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Acetaminophen, Dextromethorphan, and Pseudoephedrine


Pronunciation

 (a seet a MIN oh fen, deks troe meth OR fan, & soo doe e FED rin)


U.S. Brand Names

 Alka-Seltzer® Plus Flu Liqui-Gels® [OTC]; Comtrex® Non-Drowsy Cold and Cough Relief [OTC]; Contac® Severe Cold and Flu/Non-Drowsy [OTC]; Infants' Tylenol® Cold Plus Cough Concentrated Drops [OTC]; Sudafed® Severe Cold [OTC]; Thera-Flu® Severe Cold Non-Drowsy [OTC] [DSC]; Triaminic® Cough and Sore Throat Formula [OTC]; Tylenol® Cold Day Non-Drowsy [OTC]; Tylenol® Flu Non-Drowsy Maximum Strength [OTC]; Vicks® DayQuil® Multi-Symptom Cold and Flu [OTC]


Synonyms

 Dextromethorphan, Acetaminophen, and Pseudoephedrine; Pseudoephedrine, Acetaminophen, and Dextromethorphan; Pseudoephedrine, Dextromethorphan, and Acetaminophen


Generic Available

 Yes


Canadian Brand Names

 Contac® Cough, Cold and Flu Day & Night™; Sudafed® Cold & Cough Extra Strength; Tylenol® Cold Daytime


Use

 Treatment of mild to moderate pain and fever; symptomatic relief of cough and congestion


Adverse Reactions

 See individual agents.


Drug Interactions

Acetaminophen: Substrate (minor) of CYP1A2, 2A6, 2C8/9, 2D6, 2E1, 3A4; Inhibits CYP3A4 (weak)

Dextromethorphan: Substrate of CYP2B6 (minor), 2C8/9 (minor), 2C19 (minor), 2D6 (major), 2E1 (minor), 3A4 (minor); Inhibits CYP2D6 (weak)

Also see individual agents.


Ethanol/Nutrition/Herb Interactions

 Ethanol: Excessive intake of ethanol may increase the risk of acetaminophen-induced hepatotoxicity. Avoid ethanol or limit to <3 drinks/day.


Pharmacodynamics/Kinetics

 See individual agents.


Dosage

 Oral:

Analgesic: Based on acetaminophen component:

Children: 10-15 mg/kg/dose every 4-6 hours as needed; do not exceed 5 doses/24 hours

Adults: 325-650 mg every 4-7 hours as needed; do not exceed 4 g/day

Cough suppressant: Based on dextromethorphan component:

Children 6-12 years: 15 mg every 6-8 hours; do not exceed 60 mg/24 hours

Children >12 years and Adults: 10-20 mg every 4-8 hours or 30 mg every 8 hours; do not exceed 120 mg/24 hours

Decongestant: Based on pseudoephedrine component:

Children:

2-6 years: 15 mg every 4 hours (maximum: 90 mg/24 hours)

6-12 years: 30 mg every 4 hours (maximum: 180 mg/24 hours)

Children >12 years and Adults: 60 mg every 4 hours (maximum: 360 mg/24 hours)

Product labeling:

Alka-Seltzer Plus® Cold and Flu Liqui-Gels®:

Children 6-12 years: 1 dose every 4 hours (maximum: 4 doses/24 hours)

Children >12 years and Adults: 2 dose every 4 hours (maximum: 4 doses/24 hours)

Infants' Tylenol® Cold Plus Cough Concentrated Drops: Children 2-3 years (24-55 lb): 2 dropperfuls every 4-6 hours (maximum: 4 doses/24 hours)

Sudafed® Severe Cold, Thera-Flu® Non-Drowsy Maximum Strength (gelcap), Tylenol® Flu Non-Drowsy Maximum Strength: Children >12 years and Adults: 2 doses every 6 hours (maximum: 8 doses/24 hours)

Tylenol® Cold Non-Drowsy:

Children 6-11 years: 1 dose every 6 hours (maximum: 4 doses/24 hours)

Children 12 years and Adults: 2 doses every 6 hours (maximum: 8 doses/24 hours)

Thera-Flu® Non-Drowsy Maximum Strength: Children >12 years and Adults: 1 packet dissolved in hot water every 6 hours (maximum: 4 packets/24 hours)


Dietary Considerations

 Thera-Flu® Severe Cold Non-Drowsy contains phenylalanine 17 mg/packet.


