Note: Safety and efficacy for the use of cough and cold products in infants and young children limited; the AAP warns against the use of these products for respiratory illnesses in infants and young children (AAP 2018; FDA 2017). Approved ages and uses for generic products may vary; consult labeling for specific information.
Cough suppressant: Oral:
Oral syrup (immediate release):
Children 2 to <6 years: 5 mg every 4 hours as needed; do not exceed 6 doses in 24 hours.
Children 6 to <12 years: 10 mg every 4 hours as needed; do not exceed 6 doses in 24 hours.
Children ≥12 years and Adolescents: 20 mg every 4 hours as needed; do not exceed 6 doses in 24 hours.
Long-acting liquid: Children ≥12 years and Adolescents: 30 mg every 6 to 8 hours as needed; do not exceed 4 doses in 24 hours.
Oral capsule: Children ≥12 years and Adolescents: 30 mg every 6 to 8 hours as needed; do not exceed 4 doses in 24 hours.
Extended-release suspension (dextromethorphan polistirex):
Children 4 to <6 years: 15 mg every 12 hours as needed; do not exceed 30 mg in 24 hours.
Children 6 to <12 years: 30 mg every 12 hours as needed; do not exceed 60 mg in 24 hours.
Children ≥12 years and Adolescents: 60 mg every 12 hours as needed; do not exceed 120 mg in 24 hours.
There are no dosage adjustments provided in manufacturer's labeling.
There are no dosage adjustments provided in manufacturer's labeling.
(For additional information see "Dextromethorphan: Drug information")
Cough suppressant: Oral: 10 to 20 mg every 4 hours or 20 to 30 mg every 6 to 8 hours; extended release: 60 mg twice daily; maximum: 120 mg/24 hours
The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Altered kidney function: No dosage adjustment likely to be necessary for any degree of kidney impairment (eliminated primarily by CYP2D6) (Ref).
Hemodialysis, intermittent (thrice weekly): Not likely to be significantly dialyzable (large Vd): No supplemental dose or dosage adjustment necessary (Ref).
Peritoneal dialysis: Not likely to be significantly dialyzable (large Vd): No dosage adjustment necessary (Ref).
CRRT: No dosage adjustment necessary (Ref).
PIRRT (eg, sustained, low-efficiency diafiltration): No dosage adjustment necessary (Ref).
There are no dosage adjustment 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, nervousness, restlessness
Gastrointestinal: Gastrointestinal distress, nausea, stomach pain, vomiting
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.
Concurrent drug therapy issues:
• Serotonin syndrome: Symptoms of agitation, confusion, hallucinations, hyper-reflexia, myoclonus, shivering, and tachycardia may occur with concomitant proserotonergic drugs (ie, SSRIs/SNRIs or triptans); especially with higher dextromethorphan doses.
Special populations:
• CYP2D6 poor metabolizers: Dextromethorphan is metabolized by hepatic CYP2D6. Poor metabolizers of CYP2D6 may have exaggerated or prolonged effects of dextromethorphan. Increased risk may be seen with concomitant use of potent CYP2D6 inhibitors; use with caution (Abduljalil 2010; Jurica 2012; Sager 2014; Zhou 2009).
• Debilitated patients: Use with caution in patients who are sedated, debilitated or confined to a supine position.
• Pediatric: Use with caution in atopic children. Not for OTC use in children <4 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.
• Tartrazine: Some products may contain tartrazine.
Other warnings/precautions:
• Abuse/misuse: Healthcare providers should be alert to problems of abuse or misuse. Abuse can cause death, brain damage, seizure, loss of consciousness, and irregular heartbeat.
• 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. Do not use for persistent or chronic cough (as with smoking, asthma, chronic bronchitis, emphysema) or if cough is accompanied by excessive phlegm unless directed to do so by healthcare provider.
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).
Anecdotal reports of abuse of dextromethorphan-containing cough/cold products have increased, especially among teenagers.
