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Paracetamol/Doxylamine/Dextromethorphan/Phenylephrine

    DEA Class;  OTC

    Common Brand Names; Alka-Seltzer Plus Night Cold Formula, Tylenol Cold Multi-Symptom Nighttime Liquid, Alka-Seltzer Plus Night Severe Cold, Cough & Flu, Alka-Seltzer Plus Night Sinus Congestion, Allergy & Cough

    •  Cough/Cold, Non-narcotic Combos; 
    • Analgesic/Antihistamine/Antitussive/Decongestant Combos

    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

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

    Hypersensitivity

    Asthma

    Narrow-angle glaucoma

    Symptomatic prostate hypertrophy

    Bladder-neck obstruction

    Stenosing peptic ulcer

    G-6-PD deficiency

    Severe hepatic impairment

    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

    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

    Pregnancy category: C

    Lactation: excreted in breast milk, use caution

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

    Adults

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

    Pediatric

    <12 Years

    Ask a pediatrician

    ≥12 Years

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

    acetaminophen/doxylamine/dextromethorphan/phenylephrine

    capsule

    • 325mg/6.25mg/10mg/5mg