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Paracetamol/Caffeine/Pyrilamine

    Brands

    DEA Class;  OTC

    Common Brand Names; Midol Complete

    Analgesics, Other combo

    Acetaminophen: Acts on hypothalamus to produce analgesia

    Caffeine: Vasoconstrictive properties may be helpful when treating vascular headaches

    Pyrilamine: Elicits mild diuretic properties

    Indicated for temporary relief of symptoms associated with menstrual periods

    Hypersensitivity to drug or components

    Acetaminophen

    Pruritic maculopapular rash

    Urticaria

    Laryngeal edema

    Angioedema

    Anaphylactoid reaction

    Thrombocytopenia

    Leukopenia

    Pancytopenia

    Neutropenia

    Thrombocytopenic purpura

    Agranulocytosis

    Hepatotoxicity

    Caffeine

    Insomnia

    Restlessness

    Nervousness

    Tremor

    Tinnitus

    Irritability

    Nausea

    Vomiting

    Diarrhea

    Tachycardia

    Diuresis

    Palpitations (dose dependent)

    Pyrilamine

    Sedation

    Xerostomia

    Blurred vision

    Risk of hepatotoxicity; risk is higher in alcoholics or with use of more than one acetaminophen-containing product

    Caution regarding daily acetaminophen consumption; do not exceed 3-4 g/day and do not take for prolonged duration G6PD deficiency

    May cause CNS depression, which may impair mental and physical abilities; caution patients about performing tasks requiring mental alertness, including operating heavy machinery

    Caution with glaucoma, difficulty in urination caused by prostate gland enlargement, and emphysema or chronic bronchitis

    Allergic reactions reported with acetaminophen; discontinue immediately if symptoms of allergic or hypersensitivity reactions occur

    Additive sedation may occur if used with alcohol or sedative drugs

    Acetaminophen associated with increased 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

    Pregnancy category: C

    Lactation: Excreted in breast milk

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

    Adults

    2 caplets PO q6hr prn; not to exceed 6 caplets/day

    Pediatric

    <12 years: Safety and efficacy not established

    12 years or older: 2 caplets PO q6hr prn; not to exceed 8 caplets/day

    acetaminophen/caffeine/pyrilamine

    caplet

    • 500mg/60mg/15mg