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Dextromethorphan and phenylephrine: Drug information

Dextromethorphan and phenylephrine: Drug information
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Brand Names: US
  • Maxi-Tuss Jr [OTC];
  • PediaCare Childrens Multi-Symp [OTC];
  • Sudafed PE Cold & Cough Child [OTC];
  • Triaminic Cold/Cough Day Time [OTC] [DSC]
Pharmacologic Category
  • Antitussive;
  • Decongestant
Dosing: Adult
Cough/Decongestant

Cough/Decongestant: Oral:

Note: These are general dosage guidelines; also refer to product-specific dosing.

Dextromethorphan 5 mg/phenylephrine 2.5 mg per 5 mL: 10 mL every 4 hours (maximum: 120 mL/24 hours).

Dosing: Kidney Impairment: Adult

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

Dosing: Liver Impairment: Adult

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

Dosing: Pediatric

(For additional information see "Dextromethorphan and phenylephrine: 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). Approved ages for products may vary; consult product labeling for detail.

Cough/Decongestant

Cough/Decongestant: Dextromethorphan 5 mg and phenylephrine 2.5 mg per 5 mL: Oral:

Children ≥4 to <6 years: 5 mL every 4 hours as needed; maximum daily dose: 30 mL/24 hours.

Children ≥6 to <12 years: 5 to 10 mL every 4 hours as needed; maximum daily dose: 60 mL/24 hours.

Children ≥12 years and Adolescents: 10 mL every 4 hours as needed; maximum daily dose: Generally, maximum daily dose should not exceed 60 mL/24 hours; however, some manufacturers suggest higher allowable daily doses of 120 mL/24 hours.

Dosing: Kidney Impairment: Pediatric

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

Dosing: Liver Impairment: Pediatric

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

Adverse Reactions

See individual agents.

Contraindications

OTC labeling: When used for self-medication, do not use in children <4 years of age, or with or within 14 days of stopping a monoamine oxidase inhibitor.

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Warnings/Precautions

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 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.

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Zar 2007).

Other warnings/precautions:

• Self-medication (OTC use): Patients with hypertension, thyroid disease, diabetes mellitus, prostatic hyperplasia, or cardiovascular disease should consult health care provider prior to use. Patients with chronic cough (associated with asthma, COPD or smoking) and/or productive cough (eg, copious amounts of phlegm) should be evaluated by a healthcare provider prior to use. Notify health care provider if symptoms do not improve within 7 days or are accompanied by fever, rash, or persistent headache. Discontinue and contact health care 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).

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).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Liquid, Oral:

Maxi-Tuss Jr: Dextromethorphan hydrobromide 5 mg and phenylephrine hydrochloride 2.5 mg per 5 mL (473 mL) [alcohol free, dye free, sugar free; contains methylparaben, propylene glycol, propylparaben]

PediaCare Childrens Multi-Symp: Dextromethorphan hydrobromide 5 mg and phenylephrine hydrochloride 2.5 mg per 5 mL (118 mL) [alcohol free; contains edetate (edta) disodium, fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), sodium benzoate; grape flavor]

Solution, Oral:

Sudafed PE Cold & Cough Child: Dextromethorphan hydrobromide 5 mg and phenylephrine hydrochloride 2.5 mg per 5 mL (118 mL) [alcohol free, sugar free; contains edetate (edta) disodium, fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), sodium benzoate]

Syrup, Oral:

Triaminic Cold/Cough Day Time: Dextromethorphan hydrobromide 5 mg and phenylephrine hydrochloride 2.5 mg per 5 mL (118 mL [DSC]) [contains edetate (edta) disodium, fd&c red #40 (allura red ac dye), propylene glycol, sodium benzoate; cherry flavor]

Generic Equivalent Available: US

May be product dependent

Pricing: US

Liquid (PediaCare Childrens Multi-Symp Oral)

2.5-5 mg/5 mL (per mL): $0.05

Solution (Sudafed PE Cold & Cough Child Oral)

2.5-5 mg/5 mL (per mL): $0.05

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: Use enclosed dosing cup to administer; do not use other devices.

