48:16 Expectorants

Guaifenesin
MedWatch Notification
Special Alerts:
[Posted 01/17/2008] FDA informed consumers and healthcare professionals that the Agency
has completed its review of information regarding the safety of over-the-counter (OTC)
cough and cold medicines in children under 2 years of age and recommends that these drugs
not be used to treat children in this age group because serious and potentially life-threatening
side effects can occur. FDA's recommendation is based on both the review of the information
the Agency received about serious side effects in children in the referenced age group and the
discussion and recommendations made at the October 18 -19, 2007, public advisory
committee meeting at which this issue was discussed. FDA has not completed its review of
information about the safety of OTC cough and cold medicines in children 2 through 11 years
of age. See the FDA Public Health Advisory for Agency recommendations regarding this
issue. For more information visit the FDA website at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#cough and
http://www.fda.gov/cder/drug/advisory/cough_cold_2008.htm.
Introduction
Guaifenesin is an expectorant.
Uses
Pending revision, the material in this section should be considered in light of more recently
available information in the MEDWATCH notification at the beginning of this monograph.
Cough
Guaifenesin is used as an expectorant in the symptomatic management of coughs associated
with the common cold, bronchitis, laryngitis, pharyngitis, pertussis, influenza, and measles,
and coughs provoked by chronic paranasal sinusitis. While there is clinical evidence that
guaifenesin is an effective expectorant (i.e., increasing expectorated sputum volume over the
first 4-6 days of a productive cough, decreasing sputum viscosity and difficulty in
expectoration, and improving associated symptoms), there currently is insufficient evidence
to support efficacy of the drug as an antitussive (cough suppressant). Therefore, guaifenesin's
principal benefit in the symptomatic treatment of coughs results from the drug's ability to
loosen and thin sputum and bronchial secretions and ease expectoration. Although such
facilitation of evacuation of secretions may indirectly diminish the tendency to cough, the
mechanism of this effect differs from that of antitussives, which inhibit or suppress cough. In
addition to usefulness in the management of productive cough, guaifenesin's effects on
sputum production and viscosity and on ease of expectoration suggest that the drug may
prove useful in the management of irritative nonproductive cough and coughs productive of
scanty amounts of thick, viscous secretions.
Although cough and cold preparations that contain cough suppressants, nasal decongestants,
antihistamines, and/or expectorants commonly are used in pediatric patients younger than 2

years of age, systematic reviews of controlled trials have concluded that over-the-counter
cough and cold preparations are not more effective than placebo in reducing acute cough and
other symptoms of upper respiratory tract infection in these patients. Furthermore, adverse
events, including deaths, have been (and continue to be) reported in pediatric patients
younger than 2 years of age receiving these preparations. (See Cautions: Pediatric
Precautions.)
Guaifenesin is combined with bronchodilators, decongestants, antihistamines, or opiate
antitussives in numerous commercial liquid cough preparations.
Dosage and Administration
Administration
Guaifenesin is administered orally.
Mucinex 600-mg extended-release tablets should not be broken, crushed, or chewed and
should not be used in children younger than 12 years of age; the tablets should be kept out of
reach of young children to avoid accidental swallowing and choking.
Dosage
Pending revision, the material in this section should be considered in light of more recently
available information in the MEDWATCH notification at the beginning of this monograph.
Cough
The usual dosage of guaifenesin as an expectorant in adults and children 12 years of age and
older is 200-400 mg as conventional preparations every 4 hours, not to exceed 2.4 g daily.
The usual dosage of guaifenesin 600-mg extended-release tablets as an expectorant in adults
and children 12 years of age and older is 600 mg or 1.2 g every 12 hours, not to exceed 2.4 g
daily. The usual dosage of guaifenesin as an expectorant for children 6 to younger than 12
years of age is 100-200 mg as conventional preparations every 4 hours, not to exceed 1.2 g
daily. Alternatively, children 6-12 years of age may receive 600 mg as an appropriate
extended-release preparation every 12 hours, not to exceed 1.2 g daily. Children 2 to younger
than 6 years of age may receive 50-100 mg as conventional preparations every 4 hours, not to
exceed 600 mg daily. Alternatively, children 2-6 years of age may receive 300 mg as an
appropriate extended-release preparation every 12 hours, not to exceed 600 mg daily. Dosage
of guaifenesin in children younger than 2 years of age must be individualized. Suggested
dosages for children younger than 2 years of age# for some cough and cold preparations have
been published in various references for prescribing and parenting. Using recommended
dosages for adults and older children, some clinicians have extrapolated dosages for these
preparations based on the weight or age of children younger than 2 years of age. However,
these extrapolations were based on assumptions that pathology of the disease and
pharmacology of the drugs are similar in adults and pediatric patients. There currently are no
specific dosage recommendations (i.e., approved by the US Food and Drug Administration
[FDA]) for cough and cold preparations for this patient population. (See Cautions: Pediatric
Precautions.)
Cautions
Doses of guaifenesin larger than those required for expectorant action may produce emesis,
but GI upset at ordinary dosage levels is rare.

