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Guaifenesin and pseudoephedrine: Drug information

Guaifenesin and pseudoephedrine: Drug information
(For additional information see "Guaifenesin and pseudoephedrine: Patient drug information" and see "Guaifenesin and pseudoephedrine: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Altarussin-PE [OTC];
  • CVS Mucus D Extended Release [OTC];
  • Entex T [OTC] [DSC];
  • FT Mucus Relief D 12 Hour [OTC];
  • Maxifed [OTC];
  • Mucinex D Max Strength [OTC];
  • Mucinex D [OTC];
  • Mucus Relief D [OTC];
  • Poly-Vent IR [OTC];
  • Rydex G [OTC]
Pharmacologic Category
  • Alpha-/Beta- Agonist;
  • Expectorant
Dosing: Adult

Also refer to specific product labeling.

Expectorant/decongestant

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)

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing; use with caution.

Dosing: Pediatric

(For additional information see "Guaifenesin and pseudoephedrine: Pediatric drug information")

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

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.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling. See individual agents.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling. See individual agents.

Adverse Reactions

See individual agents.

Contraindications

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.

Warnings/Precautions

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.

Warnings: Additional Pediatric Considerations

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.

Dosage Forms: US

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 [contains fd&c yellow #6 (sunset yellow)]

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]

Mucus Relief D: Guaifenesin 600 mg and pseudoephedrine hydrochloride 60 mg [DSC] [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

Generic Equivalent Available: US

Yes

Pricing: US

Liquid (Tusnel Pediatric Oral)

7.5-50 mg/mL (per mL): $0.20

Tablet, 12-hour (Mucinex D Max Strength Oral)

120-1200 mg (per each): $2.06

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.

Administration: Adult

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.

Administration: Pediatric

Oral: Administer without regard to meals; take with full glass of water. Extended-release formulations should not be broken, crushed, or chewed.

Use: Labeled Indications

Expectorant/decongestant: 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; temporarily restores freer breathing through the nose

Medication Safety Issues
Sound-alike/look-alike issues:

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

Metabolism/Transport Effects

None known.

Drug Interactions

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.

Alkalinizing Agents: May increase the serum concentration of Alpha-/Beta-Agonists (Indirect-Acting). Risk C: Monitor therapy

Alpha1-Blockers: May diminish the vasoconstricting effect of Alpha-/Beta-Agonists. Similarly, Alpha-/Beta-Agonists may antagonize Alpha1-Blocker vasodilation. Risk C: Monitor therapy

Atomoxetine: May enhance the hypertensive effect of Sympathomimetics. Atomoxetine may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Benzylpenicilloyl Polylysine: Alpha-/Beta-Agonists may diminish the diagnostic effect of Benzylpenicilloyl Polylysine. 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

Bromocriptine: May enhance the hypertensive effect 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 enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Carbonic Anhydrase Inhibitors: May increase the serum concentration of Alpha-/Beta-Agonists (Indirect-Acting). Risk C: Monitor therapy

Chloroprocaine (Systemic): May enhance the hypertensive effect of Alpha-/Beta-Agonists. Risk C: Monitor therapy

Cocaine (Topical): May enhance the hypertensive effect 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

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

Doxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline. Risk C: Monitor therapy

Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates): May enhance the vasoconstricting effect of Alpha-/Beta-Agonists. Risk X: Avoid combination

FentaNYL: Decongestants may decrease the serum concentration of FentaNYL. Risk C: Monitor therapy

Guanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy

Iobenguane Radiopharmaceutical Products: Alpha-/Beta-Agonists (Indirect-Acting) may diminish the therapeutic effect 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 combination

Kratom: May enhance the adverse/toxic effect of Sympathomimetics. Risk X: Avoid combination

Levothyroxine: May enhance the adverse/toxic effect of Sympathomimetics. Specifically, the risk of coronary insufficiency may be increased in patients with coronary artery disease. Levothyroxine may enhance the therapeutic effect of Sympathomimetics. Sympathomimetics may enhance the therapeutic effect of Levothyroxine. Risk C: Monitor therapy

Linezolid: May enhance the hypertensive effect 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 enhance the hypertensive effect of Alpha-/Beta-Agonists. 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

Monoamine Oxidase Inhibitors: May enhance the hypertensive effect 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 combination

Ornidazole: May enhance the adverse/toxic effect of Products Containing Ethanol. Specifically, a disulfiram-like reaction may occur. Risk X: Avoid combination

Ozanimod: May enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapy

Pergolide: May enhance the hypertensive effect of Alpha-/Beta-Agonists. Risk C: Monitor therapy

Reserpine: May diminish the therapeutic effect of Alpha-/Beta-Agonists (Indirect-Acting). Risk C: Monitor therapy

Secnidazole: Products Containing Ethanol may enhance the adverse/toxic effect of Secnidazole. Risk X: Avoid combination

Serotonin/Norepinephrine Reuptake Inhibitors: May enhance the tachycardic effect of Alpha-/Beta-Agonists. Serotonin/Norepinephrine Reuptake Inhibitors may enhance the vasopressor effect 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 enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol. Risk C: Monitor therapy

Spironolactone: May diminish the vasoconstricting effect of Alpha-/Beta-Agonists. Risk C: Monitor therapy

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy

Tedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Tricyclic Antidepressants: May enhance the vasopressor effect 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

Urinary Acidifying Agents: May decrease the serum concentration of Alpha-/Beta-Agonists (Indirect-Acting). Risk C: Monitor therapy

Pregnancy Considerations

Refer to individual monographs.

