acetaminophen/caffeine/pyrilamine (OTC)

Frequency Not Defined (acetaminophen)

Pruritic maculopapular rash

Urticaria

Laryngeal edema

Angioedema

Anaphylactoid reaction

Thrombocytopenia

Leukopenia

Pancytopenia

Neutropenia

Thrombocytopenic purpura

Agranulocytosis

Hepatotoxicity

Frequency Not Defined (caffeine)

Insomnia

Restlessness

Nervousness

Tremor

Tinnitus

Irritability

Nausea

Vomiting

Diarrhea

Tachycardia

Diuresis

Palpitations (dose dependent)

Frequency Not Defined (pyrilamine)

Sedation

Xerostomia

Blurred vision

Contraindications

Hypersensitivity to drug or components

Cautions

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

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Acetaminophen: Acts on hypothalamus to produce analgesia

Caffeine: Vasoconstrictive properties may be helpful when treating vascular headaches

Pyrilamine: Elicits mild diuretic properties