Version May 2024
Expectorant:
Note: May reduce viscosity of secretions in acute or chronic cough; does not suppress cough (Ref). Adequate hydration is required for maximal efficacy.
Oral:
Immediate release: 200 to 400 mg every 4 hours as needed; maximum daily dose: 2.4 g.
Extended release: 600 mg to 1.2 g every 12 hours as needed; maximum daily dose: 2.4 g.
The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Altered kidney function: There are no specific dosage adjustments recommended; however, guaifenesin’s metabolite is renally eliminated (Ref), and thus, accumulation is possible with long-term chronic use; use with caution in severe kidney impairment (Ref).
Hemodialysis, intermittent (thrice weekly): There are no specific dosage adjustments recommended; however, guaifenesin’s metabolite is renally eliminated (Ref), and thus, accumulation is possible with long-term chronic use; use with caution (Ref).
Peritoneal dialysis: There are no specific dosage adjustments recommended; however, the guaifenesin metabolite is renally eliminated (Ref), and thus, accumulation is possible with long-term chronic use; use with caution (Ref).
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
(For additional information see "Guaifenesin: Pediatric drug information")
Dosage guidance:
Safety: Safety and efficacy for the use of cough and cold products in infants and young children is limited; the AAP warns against the use of these products for respiratory illnesses in infants and young children; the FDA does not recommend OTC use in infants and children <2 years of age due to the risk of serious and life-threatening adverse effects (including death) and recommends to use with caution in pediatric patients ≥2 years of age (Ref).
Cough (expectorant): Oral:
Liquid:
Children 2 years to <4 years: Limited data available: 50 to 100 mg every 4 hours as needed; do not exceed 6 doses in 24 hours (Ref).
Children 4 years to <6 years: 50 to 100 mg every 4 hours as needed; do not exceed 6 doses in 24 hours.
Children 6 years to <12 years: 100 to 200 mg every 4 hours as needed; do not exceed 6 doses in 24 hours
Children ≥12 years and Adolescents: 200 to 400 mg every 4 hours as needed; do not exceed 6 doses in 24 hours
Granules:
Children 4 years to <6 years: 100 mg every 4 hours as needed; do not exceed 6 doses in 24 hours
Children 6 years to <12 years: 100 to 200 mg every 4 hours as needed; do not exceed 6 doses in 24 hours
Children ≥12 years and Adolescents: 200 to 400 mg every 4 hours as needed; do not exceed 6 doses in 24 hours
Immediate release tablet:
Children 6 years to <12 years: 200 mg every 4 hours as needed do not exceed 6 doses in 24 hours
Children ≥12 years and Adolescents: 400 mg every 4 hours as needed; do not exceed 6 doses in 24 hours
Extended release tablet: Children ≥12 years and Adolescents: 600 mg to 1,200 mg every 12 hours as needed; do not exceed 2 doses nor 2,400 mg in 24 hours
There are no dosage adjustments provided in manufacturer's labeling.
There are no dosage adjustments provided in manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.
Central nervous system: Dizziness, drowsiness, headache
Dermatologic: Skin rash
Endocrine & metabolic: Hypouricemia
Gastrointestinal: Nausea, stomach pain, vomiting
<1%, postmarketing, and/or case reports: Nephrolithiasis (with consumption of large quantities)
OTC labeling: When used for self-medication, do not use extended-release tablets in children <12 years of age.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.
• Phenylalanine: Some products may contain phenylalanine.
Other warnings/precautions:
• Self-medication (OTC use): When used for self-medication (OTC), discontinue use and notify health care provider if symptoms do not improve within 7 days, or are accompanied by fever, rash, or persistent headache, or if you are hypersensitive to any component of the formulation. For persistent or chronic cough (as with smoking, asthma, chronic bronchitis, emphysema) or if cough is accompanied by excessive phlegm, consult a health care provider prior to use.
Safety and efficacy for the use of cough and cold products in pediatric patients <4 years of age is limited; the AAP warns against the use of these products for respiratory illnesses in young children. Serious adverse effects including death have been reported. Many of these products contain multiple active ingredients, increasing the risk of accidental overdose when used with other products. The FDA does not recommend OTC uses for these products in pediatric patients <2 years of age and recommends to use with caution in pediatric patients ≥2 years of age. Health care providers are reminded to ask caregivers about the use of OTC cough and cold products in order to avoid exposure to multiple medications containing the same ingredient (AAP 2018; CDC 2007; FDA 2017; FDA 2018).
Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP 1997; Shehab 2009).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Liquid, Oral:
Altarussin: 100 mg/5 mL (120 mL, 236 mL, 473 mL, 3840 mL)
Altarussin: 100 mg/5 mL (120 mL, 240 mL, 480 mL, 3840 mL) [contains alcohol, usp]
Buckleys Chest Congestion: 100 mg/5 mL (118 mL) [alcohol free, sugar free; contains butylparaben, menthol, propylene glycol, propylparaben]
Chest Congestion Relief: 100 mg/5 mL (473 mL) [alcohol free, sugar free; contains fd&c red #40 (allura red ac dye), menthol, methylparaben, propylene glycol, propylparaben]
Diabetic Tussin: 100 mg/5 mL (118 mL [DSC]) [alcohol free, dye free, fructose free, sodium free, sorbitol free, sugar free; contains aspartame, menthol, methylparaben]
FT Tussin Adult: 200 mg/10 mL (118 mL, 237 mL) [contains fd&c red #40 (allura red ac dye), menthol, saccharin sodium, sodium benzoate]
Geri-Tussin: 100 mg/5 mL (473 mL) [alcohol free, sugar free; contains fd&c red #40 (allura red ac dye), menthol, methylparaben, propylene glycol, propylparaben]
Geri-Tussin: 100 mg/5 mL (473 mL [DSC]) [alcohol free, sugar free; contains fd&c red #40 (allura red ac dye), menthol, saccharin sodium, sodium benzoate]
Max Tussin Mucus & Chest Cong: 200 mg/10 mL (236 mL) [alcohol free, dye free, gluten free; contains menthol, saccharin sodium, sodium benzoate]
Max Tussin Mucus & Chest Cong: 200 mg/10 mL (118 mL, 236 mL, 473 mL) [alcohol free, dye free, gluten free, sugar free; contains menthol, saccharin sodium, sodium benzoate; cherry flavor]
Mucinex Fast-Max Chest Cong MS: 400 mg/20 mL (180 mL) [contains edetate (edta) disodium, glycerin (soy), propylene glycol, sodium benzoate]
Robafen: 100 mg/5 mL (473 mL [DSC]) [contains fd&c red #40 (allura red ac dye), menthol, propylene glycol, saccharin sodium, sodium benzoate]
Robafen Mucus/Chest Congestion: 200 mg/10 mL (118 mL [DSC]) [gluten free; contains fd&c red #40 (allura red ac dye), menthol, propylene glycol, saccharin sodium, sodium benzoate; cherry flavor]
Robitussin Mucus+Chest Congest: 100 mg/5 mL (118 mL [DSC]) [alcohol free; contains fd&c red #40 (allura red ac dye), menthol, propylene glycol, saccharin sodium, sodium benzoate]
Siltussin SA: 100 mg/5 mL (118 mL, 237 mL, 473 mL) [strawberry flavor]
Tussin Mucus & Chest Congest: 100 mg/5 mL (118 mL) [alcohol free, gluten free; contains fd&c red #40 (allura red ac dye), propylene glycol, saccharin sodium, sodium benzoate; cherry flavor]
Tussin Mucus & Chest Congest: 100 mg/5 mL (118 mL) [alcohol free, sugar free; contains fd&c red #40 (allura red ac dye), menthol, methylparaben, propylene glycol, propylparaben]
Tussin Mucus+Chest Congest SF: 200 mg/10 mL (118 mL [DSC], 236 mL [DSC], 473 mL [DSC]) [alcohol free, dye free, gluten free, sugar free; contains menthol, saccharin sodium, sodium benzoate; cherry flavor]
Generic: 100 mg/5 mL (5 mL, 10 mL, 15 mL, 118 mL [DSC], 473 mL); 200 mg/10 mL (10 mL [DSC]); 300 mg/15 mL (15 mL [DSC])
Packet, Oral:
Mucinex For Kids: 100 mg (12 ea [DSC]) [contains aspartame; bubble-gum flavor]
Syrup, Oral:
Geri-Tussin: 100 mg/5 mL (473 mL) [alcohol free, sugar free; contains fd&c red #40 (allura red ac dye), menthol, methylparaben, propylene glycol, propylparaben; cherry flavor]
Tablet, Oral:
Bidex: 400 mg [DSC] [contains saccharin sodium]
Chest Congestion Relief: 400 mg [scored]
Fenesin IR: 400 mg [DSC]
FT Chest Congestion Relief: 400 mg [dye free]
GoodSense Mucus Relief: 400 mg [dye free]
GoodSense Mucus Relief: 400 mg [DSC] [scored; dye free, gluten free]
Liquibid: 400 mg [DSC]
Mucosa: 400 mg [DSC]
Mucus Relief: 400 mg [scored]
Pharbinex: 400 mg
Refenesen 400: 400 mg [scored; dye free]
Xpect: 400 mg [scored; contains saccharin sodium]
Generic: 200 mg, 400 mg
Tablet Extended Release 12 Hour, Oral:
FT Mucus Relief 12HR: 600 mg
FT Mucus Relief 12HR: 600 mg, 1200 mg [contains fd&c blue #1 (brill blue) aluminum lake]
Mucinex: 600 mg [contains fd&c blue #1 (brill blue) aluminum lake]
Mucinex Maximum Strength: 1200 mg [contains fd&c blue #1 (brill blue) aluminum lake]
Mucus Relief: 600 mg
Mucus Relief: 600 mg [contains fd&c blue #1 (brill blue) aluminum lake]
