Dosing & Uses
Dosage Forms & Strengths
1-2 capsules or tablets PO q4-6hr PRN
Products vary; check specific labeling for each
Severe renal impairment (CrCl <10 mL/min): Avoid use
Severe hepatic impairment: Avoid use
Safety and efficacy not established
Serious - Use Alternative
Significant - Monitor Closely
Frequency Not Defined
- Angioedema, laryngeal edema
- Pruritic maculopapular rash, urticaria
- Agranulocytosis, leukopenia, neutropenia, pancytopenia, thrombocytopenia, thrombocytopenic purpura
- Anaphylactoid reaction
- Rash, urticaria
- Dyspepsia, heartburn, nausea, stomach pain, vomiting
- Tinnitus (high dose or long-term use)
- Palpitations (dose dependent), tachycardia
- Insomnia, restlessness, nervousness, tremor, irritability
- Diarrhea, nausea, vomiting
Hepatitis or severe hepatic or renal impairment
Repeated administration in patients with anemia or with cardiac, pulmonary, or renal disease
Risk of hepatotoxicity (higher in alcoholics and with use of >1 acetaminophen-containing product)
Glucose-6-phosphate dehydrogenase (G6PD) deficiency
Gastrointestinal (GI) bleeding; exercise particular caution in patients with history of GI bleeding, alcoholism, or bleeding disorders
Avoid with active peptic ulcer disease
Avoid with severe renal impairment (ie, CrCl <10 mL/min)
Avoid with severe hepatic impairment
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
Pregnancy & Lactation
Pregnancy category: D; avoid during pregnancy, particularly in third trimester because of risk of premature closure of ductus arteriosus
Lactation: Drug is excreted in breast milk; do not nurse
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: Acts on hypothalamus to produce antipyresis
Aspirin: Acts on hypothalamus to produce antipyresis; anti-inflammatory properties are attributed to inhibition of prostaglandin synthetase, resulting in decreased formation of thromboxane A2
Caffeine: Vasoconstrictive properties may be helpful in treatment of vascular headaches