Excedrin Migraine (acetaminophen, aspirin and caffeine)

What it contains

The active ingredients are acetaminophen, aspirin (an NSAID) and caffeine. The Excedrin Migraine label states one use: “treats migraine”. Excedrin Extra Strength has the same three active ingredients, but the label opened for this page lists minor aches and pains, including headache, and does not name migraine.

Rules differ by country. The dose comes from the label or a prescriber.

Results at 2 hours

Lipton 1998 reports three double-blind, placebo-controlled trials of a single dose, with 1,220 people in the efficacy analysis.

Outcome	Combination	Placebo
Pain reduced to mild or none at 2 hours	59.3%	32.8%
Pain-free at 6 hours	50.8%	23.5%

The trials excluded the most severely disabled patients: people whose attacks usually required bed rest and people who vomited in 20% or more of attacks.

Label warnings

The warnings cover all three ingredients:

• Reye’s syndrome. Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product.
• Liver. Severe liver damage may occur above the label’s daily amount, with other medicines containing acetaminophen, or with 3 or more alcoholic drinks a day. The label says not to use it with any other medicine containing acetaminophen.
• Stomach bleeding. The risk is higher from age 60, with past ulcers or bleeding, with blood thinners, steroids or other NSAIDs, and with 3 or more alcoholic drinks a day.
• Allergy. The label lists severe skin reactions from acetaminophen and severe allergic reactions from aspirin. Do not use after an allergic reaction to either or to another pain reliever or fever reducer.
• Caffeine. Limit other caffeine-containing medicines, foods and drinks, because too much can cause nervousness, irritability, sleeplessness and occasionally rapid heartbeat.
• Pregnancy. Ask a health professional before use. The label says it is especially important not to use aspirin at 20 weeks or later unless a doctor directs it.

The label says to ask a doctor first with undiagnosed migraine, a different or worst-ever headache, a first headache after age 50, headaches after head injury, exertion, coughing or bending, fever with stiff neck, daily headaches, migraine requiring bed rest, vomiting with migraine, liver, kidney or heart conditions, high blood pressure, asthma, or diuretics. It says to ask a doctor or pharmacist first when taking prescription medicines for diabetes, gout or arthritis. For under-18s, the directions say to ask a doctor.

Monthly limit: 10 days

ICHD-3 defines a combination painkiller as a product that joins drugs of two or more classes, including an adjuvant such as caffeine. Acetaminophen with aspirin alone would not qualify. Caffeine is what moves this product to section 8.2.5, with a limit of 10 or more days a month for more than 3 months. ICHD-3 says the most commonly overused combinations join non-opioid painkillers with opioids, butalbital or caffeine.

The US label agrees: “Headaches may worsen if this product is used for 10 or more days per month.” The medication days counter has a separate line for combination painkillers.

In a headache diary

Enter this product as one combination, not as separate acetaminophen and aspirin. Otherwise the days fall under the 15-day limit instead of the 10-day limit. Record pain at 2 hours, and note how much other caffeine you had that day.