Breastfeeding Considerations

Refer to individual monographs.

Pharmacokinetics (Adult Data Unless Noted)

See individual agents.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Guafedrin | Sudafed expectorant;
  • (AR) Argentina: Robitussin d | Robitussin pe;
  • (AU) Australia: Phensedyl chesty family cough;
  • (BD) Bangladesh: Coftex;
  • (BR) Brazil: Dimetapp nf;
  • (CN) China: Compound pseudoephedrine;
  • (CO) Colombia: Robitussin pe;
  • (EC) Ecuador: Robitussin pe | Theraflu EP;
  • (EE) Estonia: Sudafed expectorant;
  • (EG) Egypt: Sudafed expectorant;
  • (ES) Spain: Iniston mucosidad y congestion;
  • (GB) United Kingdom: Benylin mucus cough plus decongestant | Boots cough and decongestant syrup 6 years plus | Robitussin chesty cough with congestion;
  • (HK) Hong Kong: Robitussin pe;
  • (ID) Indonesia: Sudafed expectorant | Zerofed;
  • (IE) Ireland: Actifed chesty n/d | Sudafed expectorant;
  • (IL) Israel: Sinufed;
  • (KW) Kuwait: Robitussin pe | Sudafed expectorant;
  • (LB) Lebanon: Sudafed expectorant;
  • (LT) Lithuania: Sudafed expectorant;
  • (MY) Malaysia: Robitussin severe congestion;
  • (NZ) New Zealand: Benadryl chesty;
  • (PK) Pakistan: Ammofed | Triaminic chest;
  • (PR) Puerto Rico: Aldex Gs | Amitex pse | Aquatab d | Centex-Pse | Congestac | Conpec LA | Deco-d | Decongestant ii | Deconsal ii | Desal-Ii | Drituss gp | Duraphen | Durasal ii | Duratuss | Duratuss am/pm | Duratuss gp | Entex pse | Entex T | Exefen | G-Phed | G-Phed-PD | Gfn/Pse | Gp 1200/75 | Guaifed | Guaifenesin & pseudoephedrine hcl er | Guaifenesin and pseudoephedrine hcl | Guaifenesin and pseudoephedrine hydrochloride | Guaifenesin-p-pd | Guaifenex pse 80 extended release | Guaifenex rx | Guaimax-d | Guaipax pse | Guiadrine gp | Guiadrine pse | Iosal ii | Iotex PSE | Liquibid-pd | Maxifed | Medent ld | Medent-Ldi | Mintab d | Miraphen PSE | Panmist la | Profen ii | Pseudoephedrine hcl 60mg guaifenesin 375mg | Pseudofen-PD | Pseudofenesin PSE | Pseudovent | Pseudovent ped | Respa 1st | Respaire | Respaire-60 | Rydex g | S-pak | Stamoist e | Sudal | Sudatex G | Syn rx | Tuss LA | Tussin pe | Zephrex | Zephrex la;
  • (QA) Qatar: Bronex | Guafedrin;
  • (RO) Romania: Bioflu expectorant;
  • (SA) Saudi Arabia: Guafedrin | Robitussin pe;
  • (SG) Singapore: Robitussin Cold | Robitussin pe | Robitussin Severe | Sudafed expectorant;
  • (TH) Thailand: Maxasin | Meditussin | Robitussin ps | Sudafed expectorant;
  • (TR) Turkey: Eksofed Ekspektoran | Rinogest Ekspektoran | Sudafed expectorant;
  • (UA) Ukraine: Sudafed;
  • (ZA) South Africa: Actifed wet cough
  1. American Academy of Pediatrics (AAP). Cough and cold medicines should not be prescribed, recommended or used for respiratory illnesses in young children. Updated June 12, 2018. Available at http://www.choosingwisely.org/clinician-lists/american-academy-pediatrics-cough-and-cold-medicines-for-children-under-four/
  2. Centers for Disease Control and Prevention (CDC). Infant deaths associated with cough and cold medications--two states, 2005. MMWR Morb Mortal Wkly Rep. 2007;56(1):1-4. [PubMed 17218934]
  3. Entex T (guaifenesin and pseudoephedrine hydrochloride tablet) [prescribing information]. Ridgeland, MS: WraSer Pharmaceuticals, LLC.; January 2016.
  4. Food and Drug Administration (FDA). Most young children with a cough or cold don't need medicines. July 18, 2017. Available at https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm422465.htm. Last accessed January 24, 2023.
  5. Food and Drug Administration (FDA). Use caution when giving cough and cold products to kids. Updated February 8, 2018. Available at https://www.fda.gov/drugs/resourcesforyou/specialfeatures/ucm263948.htm. Last accessed January 24, 2023.
  6. Guaifenesin and pseudoephedrine hydrochloride tablet, extended release [prescribing information]. Lawrenceville, NJ: Aurohealth LLC; April 2021.
  7. Maxifed (guaifenesin and pseudoephedrine hydrochloride tablet) [prescribing information]. Brooksville, FL: MCR American Pharmaceuticals; January 2018.
  8. Mucinex D (guaifenesin and pseudoephedrine hydrochloride tablet, extended release) [prescribing information]. Parsippany, NJ: Reckitt Benckiser, LLC.; July 2012.
  9. Mucinex D Maximum Strength (guaifenesin and pseudoephedrine hydrochloride tablet, extended release) [prescribing information]. Parsippany, NJ: RB Health (US); received May 2020.
Topic 8963 Version 254.0

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