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Guaifenesin

Pronunciation

Class: Expectorants
VA Class: RE516
CAS Number: 93-14-1
Brands: Bronkaid, Cheratussin AC, Children’s Mucinex, Children’s Mucinex Cold, Children’s Mucinex Cough, Children’s Robitussin, Codar GF, Congestac, Diabetic Tussin, Guaiatussin AC, Guiatuss, Mucinex, Mucinex Cough, Mucinex D, Mucinex DM, Pediacare, Primatene, Rescon-GG, Robitussin Peak, Robafen AC, Theraflu, Triaminic, Tylenol Cold & Flu Severe, Tylenol Cold Multi-Symptom Severe, Vick’s Dayquil, Vick’s Formula 44, Vick’s Nature Fusion

Introduction

Expectorant.a

Uses for Guaifenesin

Cough

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

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

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

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.a

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).e f g h i j

Guaifenesin Dosage and Administration

Administration

Administer orally.a

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

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.a (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.a (See Pediatric Use under Cautions.)

Children 2–6 years of age, extended-release preparations: 300 mg every 12 hours, up to 600 mg daily.a (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.a

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

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

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.a

Adults

Cough
Oral

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

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

Prescribing Limits

Pediatric Patients

Cough
Oral

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

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

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

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

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

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

Adults

Cough
Oral

Conventional preparations: Maximum 2.4 g daily.a

Extended-release preparations: Maximum 2.4 g daily.a

Cautions for Guaifenesin

Contraindications

  • Known hypersensitivity to guaifenesin.

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.a

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.a

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.a

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).e f g h i j

Specific Populations

Pregnancy

Category C.b

Lactation

Not known whether guaifenesin is distributed into milk.b

Pediatric Use

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

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.c d Limited evidence of efficacy for these preparations in this age group; appropriate dosages not established.c Therefore, FDA recommends not to use such preparations in children <2 years of age; safety and efficacy in older children currently 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 recently agreed to voluntarily revise the product labeling to state that such preparations should not be used in children <4 years of age. During the transition period, some preparations on pharmacy shelves will have the new recommendation (“do not use in children <4 years of age”), while others will have the previous recommendation (“do not use in children <2 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.a

Actions

  • Reduces the viscosity of tenacious secretions and acts as an expectorant by increasing respiratory tract fluid.a

  • Increases expectorated sputum volume over the first 4–6 days of a productive cough, decreases sputum viscosity and difficulty in expectoration, and improves associated symptoms.a

Advice to Patients

  • Importance of contacting a clinician if cough persists for >1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.a

  • Importance of not using for self-medication for persistent or chronic cough unless directed by a clinician.a

  • Importance of keeping Mucinex 600-mg extended-release tablets out of reach of young children to avoid accidental swallowing and choking.a

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

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

Many prescription cough, cold, and allergy preparations commercially available in the US have not been approved by the US Food and Drug Administration (FDA). Because of the potentially serious health risks associated with unapproved preparations, FDA announced on March 3, 2011, that it would take enforcement action (e.g., seizure, injunction, other judicial or administrative proceeding) against any currently marketed and listed unapproved cough, cold, and allergy preparation manufactured on or after June 1, 2011, or shipped on or after August 30, 2011. For additional information and for a complete list of unapproved cough, cold, and allergy preparations affected by this FDA notice, see FDA website ().

* 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

Guaifenesin also is commercially available in combination with antihistamines, antitussives, bronchodilators, decongestants, and expectorants.

