Acetaminophen, Chlorpheniramine, and Pseudoephedrine

Pronunciation

(a seet a MIN oh fen, klor fen IR a meen, & soo doe e FED rin)

U.S. Brand Names

Actifed® Cold and Sinus [OTC]; Alka-Seltzer® Plus Cold Liqui-Gels® [OTC]; Children's Tylenol® Plus Cold [OTC]; Comtrex® Maximum Strength Sinus and Nasal Decongestant [OTC]; Sinutab® Sinus Allergy Maximum Strength [OTC]; Thera-Flu® Cold and Sore Throat Night Time [OTC]; Tylenol® Allergy Sinus [OTC]

Synonyms

Acetaminophen, Pseudoephedrine, and Chlorpheniramine; Chlorpheniramine, Acetaminophen, and Pseudoephedrine; Chlorpheniramine, Pseudoephedrine, and Acetaminophen; Pseudoephedrine, Acetaminophen, and Chlorpheniramine; Pseudoephedrine, Chlorpheniramine, and Acetaminophen

Generic Available

Yes

Canadian Brand Names

Sinutab® Sinus & Allergy; Tylenol® Allergy Sinus

Use

Temporary relief of sinus symptoms

Pregnancy Risk Factor

Adverse Reactions

See individual agents.

Drug Interactions

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

Chlorpheniramine: Substrate of CYP2D6 (minor), 3A4 (major); 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 in 24 hours

Adults: 325-650 mg every 4-6 hours as needed; do not exceed 4 g/day

Antihistamine: Based on chlorpheniramine maleate component:

Children:

2-6 years: 1 mg every 4-6 hours (maximum: 6 mg/24 hours)

6-12 years: 2 mg every 4-6 hours (maximum: 12 mg/24 hours)

Children >12 years and Adults: 4 mg every 4-6 hours (maximum: 24 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 Medicine Liqui-Gels®:

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

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

Sinutab® Sinus Allergy Maximum Strength: Children >12 years and Adults: 2 tablets/caplets every 6 hours (maximum: 8 doses/24 hours)

Thera-Flu® Cold and Sore Throat Night Time: Children >12 years and Adults: 1 packet dissolved in hot water every 6 hours (maximum: 4 packets/24 hours)

Dietary Considerations

Children's Tylenol® Plus Cold contains phenylalanine 6 mg/tablet.

Thera-Flu® Cold and Sore Throat Night Time contains phenylalanine 11 mg/packet.

Dental Health: Effects on Dental Treatment

Key adverse event(s) related to dental treatment:

Chlorpheniramine: Significant xerostomia with prolonged use (normal salivary flow resumes upon discontinuation).

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 chlorpheniramine is countered by the excitability associated with pseudoephedrine; one effect may predominate in any particular patient

Mental Health: Effects on Psychiatric Treatment

Usually none; sedative effect of chlorpheniramine may be potentiated by other CNS depressants and MAO inhibitors

Dosage Forms

Caplet (Actifed® Cold and Sinus, Comtrex® Maximum Strength Sinus and Nasal Decongestant, Sinutab® Sinus Allergy Maximum Strength, Tylenol® Allergy Sinus): Acetaminophen 500 mg, chlorpheniramine maleate 2 mg, and pseudoephedrine hydrochloride 30 mg

Capsule, softgel (Alka-Seltzer® Plus Cold Liqui-Gels®): Acetaminophen 325 mg, chlorpheniramine maleate 2 mg, and pseudoephedrine hydrochloride 30 mg

Gelcap (Tylenol® Allergy Sinus): Acetaminophen 500 mg, chlorpheniramine maleate 2 mg, and pseudoephedrine hydrochloride 30 mg

Geltab (Tylenol® Allergy Sinus): Acetaminophen 500 mg, chlorpheniramine maleate 2 mg, and pseudoephedrine hydrochloride 30 mg

Powder for oral solution [packet] (Thera-Flu® Cold and Sore Throat Night Time): Acetaminophen 650 mg, chlorpheniramine maleate 4 mg, and pseudoephedrine hydrochloride 60 mg [contains phenylalanine 11 mg/packet; lemon flavor]

Suspension (Children's Tylenol® Plus Cold): Acetaminophen 160 mg, chlorpheniramine maleate 1 mg, and pseudoephedrine hydrochloride 15 mg per 5 mL (120 mL) [contains sodium benzoate; grape flavor]

Tablet, chewable (Children's Tylenol® Plus Cold): Acetaminophen 80 mg, chlorpheniramine maleate 0.5 mg, and pseudoephedrine hydrochloride 7.5 mg [contains phenylalanine 6 mg/tablet; grape flavor]

References

Barker JD Jr, de Carle DJ, and Anuras S, "Chronic Excessive Acetaminophen Use in Liver Damage," Ann Intern Med , 1977, 87(3):299-301.

Dionne RA, Campbell RA, Cooper SA, et al, "Suppression of Postoperative Pain by Preoperative Administration of Ibuprofen in Comparison to Placebo, Acetaminophen, and Acetaminophen Plus Codeine," J Clin Pharmacol , 1983, 23(1):37-43.

Licht H, Seeff LB, and Zimmerman HJ, "Apparent Potentiation of Acetaminophen Hepatotoxicity by Alcohol," Ann Intern Med , 1980, 92(4):511.

Mokhlesi B, Leikin JB, Murray P, et al, "Adult Toxicology in Critical Care: Part II: Specific Poisonings," Chest , 2003, 123(3):897-922.

International Brand Names

Sinutab® Sinus & Allergy (CA); Tylenol® Allergy Sinus (CA)

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