For self-medication, unless directed by a physician, guaifenesin should not be used for
persistent or chronic cough such as that occurring with smoking, asthma, chronic bronchitis,
or emphysema, or for cough accompanied by excessive phlegm. A persistent cough may be
indicative of a serious condition. If cough persists for more than one week, is recurrent, or is
accompanied by fever, rash, or persistent headache, a physician should be consulted.
Pediatric Precautions
Pending revision, the material in this section should be considered in light of more recently
available information in the MEDWATCH notification at the beginning of this monograph.
Overdosage and toxicity (including death) have been reported in children younger than 2
years of age receiving nonprescription (over-the-counter, OTC) preparations containing
antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in
combination for relief of symptoms of upper respiratory tract infection. There is limited
evidence of efficacy for these preparations in this age group, and appropriate dosages (i.e.,
approved by the US Food and Drug Administration [FDA]) for the symptomatic treatment of
cold and cough have not been established. Such preparations should be used in children
younger than 2 years of age with caution and only as directed by a clinician. Clinicians
should use caution in prescribing cough and cold preparations in these children and should
ask caregivers about use of nonprescription cough and cold preparations to avoid overdosage.
For additional information on precautions associated with the use of cough and cold
preparations in pediatric patients, see Cautions: Pediatric Precautions in Dextromethorphan
48:08.
Pharmacology
By increasing respiratory tract fluid, guaifenesin reduces the viscosity of tenacious secretions
and acts as an expectorant.
Chemistry and Stability
Chemistry
Guaifenesin is an expectorant. Guaifenesin occurs as a white to slightly gray, crystalline
powder, having a bitter taste. Guaifenesin may have a slight characteristic odor. Guaifenesin
is soluble in alcohol and in water.
Stability
Guaifenesin powder tends to become lumpy on storage. Guaifenesin preparations should be
stored in tight containers.
Preparations
In response to concerns regarding the safety and efficacy of cough and cold preparations in
young children, many nonprescription cough and cold preparations specifically formulated
for infants have been voluntarily withdrawn from the US market. Therefore, some of the
preparations described below may no longer be commercially available in the US.
* available generically
Guaifenesin
Routes Dosage Forms Strengths Brand Names Manufacturer Oral Capsules 200 mg Hytuss2X Hyrex Capsules, 300 mg Humibid Pediatric Celltech extended- release Solution 100