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 04/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Cheratussin AC 100-10MG/5ML Syrup (QUALITEST): 118/$12.99 or 354/$19.97

Cheratussin AC 100-10MG/5ML Syrup (QUALITEST): 473/$15.99 or 1419/$25.97

Cheratussin DAC 30-10-100MG/5ML Solution (QUALITEST): 473/$35.99 or 946/$60.97

Donatussin 10-2-15-100MG/5ML Syrup (LASER PHARMACEUTICALS): 473/$36.25 or 1419/$108.75

Duraphen Forte 30-30-1200MG 12-hr Tablets (KOWA PHARMACEUTICALS AMERICA): 100/$135.98 or 300/$375.97

GFN 1200/DM 60 1200-60MG 12-hr Tablets (CYPRESS PHARMACEUTICAL): 30/$24.99 or 90/$65.97

GNP Mucus Relief 400MG Tablets (BERGEN BRUNSWIG): 50/$14.99 or 100/$19.97

GNP Tab Tussin DM 20-400MG Tablets (AMERISOURCE BERGEN DRUGS): 24/$12.99 or 48/$15.97

Guaifenesin-Codeine 100-10MG/5ML Solution (PHARMACEUTICAL ASSOCIATES): 473/$14.99 or 946/$18.97

Guaifenesin-DM 100-10MG/5ML Liquid (MORTON GROVE PHARMACEUTICALS): 240/$18.99 or 720/$49.97

Guiatuss 100MG/5ML Syrup (IVAX PHARMACEUTICALS): 473/$14.99 or 946/$18.97

Mucinex 600MG 12-hr Tablets (RECKITT BENCKISER): 20/$19.99 or 40/$28.97

Mytussin DAC 30-10-100MG/5ML Solution (MORTON GROVE PHARMACEUTICALS): 473/$39.66 or 1419/$118.98

Q-Tussin DM 100-10MG/5ML Syrup (QUALITEST): 120/$11.99 or 240/$13.97

Respaire-30 30-150MG Capsules (LASER PHARMACEUTICALS): 100/$58.99 or 200/$105.98

Robitussin DM 100-10MG/5ML Syrup (PFIZER CONSUMER HEALTHCARE): 237/$17.99 or 474/$25.98

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions March 31, 2014. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. AHFS drug information 2004. McEvoy GK, ed. Guaifenesin. Bethesda, MD: American Society of Health-System Pharmacists; 2004: 2605-7.

b. Briggs GG, Freeman RK, Yaffee SJ. Drugs in pregnancy and lactation. 6th ed. Philadelphia, PA: Lippincott Williams &Wilkins; 2002: 636-7/g.

c. Srinivasan A, Budnitz D, Shehab N et al. Infant deaths associated with cough and cold medications—two states, 2005. MMWR Morb Mortal Wkly Rep. 2007; 56:1-4. [PubMed 17218934]

d. Food and Drug Administration. Cough and cold medications in children less than two years of age. Rockville, MD; 2007 Jan 12. From FDA website ().

e. Ethex Corporation. Pseudovent 400 (pseudoephedrine hydrochloride and guaifenesin) extended-release capsules prescribing information. St. Louis, MO; 2004 Aug.

f. Novartis Consumer Health, Inc. Triaminic Chest & Nasal Congestion (guaifenesin and phenylephrine hydrochloride) oral solution patient information. From Novartis Consumer Health website (). Accessed 2008 Feb 26.

g. Hogil Pharmaceutical Corp. Sine-Off Severe Cold (acetaminophen, guaifenesin, and phenylephrine hydrochloride) caplets patient information. From Hogil website (). Accessed 2008 Feb 27.

h. Wyeth Consumer Healthcare. Primatene (ephedrine hydrochloride and guaifenesin) tablets patient information. From Wyeth Consumer Healthcare website (). Accessed 2008 Feb 26.

i. Wyeth Consumer Healthcare. Robitussin Cough & Cold CF (dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride) syrup patient information. From Wyeth Consumer Healthcare website (). Accessed 2008 Feb 26.

j. Cypress Pharmaceutical Inc. ChlorDex GP (dextromethorphan hydrobromide, chlorpheniramine maleate, phenylephrine hydrochloride, and guaifenesin) syrup prescribing information. Madison, MS; 2006 Oct.

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