Excedrin Migraine

Excedrin Migraine is a combination over-the-counter medication containing three active ingredients that work together to relieve migraine headache pain:

• Acetaminophen (250 mg): A pain reliever and fever reducer
• Aspirin (250 mg): A salicylate NSAID that reduces pain, fever, and inflammation by blocking substances in the body that cause these symptoms
• Caffeine (65 mg): A central nervous system stimulant that enhances pain relief and improves blood flow by relaxing muscle contractions in blood vessels.

This triple-action formula is specifically designed to treat migraine headaches and tension headaches.

The three-ingredient combination provides comprehensive migraine relief through multiple mechanisms:

• Pain blocking: Acetaminophen and aspirin work through different pathways to interrupt pain signals
• Anti-inflammatory action: Aspirin reduces inflammation that contributes to headache pain
• Enhanced effectiveness: Caffeine acts as a pain-relieving aid, making the other ingredients work more effectively while also constricting dilated blood vessels associated with migraines.

The caffeine content (65 mg per dose) is approximately equivalent to one cup of coffee.

Approved use:

• Treatment of migraine headaches
• Relief of tension headaches.

Not approved for:

• Daily headache prevention
• Chronic migraine management (prolonged use may cause medication overuse headaches)
• Headaches in children under 18 without doctor guidance.

Reye's Syndrome Risk in Children

Never give Excedrin Migraine to children or teenagers with fever, flu symptoms, or chickenpox. Aspirin can cause Reye's syndrome, a rare but serious and sometimes fatal condition affecting the liver and brain.

Liver Damage Warning

Acetaminophen overdose can cause severe liver damage or death. The maximum safe dose is 2 caplets in 24 hours. Early signs of liver problems include nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, and jaundice (yellowing of skin or eyes).

Severe liver damage may occur if you take:

• More than 2 caplets in 24 hours (the maximum daily amount)
• With other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product.

Stomach Bleeding Risk

Aspirin may cause severe stomach or intestinal bleeding, which can be fatal. This risk increases if you:

• Are aged 60 or older
• Have a history of stomach ulcers or bleeding
• Take blood thinners or steroid medications
• Use other NSAIDs (ibuprofen, naproxen)
• Consume 3 or more alcoholic drinks daily
• Take more than directed or use for longer than recommended.

Allergy Alerts

Acetaminophen: May rarely cause severe, potentially fatal skin reactions, including skin reddening, blisters, rash, and peeling. Stop use immediately and seek medical help if skin reactions occur.

Aspirin: May cause severe allergic reactions, including hives, facial swelling, asthma (wheezing), and shock.

Medication Overuse Headache

Using Excedrin Migraine for 10 or more days per month may worsen headaches. This creates a cycle where headaches become more frequent and severe, requiring more medication.

Do not use this medication if you:

• Are allergic to acetaminophen, aspirin, caffeine, or any NSAIDs (ibuprofen, naproxen, celecoxib, indomethacin, meloxicam, others)
• Are a child or teenager under 18 with fever, flu, or chickenpox
• Are taking other products containing acetaminophen (risk of overdose)
• Have had severe skin reactions to acetaminophen or aspirin in the past.

Pregnancy and Breastfeeding Considerations

Pregnancy

Aspirin may harm an unborn baby's heart, reduce birth weight, or cause other dangerous effects. It is especially important not to use aspirin during the last 3 months of pregnancy unless your doctor specifically directs you to do so, as it may cause complications during delivery.

Tell your doctor immediately if you are pregnant or planning to become pregnant.

Breastfeeding

Acetaminophen, aspirin, and caffeine pass into breast milk and may harm a nursing infant. Do not breastfeed while taking Excedrin Migraine.

Consult Your Doctor First If You Have:

• Liver disease - Including cirrhosis or a history of alcoholism
• Stomach problems - Ulcers, bleeding, ulcerative colitis, or heartburn
• Kidney disease
• Bleeding disorders - Hemophilia or clotting problems
• Heart disease or high blood pressure
• Asthma or seasonal allergies
• Diabetes (taking medication)
• Gout or arthritis (taking medication).

Seek Medical Evaluation Before Using If You Experience:

• Your first headache after age 50
• Headaches you've never had diagnosed by a healthcare professional
• A headache different from your usual migraines
• The worst headache of your life
• Headaches so severe that you must lie down
• Headaches with vomiting
• Daily headaches
• Headaches with fever and stiff neck
• Headaches after coughing, bending, exercise, or head injury.

These symptoms may indicate a serious underlying condition requiring immediate medical attention.

Seek Emergency Help for Signs of an Allergic Reaction:

• Hives
• Difficulty breathing
• Swelling of the face, lips, tongue, or throat
• Severe skin rash with blistering and peeling.