Administration: Pediatric

Oral: Administer with an accurate measuring device; do not use a household teaspoon (overdosage may occur).

Use: Labeled Indications

Cough/decongestant: Temporary control of nasal congestion and cough due to common cold, hay fever (allergic rhinitis), or other upper respiratory allergies.

Medication Safety Issues
High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs (pediatric liquid medications requiring measurement) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Community/Ambulatory Care Settings).

Metabolism/Transport Effects

Refer to individual components.

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 drug interactions program by clicking on the “Launch drug interactions program” link above.

Acetaminophen: May increase serum concentration of Phenylephrine (Systemic). Risk C: Monitor

Ajmaline: May increase serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor

Alpha1-Blockers: May decrease vasoconstricting effects of Phenylephrine (Systemic). Risk C: Monitor

Artemether and Lumefantrine: May increase serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor

Atomoxetine: May increase hypertensive effects of Sympathomimetics. Atomoxetine may increase tachycardic effects of Sympathomimetics. Risk C: Monitor

Atropine (Systemic): May increase hypertensive effects of Alpha1-Agonists. Risk C: Monitor

Benzylpenicilloyl Polylysine: Coadministration of Alpha1-Agonists and Benzylpenicilloyl Polylysine may alter diagnostic results. Management: Consider delaying skin testing until alpha1-agonists are no longer required, or 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 Alpha1-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 hypotensive effects of Phenylephrine (Systemic). Risk C: Monitor

CloZAPine: May decrease therapeutic effects of Phenylephrine (Systemic). 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

CYP2D6 Inhibitors (Moderate): May increase serum concentration of Dextromethorphan. Risk C: Monitor

CYP2D6 Inhibitors (Strong): May increase serum concentration of Dextromethorphan. Risk C: Monitor

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 Alpha1-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

Hyaluronidase: May increase vasoconstricting effects of Phenylephrine (Systemic). Management: Do not use hyaluronidase to enhance the dispersion or absorption of phenylephrine. Use of hyaluronidase for other purposes in patients receiving phenylephrine may be considered as clinically indicated. Risk D: Consider Therapy Modification

Iobenguane Radiopharmaceutical Products: Alpha1-Agonists 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

Lisuride: May increase hypertensive effects of Alpha1-Agonists. Risk X: Avoid

Mavorixafor: May increase serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk X: Avoid

Melperone: May decrease therapeutic effects of Phenylephrine (Systemic). Risk C: Monitor

Memantine: NMDA Receptor Antagonists may increase adverse/toxic effects of Memantine. Risk C: Monitor

Metergoline: May increase adverse/toxic effects of Alpha1-Agonists. 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: Dextromethorphan may increase serotonergic effects of Monoamine Oxidase Inhibitors. This may cause serotonin syndrome. Risk X: Avoid

Parecoxib: May increase serum concentration of Dextromethorphan. Risk C: Monitor

Peginterferon Alfa-2b: May decrease serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Peginterferon Alfa-2b may increase serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor

Pergolide: May increase hypertensive effects of Alpha1-Agonists. Risk C: Monitor

Propacetamol: May increase serum concentration of Phenylephrine (Systemic). Management: Monitor patients closely for increased side effects of phenylephrine if propacetamol is used concomitantly. Patients with underlying blood pressure issues or arrhythmias may need closer monitoring and may warrant consideration of alternative therapies. Risk C: Monitor

Secnidazole: Products Containing Ethanol may increase adverse/toxic effects of Secnidazole. Risk X: Avoid

Selective Serotonin Reuptake Inhibitors (Strong CYP2D6 Inhibitors): Dextromethorphan may increase serotonergic effects of Selective Serotonin Reuptake Inhibitors (Strong CYP2D6 Inhibitors). This could result in serotonin syndrome. Selective Serotonin Reuptake Inhibitors (Strong CYP2D6 Inhibitors) may increase serum concentration of Dextromethorphan. Management: Consider alternatives to this drug combination. The dose of dextromethorphan/bupropion product should not exceed 1 tablet once daily. Monitor for signs and symptoms of serotonin syndrome/serotonin toxicity. Risk D: Consider Therapy Modification