mg/5 Phanasin Diabetic Choice (with Pharmakon mL* parabens and propylene glycol)
Diabetic Tussin EX (with Health Care methylparaben) Products Ganidin NR Cypress
Guiatuss Syrup Actavis, Teva Robitussin Wyeth 200 mg/5 mL Naldecon Senior EX
Bristol-Myers Squibb Tablets 100 mg Hytuss (scored) Hyrex 200 mg Guaifenesin Tablets
United Research Organidin NR (scored) MedPointe X-Pect (with povidone) Hawthorn
Tablets, 1.2 g Mucinex Adams extended- release
Dyphylline and Guaifenesin
Routes Dosage Strengths Brand Names Manufacturer Forms Oral Solution 33.3 mg/5 mL
Dyphyllyine and Dyphylline GG Elixir Cypress Guaifenesin 33.3 mg/5 mL (with alcohol
17%) Lufyllin-GG Elixir (with MedPointe alcohol 17%) 100 mg/5 mL Dyphylline and DyG Cypress Guaifenesin 100 mg/5 mL Tablets 200 mg Dyphylline and Dyflex-G EconoMed
Guaifenesin 200 mg Dyphylline GG (scored) Breckenridge, United Research Lufyllin-GG
(scored) MedPointe
* available generically
Guaifenesin and Codeine Phosphate
Routes Dosage Strengths Brand Names Manufacturer Forms Oral Solution 75 mg/5 mL
Guaifenesin Brontex (C-V; with methylparaben) Kenwood and Codeine Phosphate 2.5 mg/5
mL 100 mg/5 mL Guaifenesin Cheracol Syrup (C-V; with alcohol Lee and Codeine
Phosphate 4.75%) 10 mg/5 mL* Gani-Tuss NR (C-V) Cypress Guaifenesin AC Liquid
(C-V; alcohol- Morton Grove and sugar-free) Guiatuss AC Syrup (C-V; with alcohol
Actavis, Teva 3.5%) Halotussin AC (C-V) Watson Mytussin AC Cough Syrup (C-V; with
Morton Grove alcohol 3.5%) Robitussin A-C Syrup (C-V; with Wyeth alcohol 3.5%)
Tussi-Organidin NR (C-V; with MedPointe propylene glycol) Tussi-Organidin-S NR (CV; with MedPointe propylene glycol and with graduated oral syringe) Tablets 300 mg
Guaifenesin and Brontex (C-III) Kenwood Codeine Phosphate 10 mg
Theophylline and Guaifenesin
Routes Dosage Forms Strengths Brand Names Manufacturer Oral Capsules, 150 mg
Theophylline (anhydrous) and Quibron Monarch liquid- Guaifenesin 90 mg filled Solution
33.3 mg/5 mL Theophylline Elixophyllin-GG (with Forest (anhydrous) and Guaifenesin
33.3 parabens and propylene mg/5 mL glycol)
* available generically
Other Guaifenesin Combinations
Routes Dosage Strengths Brand Names Manufacturer Forms Oral Capsules, 200 mg with
Phenylephrine Guaifed-PD Victory Pharma extended- Hydrochloride 7.5 mg release 200
mg with Pseudoephedrine Respaire-60 SR Laser Hydrochloride 60 mg 250 mg with
Pseudoephedrine Respaire-120 SR Laser Hydrochloride 120 mg 300 mg with
Pseudoephedrine Guaifed-PD Muro Hydrochloride 60 mg Capsules, 200 mg with
Pseudoephedrine Robitussin Cold Severe Wyeth liquid- Hydrochloride 30 mg Congestion
Liqui-Gels filled (with povidone and propylene glycol) Sinutab Non-Drowsy Non- Pfizer
Drying Sinus Liquid Caps (with povidone and propylene glycol) Sudafed Non-Drying
Sinus Pfizer Liquid Caps (with povidone and propylene glycol) Kit 28 Tablets, extendedrelease, Guaifenex-Rx 14-Day Ethex Guaifenesin 600 mg with Treatment Regimen
Pseudoephedrine Hydrochloride 60 mg (AM Treatment Phase (scored) 28 Tablets, extendedrelease, Guaifenesin 600 mg (PM Treatment Phase (scored) Solution 3.125 mg/mL with
Pseudoephedrine PediaCare Decongestant Pfizer Hydrochloride 9.375 mg/mL Plus Cough