Dental Health: Effects on Dental Treatment

 Key adverse event(s) related to dental treatment: Pseudoephedrine: Xerostomia (normal salivary flow resumes upon discontinuation).


Dental Health: Vasoconstrictor/Local Anesthetic Precautions

 Use with caution since pseudoephedrine is a sympathomimetic amine which could interact with epinephrine to cause a pressor response


Mental Health: Effects on Mental Status

 Sedation with dextromethorphan tends to be countered by the excitability associated with pseudoephedrine; one effect may predominate in any particular patient


Mental Health: Effects on Psychiatric Treatment

 Increased toxicity and hypertensive crisis may be seen with concurrent use of MAO inhibitors and CNS depressants, effects of CNS depressants may be lessened


Dosage Forms

 [DSC] = Discontinued product

Caplet:

Contac® Severe Cold and Flu/Non-Drowsy, Sudafed® Severe Cold, Tylenol® Cold Non-Drowsy: Acetaminophen 325 mg, dextromethorphan hydrobromide 15 mg, and pseudoephedrine hydrochloride 30 mg

Comtrex® Non-Drowsy Cold and Cough Relief: Acetaminophen 500 mg, dextromethorphan hydrobromide 15 mg, and pseudoephedrine hydrochloride 30 mg [contains benzoic acid]

Thera-Flu® Severe Cold Non-Drowsy: Acetaminophen 500 mg, dextromethorphan hydrobromide 15 mg, and pseudoephedrine hydrochloride 30 mg [contains lactose] [DSC]

Tylenol® Cold Day Non-Drowsy: Acetaminophen 325 mg dextromethorphan hydrobromide 15 mg, and pseudoephedrine hydrochloride 30 mg

Capsule, liquid

Alka-Seltzer Plus® Flu Liqui-Gels®: Acetaminophen 325 mg, dextromethorphan hydrobromide 10 mg, and pseudoephedrine hydrochloride 30 mg

Vicks® DayQuil® Multi-Symptom Cold and Flu: Acetaminophen 250 mg, dextromethorphan hydrobromide 10 mg, and pseudoephedrine hydrochloride 30 mg

Gelcap:

Tylenol® Cold Day Non-Drowsy: Acetaminophen 325 mg dextromethorphan hydrobromide 15 mg, and pseudoephedrine hydrochloride 30 mg [contains benzyl alcohol]

Tylenol® Flu Non-Drowsy Maximum Strength: Acetaminophen 500 mg, dextromethorphan hydrobromide 15 mg, and pseudoephedrine hydrochloride 30 mg

Liquid:

Triaminic® Cough and Sore Throat Formula: Acetaminophen 160 mg, dextromethorphan hydrobromide 7.5 mg, and pseudoephedrine hydrochloride 15 mg per 5 mL (120 mL, 240 mL) [contains benzoic acid; grape flavor]

Vicks® DayQuil® Multi-Symptom Cold and Flu: Acetaminophen 325 mg, dextromethorphan hydrobromide 10 mg, and pseudoephedrine hydrochloride 30 mg per 15 mL (175 mL)

Powder for oral solution [packet] (Thera-Flu® Severe Cold Non-Drowsy): Acetaminophen 1000 mg, dextromethorphan hydrobromide 30 mg, and pseudoephedrine hydrochloride 60 mg [contains phenylalanine 17 mg/packet; lemon flavor] [DSC]

Suspension, oral drops (Infants' Tylenol® Cold Plus Cough Concentrated Drops): Acetaminophen 160 mg, dextromethorphan hydrobromide 5 mg, and pseudoephedrine hydrochloride 15 mg per 1.6 mL (15 mL) [1.6 mL = 2 dropperfuls] [cherry flavor]


International Brand Names

 Contac® Cough, Cold and Flu Day & Night™ (CA); Sudafed® Cold & Cough Extra Strength (CA); Tylenol® Cold Daytime (CA)


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