Serotonergic Agents (High Risk): Dextromethorphan may increase serotonergic effects of Serotonergic Agents (High Risk). This could result in serotonin syndrome. Management: Monitor for signs and symptoms of serotonin syndrome/serotonin toxicity (eg, hyperreflexia, clonus, hyperthermia, diaphoresis, tremor, autonomic instability, mental status changes) when these agents are combined. Risk C: Monitor

Solriamfetol: Sympathomimetics may increase hypertensive effects of Solriamfetol. Sympathomimetics may increase tachycardic effects of Solriamfetol. 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

Pregnancy Considerations

Refer to individual monographs.

Breastfeeding Considerations

Refer to individual monographs.

Dietary Considerations

Some products may contain sodium.

Mechanism of Action

See individual agents.

Pharmacokinetics (Adult Data Unless Noted)

See individual agents.

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

  • (IL) Israel: Tussocal;
  • (IN) India: T-minic actikof;
  • (PR) Puerto Rico: Triaminic Day Time Cold & 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. American Academy of Pediatrics Committee on Drugs. "Inactive" ingredients in pharmaceutical products: update (subject review). Pediatrics. 1997;99(2):268-278. doi:10.1542/peds.99.2.268 [PubMed 9024461]
  3. Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319. doi:10.1067/mpd.2001.116281 [PubMed 11487763]
  4. 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]
  5. Centers for Disease Control (CDC). Neonatal deaths associated with use of benzyl alcohol--United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291. [PubMed 6810084]
  6. Children's Daytime Cold and Cough (dextromethorphan hydrobromide/phenylephrine hydrochloride) liquid [prescribing information]. Woonsocket, RI: CVS Pharmacy, Inc; 2019.
  7. Children's Sudafed PE Cold Plus Cough (dextromethorphan hydrobromide/phenylephrine hydrochloride) solution [prescribing information]. Fort Washington, PA: Johnson & Johnson Consumer Inc; April 2017.
  8. Children's Sudafed PE Cough + Cold (dextromethorphan hydrobromide/phenylephrine hydrochloride) solution [prescribing information]. Fort Washington, PA: Johnson & Johnson Consumer Inc; 2020.
  9. 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 November 2, 2018.
  10. 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 November 2, 2018.
  11. Maxi-Tuss Jr (dextromethorphan hydrobromide/phenylephrine hydrochloride) solution [prescribing information]. Brooksville, FL: MCR American Pharmaceuticals, Inc; May 2020.
  12. PediaCare Children's Multi-Symptom Cold (dextromethorphan hydrobromide/phenylephrine hydrochloride) liquid [prescribing information]. Tarrytown, NY: Prestige Brands Holdings, Inc; February 2014.
  13. Shehab N, Lewis CL, Streetman DD, Donn SM. Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates. Pediatr Crit Care Med. 2009;10(2):256-259. [PubMed 19188870]
  14. Taverner D, Latte J. Nasal decongestants for the common cold. Cochrane Database Syst Rev. 2007;(1):CD001953. doi:10.1002/14651858.CD001953.pub3 [PubMed 17253470]
  15. Triaminic Children's Day Time Cold and Cough (dextromethorphan hydrobromide/phenylephrine hydrochloride) [prescribing information]. Parsippany, NJ: Novartis Consumer Health, Inc; October 2012.
  16. Triaminic Day Time Cold and Cough (dextromethorphan hydrobromide/phenylephrine hydrochloride) syrup [prescribing information]. Warren, NJ: GSK Consumer Healthcare; 2017.
  17. Zar T, Graeber C, Perazella MA. Recognition, treatment, and prevention of propylene glycol toxicity. Semin Dial. 2007;20(3):217-219. doi:10.1111/j.1525-139X.2007.00280.x [PubMed 17555487]
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