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Guaifenesin (Monograph)

Brand names: Children’s Mucinex, Diabetic Tussin, Guiatuss, Mucinex
Drug class: Expectorants
VA class: RE516
CAS number: 93-14-1

Medically reviewed by Drugs.com on Jan 22, 2024. Written by ASHP.

Introduction

Expectorant.

Uses for Guaifenesin

Cough

Symptomatic management of productive cough to loosen and thin sputum and bronchial secretions and ease expectoration.

Improves cough symptoms associated with common cold, bronchitis, laryngitis, pharyngitis, pertussis, influenza, measles, and coughs provoked by chronic paranasal sinusitis.

May be useful in the management of irritative nonproductive cough and coughs productive of scanty amounts of thick, viscous secretions.

May indirectly diminish the tendency to cough, but mechanism of this effect differs from that of antitussives (which inhibit or suppress cough); insufficient evidence to support efficacy as antitussive.

Used in fixed combination with other agents (e.g., acetaminophen, chlorpheniramine, dextromethorphan, ephedrine, phenylephrine, pseudoephedrine) for the temporary relief of productive cough and/or other symptoms (nasal congestion, fever).

Guaifenesin Dosage and Administration

Administration

Administer orally.

Do not break, crush, or chew extended-release tablets.

Dosage

Because combinations and dosage strengths vary for fixed-combination preparations, consult manufacturer’s product labeling for appropriate dosage of the specific preparation.

Pediatric Patients

Cough
Oral

Children <2 years of age: Individualize dosage. (See Pediatric Use under Cautions.)

Children 2 to <6 years of age, conventional preparations: 50–100 mg every 4 hours, up to 600 mg daily. (See Pediatric Use under Cautions.)

Children 2–6 years of age, extended-release preparations: 300 mg every 12 hours, up to 600 mg daily. (See Pediatric Use under Cautions.)

Children 6 to <12 years of age, conventional preparations: 100–200 mg every 4 hours, up to 1.2 g daily.

Children 6–12 years of age, extended-release preparations: 600 mg every 12 hours, up to 1.2 g daily.

Children ≥12 years of age, conventional preparations: 200–400 mg every 4 hours, up to 2.4 g daily.

Children ≥12 years of age, 600-mg extended-release tablets: 600 mg or 1.2 g every 12 hours, up to 2.4 g daily.

Adults

Cough
Oral

Conventional preparations: 200–400 mg every 4 hours, up to 2.4 g daily.

600-mg extended-release tablets: 600 mg or 1.2 g every 12 hours, up to 2.4 g daily.

Prescribing Limits

Pediatric Patients

Cough
Oral

Children 2 to <6 years of age, conventional preparations: Maximum 600 mg daily.

Children 2–6 years of age, extended-release preparations: Maximum 600 mg daily.

Children 6 to <12 years of age, conventional preparations: Maximum 1.2 g daily.

Children 6–12 years of age, extended-release preparations: Maximum 1.2 g daily.

Children ≥12 years of age, conventional preparations: Maximum 2.4 g daily.

Children ≥12 years of age, extended-release preparations: Maximum 2.4 g daily.

Adults

Cough
Oral

Conventional preparations: Maximum 2.4 g daily.

Extended-release preparations: Maximum 2.4 g daily.

Cautions for Guaifenesin

Contraindications

Warnings/Precautions

General Precautions

Excessive Dosage

Emesis may result from doses larger than those required for expectorant action, but GI upset at ordinary dosage is rare.

Persistent Cough

Do not use as self-medication for persistent or chronic cough (e.g., that associated with smoking, asthma, chronic bronchitis, emphysema), or cough accompanied by excessive phlegm unless directed by a clinician.

Persistent cough may indicate serious condition; if it persists for >1 week, is recurrent, or is accompanied by fever, rash, or persistent headache, consult a clinician.

Use of Fixed Combinations

When used in fixed combination with other agents (e.g., acetaminophen, chlorpheniramine, codeine, dextromethorphan, ephedrine, phenylephrine, pseudoephedrine), consider the cautions, precautions, and contraindications associated with the concomitant agent(s).

Specific Populations

Pregnancy

Category C.

Lactation

Not known whether guaifenesin is distributed into milk.

Pediatric Use

Safety and efficacy of Mucinex 600-mg extended-release tablets not established in children <12 years of age.

Risk of overdosage and toxicity (including death) in children <2 years of age receiving OTC preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection. Limited evidence of efficacy for these preparations in this age group; appropriate dosages not established. Therefore, FDA recommends not to use such preparations in children <2 years of age; safety and efficacy in older children under evaluation. Because children 2–3 years of age also are at increased risk of overdosage and toxicity, some manufacturers of oral nonprescription cough and cold preparations agreed to voluntarily revise the product labeling to state that such preparations should not be used in children <4 years of age. FDA recommends that parents and caregivers adhere to dosage instructions and warnings on the product labeling that accompanies the preparation and consult a clinician about any concerns. Clinicians should ask caregivers about use of OTC cough/cold preparations to avoid overdosage.

Stability

Storage

Tight containers.

