acetaminophen/doxylamine/phenylephrine (OTC)

Brand and Other Names:Alka-Seltzer Plus Severe Allergy Sinus Congestion & Headache, Vicks NyQuil Sinus, more...QlearQuil Nighttime Sinus & Congestion Relief
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

acetaminophen/doxylamine/phenylephrine

capsule

  • 325mg/6.25mg/5mg
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Sinus Pain, Congestion, Rhinorrhea, Sneezing, Headache

2 capsules PO q4hr; not to exceed 6 doses/day

Dosage Forms & Strengths

acetaminophen/doxylamine/phenylephrine

capsule

  • 325mg/6.25mg/5mg
more...

Sinus Pain, Congestion, Rhinorrhea, Sneezing, Headache

Vicks NyQuil Sinus

  • <12 years: Ask a pediatrician
  • ≥12 years: 2 capsules PO q4hr; not to exceed 6 doses/day
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Interactions

Interaction Checker

and acetaminophen/doxylamine/phenylephrine

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Adverse Effects

            Frequency Not Defined

            Hypertension

            Reflex tachycardia

            Severe peripheral & visceral vasoconstriction

            Dizziness

            Drowsiness

            Excitability

            Headache

            Restlessness

            Tremor

            Dermatologic rash

            Anemia blood dyscrasias (neutropenia, pancytopenia, leukopenia)

            Bilirubin & alkaline phosphatase may increase

            Dry mouth, throat, and nose

            Thickening of mucus in nose or throat

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            Warnings

            Contraindicated in documented hypersensitivity; asthma attacks, narrow-angle glaucoma, symptomatic prostate hypertrophy, bladder-neck obstruction, and stenosing peptic ulcer; known G-6-PD deficiency

            Acetaminophen hepatotoxicity possible in chronic alcoholics following various dose levels; severe or recurrent pain or high or continued fever may indicate a serious illness; contained in many OTC products and combined use with these products may result in toxicity due to cumulative doses exceeding recommended maximum dose

            Doxylamine may exacerbate angle closure glaucoma, hyperthyroidism, peptic ulcer, or urinary tract obstruction; xerostomia may occur

            Phenylephrine is a vasoconstrictor and a decongestant that relieves symptoms resulting from irritation of upper respiratory tract tissue. It shrinks swollen mucous membranes, reduces nasal congestion and tissue hyperemia.

            Contraindications

            Documented hypersensitivity

            Asthma

            Narrow-angle glaucoma

            Symptomatic prostate hypertrophy

            Bladder-neck obstruction

            Stenosing peptic ulcer

            Known G-6-PD deficiency

            Cautions

            Acetaminophen hepatotoxicity possible in chronic alcoholics following various dose levels; severe or recurrent pain or high or continued fever may indicate a serious illness; contained in many OTC products and combined use with these products may result in toxicity due to cumulative doses exceeding recommended maximum dose

            Acetaminophen: Risk for rare, but serious skin reactions that can be fatal; these reactions include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP); symptoms may include skin redness, blisters and rash

            Doxylamine may exacerbate angle closure glaucoma, hyperthyroidism, peptic ulcer, or urinary tract obstruction; xerostomia may occur

            Phenylephrine is a vasoconstrictor and may increase blood pressure

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            Pregnancy & Lactation

            Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Acetaminophen: Blocks pain impulse generation peripherally & may inhibit the generation of prostaglandin in the CNS; reduces fever by inhibiting hypothalamic heat-regulating center

            Doxylamine: Competitively blocks histamine from binding to H1 receptors; significant antimuscarinic activity & penetrates CNS, which causes pronounced tendency to induce sedation

            Phenylephrine: Vasoconstrictor & decongestant that relieves symptoms resulting from irritation of upper respiratory tract tissue; shrinks swollen mucous membranes, reduces nasal congestion & tissue hyperemia

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