acetaminophen/phenyltoloxamine (OTC)

Frequency Not Specified

Angioedema

Laryngeal edema

Sedation

Pruritic maculopapular rash

Urticaria

Xerostomia

Agranulocytosis

Leukopenia

Neutropenia

Pancytopenia

Thrombocytopenia

Thrombocytopenic purpura

Hepatotoxicity

Blurred vision

Anaphylactoid reaction

Contraindications

Hypersensitivity to drugss or formulation components

Hepatitis or severe hepatic/renal impairment

Cautions

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

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: Inhibitis prostaglandin sythesis in CNS and may block peripheral pain impulse generation; acts on hypothalamus to produce antipyresis

Phenyltoloxamine: Antihistamine H1 blocking agent; used for sedative properties