Actions

Advice to Patients

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

guaiFENesin

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Granules

50 mg per packet

Mucinex Mini Melts

Reckitt Benckiser

100 mg per packet

Mucinex Mini Melts

Reckitt Benckiser

Solution

100 mg/5 mL*

Children’s Mucinex Chest Congestion

Reckitt Benckiser

Diabetic Tussin Expectorant

Health Care Products

Guaifenesin Oral Solution

Guiatuss Syrup

Goldline

200 mg/5 mL

Diabetic Tussin Mucus Relief

Health Care Products

Tablets

200 mg*

Guaifenesin Tablets

Tablets, extended-release

600 mg

Mucinex

Reckitt Benckiser

1.2 g

Mucinex Maximum Strength

Reckitt Benckiser

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

guaiFENesin and Codeine Phosphate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Solution

100 mg/5 mL Guaifenesin and Codeine Phosphate 10 mg/5 mL*

Cheratussin AC (C-V)

Qualitest

Guaiatussin AC (C-V)

Hi-Tech

Guaifenesin AC Cough Syrup (C-V)

Guaifenesin and Codeine Phosphate Oral Solution (C-V)

Robafen AC (C-V)

Major

200 mg/5 mL Guaifenesin and Codeine Phosphate 8 mg/5 mL

Codar GF (C-V)

Respa

Other guaiFENesin Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

For Solution

400 mg/packet with Acetaminophen 1 g/packet

Theraflu Flu & Chest Congestion

Novartis

400 mg/packet with Acetaminophen 1 g/packet, Dextromethorphan Hydrobromide 30 mg/packet, and Pseudoephedrine Hydrochloride 60 mg/packet

Theraflu Max-D Severe Cold & Flu

Novartis

Granules

50 mg per packet with Dextromethorphan Hydrobromide 5 mg/packet

Mucinex Cough Mini Melts

Reckitt Benckiser

Solution

33.3 mg/5 mL with Dextromethorphan Hydrobromide 3.3 mg/5 mL

Vick’sNature Fusion Cough and Chest Congestion

Procter & Gamble

50 mg/5 mL with Dextromethorphan Hydrobromide 5 mg/5 mL and Phenylephrine Hydrochloride 2.5 mg/5 mL

Children’s Robitussin Cold & Cough CF

Pfizer

50 mg/5 mL with Phenylephrine Hydrochloride 2.5 mg/5 mL

Triaminic Chest and Nasal Congestion

Novartis

66.6 mg/5 mL with Acetaminophen 108.3 mg/5 mL, Dextromethorphan Hydrobromide 3.3 mg/5 mL, and Phenylephrine Hydrochloride 1.6 mg/5 mL

Tylenol Cold Multi-Symptom Severe

McNeil

Tylenol Cold & Flu Severe

McNeil

66.6 mg/5 mL with Acetaminophen 108.3 mg/5 mL, and Phenylephrine Hydrochloride 1.6 mg/5 mL

Theraflu Warming Relief Cold & Chest Congestion

Novartis

66.6 mg/5 mL with Dextromethorphan Hydrobromide 3.3 mg/5 mL

Vick’s Dayquil Mucus Control DM

Procter & Gamble

66.6 mg/5 mL with Dextromethorphan Hydrobromide 6.6 mg/5 mL

Vick’s Formula 44 Custom Care Chesty Cough

Procter & Gamble

100 mg/5mL with Acetaminophen 162.5 mg/5 mL, Dextromethorphan Hydrobromide 5 mg/5 mL, and Phenylephrine Hydrochloride 2.5 mg/5 mL

Children’s Mucinex Cold, Cough, and Sore Throat

Reckitt Benckiser

Children’s Mucinex Multi-symptom Cold & Fever

Reckitt Benckiser

100 mg/5 mL with Dextromethorphan Hydrobromide 5 mg/5 mL

Children’s Mucinex Cough

Reckitt Benckiser

Pediacare Children’s Cough & Congestion

Prestige Brands

100 mg/5 mL with Dextromethorphan Hydrobromide 5 mg/5 mL and Phenylephrine Hydrochloride 2.5 mg/5 mL

Children’s Mucinex Multi-symptom Cold

Reckitt Benckiser

100 mg/5 mL with Dextromethorphan Hydrobromide 10 mg/5 mL

Robitussin Peak Cold Cough + Chest Congestion DM

Pfizer

100 mg/5 mL with Dextromethorphan Hydrobromide 10 mg/5 mL and Phenylephrine Hydrochloride 5 mg/5 mL

Robitussin Peak Cold Multi-Symptom Cold

Pfizer

100 mg/5 mL with Phenylephrine Hydrochloride 2.5 mg/5 mL

Children’s Mucinex Stuffy Nose & Cold

Reckitt Benckiser

100 mg/5 mL with Phenylephrine Hydrochloride 5 mg/5 mL

Rescon-GG

Capellon

200 mg/5 mL with Dextromethorphan Hydrobromide 10 mg/5 mL

Robitussin Peak Cold Maximum Strength Cough + Chest Congestion DM

Pfizer

200 mg/5 mL with Dextromethorphan Hydrobromide 10 mg/5 mL and Phenylephrine Hydrochloride 5 mg/5 mL

Robitussin Peak Cold Maximum Strength Multi-Symptom Cold

Pfizer

Tablets

200 mg with Acetaminophen 325 mg, Dextromethorphan 10 mg, and Phenylephrine Hydrochloride 5 mg

Tylenol Cold Multi-symptom Severe

McNeil

Tylenol Cold & Flu Severe

McNeil

200 mg with Ephedrine Hydrochloride 12.5 mg

Primatene

Pfizer

400 mg with Ephedrine Sulfate 25 mg

Bronkaid Dual Action Caplets

Bayer

400 mg with Pseudoephedrine Hydrochloride 60 mg

Congestac Caplets

Ascher

Tablets, extended-release

600 mg with Dextromethorphan Hydrobromide 30 mg

Mucinex DM

Reckitt Benckiser

600 mg with Pseudoephedrine Hydrochloride 60 mg

Mucinex D

Reckitt Benckiser

1.2 g with Dextromethorphan Hydrobromide 60 mg

Mucinex DM Maximum Strength

Reckitt Benckiser

1.2 g with Pseudoephedrine Hydrochloride 120 mg

Mucinex D Maximum Strength

Reckitt Benckiser

AHFS DI Essentials™. © Copyright 2024, Selected Revisions February 1, 2016. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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