Guaifenesin

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

# Overview
Guaifenesin is an expectorant that is FDA approved for the treatment of loosening phlegm (mucus) and thinning of bronchial secretions to make coughs more productive..   Common adverse reactions include nausea, vomiting.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)

# Indications
- Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

# Dosage
- Follow dosage below or use as directed by a physician.
- Do not take more than 6 doses in any 24-hour period.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Guaifenesin in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Guaifenesin in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)

# Indication
- Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive.

# Dosage
- Follow dosage below or use as directed by a physician.
- Do not take more than 6 doses in any 24-hour period.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Guaifenesin in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Guaifenesin in pediatric patients.

# Contraindications
There is limited information regarding Guaifenesin Contraindications in the drug label.

# Warnings
Ask a doctor before use if you have
- Cough that occurs with too much phlegm (mucus)
- Cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Stop use and ask a doctor if
Cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
- You are hypersensitive to any of the ingredients.
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.

# Adverse Reactions

## Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Guaifenesin in the drug label.

## Postmarketing Experience
Common
Gastrointestinal: nausea, vomiting

# Drug Interactions
There is limited information regarding Guaifenesin Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): 
There is no FDA guidance on usage of Guaifenesin in women who are pregnant.
Pregnancy Category (AUS): 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of guaifenesin in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of guaifenesin during labor and delivery.

### Nursing Mothers
There is no FDA guidance on the use of guaifenesin with respect to nursing mothers.

### Pediatric Use
There is no FDA guidance on the use of guaifenesin with respect to pediatric patients.

### Geriatic Use
There is no FDA guidance on the use of guaifenesin  with respect to geriatric patients.

### Gender
There is no FDA guidance on the use of guaifenesin with respect to specific gender populations.

### Race
There is no FDA guidance on the use of guaifenesin with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of guaifenesin in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of guaifenesin in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of guaifenesin in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of guaifenesin in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Oral

### Monitoring
There is limited information regarding Monitoring of guaifenesin in the drug label.

# IV Compatibility
There is limited information regarding IV Compatibility of guaifenesin in the drug label.

# Overdosage
There is limited information regarding Guaifenesin overdosage.  If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

# Pharmacology
There is limited information regarding Guaifenesin Pharmacology in the drug label.

## Mechanism of Action
There is limited information regarding Guaifenesin Mechanism of Action in the drug label.

## Structure
There is limited information regarding Guaifenesin Structure in the drug label.

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of guaifenesin in the drug label.

## Pharmacokinetics
There is limited information regarding Pharmacokinetics of guaifenesin in the drug label.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of guaifenesin in the drug label.

# Clinical Studies
There is limited information regarding Guaifenesin Clinical Studies in the drug label.

# How Supplied
There is limited information regarding Guaifenesin How Supplied in the drug label.

## Storage
- Keep tightly closed. Store at controlled room temperature, 20-25C (68-77F).  Protect from light.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Patient Counseling Information of guaifenesin in the drug label.

# Precautions with Alcohol
- Alcohol-guaifenesin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- GUAIFENESIN

# Look-Alike Drug Names
There is limited information regarding Guaifenesin Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price