Dextromethorphan Hydrobromide

Pronunciation

Class: Antitussives
ATC Class: RO5DA09
VA Class: RE302
CAS Number: 6700-34-1
Brands: Alka-Seltzer Plus Cold & Cough, Alka-Seltzer Plus Day Cold, Alka-Seltzer Plus Night Cold, Cheracol D Cough, Children’s Vicks NyQuil Cold/Cough, Children’s Dimetapp Cold & Cough, Children’s Dimetapp Multi-Symptom Cold & Flu, Children’s Sudafed PE Cold & Cough, Children’s Tylenol Plus Cough & Runny Nose, Children’s Tylenol Plus Cough & Sore Throat, Children’s Tylenol Plus Flu, Children’s Tylenol Plus Multi-Symptom Cold, Comtrex Cold & Cough, Comtrex Non-Drowsy Maximum Strength Caplets, Coricidin HBP, Delsym, Diabetic Tussin DM, Dicel DM, Guiatuss DM, Hold DM, Kidkare Cough & Cold Liquid, Maximum Strength Mucinex DM, Mucinex DM, Pediacare Cough & Congestion, Pediacare Fever Reducer Plus Cold & Cough, Pediacare Fever Reducer Plus Cough & Runny Nose, Pediacare Fever Reducer Plus Cough & Sore Throat, Pediacare Fever Reducer Plus Flu, Pediacare Fever Reducer Plus Multi-Symptom Cold, Pediacare Multi-Symptom Cold, Robitussin Children’s Cough & Cold CF, Robitussin Long-Acting CoughGels, Robitussin Maximum Strength Cough + Chest Congestion, Robitussin Peak Cold Cough + Chest Congestion DM, Robitussin Peak Cold Maximum Strength Cough + Chest Congestion, Robitussin Peak Cold Multi-Symptom Cold, Robitussin Sugar-Free Cough + Chest Congestion DM, Safe Tussin, Sucrets DM Cough Formula, Suppress DX Pediatric Drops, TheraFlu Max-D Severe Cold & Flu, TheraFlu Warming Relief, TriaminicCough and Sore Throat, Triaminic Daytime Cold & Cough, Triaminic Multi-Symptom Fever, Tylenol Cold & Cough, Tylenol Cold & Flu Severe, Tylenol Cold Head Congestion Severe, Tylenol Cold Multi-Symptom, Vicks DayQuil, Vicks Formula 44 Custom Care, Vicks NyQuil

Introduction

Antitussive agent; derivative of levorphanol.b

Uses for Dextromethorphan Hydrobromide

Cough

Temporary relief of coughs (antitussive, cough suppressant) caused by minor throat and bronchial irritation that may occur with common colds, allergies, or inhaled irritants.105 106 111 a b c d

Used in fixed combination with other agents (e.g., acetaminophen, brompheniramine, chlorpheniramine, doxylamine, guaifenesin, phenylephrine, pseudoephedrine) for the temporary relief of coughs and/or other symptoms (e.g., rhinorrhea, sneezing, lacrimation, itching eyes, oronasopharyngeal itching, nasal congestion) associated with seasonal (e.g., hay fever) or perennial allergic rhinitis, other upper respiratory allergies, or the common cold.g h i j k

Slideshow: COPD - Could You Be At Risk?

Most effective in the treatment of chronic, nonproductive cough.b

In pediatric patients <2 years of age, OTC cough and cold preparations (i.e., containing cough suppressants [including dextromethorphan], antihistamines, expectorants, and/or nasal decongestants) were not more effective than placebo in reducing acute cough and other symptoms of upper respiratory tract infection and reportedly are associated with adverse events and sometimes death (albeit rarely).116 (See Pediatric Use under Cautions.)

Abuse and recreational use reported.111 112 113 (See Abuse Potential under Cautions.)

Dextromethorphan Hydrobromide Dosage and Administration

Administration

Oral Administration

Administer orally.b

Dosage

Dosages of dextromethorphan hydrobromide and dextromethorphan polistirex are expressed in terms of dextromethorphan hydrobromide.105 b

Because combinations and dosage strengths vary for fixed-combination preparations, consult manufacturer’s product labeling for appropriate dosage of the specific preparation.

Pediatric Patients

Cough
Immediate-release Preparations
Oral

Children <2 years of age: Dosage must be individualized.b d Currently there are no FDA-approved dosage recommendations for cough and cold preparations for children <2 years of age.116 (See Pediatric Use under Cautions.)

