acetaminophen/doxylamine/dextromethorphan/phenylephrine (OTC)

Brand and Other Names:Alka-Seltzer Plus Night Cold Formula, Tylenol Cold Multi-Symptom Nighttime Liquid, more...Alka-Seltzer Plus Night Severe Cold, Cough & Flu, Alka-Seltzer Plus Night Sinus Congestion, Allergy & Cough
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

acetaminophen/doxylamine/dextromethorphan/phenylephrine

capsule

  • 325mg/6.25mg/10mg/5mg
more...

Congestion, Rhinorrhea, Cough, Sore Throat, Headache, Fever, Minor Aches & Pains

2 caps PO q4hr PRN; not to exceed 12 caps/day

Dosage Forms & Strengths

acetaminophen/doxylamine/dextromethorphan/phenylephrine

capsule

  • 325mg/6.25mg/10mg/5mg
more...

Congestion, Rhinorrhea, Cough, Sore Throat, Headache, Fever, Minor Aches & Pains

<12 Years

  • Ask a pediatrician

≥12 Years

  • 2 caps PO q4hr PRN; not to exceed 12 caps/day
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Interactions

Interaction Checker

and acetaminophen/doxylamine/dextromethorphan/phenylephrine

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      Serious - Use Alternative

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            Adverse Effects

            Frequency Not Defined

            Hypertension

            Reflex tachycardia

            Severe peripheral and visceral vasoconstriction

            Dizziness

            Drowsiness

            Excitability

            Headache

            Restlessness

            Tremor

            Dermatologic rash

            GI disturbances

            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

            Contraindications

            Hypersensitivity

            Asthma

            Narrow-angle glaucoma

            Symptomatic prostate hypertrophy

            Bladder-neck obstruction

            Stenosing peptic ulcer

            G-6-PD deficiency

            Severe hepatic impairment

            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

            Acetaminophen contained in many OTC products & combined use with these products may result in toxicity due to cumulative doses exceeding recommended maximum dose

            Do not take dextromethorphan for persistent or chronic cough associated with smoking, asthma, or emphysema, or if it is accompanied by excessive phlegm unless directed by a healthcare provider

            Dextromethorphan may slow respiration rate

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

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: excreted in breast milk, use caution

            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 the hypothalamic heat-regulating center

            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

            Dextromethorphan: cough suppressant that acts centrally on the cough center in the medulla

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

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

            Pharmacokinetics

            Acetaminophen

            • Peak plasma time: 10-60 min (PO immediate release); 60-120 min (PO extended release); 6 hr (PO 500 mg tablet); 8 hr (PO 650 mg extended release tablet)
            • Vd: 1 L/kg
            • Protein binding: 10-25%
            • Metabolism: Liver (microsomal enzyme systems); conjugation (glucuronic acid)
            • Half-life: 1.25-3hr
            • Excretion: Urine

            Dextromethorphan

            • Onset: 15-30 min
            • Duration: 3-6 hr
            • Metabolism: Hepatic P450 enzyme CYP2D6
            • Excretion: Urine
            • Half-life: 2-4 hr (extensive metabolizers); 24 hr (poor metabolizers)
            • Peak plasma time: 2-3 hr

            Phenylephrine

            • Half-life: 2-3 hr
            • Onset: 10-15 min
            • Duration: 15 min
            • Bioavailability: < 38%
            • Excretion: Urine (80-90%)
            • Peak plasma time: 0.75-2 hr
            • Vd: 26-61 L
            • Vdss: 340 L

            Doxylamine

            • Peak plasma time: 2-3 hr
            • Half-life: 10-12 hr
            • Excretion: Urine
            • Metabolism: Liver (CYP450)
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            Images

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