Excedrin Migraine

Description

EXCEDRIN® is a combination medication indicated for the relief of migraine pain. Each caplet contains Acetaminophen, Aspirin (a nonsteroidal anti-inflammatory drug), and Caffeine, which work synergistically to alleviate headache symptoms. The dosage form is presented as capsule-shaped tablets, with each packet containing two caplets.

Uses and Indications

This drug is indicated for the acute treatment of migraine in adults.

There are no known teratogenic or nonteratogenic effects associated with this medication.

Dosage and Administration

Adults are advised to take 2 caplets with a full glass of water. In cases where symptoms persist or worsen, it is recommended to consult a healthcare professional. The maximum dosage should not exceed 2 caplets within a 24-hour period unless otherwise directed by a physician.

For individuals under 18 years of age, it is essential to seek guidance from a healthcare provider before administration.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to acetaminophen, aspirin, or any other pain reliever or fever reducer. Additionally, this product should not be used concurrently with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Warnings and Precautions

Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product. If behavioral changes accompanied by nausea and vomiting occur during use, it is imperative to consult a healthcare professional, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

Acetaminophen, a component of this product, has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, and rash. Should any skin reaction occur, the use of the product must be discontinued immediately, and medical assistance should be sought.

This product contains acetaminophen, and severe liver damage may result from exceeding the maximum daily dosage of 2 caplets within a 24-hour period, using it concurrently with other medications containing acetaminophen, or consuming three or more alcoholic drinks daily while using this product.

Additionally, the product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The risk of such complications is heightened in individuals aged 60 years or older, those with a history of stomach ulcers or bleeding disorders, and patients taking anticoagulants or steroid medications. The risk is also increased when combined with other NSAIDs (such as aspirin, ibuprofen, or naproxen), or when exceeding the recommended duration or dosage. Consumption of three or more alcoholic drinks daily while using this product further elevates the risk of stomach bleeding.

The recommended dosage of this product contains approximately the same amount of caffeine as a standard cup of coffee. Therefore, it is advisable to limit the intake of other caffeine-containing medications, foods, or beverages during treatment, as excessive caffeine consumption may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional prior to use. Special caution is warranted regarding the use of aspirin during the last trimester of pregnancy, as it may pose risks to the unborn child or lead to complications during delivery.

In the event of an overdose, immediate medical attention is crucial. Contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is vital for both adults and children, even in the absence of noticeable signs or symptoms.

Users should discontinue the product and consult a healthcare provider if any of the following occur: an allergic reaction, signs of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain), if migraines are not alleviated or worsen after the first dose, if new or unexpected symptoms arise, or if there is ringing in the ears or loss of hearing.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which can be serious.

Reye's syndrome is a rare but serious condition that may occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. If patients exhibit changes in behavior accompanied by nausea and vomiting while using this product, they should consult a healthcare professional immediately, as these symptoms could indicate the onset of Reye's syndrome.

Severe skin reactions have been reported in patients using acetaminophen, which may manifest as skin reddening, blisters, or rash. If any skin reaction occurs, patients are advised to discontinue use and seek medical assistance promptly. Additionally, aspirin may provoke severe allergic reactions, including hives, facial swelling, asthma (wheezing), and shock.

The product contains acetaminophen, and patients should be aware of the risk of severe liver damage, particularly if they exceed the maximum daily dosage of two caplets within 24 hours, use other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should also be cautious of the potential for severe stomach bleeding, a risk associated with the NSAID component of the product. This risk is heightened in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, and patients taking blood thinners, steroids, or other NSAIDs. Symptoms of stomach bleeding may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Patients should seek medical attention if any of these symptoms occur.

The recommended dose of this product contains caffeine, approximately equivalent to a cup of coffee. Patients are advised to limit the intake of other caffeine-containing medications, foods, or beverages, as excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients should discontinue use and consult a healthcare provider if they experience an allergic reaction, if their migraine is not relieved or worsens after the first dose, or if new or unexpected symptoms arise, including ringing in the ears or loss of hearing.

It is important for patients to avoid using this product if they have a history of allergic reactions to acetaminophen, aspirin, or any other pain reliever or fever reducer. Prior to use, patients should consult a healthcare professional if they have never had a migraine diagnosed, experience headaches that differ from their usual migraines, or have other specific medical conditions, including liver disease, high blood pressure, or a history of stomach problems. Additionally, patients taking prescription medications for diabetes, gout, or arthritis should seek advice from a healthcare provider before using this product.

Drug Interactions

Concurrent use of this product with any other medications containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose.

Patients should consult a healthcare professional prior to using this product if they are currently taking prescription medications for diabetes, gout, arthritis, or if they are under medical supervision for any serious health condition.

