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Paracetamol/Phenyltoloxamine

    DEA Class;  OTC

    Common Brand Names; Phenagesic, AcetaGesic, Lagesic, PB Poly-650, Flextra DS, Phenylgesic, Relagesic Liquid, Staflex

    • Analgesic/Other  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 Analgesia

    Hypersensitivity to drugss or formulation components

    Hepatitis or severe hepatic/renal impairment

    Angioedema

    Laryngeal edema

    Sedation

    Pruritic maculopapular rash

    Urticaria

    Xerostomia

    Agranulocytosis

    Leukopenia

    Neutropenia

    Pancytopenia

    Thrombocytopenia

    Thrombocytopenic purpura

    Hepatotoxicity

    Blurred vision

    Anaphylactoid reaction

    Caution in G6PD deficiency

    Consumption of 3 or more alcoholic beverages/day may increase risk for liver damage (associated with acetaminophen)

    Do not take with other products that contain acetaminophen due to risk of additive toxicity/overdose

    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

    May cause CNS depression and impair ability to operate heavy machinery

    May cause hepatotoxicity in acute overdose

    Use caution in glaucoma, hepatic impairment, prostatic hyperplasia, respiratory disease, and renal impairment

    Pregnancy category: C

    Lactation: Excreted in breast milk

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

    Adults

    1-2 tablets or capsules PO q4-6hr PRN

    Products vary, see brand section & check specific labeling for each

    Pediatric

    Safety & efficacy not established

    acetaminophen/phenyltoloxamine

    tablet

    • 325mg/30mg
    • 500mg/50mg
    • 500mg/55mg
    • 600mg/66mg
    • 650mg/60mg