Note: 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 and upper respiratory symptoms (expectorant/decongestant)
Immediate-release tablet:
Guaifenesin 360 mg and pseudoephedrine 60 mg (eg, Maxifed):
Children 6 to <12 years: Oral: 1/2 tablet every 4 hours as needed; maximum daily dose: 2 tablets per 24 hours.
Children ≥12 years and Adolescents: Oral: 1 tablet every 4 hours as needed; maximum daily dose: 4 tablets per 24 hours.
Extended-release tablets:
Guaifenesin 1,200 mg and pseudoephedrine 120 mg (eg, Mucinex D):
Children ≥12 years and Adolescents: Oral: 1 tablet every 12 hours as needed; maximum daily dose: 2 tablets per 24 hours.
There are no dosage adjustments provided in the manufacturer's labeling. See individual agents.
There are no dosage adjustments provided in the manufacturer's labeling. See individual agents.
(For additional information see "Guaifenesin and pseudoephedrine: Drug information")
Also refer to specific product labeling.
Expectorant/Decongestant: Oral:
Tablet (Entex T): Guaifenesin 375 mg/pseudoephedrine 60 mg every 4 hours (maximum: Guaifenesin 1,500 mg/pseudoephedrine 240 mg/24 hours)
Tablet (Maxifed): Guaifenesin 360 mg/pseudoephedrine 60 mg every 4 hours (maximum: Guaifenesin 1,440 mg/pseudoephedrine 240 mg/24 hours)
Tablet, extended release (Mucinex D, Mucinex D Maximum Strength): Guaifenesin 1,200 mg/pseudoephedrine 120 mg every 12 hours (maximum: Guaifenesin 2,400 mg/pseudoephedrine 240 mg/24 hours)
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
See individual agents.
Concurrent administration with or within 2 weeks of discontinuing an MAO inhibitor.
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Disease-related concerns:
• Cardiovascular disease: Use with caution in patients with cardiovascular disease (including hypertension and ischemic heart disease); contraindicated with severe disease.
• Diabetes: Use with caution in patients with diabetes mellitus.
• Increased intraocular pressure/glaucoma: Use with caution in patients with increased intraocular pressure or glaucoma.
• Prostatic hyperplasia/urinary obstruction: Use with caution in patients with prostatic hyperplasia and/or GU obstruction.
• Thyroid dysfunction: Use with caution in patients with thyroid dysfunction.
Special populations:
• Older adult: Use with caution in the elderly; may be more sensitive to adverse effects.
• Pediatric: Safety and efficacy have not been established in children <2 years of age.
Other warnings/precautions:
• Cough: Appropriate use: Underlying cause of cough should be determined prior to prescribing.
• Self-medication (OTC use): When used for self-medication (OTC), notify healthcare provider if symptoms do not improve within 7 days or are accompanied by fever, rash, or persistent headache. Discontinue and contact healthcare provider if nervousness, dizziness, or sleeplessness occur.
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 (in some cases, high blood concentrations of pseudoephedrine were found). 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). Multiple concentrations of oral liquid formulations exist; close attention must be paid to the concentration when ordering or administering.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Syrup, Oral:
Altarussin-PE: Guaifenesin 100 mg and pseudoephedrine hydrochloride 30 mg per 5 mL (240 mL)
Altarussin-PE: Guaifenesin 100 mg and pseudoephedrine hydrochloride 30 mg per 5 mL (118 mL) [alcohol free; contains fd&c red #40 (allura red ac dye), menthol, saccharin sodium, sodium benzoate]
Tablet, Oral:
Entex T: Guaifenesin 375 mg and pseudoephedrine hydrochloride 60 mg [DSC] [scored]
Maxifed: Guaifenesin 360 mg and pseudoephedrine hydrochloride 60 mg [scored]
Mucus Relief D: Guaifenesin 400 mg and pseudoephedrine hydrochloride 40 mg [scored]
Poly-Vent IR: Guaifenesin 380 mg and pseudoephedrine hydrochloride 60 mg [gluten free; contains fd&c blue #2 (indigotine,indigo carmine)]
Rydex G: Guaifenesin 398 mg and pseudoephedrine hydrochloride 38.5 mg
Generic: Guaifenesin 375 mg and pseudoephedrine hydrochloride 60 mg [DSC]
Tablet Extended Release 12 Hour, Oral:
CVS Mucus D Extended Release: Guaifenesin 600 mg and pseudoephedrine hydrochloride 60 mg
FT Mucus Relief D 12 Hour: Guaifenesin 600 mg and pseudoephedrine hydrochloride 60 mg
FT Mucus Relief D 12 Hour: Guaifenesin 600 mg and pseudoephedrine hydrochloride 60 mg [contains fd&c yellow #6 (sunset yellow)]