Children 2 to <6 years of age: 2.5–5 mg every 4 hours or 7.5 mg every 6–8 hours, not to exceed 30 mg daily, or as directed by a clinician.105 106 b c d (See Pediatric Use under Cautions.)

Children 6 to <12 years of age: 5–10 mg every 4 hours or 15 mg every 6–8 hours, not to exceed 60 mg daily, or as directed by a clinician.105 106 c d

Children ≥12 years of age: 10–20 mg every 4 hours or 30 mg every 6–8 hours, not to exceed 120 mg daily, or as directed by a clinician.105 106 110 c d

Extended-release Oral Suspension (containing polistirex)
Oral

Children 2 to <6 years of age: 15 mg twice daily.b

Children 6 to <12 years of age: 30 mg twice dailyb

Children ≥12 years of age: 60 mg twice daily.b

Adults

Cough
Immediate-release Preparations
Oral

10–20 mg every 4 hours or 30 mg every 6–8 hours, not to exceed 120 mg daily, or as directed by a clinician.105 106 110 c d

Extended-release Oral Suspension (containing polistirex)
Oral

60 mg twice daily.b

Prescribing Limits

Pediatric Patients

Cough
Oral

Children 2 to <6 years of age: Maximum 30 mg daily, or as directed by a clinician.105 106

Children 6 to <12 years of age: Maximum 60 mg daily, or as directed by a clinician.105 106

Children ≥12 years of age: Maximum 120 mg daily, or as directed by a clinician.105 106 110 c d

Adults

Cough
Oral

Maximum 120 mg daily, or as directed by a clinician.105 106 110 c d

Special Populations

Hepatic Impairment

No specific dosage recommendations for hepatic impairment.a b

Renal Impairment

No specific dosage recommendations for renal impairment.a b

Geriatric Patients

No specific geriatric dosage recommendations.a

Cautions for Dextromethorphan Hydrobromide

Contraindications

  • During or within 14 days of discontinuing MAO inhibitor therapy because of risk of serotonin syndrome.109 110 b c d (See Interactions.)

  • Known hypersensitivity to the drug or any ingredient in the respective formulation.a

Warnings/Precautions

Warnings

Persistent Cough

Do not take for persistent or chronic cough (e.g., with smoking, emphysema, asthma) or when coughing is accompanied by excessive secretions, unless directed by a clinician.b

Consult a clinician for cough that persists for longer than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.d

Persistent cough may be a sign of a serious condition.d

Sensitivity Reactions

May be associated with histamine release and should be used with caution in atopic children.b

General Precautions

Sedated, Debilitated, and Supine Patients

Use with caution in sedated or debilitated patients and in patients confined to the supine position.b

Phenylketonuria

Individuals with phenylketonuria and other individuals who must restrict their intake of phenylalanine should be warned that some commercially available preparations of dextromethorphan contain aspartame (NutraSweet), which is metabolized in the GI tract to phenylalanine.b

Abuse Potential

Generally low, but recreational use reported with OTC dextromethorphan-containing preparations and with dextromethorphan powder sold illicitly.111 112 113 114

Deaths possibly associated with ingestion of powdered dextromethorphan sold illicitly in capsules reported.111 112 113 114 Pure dextromethorphan in powder form reportedly is being encapsulated for illicit sale as a street drug.111 112 113 114

Use of Fixed Combinations

When used in fixed combination with other agents (e.g., acetaminophen, brompheniramine, chlorpheniramine, doxylamine, guaifenesin, phenylephrine, pseudoephedrine), consider the cautions, precautions, and contraindications associated with the concomitant agent(s).g h i j k

Specific Populations

Pregnancy

Category C.e

Lactation

Unknown whether distributed into milk but likely based on low molecular weight.e Preparations containing alcohol should be avoided in nursing women.e Preparations that do not contain alcohol probably are safe.e

Pediatric Use

Risk of overdosage and toxicity (including death) in children <2 years of age receiving OTC preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection.116 117 Limited evidence of efficacy for these preparations in this age group; appropriate dosages not established.116 Therefore, FDA recommends not to use such preparations in children <2 years of age; safety and efficacy in older children currently under evaluation. Because children 2–3 years of age also are at increased risk of overdosage and toxicity, some manufacturers of oral nonprescription cough and cold preparations recently agreed to voluntarily revise the product labeling to state that such preparations should not be used in children <4 years of age. During the transition period, some preparations on pharmacy shelves will have the new recommendation (“do not use in children <4 years of age”), while others will have the previous recommendation (“do not use in children <2 years of age”). FDA recommends that parents and caregivers adhere to dosage instructions and warnings on the product labeling that accompanies the preparation and consult a clinician about any concerns. Clinicians should ask caregivers about use of OTC cough/cold preparations to avoid overdosage.