Caution is advised for individuals taking additional products that contain aspirin, acetaminophen, or other pain relievers/fever reducers, as this may increase the risk of adverse effects.

The concomitant use of this product with anticoagulants or steroid medications may elevate the risk of severe gastrointestinal bleeding. Close monitoring is recommended for patients on these therapies.

Additionally, it is advisable to limit the intake of caffeine-containing medications, foods, or beverages while using this product. Excessive caffeine consumption may lead to symptoms such as nervousness, irritability, insomnia, and, in some cases, tachycardia.

Packaging & NDC

Below are the non-prescription pack sizes of Excedrin Migraine (acetaminophen, aspirin, and caffeine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product due to the risk of Reye's syndrome. It is important for healthcare professionals to advise parents and guardians to consult a doctor if their child exhibits changes in behavior accompanied by nausea and vomiting, as these may be early signs of Reye's syndrome.

For individuals under 18 years of age, it is recommended to seek medical advice prior to use. This precaution ensures the safety and appropriateness of the product for pediatric patients.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor elderly patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit profile is essential in this population to ensure safe and effective use of the medication.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on the unborn child or complications during delivery. Therefore, it is essential for healthcare providers to evaluate the risks and benefits before recommending this medication to pregnant women, especially in the later stages of pregnancy.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication in lactating mothers.

Renal Impairment

Patients with renal impairment may require careful consideration regarding dosing adjustments and monitoring. In individuals with reduced kidney function, particularly those with high blood pressure, heart disease, liver cirrhosis, or kidney disease, it is essential to assess renal function prior to initiating treatment. Regular monitoring of renal parameters is recommended to ensure safety and efficacy. Adjustments to the dosing regimen may be necessary based on the severity of renal impairment to avoid potential adverse effects and to optimize therapeutic outcomes.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 2 caplets within a 24-hour period. Additionally, patients should avoid concurrent use with other medications containing acetaminophen, as this can further increase the risk of liver damage.

It is also advised that patients refrain from consuming 3 or more alcoholic drinks daily while using this product, as alcohol can exacerbate the potential for liver injury.

Before initiating treatment, patients with known liver disease, high blood pressure, heart disease, liver cirrhosis, or kidney disease should consult a healthcare professional to assess the appropriateness of this product for their condition. Regular monitoring of liver function may be warranted in these patients to ensure safety and efficacy.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of observable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. Severe skin reactions, including skin reddening, blisters, and rash, have been associated with acetaminophen use. Additionally, severe allergic reactions such as hives, facial swelling, asthma (wheezing), and shock have been reported in connection with aspirin.

Liver damage has been noted in cases of excessive acetaminophen intake. Stomach bleeding has been associated with the use of NSAIDs, particularly in individuals over 60 years of age or those with a history of stomach ulcers or bleeding problems. Reports have also indicated the occurrence of new or unexpected symptoms following use, as well as instances of ringing in the ears or loss of hearing.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. In the event of an overdose, patients must seek medical help or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this medication if they have ever experienced an allergic reaction to acetaminophen, aspirin, or any other pain reliever or fever reducer. Additionally, they should not use this product in conjunction with any other medication containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a doctor or pharmacist.

Patients must be instructed to stop using the medication and consult a doctor if they experience any signs of an allergic reaction or if they notice symptoms such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. They should also be advised to seek medical attention if their migraine is not relieved or worsens after the first dose, or if new or unexpected symptoms arise. Patients should be made aware that ringing in the ears or loss of hearing warrants immediate consultation with a healthcare provider.

Before using this medication, patients should be encouraged to ask a doctor if they have never had migraines diagnosed by a health professional, if they have a headache that differs from their usual migraines, or if they are experiencing the worst headache of their life. They should also consult a doctor if they have a fever accompanied by a stiff neck, headaches that begin after or are caused by head injury, exertion, coughing, or bending, or if they experienced their first headache after the age of 50. Patients with daily headaches or migraines severe enough to require bed rest should also seek medical advice prior to use.

Furthermore, patients with liver disease, a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease should consult a doctor before using this medication. Those taking diuretics, individuals with asthma, or patients who have experienced serious side effects from pain relievers or fever reducers should also seek medical advice. Patients experiencing vomiting with their migraine headache should consult a doctor, as should those taking prescription drugs for diabetes, gout, or arthritis. Lastly, patients should be encouraged to speak with a doctor or pharmacist before using this medication if they are under care for any serious condition or if they are taking any other drugs or products that contain aspirin, acetaminophen, or any other pain reliever or fever reducer.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled room temperature, maintaining a range of 20° to 25°C (68° to 77°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid aspirin during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Excedrin Migraine, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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