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
Capsule, Oral, as hydrobromide:
Robafen Cough: 15 mg [DSC] [contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye)]
Robitussin Lingering CoughGels: 15 mg [DSC] [contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), polyethylene glycol (macrogol), propylene glycol]
Generic: 15 mg
Gel, Oral, as hydrobromide:
ElixSure Cough: 7.5 mg/5 mL (120 mL) [alcohol free; contains carbomer 934p, propylene glycol, propylparaben; cherry bubblegum flavor]
Liquid, Oral, as hydrobromide:
Buckleys Cough: 12.5 mg/5 mL (118 mL) [alcohol free, sugar free; contains butylparaben, menthol, propylparaben, saccharin sodium]
Little Colds Cough Formula: 7.5 mg/mL (30 mL [DSC]) [alcohol free, dye free, saccharin free; contains sodium benzoate]
PediaCare Childrens Long-Act: 7.5 mg/5 mL (118 mL) [contains fd&c blue #1 (brilliant blue), saccharin sodium, sodium benzoate]
Triaminic Long Acting Cough: 7.5 mg/5 mL (118 mL) [alcohol free, dye free, pseudoephedrine free; contains benzoic acid, propylene glycol]
Lozenge, Mouth/Throat, as hydrobromide:
Hold: 5 mg (10 ea)
Hold: 5 mg (10 ea) [cherry flavor]
Strip, Oral, as hydrobromide:
Triaminic Long Acting Cough: 7.5 mg (14 ea, 16 ea) [contains alcohol, usp, fd&c red #40 (allura red ac dye); cherry flavor]
Triaminic Long Acting Cough: 7.5 mg (14 ea) [contains alcohol, usp, fd&c red #40 (allura red ac dye), isopropyl alcohol]
Suspension Extended Release, Oral:
Cough DM: Dextromethorphan polistirex [equivalent to dextromethorphan hydrobromide 30 mg/5 mL] (89 mL) [alcohol free; contains methylparaben, polysorbate 80, propylparaben, quinoline (d&c yellow #10) aluminum lake, sodium metabisulfite; orange flavor]
Delsym: Dextromethorphan polistirex [equivalent to dextromethorphan hydrobromide 30 mg/5 mL] (89 mL, 148 mL) [alcohol free; contains disodium edta, fd&c blue #1 (brilliant blue), methylparaben, polyethylene glycol (macrogol), polysorbate 80, propylene glycol, propylparaben; grape flavor]
Delsym: Dextromethorphan polistirex [equivalent to dextromethorphan hydrobromide 30 mg/5 mL] (89 mL, 148 mL) [alcohol free; contains edetate (edta) disodium, fd&c yellow #6 (sunset yellow), methylparaben, polyethylene glycol (macrogol), polysorbate 80, propylene glycol, propylparaben; orange flavor]
Delsym Cough Childrens: Dextromethorphan polistirex [equivalent to dextromethorphan hydrobromide 30 mg/5 mL] (89 mL, 148 mL) [alcohol free; contains edetate (edta) disodium, fd&c blue #1 (brilliant blue), methylparaben, polyethylene glycol (macrogol), polysorbate 80, propylene glycol, propylparaben, soybean oil; grape flavor]
Delsym Cough Childrens: Dextromethorphan polistirex [equivalent to dextromethorphan hydrobromide 30 mg/5 mL] (89 mL, 148 mL) [alcohol free; contains edetate (edta) disodium, fd&c yellow #6 (sunset yellow), methylparaben, polyethylene glycol (macrogol), polysorbate 80, propylene glycol, propylparaben, soybean oil; orange flavor]
FT 12 Hour Cough Relief: Dextromethorphan polistirex [equivalent to dextromethorphan hydrobromide 30 mg/5 mL] (89 mL) [alcohol free; contains fd&c blue #1 (brill blue) aluminum lake, methylparaben, polysorbate 80, propylparaben, sodium metabisulfite; grape flavor]