Efficacy of OTC cough and cold preparations in children <6 years of age also has been questioned.120 An FDA advisory panel recommended that these products not be used in these children;120 FDA has not yet announced its decision.

Do not use lozenges in children <6 years of age.110

Do not use liquid-filled capsules in children <12 years of age, unless otherwise directed by a clinician.110

Common Adverse Effects

Adverse effects with dextromethorphan are rare, but nausea and/or other GI disturbances, slight drowsiness, and dizziness sometimes occur.b

Interactions for Dextromethorphan Hydrobromide

Specific Drugs

Drug

Interaction

Comments

CNS depressants (e.g., alcohol, hypnotics, sedatives, tranquilizers, tricyclic antidepressants)

Possible additive CNS depressiong h k

MAO inhibitors

Concomitant therapy may produce serotonin syndrome, which can manifest with serious complications (e.g., hypertensive crisis, hyperpyrexia, cardiac arrhythmias, myoclonus), including death109 110 c

Concomitant use with MAO inhibitors or within 2 weeks after discontinuance is contraindicated109 110 b c d

Dextromethorphan Hydrobromide Pharmacokinetics

Absorption

Bioavailability

Rapidly and well absorbed from the GI tract.b c

Onset

Exerts antitussive effect in 15–30 minutes after oral administration.b c

Duration

Approximately 3–6 hours with conventional dosage forms.b c

Elimination

Metabolism

Undergoes hepatic metabolism.k

Elimination Route

Excreted primarily in urine.k

Stability

Storage

Oral

Tight, light-resistant containers.b f

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Dextromethorphan is incompatible with penicillins, tetracyclines, salicylates, phenobarbital sodium, hydriodic acid, and high concentrations of sodium or potassium iodide.b

Actions

  • Retains only the antitussive activity of other morphinan derivatives.b

  • Acts centrally on the respiratory center in the medulla and nucleus tractus solaris to increase the cough threshold.c

  • About equal to codeine in depressing the cough reflex and has no expectorant action.b

Advice to Patients

  • Risk of drowsiness; avoid alcohol and use caution when driving, operating machinery, or engaging in other hazardous tasks.g h k

  • Importance of warning individuals with phenylketonuria and other individuals who must restrict their intake of phenylalanine that some commercially available preparations of dextromethorphan contain aspartame (NutraSweet), which is metabolized in the GI tract to phenylalanine following oral administration.b

  • Importance of contacting a clinician if cough persists for longer than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.d

  • Advise patient not to use for persistent or chronic cough (e.g., with smoking, emphysema, asthma) or when coughing is accompanied by excessive secretions, unless directed by a clinician.b d

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs (e.g., other cough and cold preparations) as well as any concomitant illnesses.

    Importance of not using during or within 14 days of discontinuing MAO inhibitor therapy because of the risk of serotonin syndrome, which is potentially fatal.109 110 b c d Advise patients to consult their pharmacist or clinician if they do not know whether drugs they are taking contain an MAO inhibitor.d

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Many prescription cough, cold, and allergy preparations commercially available in the US have not been approved by the US Food and Drug Administration (FDA).500 Because of the potentially serious health risks associated with unapproved preparations, FDA announced on March 3, 2011, that it would take enforcement action (e.g., seizure, injunction, other judicial or administrative proceeding) against any currently marketed and listed unapproved cough, cold, and allergy preparation manufactured on or after June 1, 2011, or shipped on or after August 30, 2011.500 For additional information and for a complete list of unapproved cough, cold, and allergy preparations affected by this FDA notice, see FDA website ().

