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Paracetamol/Phenylephrine/Guaifenesin

    DEA Class;  OTC

    Common Brand Names; Theraflu Warming Relief Cold & Chest Congestion, Tylenol Sinus Congestion & Pain Severe, Sudafed PE Triple Action, Mucinex Fast-Max Cold & Sinus

    •  Cough/Cold, Other Combos; 
    • Analgesic/Decongestant/Expectorant 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

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

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

    Indicated for Temporary Relief of Sinus Congestion, Headache, Minor Aches & Pains

    Hypersensitivity

    G-6-PD deficiency

    Severe hepatotoxicity

    Hypertension

    Severe peripheral and visceral vasoconstriction

    Tachycardia

    Dizziness

    Drowsiness

    Excitability

    Headache

    Restlessness

    Tremor

    Dermatologic rash

    Nausea

    Vomiting

    Anemia blood dyscrasias (neutropenia, pancytopenia, leukopenia)

    Bilirubin and alkaline phosphatase may increase

    Phenylephrine: Caution in elderly patients, hyperthyroidism, myocardial disease, bradycardia, partial heart block or severe arteriosclerosis

    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

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

    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 tabs PO q4hr; not to exceed 12 tabs/24hr; not to exceed 1g/hr or 4g/day of acetaminophen

    30 mL [(325mg/5mg/200mg)/15mL] PO q4hr

    20 mL [(162.5mg/5mg/2.5mg/100mg)/5mL] PO q4hr

    Pediatric

    <12 years: Ask a pediatrician

    ≥12 years

    2 tabs PO q4hr; not to exceed 12 tabs/24hr; not to exceed 1g/hr or 4g/day of acetaminophen

    30 mL [(325mg/5mg/200mg)/15mL] PO q4hr

    20 mL [(162.5mg/5mg/2.5mg/100mg)/5mL] PO q4hr

    acetaminophen/phenylephrine/guaifenesin

    tablet

    • 325mg/5mg/200mg

    oral solution

    • (325mg/5mg/200mg)/15mL
    • (162.5mg/5mg/2.5mg/100mg)/5mL