Section 02 · Monograph
Aspirin-acetaminophen-caffeine
Reviewed Nov 2026FDA label
Excedrin MigraineAnalgesic combination
- Forms
- Tab: 250/250/65mg
- Dose
- 2 tabs once; max 2 tabs/24h (OTC)
- MOA
- COX inhibition + central analgesia; caffeine adjunct
Indications
- Over-the-counter treatment of mild to moderate migraine painFDA-labeled
Mechanism of Action
- Aspirin inhibits COX; acetaminophen provides central analgesia; caffeine adds analgesic enhancement and may speed absorption
Full Dosing
Adult / usual
- Two caplets (each aspirin 250mg, acetaminophen 250mg, caffeine 65mg) with water; for migraine, no more than 2 caplets in 24 hours
- Limit use to fewer than 10-15 days per month to avoid medication overuse headache
- Account for total daily acetaminophen intake (maximum 4g from all sources)
Contraindications
- Aspirin or NSAID allergy
- Children and teens with viral illness (Reye syndrome)
- Active bleeding; severe liver disease
Drug Interactions
- Anticoagulants and other NSAIDs: bleeding risk
- Alcohol and other acetaminophen products: hepatotoxicity risk
- Other caffeine sources increase jitteriness
Adverse Effects
- Nervousness, insomnia, palpitations
- GI upset and bleeding
- Medication overuse headache with frequent use
- Hepatotoxicity if acetaminophen limits are exceeded
Monitoring Parameters
- Frequency of use (headache days)
- Total daily acetaminophen
- GI bleeding signs
Pregnancy & Lactation
- Avoid in the third trimester (aspirin); moderate caffeine intake
- Small amounts in milk