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Dextromethorphan Hydrobromide

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules, liquid-filled

15 mg

Robitussin Long-Acting CoughGels

Pfizer

Lozenges

5 mg

Hold DM

Ascher

10 mg

Sucrets DM Cough Formula

Insight

Solution

7.5 mg/5 mL*

Dextromethorphan Hydrobromide Solution

10 mg/5 mL*

Dextromethorphan Hydrobromide Solution

Vicks 44 Custom Care Dry Cough

Procter & Gamble

15 mg/5 mL*

Dextromethorphan Hydrobromide Solution

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Dextromethorphan Hydrobromide Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules, liquid-filled

10 mg with Acetaminophen 325 mg, Chlorpheniramine Maleate 2 mg, and Phenylephrine Hydrochloride 5 mg

Alka-Seltzer Plus Cold & Cough Formula Liquid Gels

Bayer

Tylenol Cold Multi-Symptom Nighttime Rapid Release Gels

McNeil

10 mg with Acetaminophen 325 mg, Doxylamine Succinate 6.25 mg, and Phenylephrine Hydrochloride 5 mg

Alka-Seltzer Plus Night Cold Formula Liquid Gels

Bayer

10 mg with Acetaminophen 325 mg and Phenylephrine Hydrochloride 5 mg

Alka-Seltzer Plus Day Cold Formula Liquid Gels

Bayer

Vicks DayQuil Cold & Flu Relief LiquiCaps

Procter & Gamble

15 mg with Acetaminophen 325 mg and Doxylamine Succinate 6.25 mg

Vicks NyQuil Cold & Flu Relief LiquiCaps

Procter & Gamble

For solution

30 mg with Acetaminophen 1 g, Guaifenesin 400 mg, and Pseudoephedrine Hydrochloride 60 mg per packet

TheraFlu Max-D Severe Cold & Flu

Novartis

Kit

12 Tablets, film-coated, Acetaminophen 325 mg with Dextromethorphan Hydrobromide 10 mg and Phenylephrine Hydrochloride 5 mg (Comtrex Daytime Caplets)

12 Tablets, film-coated, Acetaminophen 325 mg with Chlorpheniramine Maleate 2 mg, Dextromethorphan Hydrobromide 10 mg, and Phenylephrine Hydrochloride 5 mg (Comtrex Nighttime Caplets)

Comtrex Cold & Cough Day-Night Maximum Strength Caplets

Novartis

Solution

3.3 mg/5 mL with Acetaminophen 108.3 mg/5 mL, Doxylamine Succinate 1.25 mg/5 mL, and Phenylephrine Hydrochloride 1.6 mg/5 mL

Tylenol Cold Multi-Symptom Nighttime

McNeil

3.3 mg/5 mL with Acetaminophen 108.3 mg/5 mL, Guaifenesin 66.6 mg/5 mL, and Phenylephrine Hydrochloride 1.6 mg/5 mL

Tylenol Cold Multi-Symptom Severe

McNeil

Tylenol Cold & Flu Severe

McNeil

3.3 mg/5 mL with Acetaminophen 108.3 mg/5 mL and Phenylephrine Hydrochloride 1.6 mg/5 mL

Tylenol Cold Multi-Symptom Daytime

McNeil

Vicks DayQuil Cold & Flu Relief

Procter & Gamble

5 mg/5 mL with Acetaminophen 108.3 mg/5 mL and Doxylamine Succinate 2.08 mg/5 mL

Vicks NyQuil Cold & Flu Relief

Procter & Gamble

5 mg/5 mL with Acetaminophen 160 mg/5 mL

Children’s Tylenol Plus Cough & Sore Throat

Prestige Brands

TriaminicCough and Sore Throat

Novartis

5 mg/5 mL with Acetaminophen 160 mg/5 mL and Chlorpheniramine Maleate 1 mg/5 mL

Children’s Tylenol Plus Cough & Runny Nose

McNeil

5 mg/5 mL with Acetaminophen 160 mg/5 mL, Chlorpheniramine Maleate 1 mg/5 mL, and Phenylephrine Hydrochloride 2.5 mg/5 mL

Children’s Dimetapp Multi-Symptom Cold & Flu

Pfizer

Children’s Tylenol Plus Flu

McNeil

5 mg/5 mL with Acetaminophen 166.6 mg/5 mL

Tylenol Cold & Cough Daytime

McNeil

5 mg/5 mL with Acetaminophen 166.6 mg/5 mL and Doxylamine Succinate 2.08 mg/5 mL

Tylenol Cold & Cough Nighttime

McNeil

5 mg/5 mL with Brompheniramine Maleate 1 mg/5 mL and Phenylephrine Hydrochloride 2.5 mg/5 mL