GoodSense Cough DM: Dextromethorphan polistirex [equivalent to dextromethorphan hydrobromide 30 mg/5 mL] (148 mL) [alcohol free, gluten free; contains methylparaben, polysorbate 80, propylparaben, quinoline (d&c yellow #10) aluminum lake, sodium metabisulfite]
GoodSense Cough DM Childrens: Dextromethorphan polistirex [equivalent to dextromethorphan hydrobromide 30 mg/5 mL] (89 mL, 148 mL) [alcohol free, gluten free; contains methylparaben, polysorbate 80, propylparaben, quinoline (d&c yellow #10) aluminum lake, sodium metabisulfite]
Robitussin 12 Hour Cough: Dextromethorphan polistirex [equivalent to dextromethorphan hydrobromide 30 mg/5 mL] (89 mL) [alcohol free; contains fd&c blue #1 (brilliant blue), methylparaben, polysorbate 80, propylparaben, sodium metabisulfite]
Robitussin 12 Hour Cough: Dextromethorphan polistirex [equivalent to dextromethorphan hydrobromide 30 mg/5 mL] (89 mL) [alcohol free; contains methylparaben, polysorbate 80, propylparaben, quinoline yellow (d&c yellow #10), sodium metabisulfite]
Robitussin 12 Hour Cough Child: Dextromethorphan polistirex [equivalent to dextromethorphan hydrobromide 30 mg/5 mL] (89 mL) [alcohol free; contains fd&c blue #1 (brilliant blue), methylparaben, polysorbate 80, propylparaben, sodium metabisulfite]
Generic: Dextromethorphan polistirex [equivalent to dextromethorphan hydrobromide 30 mg/5 mL] (89 mL)
Syrup, Oral, as hydrobromide:
Robitussin Childrens Cough LA: 7.5 mg/5 mL (118 mL) [alcohol free; contains fd&c red #40 (allura red ac dye), propylene glycol, saccharin sodium, sodium benzoate; fruit punch flavor]
Tablet, Oral, as hydrobromide:
Delsym: 15 mg [contains fd&c yellow #6(sunset yellow)alumin lake]
May be product dependent
Capsules (Dextromethorphan HBr Oral)
15 mg (per each): $0.16
Gel (ElixSure Cough Oral)
7.5 mg/5 mL (per mL): $0.04
Liquid (Buckleys Cough Oral)
12.5 mg/5 mL (per mL): $0.04
Liquid (Giltuss Honey DM Childrens Oral)
15 mg/5 mL (per mL): $0.06
Liquid (Giltuss Honey DM Oral)
30 mg/10 mL (per mL): $0.06
Liquid (PediaCare Childrens Long-Act Oral)
7.5 mg/5 mL (per mL): $0.05
Liquid (Triaminic Long Acting Cough Oral)
7.5 mg/5 mL (per mL): $0.04
Lozenge (Hold Mouth/Throat)
5 mg (per each): $0.24
Strip (Triaminic Long Acting Cough Oral)
7.5 mg (per each): $0.35
Suspension Extended Release (Delsym Cough Childrens Oral)
30 mg/5 mL (per mL): $0.12
Suspension Extended Release (Delsym Oral)
30 mg/5 mL (per mL): $0.12
Suspension Extended Release (Dextromethorphan Polistirex ER Oral)
30 mg/5 mL (per mL): $0.09
Suspension Extended Release (Robitussin 12 Hour Cough Child Oral)
30 mg/5 mL (per mL): $0.10
Suspension Extended Release (Robitussin 12 Hour Cough Oral)
30 mg/5 mL (per mL): $0.10
Syrup (Robitussin Childrens Cough LA Oral)
7.5 mg/5 mL (per mL): $0.05
Tablets (Delsym Oral)
15 mg (per each): $0.67
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 liquid/suspension products with an accurate measuring device; do not use a household teaspoon (overdosage may occur).
Suspension: Shake well prior to administration.
Shake extended release suspension well before use. Only use dosing cup provided to measure liquid doses.
Symptomatic relief of coughs due to minor throat or bronchial irritation caused by the common cold (FDA approved in adults; refer to product specific information regarding FDA approval in pediatric patients). Note: Approved ages and uses for generic products may vary; consult labeling for specific information.
