Guaifenesin

Guaifenesin
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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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.

This image is provided by the National Library of Medicine.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-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.

This image is provided by the National Library of Medicine.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-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°-25°C (68°-77°F). [See USP] Protect from light.

Images

Drug Images

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Package and Label Display Panel

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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

There is limited information regarding Guaifenesin Brand Names in the drug label.

Look-Alike Drug Names

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

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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