Children’s Dimetapp Cold & Cough

Pfizer

5 mg/5 mL with Chlorpheniramine Maleate 0.67 mg/5 mL

Children’s Vicks NyQuil Cold/Cough

Procter & Gamble

5 mg/5 mL with Chlorpheniramine Maleate 1 mg/5 mL and Pseudoephedrine Hydrochloride 15 mg/5 mL

Kidkare Cough & Cold Liquid

Watson

5 mg/5 mL with Doxylamine Succinate 2.08 mg/5 mL

Vicks NyQuil Cough

Procter & Gamble

5 mg/5 mL with Guaifenesin 50 mg/5 mL and Phenylephrine Hydrochloride 2.5 mg/5 mL

Robitussin Children’s Cough & Cold CF

Pfizer

5 mg/5 mL with Guaifenesin 100 mg/5 mL

Pediacare Cough & Congestion

Prestige Brands

5 mg/5 mL with Phenylephrine Hydrochloride 2.5 mg/5 mL

Children’s Sudafed PE Cold & Cough

McNeil

Pediacare Multi-Symptom Cold

Prestige Brands

Triaminic Daytime Cold & Cough

Novartis

6.7 mg/5 mL with Guaifenesin 66.7 mg/5 mL

Vicks Formula 44 Custom Care Chesty Cough

Procter & Gamble

7.5 mg/5 mL with Acetaminophen 160 mg/5 mL and Chlorpheniramine Maleate 1 mg/5 mL

Triaminic Multi-Symptom Fever

Novartis

10 mg/5 mL with Acetaminophen 216.7 mg/5 mL and Chlorpheniramine Maleate 1.3 mg/5 mL

Vicks Formula 44 Custom Care Cough & Cold PM

Procter & Gamble

10 mg/5 mL with Guaifenesin 100 mg/5 mL*

Cheracol D Cough Formula

Lee

Dextromethorphan Hydrobromide with Guaifenesin Syrup

Diabetic Tussin DM

Health Care Products

Guiatuss DM

Goldline

Robitussin Peak Cold Cough + Chest Congestion DM

Pfizer

Robitussin Sugar-Free Cough + Chest Congestion DM

Pfizer

10 mg/5 mL with Guaifenesin 100 mg/5 mL and Phenylephrine Hydrochloride 5 mg/5 mL*

Robitussin Peak Cold Multi-Symptom Cold

Pfizer

10 mg/5 mL with Guaifenesin 200 mg/5 mL

Diabetic Tussin DM Maximum Strength

Health Care Products

Robitussin Maximum Strength Cough + Chest Congestion

Pfizer

Robitussin Peak Cold Maximum Strength Cough + Chest Congestion

Pfizer

15 mg/5 mL with Guaifenesin 100 mg/5 mL*

Safe Tussin

Kramer

15 mg/5 mL with Promethazine Hydrochloride 6.25 mg/5 mL*

Promethazine Hydrochloride with Dextromethorphan Hydrobromide Cough Syrup

5 mg/mL with Guaifenesin 50 mg/mL and Phenylephrine Hydrochloride 2.5 mg/mL

Suppress DX Pediatric Drops

Kramer Novis

Suspension

5 mg/5 mL with Acetaminophen 160 mg/5 mL

Pediacare Fever Reducer Plus Cough & Sore Throat

Prestige Brands

5 mg/5 mL with Acetaminophen 160 mg/5 mL and Chlorpheniramine Maleate 1 mg/5 mL

Pediacare Fever Reducer Plus Cough & Runny Nose

Prestige Brands

5 mg/5 mL with Acetaminophen 160 mg/5 mL, Chlorpheniramine Maleate 1 mg/5 mL, and Phenylephrine Hydrochloride 2.5 mg/5 mL

Children’s Tylenol Plus Multi-Symptom Cold

McNeil

Pediacare Fever Reducer Plus Multi-Symptom Cold

Prestige Brands

Pediacare Fever Reducer Plus Flu

Prestige Brands

5 mg/5 mL with Acetaminophen 160 mg/5 mL and Phenylephrine Hydrochloride 2.5 mg/5 mL

Pediacare Fever Reducer Plus Cold & Cough

Prestige Brands

Tablets

10 mg with Acetaminophen 325 mg, Guaifenesin 200 mg, and Phenylephrine Hydrochloride 5 mg