Mucus Relief ER: 600 mg [contains fd&c blue #1 (brill blue) aluminum lake]
Mucus Relief Max St: 1200 mg
Generic: 600 mg, 1200 mg
May be product dependent
Liquid (Buckleys Chest Congestion Oral)
100 mg/5 mL (per mL): $0.04
Liquid (Giltuss EX Expectorant Child Oral)
200 mg/5 mL (per mL): $0.06
Liquid (Giltuss EX Maximum Strength Oral)
400 mg/10 mL (per mL): $0.06
Liquid (guaiFENesin Oral)
100 mg/5 mL (per mL): $0.38 - $0.42
Liquid (Max Tussin Mucus & Chest Cong Oral)
200 mg/10 mL (per mL): $0.02
Liquid (Mucinex Fast-Max Chest Cong MS Oral)
400 mg/20 mL (per mL): $0.12
Liquid (Tusnel-EX Oral)
100 mg/5 mL (per mL): $0.01
Tablet, 12-hour (guaiFENesin ER Oral)
600 mg (per each): $1.03
1200 mg (per each): $0.73
Tablet, 12-hour (Mucinex Maximum Strength Oral)
1200 mg (per each): $1.04
Tablet, 12-hour (Mucinex Oral)
600 mg (per each): $0.47
Tablets (guaiFENesin Oral)
200 mg (per each): $0.02 - $0.24
400 mg (per each): $0.04 - $0.08
Tablets (Xpect Oral)
400 mg (per each): $0.25
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Oral: Adequate hydration is required for maximal efficacy. Administer with a full glass of water.
ER tablet: Do not break, crush, or chew ER tablet.
Bariatric surgery: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. Switch to IR tablet or oral solution.
Granules: Empty contents of packet onto tongue and swallow; for best taste, do not chew granules.
Oral: Administer with a large quantity of fluid to ensure proper action:
Extended release tablet: Do not crush or chew extended release tablet.
Granules (immediate release): Empty contents of packet onto tongue and swallow; for best taste, do not chew granules.
Expectorant: Help loosen phlegm (mucus) and thin bronchial secretions to facilitate the removal of mucus during coughing and natural processes.
Bidex may be confused with Videx.
GuaiFENesin may be confused with guanFACINE.
Mucinex may be confused with Mucinex Allergy, Mucomyst.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Disulfiram: May enhance the adverse/toxic effect of Products Containing Ethanol. Management: Do not use disulfiram with dosage forms that contain ethanol. Risk X: Avoid combination
Methotrimeprazine: Products Containing Ethanol may enhance the adverse/toxic effect of Methotrimeprazine. Specifically, a disulfiram-like reaction may occur and CNS depressant effects may be increased. Management: Avoid products containing alcohol in patients treated with methotrimeprazine. Risk X: Avoid combination
Ornidazole: May enhance the adverse/toxic effect of Products Containing Ethanol. Specifically, a disulfiram-like reaction may occur. Risk X: Avoid combination
Secnidazole: Products Containing Ethanol may enhance the adverse/toxic effect of Secnidazole. Risk X: Avoid combination
Guaifenesin has been investigated as an agent to improve fertility (Check 1982; Means 2011).
When treatment for cough is needed during pregnancy, guaifenesin at standard OTC doses is generally considered acceptable. Some sources recommend use be reserved for significant maternal need; products containing alcohol should be avoided (Conover 2003; Ward 2005).
Information related to the presence of guaifenesin in breast milk has not been located. Products containing alcohol should be avoided.
Some products may contain phenylalanine and/or sodium.
Thought to act as expectorant by increasing the effective hydration of the respiratory tract, maintains the sol layer needed for ciliary clearance and reduces the viscosity of respiratory mucus, thereby further facilitating its removal by natural clearance processes.
Guaifenesin may inhibit cough reflex sensitivity in subjects with upper respiratory tract infections whose cough receptors are transiently hypersensitive, but not in healthy volunteers. Possible mechanisms include a central antitussive effect, or a peripheral effect by increased sputum volume serving as a barrier shielding cough receptors within the respiratory epithelium from the tussive stimulus (Dicpinigaitis 2003).
Absorption: Well absorbed.
Excretion: Urine.
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