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Paracetamol/Dextromethorphan/Pseudoephedrine/Guaifenesin

    DEA Class;  OTC

    Common Brand Names; Tylenol Cold Severe Congestion

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

    Acetaminophen blocks pain impulse generation peripherally and may inhibit the generation of prostaglandin in the CNS. Reduces fever by inhibiting the hypothalamic heat-regulating center.

    Dextromethorphan is a cough suppressant that acts centrally on the cough center in the medulla.

    Pseudoephedrine stimulates the alpha-adrenergic receptors causing bronchodilation and vasoconstriction.

    Guaifenesin increases respiratory tract fluid secretions and helps to loosen phlegm and bronchial secretions.

    For Symptomatic Relief of Cough & Congestion

    Documented hypersensitivity to the drugs or within 14 days of MAO inhibitor therapy; known G-6-PD deficiency

    Arrhythmia

    Palpitations

    Convulsion

    Dizziness

    Drowsiness

    Excitability

    Headache

    Tremor

    Weakness

    Dermatologic rash

    GI disturbances

    Nausea

    Vomiting

    Anemia blood dyscrasias (neutropenia, pancytopenia, leukopenia)

    Bilirubin and alkaline phosphatase may increase

    Caution in cardiovascular disease, diabetes mellitus, prostatic hypertrophy and increased intraocular pressure when taking pseudoephedrine

    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

    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 the breathing

    Guaifenesin is not for administration in persistent cough associated with chronic bronchitis, smoking, asthma, or accompanied with excessive secretions

    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

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

    Adults

    2 tablets PO q6hr; not to exceed 8 tablets/day

    Pediatric

    <12 Years Old

    Not recommended

    >12 Years Old

    2 tablets PO q6hr; not to exceed 8 tablets/day

    acetaminophen/dextromethorphan/pseudoephedrine/guaifenesin

    tablet

    • 325mg/15mg/30mg/200mg