Tylenol Cold & Flu Severe

McNeil

Tylenol Cold Head Congestion Severe

McNeil

10 mg with Acetaminophen 325 mg and Phenylephrine Hydrochloride 5 mg

Tylenol Cold Multi-Symptom Daytime

McNeil

10 mg with Acetaminophen 325 mg and Phenylephrine Hydrochloride 15 mg

Comtrex Cold & Cough Multi-Symptom Relief Maximum Strength Tablets

Novartis

30 mg with Chlorpheniramine Maleate 4 mg

Coricidin HBP Cough & Cold

Schering-Plough

Tablets, chewable

10 mg with Chlorpheniramine Maleate 2 mg and Pseudoephedrine Hydrochloride 30 mg

Dicel DM

Centrix

Tablets, extended-release

15 mg with Acetaminophen 500 mg and Chlorpheniramine Maleate 2 mg

Coricidin HBP Flu Maximum Strength

Schering-Plough

30 mg with Guaifenesin 600 mg

Mucinex DM

Reckitt Benckiser

60 mg with Guaifenesin 1200 mg

Maximum Strength Mucinex DM

Reckitt Benckiser

Tablets, film-coated

10 mg with Acetaminophen 325 mg, Chlorpheniramine Maleate 2 mg, and Phenylephrine Hydrochloride 5 mg

TheraFlu Warming Relief Caplets Nighttime Multi-Symptom Cold

Novartis

10 mg with Acetaminophen 325 mg and Phenylephrine Hydrochloride 5 mg

Comtrex Non-Drowsy Maximum Strength Caplets

Novartis

TheraFlu Warming Relief Caplets Daytime Multi-Symptom Cold

Novartis

Tylenol Cold Multi-Symptom Daytime

McNeil

15 mg with Acetaminophen 325 mg, Guaifenesin 200 mg, and Phenylephrine Hydrochloride 5 mg

Tylenol Cold Head Congestion Severe

McNeil

Dextromethorphan hydrobromide is also commercially available in combination with analgesic-antipyretics, antihistamines, and decongestants.

Dextromethorphan Polistirex

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Suspension, extended-release

equivalent to Dextromethorphan Hydrobromide 30 mg/5 mL

Delsym

Reckitt Benckiser

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 04/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Donatussin 10-2-15-100MG/5ML Syrup (LASER PHARMACEUTICALS): 473/$36.25 or 1419/$108.75

Duraphen Forte 30-30-1200MG 12-hr Tablets (KOWA PHARMACEUTICALS AMERICA): 100/$135.98 or 300/$375.97

Duratuss AC 12 15-12.5-15MG/5ML Suspension (VICTORY PHARMA): 473/$215.99 or 1419/$609.96

GFN 1200/DM 60 1200-60MG 12-hr Tablets (CYPRESS PHARMACEUTICAL): 30/$24.99 or 90/$65.97

GNP Tab Tussin DM 20-400MG Tablets (AMERISOURCE BERGEN DRUGS): 24/$12.99 or 48/$15.97

GNP Tussin Cough Long Acting 15MG/5ML Syrup (BERGEN BRUNSWIG): 118/$13.99 or 236/$16.97

Guaifenesin-DM 100-10MG/5ML Liquid (MORTON GROVE PHARMACEUTICALS): 240/$18.99 or 720/$49.97

Promethazine-DM 6.25-15MG/5ML Syrup (ACTAVIS MID ATLANTIC): 118/$20.99 or 236/$30.01

Q-Tussin DM 100-10MG/5ML Syrup (QUALITEST): 120/$11.99 or 240/$13.97

Robitussin DM 100-10MG/5ML Syrup (PFIZER CONSUMER HEALTHCARE): 237/$17.99 or 474/$25.98

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions March 27, 2014. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

Only references cited for selected revisions after 1984 are available electronically.

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101. Katona B, Wason S. Dextromethorphan danger. N Engl J Med. 1986; 314:993. [IDIS 213162] [PubMed 3960067]

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103. Dodds A, Revai E. Toxic psychosis due to dextromethorphan. Med J Aust. 1967; 2:231.

104. Weir JH. Dextromethorphan danger. N Engl J Med. 1986; 314:993.

105. Food and Drug Administration. Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; final monograph for OTC antitussive drug products. [21 CFR Parts 310, 341, and 369] Fed Regist. 1987; 52:30042-57.

106. Food and Drug Administration. Over-the-counter drug products; final monographs for antiemetic, antitussive, bronchodilator, and anthelmintic drug products; updating and technical changes. [21 CFR Parts 336, 341, and 357] Fed Regist. 1988; 53:35808-10.