Infant Drops 50 mg/5 mL with Pseudoephedrine Triaminic Chest and Nasal Novartis
Hydrochloride 15 mg/5 mL Congestion (with propylene glycol) 100 mg/5 mL with
Ephedrine Broncholate Syrup Sanofi-Aventis Hydrochloride 6.25 mg/5 mL 100 mg/5 mL
with Phenylephrine 5 mg/ Rescon-GG (with parabens Capellon 5 mL and propylene glycol)
100 mg/5 mL with Pseudoephedrine Robitussin-PE (with Wyeth Hydrochloride 30 mg/5
mL propylene glycol) 20 mg/mL with Chlorpheniramine Donatussin Pediatric Laser
Maleate 1 mg/mL and Phenylephrine Drops Hydrochloride 2 mg/mL 200 mg/5 mL with
Pseudoephedrine Guaifed Syrup (with Muro Hydrochloride 30 mg/5 mL povidone) Tablets
200 mg with Ephedrine Hydrochloride Primatene Wyeth 12.5 mg 400 mg with Ephedrine
Hydrochloride Bronkaid Dual Action Bayer 25 mg Caplets (with povidone) 400 mg with
Pseudoephedrine Congestac Caplets (with Ascher Hydrochloride 60 mg povidone)
Tablets, 300 mg with Phenylephrine Endal Forest extended- Hydrochloride 20 mg release
400 mg with Pseudoephedrine Anatuss LA (scored) Merz Hydrochloride 120 mg EudalSR (scored) Forest 500 mg with Pseudoephedrine Nasatab LA ECR Hydrochloride 120 mg
Touro LA LA Caplets Dartmouth (scored) 600 mg with Pseudoephedrine Respa-1st
(scored) Respa Hydrochloride 58 mg Pharmaceuticals 600 mg with Pseudoephedrine DefenLA Horizon Hydrochloride 60 mg D-Feda II WE Pharmaceuticals Guaifenex PSE 60
Ethex 600 mg with Pseudoephedrine Guaifenex PSE 120 Ethex Hydrochloride 120 mg*
GuaiMax-D (scored) Schwarz Zephrex-LA Sanofi-Aventis 800 mg with Pseudoephedrine
Profen II Teva Hydrochloride 45 mg 800 mg with Pseudoephedrine Profen Forte Teva
Hydrochloride 90 mg Tablets, 600 mg with Pseudoephedrine Defen-LA First Horizon
extended- Hydrochloride 60 mg release, film- coated 600 mg with Pseudoephedrine
Duratuss (scored) Victory Pharma Hydrochloride 120 mg Entex PSE (scored) Dura 1.2 g
with Pseudophedrine Duratuss GP Victory Pharma Hydrochloride 120 mg Guaifenesin
with United Research Pseudoephedrine Hydrochloride Tablets Tablets, 400 mg with
Pseudoephedrine Zephrex Sanofi-Aventis film- Hydrochloride 60 mg coated
Guaifenesin also is commercially available in combination with antihistamines, antitussives,
bronchodilators, decongestants, and expectorants.
Comparative Pricing
Pricing information provided by drugstore.com.
Amibid DM 30-600MG TB12 (ACTAVIS TOTOWA): 100/$19.99 or 300/$51.54
Aquatab DM 28-835MG TB12 (DESTON THERAPEUTICS): 100/$245.51 or 300/$692.91
Atuss G 10-2-100MG/5ML SYRP (ATLEY PHARMACEUTICALS): 120/$17.99 or
360/$50.98
Bidex-DM 30-800MG TB12 (STEWART JACKSON): 30/$29.99 or 90/$81.97
Brontex 10-300MG/20ML LIQD (KENWOOD): 120/$32.99 or 360/$95.98
Brontex 10-300MG TABS (KENWOOD): 30/$97.99 or 90/$281.98
Cheratussin AC 100-10MG/5ML SYRP (QUALITEST): 118/$10.99 or 354/$19.97
Cheratussin AC 100-10MG/5ML SYRP (QUALITEST): 480/$7.99 or 1440/$20.02
Cheratussin DAC 30-10-100MG/5ML SOLN (QUALITEST): 480/$9.12 or 960/$16.22

Crantex LA 30-600MG TB12 (BRECKENRIDGE): 30/$29.99 or 90/$75.98

Donatussin Pediatric 1-20-2MG/ML SOLN (LASER PHARMACEUTICALS): 30/$8.99 or
90/$19.97
Donatussin-DC 7.5-2.5-50MG/5ML SYRP (LASER PHARMACEUTICALS): 120/$8.99 or
360/$15.98
DuraDex Forte 45-1200MG TB12 (PROETHIC PHARMACEUTICALS): 30/$30.38 or
90/$84.97
Duraphen 1000 30-1000MG TB12 (PROETHIC PHARMACEUTICALS): 100/$99.99 or
300/$271.86
Duraphen Forte 30-30-1200MG TB12 (PROETHIC PHARMACEUTICALS): 100/$132.57
or 300/$375.84
Duraphen II 25-800MG TB12 (PROETHIC PHARMACEUTICALS): 30/$36.5 or
90/$101.07
Duraphen II DM 20-20-800MG TB12 (PROETHIC PHARMACEUTICALS): 30/$41.76 or
90/$125.02
Dyphylline-Guaifenesin 200-200MG TABS (URL): 100/$119.99 or 300/$348.96
G-Bid DM 60-1200MG TB12 (BOCA PHARMACAL): 100/$83.74 or 300/$225.6
GFN 1200/DM 60 1200-60MG TB12 (CYPRESS PHARMACEUTICAL): 30/$24.99 or
90/$65.97
GFN 600/Phenylephrine 20 600-20MG TB12 (CYPRESS PHARMACEUTICAL): 30/$15.99
or 90/$40
Guaifenesin-Codeine 300-10MG TABS (ACTAVIS TOTOWA): 30/$13.99 or 90/$38.97
Guaifenesin-DM 100-10MG/5ML LIQD (MORTON GROVE PHARMACEUTICALS):
240/$17.26 or 720/$45.65
Guaifenex GP 120-1200MG TB12 (ETHEX): 20/$16.21 or 90/$64.21
Guaifenex PSE 120 120-600MG TB12 (ETHEX): 30/$12.99 or 90/$29.97
Guaifenex PSE 80 80-800MG TB12 (ETHEX): 30/$13.99 or 90/$29.97
Guaiphen-D 40-600MG TB12 (BOCA PHARMACAL): 100/$43.99 or 300/$122.97
Guaiphen-PD 25-275MG TB12 (BOCA PHARMACAL): 100/$51.54 or 300/$144.09
Guaphen Forte 30-30-1200MG TB12 (RIVER'S EDGE PHARMACEUTICALS): 30/$31.52
or 90/$85.1
Liquibid-D 40-600MG TB12 (CAPELLON PHARMACEUTICALS): 30/$22.99 or
90/$49.97

