Dosing & Uses
Dosage Forms & Strengths
1-2 tablets or capsules PO q4-6hr PRN
Products vary, see brand section & check specific labeling for each
Safety & efficacy not established
Frequency Not Specified
Pruritic maculopapular rash
Hypersensitivity to drugss or formulation components
Hepatitis or severe hepatic/renal impairment
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 & Lactation
Pregnancy category: C
Lactation: Excreted in breast milk
Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs
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