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108. Rivers N, Horner B. Possible lethal reaction between Nardil and dextromethorphan. Can Med Assoc J. 1970; 103:85. [PubMed 20311659]

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110. Wyeth Consumer Healthcare. Robitussin (dextromethorphan hydrobromide) CoughGels liquid-filled capsules patient information. Radnor, PA. 2003.

111. Anon. FDA warns against abuse of dextromethorphan (DXM). FDA Talk Paper. 2005 May 20.

112. Boyer EW. Dextromethorphan abuse. Pediatr Emerg Care. 2004; 20:858-63. [PubMed 15572980]

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114. Banerji S, Anderson IB. Abuse of Coricidin HBP cough & cold tablets: episodes recorded by a poison center. Am J Health-Syst Pharm. 2001; 58:1811-4. [IDIS 470476] [PubMed 11596695]

115. Bryner JK, Wang UK, Hui JW et al. Dextromethorphan abuse in adolescence: an increasing trend: 1999-2004. Arch Pediatr Adolesc Med. 2006; 160:1217-22. [PubMed 17146018]

116. Srinivasan A, Budnitz D, Shehab N et al. Infant deaths associated with cough and cold medications—two states, 2005. MMWR Morb Mortal Wkly Rep. 2007; 56:1-4. [PubMed 17218934]

117. Food and Drug Administration. Cough and cold medications in children less than two years of age. Rockville, MD; 2007 Jan 12. From FDA website.

118. Anon. Makers pull cold medicines sold for infants. CNN News, 2007 Oct 11. From CNN.com website.

119. FDA public health advisory: nonprescription cough and cold medicine use in children. Rockville, MD; 2007 August 15. From FDA web site.

500. Food and Drug Administration. Drugs for human use; unapproved and misbranded oral drugs labeled for prescription use and offered for relief of symptoms of cold, cough, or allergy, enforcement action dates. Notice. [Docket No. FDA-2011-N-0100] Fed Regist. 2011; 76:11794-8.

120. Richwine L. U.S. panel against cold drugs for kids under 6. Reuters, 2007 Oct 19. From Reuters website.

a. Ballay Pharmaceuticals, Inc. Alacol DM Syrup (dextromethorphan HBr, phenylephrine, brompheniramine) prescribing information. Wimberley, TX: 2001 Nov.

b. AHFS Drug Information 2003. McEvoy GK, ed. Dextromethorphan. American Society of Health-System Pharmacists; 2003: page 2572-3.

c. American Pharmaceutical Association. Handbook of nonprescriptin drugs. 14th ed. Washington, DC: American Pharmaceutical Association; 2004:201-5.

d. Department of Health and Human Services, Food and Drug Administration. Part 341—Cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-counter human use; Subpart C—Labeling; Section 341.74—Labeling of antitussive drug products. [21 CFR 341.74] Available at GPO website. Accessed 2004 Apr 15.

e. Dextromethorphan. In: Briggs GG, Freeman RK, Yaffe SJ. Drug in pregnancy and lactation: a reference guide to fetal and neonatal risk. 6th ed. Philadelphia: Lippincott Williams & Wilkins; 2002:384-8.

f. The United States pharmacopeia, 27th rev, and The national formulary, 22nd ed. Rockville, MD: The United States Pharmacopeial Convention, Inc; 2004:580-1.

g. Wyeth Consumer Healthcare. DimetappCold & Cough DM (brompheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride) elixir patient information. From Wyeth Consumer Healthcare website. Accessed 2008 Feb 27.

h. Wyeth Consumer Healthcare. Dimetapp Long Acting Cough Plus Cold (chlorpheniramine maleate and dextromethorphan hydrobromide) oral solution patient information. From Wyeth Consumer Healthcare website. Accessed 2008 Feb 27.

i. McNeil-PPC, Inc. Tylenol Cold Multi-Symptom Nighttime (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, and phenylephrine hydrochloride) liquid patient information. From McNeil-PPC website. Accessed 2008 Feb 27.

j. McNeil-PPC, Inc. Tylenol Cold Multi-Symptom Severe (acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride) liquid patient information. From McNeil-PPC website. Accessed 2008 Feb 27.

k. Ethex Corporation. Tri-Vent DM (guaifenesin, pseudoephedrine hydrochloride, and dextromethorphan hydrobromide) syrup prescribing information. St. Louis, MO; 2002 Nov.

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