Stop Using and Call a Doctor Immediately If You Experience:

Severe reactions:

• Severe anxiety, agitation, confusion, panic attacks
• Easy bruising or unusual bleeding
• Feeling faint or lightheaded
• Extreme thirst with inability to urinate, heavy sweating, hot/dry skin.

Stomach bleeding symptoms:

• Bloody or black, tarry stools
• Coughing up blood
• Vomit that looks like coffee grounds
• Severe stomach pain that doesn't improve
• Feeling faint.

Liver problems:

• Nausea and upper stomach pain
• Loss of appetite
• Dark urine
• Clay-colored stools
• Jaundice (yellowing of skin or eyes)
• Itching.

Other serious symptoms:

• High potassium - slow heart rate, weak pulse, muscle weakness, tingling
• Ringing in your ears or hearing loss
• Severe skin reddening or rash.

Common Side Effects (Usually Mild):

• Upset stomach, heartburn
• Feeling nervous or restless
• Depressed mood or anxiety
• Sleep problems (insomnia).

These common side effects often improve as your body adjusts to the medication.

Standard Adult Dose (18+ years)

For migraine or tension headache:

• Take 2 caplets with a full glass of water, no more than once daily.
• Do not exceed 2 caplets in 24 hours unless directed by a doctor.
• Take with food or milk if stomach upset occurs.
• If symptoms persist or worsen after the first dose, consult your doctor.

Note: Caplets are capsule-shaped tablets.

Children and Adolescents (Under 18)

Ask a doctor before giving to anyone under 18 years of age.

Important Dosing Information

• Do not exceed the maximum dose. Taking more than 2 caplets in a 24-hour period increases the risk of serious side effects.
• Avoid long-term use: Call your doctor if symptoms don't improve after 7 days, or if you have a fever lasting longer than 3 days, or pain/swelling lasting longer than 10 days.
• Do not use daily. Using for 10+ days per month may cause medication-overuse headaches.

Alcohol

Avoid alcohol completely while using this medication. Alcohol increases the risk of:

• Stomach bleeding (from aspirin)
• Liver damage (from acetaminophen).

Caffeine

Limit or avoid additional caffeine sources, including:

• Coffee, tea, cola
• Energy drinks
• Caffeine-containing medications
• Chocolate (large amounts).

Excessive caffeine may cause nervousness, irritability, insomnia, anda rapid heartbeat.

Other Medications Containing Similar Ingredients

Check labels carefully. Many medications contain acetaminophen (APAP), aspirin, or caffeine:

• Other pain relievers (Tylenol, Anacin, BC Powder)
• Cold and flu medicines
• Menstrual symptom products
• Fever reducers
• Sleep aids with pain relief.

Taking multiple products containing the same ingredients can cause a dangerous overdose.

Other NSAIDs

Do not take with other nonsteroidal anti-inflammatory drugs:

• Ibuprofen (Advil, Motrin)
• Naproxen (Aleve)
• Celecoxib (Celebrex)
• Diclofenac, indomethacin, meloxicam, and others

If overdose is suspected, call Poison Control immediately: 1-800-222-1222 or seek emergency medical care.

Overdose Symptoms:

• Nausea, vomiting, stomach pain, sweating
• Loss of appetite, confusion, weakness
• Dark urine, yellowing of skin or eyes
• Ringing in the ears, severe headache, diarrhea
• Hallucinations, seizures
• Irregular heart rate (fast or slow).

Critical: Liver damage from acetaminophen overdose may occur even without immediate symptoms. Seek medical help immediately, even if you feel fine - early treatment can prevent serious liver damage or death.

Excedrin Migraine can interact with many medications. Tell all healthcare providers about every medicine you use, including:

Major Interactions:

• Blood thinners (warfarin, apixaban, rivaroxaban) - Increased bleeding risk
• Diabetes medications - May affect blood sugar levels
• Gout medications - Aspirin may interfere with effectiveness
• Diuretics (water pills) - Reduced effectiveness
• Methotrexate - Increased toxicity risk
• Corticosteroids - Increased stomach bleeding risk
• Other NSAIDs - Increased side effect risk

Also, Tell Your Doctor About:

• Prescription medications
• Over-the-counter drugs
• Vitamins and supplements
• Herbal products.

Certain combinations may require dose adjustments or alternative treatments.

Excedrin Migraine can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using Excedrin Migraine.

If you need surgery, tell the surgeon ahead of time that you are using Excedrin Migraine. You may need to stop using the medicine for a short time.

Store Excedrin Migraine at room temperature away from moisture and heat.