FT Mucus Relief-D: Guaifenesin 600 mg and pseudoephedrine hydrochloride 60 mg [gluten free; contains fd&c yellow #6(sunset yellow)alumin lake]
FT Mucus Relief-D Max Strength: Guaifenesin 1200 mg and pseudoephedrine hydrochloride 120 mg [gluten free; contains fd&c yellow #6(sunset yellow)alumin lake]
Mucinex D: Guaifenesin 600 mg and pseudoephedrine hydrochloride 60 mg [contains fd&c yellow #6(sunset yellow)alumin lake]
Mucinex D Max Strength: Guaifenesin 1200 mg and pseudoephedrine hydrochloride 120 mg [contains fd&c yellow #6(sunset yellow)alumin lake]
Generic: Guaifenesin 1200 mg and pseudoephedrine hydrochloride 120 mg, Guaifenesin 600 mg and pseudoephedrine hydrochloride 60 mg
Yes
Tablet, 12-hour (Mucinex D Max Strength Oral)
120-1200 mg (per each): $1.20
Tablet, 12-hour (Mucinex D Oral)
60-600 mg (per each): $0.85
Tablet, 12-hour (Pseudoephedrine-guaiFENesin ER Oral)
60-600 mg (per each): $0.48 - $0.57
120-1200 mg (per each): $0.81
Tablets (Maxifed Oral)
60-360 mg (per each): $0.75
Tablets (Poly-Vent IR Oral)
60-380 mg (per each): $0.74
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: Administer without regard to meals; take with full glass of water. Extended-release formulations should not be broken, crushed, or chewed.
Oral: Do not crush, chew, or break ER formulations. May interfere with sleep; administering some products a few hours before bedtime may help minimize insomnia. Take with full glass of water.
Bariatric surgery: Tablet, extended release: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. Switch to IR tablet, capsule, or oral solution. Scored ER tablets can be cut in half but not crushed. ER capsules may be opened and sprinkled onto soft food of choice as long as patient swallows mixture without biting down or chewing.
Temporary relief of nasal/sinus congestion and sinus pressure by promoting nasal/sinus drainage associated with common cold, hay fever, or upper respiratory allergies; loosens mucus and thins bronchial secretions making coughs more productive; and temporarily restores freer breathing through the nose (OTC product: Immediate-release products: FDA approved in ages ≥6 years and adults; Extended-release products: FDA approved in ages ≥12 years and adults).
Note: Approved ages and uses for products may vary; consult labeling for specific information.
Entex may be confused with Tenex
Entex LA brand name represents a different product in the U.S. than it does in Canada. In the U.S., Entex LA contains guaifenesin and phenylephrine, while in Canada the product bearing this brand name contains guaifenesin and pseudoephedrine.
Mucinex D may be confused with Mucinex DM
Refer to individual components.
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 drug interactions program by clicking on the “Launch drug interactions program” link above.
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 drug interactions program
Alpha1-Blockers: May decrease therapeutic effects of Alpha-/Beta-Agonists. Risk C: Monitor
Atomoxetine: May increase hypertensive effects of Sympathomimetics. Atomoxetine may increase tachycardic effects of Sympathomimetics. Risk C: Monitor
Benzylpenicilloyl Polylysine: Coadministration of Alpha-/Beta-Agonists and Benzylpenicilloyl Polylysine may alter diagnostic results. Management: Consider use of a histamine skin test as a positive control to assess a patient's ability to mount a wheal and flare response. Risk D: Consider Therapy Modification
Bornaprine: Sympathomimetics may increase anticholinergic effects of Bornaprine. Risk C: Monitor
Bromocriptine: May increase hypertensive effects of Alpha-/Beta-Agonists. Management: Consider alternatives to this combination when possible. If combined, monitor for hypertension and tachycardia, and do not coadminister these agents for more than 10 days. Risk D: Consider Therapy Modification
Cannabinoid-Containing Products: May increase tachycardic effects of Sympathomimetics. Risk C: Monitor
Chloroprocaine (Systemic): May increase hypertensive effects of Alpha-/Beta-Agonists. Risk C: Monitor
Cocaine (Topical): May increase hypertensive effects of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Risk D: Consider Therapy Modification
Dihydralazine: Sympathomimetics may decrease therapeutic effects of Dihydralazine. Risk C: Monitor
Disulfiram: May increase adverse/toxic effects of Products Containing Ethanol. Management: Do not use disulfiram with dosage forms that contain ethanol. Risk X: Avoid
Doxofylline: Sympathomimetics may increase adverse/toxic effects of Doxofylline. Risk C: Monitor
Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates): May increase vasoconstricting effects of Alpha-/Beta-Agonists. Risk X: Avoid
Esketamine (Injection): May increase adverse/toxic effects of Sympathomimetics. Specifically, the risk for elevated heart rate, hypertension, and arrhythmias may be increased. Risk C: Monitor
FentaNYL: Decongestants may decrease serum concentration of FentaNYL. Risk C: Monitor
Guanethidine: May increase hypertensive effects of Sympathomimetics. Guanethidine may increase arrhythmogenic effects of Sympathomimetics. Risk C: Monitor
Hexoprenaline: May increase adverse/toxic effects of Alpha-/Beta-Agonists. Risk X: Avoid
Iobenguane Radiopharmaceutical Products: Alpha-/Beta-Agonists (Indirect-Acting) may decrease therapeutic effects of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Risk X: Avoid
Kratom: May increase adverse/toxic effects of Sympathomimetics. Risk X: Avoid
Landiolol: Sympathomimetics may decrease therapeutic effects of Landiolol. Risk C: Monitor
Levothyroxine: May increase therapeutic effects of Sympathomimetics. Sympathomimetics may increase therapeutic effects of Levothyroxine. Levothyroxine may increase adverse/toxic effects of Sympathomimetics. Specifically, the risk of coronary insufficiency may be increased in patients with coronary artery disease. Risk C: Monitor
Linezolid: May increase hypertensive effects of Sympathomimetics. Management: Consider initial dose reductions of sympathomimetic agents, and closely monitor for enhanced blood pressure elevations, in patients receiving linezolid. Risk D: Consider Therapy Modification
Lisuride: May increase hypertensive effects of Alpha-/Beta-Agonists. Risk X: Avoid
Metergoline: May increase adverse/toxic effects of Alpha-/Beta-Agonists (Indirect-Acting). Risk C: Monitor
Methotrimeprazine: May increase CNS depressant effects of Products Containing Ethanol. Management: Avoid products containing alcohol in patients treated with methotrimeprazine. Risk X: Avoid
MetroNIDAZOLE (Systemic): May increase adverse/toxic effects of Products Containing Ethanol. A disulfiram-like reaction may occur. Risk X: Avoid
MetroNIDAZOLE (Topical): May increase adverse/toxic effects of Products Containing Ethanol. A disulfiram-like reaction may occur. Risk C: Monitor
Monoamine Oxidase Inhibitors: May increase hypertensive effects of Alpha-/Beta-Agonists (Indirect-Acting). While linezolid is expected to interact via this mechanism, management recommendations differ from other monoamine oxidase inhibitors. Refer to linezolid specific monographs for details. Risk X: Avoid
Pergolide: May increase hypertensive effects of Alpha-/Beta-Agonists. Risk C: Monitor
Reserpine: May decrease therapeutic effects of Alpha-/Beta-Agonists (Indirect-Acting). Risk C: Monitor
Secnidazole: Products Containing Ethanol may increase adverse/toxic effects of Secnidazole. Risk X: Avoid
Serotonin/Norepinephrine Reuptake Inhibitor: May increase tachycardic effects of Alpha-/Beta-Agonists. Serotonin/Norepinephrine Reuptake Inhibitor may increase vasopressor effects of Alpha-/Beta-Agonists. Management: If possible, avoid coadministration of direct-acting alpha-/beta-agonists and serotonin/norepinephrine reuptake inhibitors. If coadministered, monitor for increased sympathomimetic effects (eg, increased blood pressure, chest pain, headache). Risk D: Consider Therapy Modification
Solriamfetol: Sympathomimetics may increase hypertensive effects of Solriamfetol. Sympathomimetics may increase tachycardic effects of Solriamfetol. Risk C: Monitor
Spironolactone: May decrease vasoconstricting effects of Alpha-/Beta-Agonists. Risk C: Monitor
Sympathomimetics: May increase adverse/toxic effects of Sympathomimetics. Risk C: Monitor
Tedizolid: May increase adverse/toxic effects of Sympathomimetics. Specifically, the risk for increased blood pressure and heart rate may be increased. Risk C: Monitor
Tranylcypromine: May increase hypertensive effects of Alpha-/Beta-Agonists (Indirect-Acting). Risk X: Avoid
Tricyclic Antidepressants: May increase vasopressor effects of Alpha-/Beta-Agonists. Management: Avoid, if possible, the use of alpha-/beta-agonists in patients receiving tricyclic antidepressants. If combined, monitor for evidence of increased pressor effects and consider reductions in initial dosages of the alpha-/beta-agonist. Risk D: Consider Therapy Modification
Refer to individual monographs.
See individual agents.