more than 6 doses in 24 hours. Shake the bottle well before each use. Use the provided dosing cup to measure the correct amount.

Pregnancy & Breastfeeding

Talk to your doctor before taking this medicine if you are pregnant or breastfeeding. It is important to weigh the potential benefits against any risks to your baby.

Missed Dose

If you miss a dose, take it as soon as you remember. Do not take more than 6 doses in 24 hours.

Storage

Store at room temperature, away from heat and moisture.

Side Effects (from patient reports)

Based on 17,156 FDA adverse event reports.

Medicine not working
2,450
Difficulty breathing
2,178
Tiredness
1,782
Feeling sick to your stomach
1,742
Loose stool
1,645
Lung infection
1,641
Cough
1,557
Headache
1,506
Feeling lightheaded
1,404
Pain
1,251

FDA Adverse Event Report Analysis

Detailed analysis of 29,404 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 1998–2025.

Total Reports

29,404

Death-Related Reports

2,163

Hospitalization Reports

7,581

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 17,337 (63%)
Male 10,064 (37%)

Age Distribution

0–17 504
18–44 2,151
45–64 5,618
65–74 4,522
75+ 4,549

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 DRUG INEFFECTIVE 2,450
2 DYSPNOEA 2,178
3 FATIGUE 1,782
4 NAUSEA 1,743
5 DIARRHOEA 1,645
6 PNEUMONIA 1,641
7 COUGH 1,557
8 HEADACHE 1,506
9 DIZZINESS 1,400
10 PAIN 1,251
11 OFF LABEL USE 980
12 VOMITING 945
13 ASTHENIA 928
14 DEATH 917
15 FALL 887

Reactions in Death Reports

DEATH 915
PNEUMONIA 265
DYSPNOEA 204
RESPIRATORY FAILURE 179
CHRONIC OBSTRUCTIVE PULMONARY DISEASE 139
ASTHENIA 136
CARDIAC FAILURE CONGESTIVE 119
FATIGUE 119
SEPSIS 112
HYPOTENSION 108

Reactions in Hospitalization Reports

PNEUMONIA 1,320
DYSPNOEA 1,044
NAUSEA 618
FATIGUE 592
FALL 557
PAIN 543
COUGH 525
DIARRHOEA 518
ASTHENIA 476
CHRONIC OBSTRUCTIVE PULMONARY DISEASE 446

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Do not give to children under 4 years of age.

Common Questions

What is guaifenesin used for?
It is used to relieve coughs and loosen mucus in your lungs.
How often can I take this medicine?
You can take it every 4 hours as needed.
Can I give this to my child?
Do not give to children under 4 years of age. For children 4 to under 6 years, the dose is 2.5 mL every 4 hours. For children 6 to under 12 years, the dose is 5 mL every 4 hours.
What should I do if I miss a dose?
Take the missed dose as soon as you remember.
Are there any side effects?
Common side effects include nausea, vomiting, and headache.
Can I take this while pregnant?
Talk to your doctor before taking this medicine if you are pregnant.
How should I store this medicine?
Store it at room temperature, away from heat and moisture.
Can I take this with other medicines?
Check with your doctor or pharmacist before taking this with other medicines.
What if it doesn't seem to be working?
Talk to your doctor if your cough does not get better after 7 days.
Do I need a prescription for this medicine?
No, you can buy it over the counter.
What are the common side effects of guaifenesin?
The most commonly reported side effects of guaifenesin include Nausea, Vomiting, Headache, Dizziness. Based on 17,156 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
What drug class is guaifenesin?
guaifenesin belongs to the Expectorant drug class. It is available over the counter (OTC). This medicine helps with coughs caused by minor throat and lung irritation.
Is guaifenesin safe during pregnancy?
Talk to your doctor before taking this medicine if you are pregnant or breastfeeding. It is important to weigh the potential benefits against any risks to your baby. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.
Has guaifenesin been recalled?
There is 1 recall associated with guaifenesin products. CGMP Deviations: Firm went out of business and could no longer continue stability studies. Check the recalls section below for full details and affected products.

Active Recalls

Class II April 26, 2023

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Akorn, Inc.

Related Medications in Expectorant

Other drugs grouped near guaifenesin — same-class peers and common alternatives.

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Medication Guides

Related Health & Safety Data

What the FDA Data Shows for guaifenesin

The FDA label for guaifenesin (sold under brand names such as Mucinex) classifies it as an over-the-counter product in the Expectorant class. This medicine helps with coughs caused by minor throat and lung irritation. Official labeling lists 4 commonly reported side effects, including Nausea, Vomiting, Headache.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 17,156 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS shows a generic unit cost of $0.01.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

Data Sources

Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).

FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.

Last updated: October 14, 2025

All federal data sources used on this page