Benylin may be confused with Benadryl, Ventolin
Delsym may be confused with Delfen, Desyrel
Substrate of CYP2B6 (minor), CYP2C19 (minor), CYP2C9 (minor), CYP2D6 (major), CYP2E1 (minor), CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
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.
Ajmaline: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
Artemether and Lumefantrine: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
CYP2D6 Inhibitors (Moderate): May increase the serum concentration of Dextromethorphan. Risk C: Monitor therapy
CYP2D6 Inhibitors (Strong): May increase the serum concentration of Dextromethorphan. Risk C: Monitor therapy
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
Memantine: NMDA Receptor Antagonists may enhance the adverse/toxic effect of Memantine. Risk C: Monitor therapy
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: Dextromethorphan may enhance the serotonergic effect of Monoamine Oxidase Inhibitors. This may cause serotonin syndrome. 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
Parecoxib: May increase the serum concentration of Dextromethorphan. Risk C: Monitor therapy
Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Peginterferon Alfa-2b may increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
Secnidazole: Products Containing Ethanol may enhance the adverse/toxic effect of Secnidazole. Risk X: Avoid combination
Selective Serotonin Reuptake Inhibitors (Strong CYP2D6 Inhibitors): Dextromethorphan may enhance the serotonergic effect of Selective Serotonin Reuptake Inhibitors (Strong CYP2D6 Inhibitors). This could result in serotonin syndrome. Selective Serotonin Reuptake Inhibitors (Strong CYP2D6 Inhibitors) may increase the 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 enhance the serotonergic effect 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 therapy
Some products may contain sodium.
Dextromethorphan is metabolized in the liver via CYP2D6 and CYP3A enzymes. The activity of both enzymes is increased in the mother during pregnancy (Tracy 2005; Wadelius 1997). In the fetus, CYP2D6 activity is low in the fetal liver and CYP3A4 activity is present by ~17 weeks' gestation (Jacqz-Aigrain 1992).
When an antitussive is needed during pregnancy, dextromethorphan at standard OTC doses is generally considered acceptable. Some sources recommend use be reserved for significant maternal need; products containing alcohol should be avoided (Chasnoff 1981; Conover 2003; Koren 1998; Ward 2005).
Cough, mental status
Decreases the sensitivity of cough receptors and interrupts cough impulse transmission by depressing the medullary cough center through sigma receptor stimulation; structurally related to codeine
Onset of action: Antitussive: 15 to 30 minutes.
Metabolism: Hepatic via demethylation via CYP2D6 to dextrorphan (active); CYP3A4 and CYP3A5 form smaller amounts of 3-hydroxy and 3-methoxy derivatives.
Half-life elimination:
Dextromethorphan:
Pediatric patients: Excluding poor metabolizers (Guenin 2014).
Children 2 to 5 years: 4.09 ± 1.44 hours.
Children 6 to 11 years: 4.8 ± 1.59 hours.
Children ≥12 years and Adolescents: 6.41 ± 1.639 hours.
Adults: Extensive metabolizers: 2 to 4 hours; poor metabolizers: 24 hours.
Time to peak:
Children 2 to 5 years: 1.44 ± 0.563 hours (Guenin 2014).
Children 6 to 11 years: 2.12 ± 0.801 hours (Guenin 2014).
Children ≥12 years and Adolescents: 2.04 ± 0.865 hours (Guenin 2014).
Adults: Mean range: 2.1 to 2.6 hours (Silvasti 1987).
Peak concentration:
Pediatric patients: Excluding poor metabolizers (Guenin 2014).
Children 2 to 5 years (following doses of 7.5 to 11.25 mg): 1.47 ± 1.597 ng/mL.
Children 6 to 11 years (following doses of 15 to 24.75 mg): 1.26 ± 1.211 ng/mL.
Children ≥12 years and Adolescents (following doses of 30 mg): 4.9 ± 4.215 ng/mL.
Adults (following doses of 60 mg): Mean range: 5.2 to 5.8 ng/mL (Silvasti 1987).
Excretion: Primarily in urine as metabolites.
Metabolism: Pharmacokinetic parameters are affected by the genetic predisposition of CYP2D6 activity (Guenin 2014).
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