Liquibid-PD 25-275MG TB12 (CAPELLON PHARMACEUTICALS): 60/$39.67 or

180/$112.41
Lufyllin-GG 200-200MG TABS (MEDPOINTE PHARMACEUTICALS): 120/$400.97 or
360/$1201.93
Medent LD 60-800MG TB12 (STEWART JACKSON): 30/$26.99 or 90/$72.97
Mucinex 600MG TB12 (ADAMS LABORATORIES): 20/$8.99 or 60/$26.46
Muco-Fen DM 60-1000MG TB12 (IVAX PHARMACEUTICALS, INC.): 30/$35.83 or
90/$95.16
Mytussin DAC 30-10-100MG/5ML SOLN (MORTON GROVE PHARMACEUTICALS):
120/$8.99 or 360/$14.36
Naldecon Senior EX 200MG/5ML SYRP (APOTHECON): 118/$8.99 or 354/$20.96
Organidin NR 100MG/5ML LIQD (MEDPOINTE PHARMACEUTICALS): 120/$48.98 or
360/$138.96
Organidin NR 200MG TABS (MEDPOINTE PHARMACEUTICALS): 30/$23.99 or
90/$65.97
PanMist DM 48-32-595MG TB12 (PAM LABORATORIES): 30/$16.83 or 90/$48.9
Profen II 45-800MG TB12 (IVAX PHARMACEUTICALS, INC.): 30/$19.81 or 90/$52.44
PSE-GG CR 120-250MG CPCR (URL): 20/$8.99 or 60/$18.97
Pseudoephedrine-Guaifenesin 90-800MG TB12 (URL): 30/$17.99 or 90/$39.97
Pseudovent 400 120-400MG CP12 (ETHEX): 30/$37.99 or 90/$100.97
Pseudovent Ped 300-60MG CPCR (ETHEX): 30/$14.99 or 90/$38.97
Quibron 90-150MG CAPS (MONARCH PHARMACEUTICALS): 30/$21.83 or 90/$59.26
Ru-Tuss Jr 45-600MG TB12 (CARWIN ASSOCIATES): 30/$18.04 or 90/$43.32
Sina-12X 25-200MG TABS (MEDPOINTE PHARMACEUTICALS): 30/$67.32 or
90/$182.92
Sinuvent PE 15-600MG TABS (DEXO PHARMA): 30/$29.15 or 90/$68.04
Sitrex 30-1200MG TB12 (VINDEX PHARMACEUTICALS, INC.): 30/$19.94 or 90/$58.76
Touro DM 30-575MG TB12 (DARTMOUTH): 100/$113.99 or 300/$313.98
Tussafed HC 7.5-2.5-50MG/5ML SYRP (EVERETT): 473/$133.1 or 1419/$391.5
Tussend Expectorant 30-2.5-100MG/5ML SOLN (MONARCH PHARMACEUTICALS):
120/$23.99 or 360/$66.96

Zephrex 60-400MG TABS (SANOFI PHARMACEUTICALS): 30/$25.99 or 90/$70.97

AHFS Drug Information. Copyright, 1959-2008, Selected Revisions March 2008.
American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda,
Maryland 20814.
#

Use is not currently included in the labeling approved by the US Food and Drug
Administration.
Copyright 2008 by the American Society of Health-System Pharmacists, Inc. All rights
reserved.
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48:00 Respiratory Tract Agents
48:16 Expectorants

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