Excedrin

Description

Excedrin® is indicated for the treatment of migraine. The formulation contains three active ingredients: acetaminophen, aspirin (a nonsteroidal anti-inflammatory drug), and caffeine. The dosage form is presented as GELTABS*, which are gelatin-coated tablets. Each bottle contains 20 tablets and is packaged in a tamper-evident container. A warning is included stating that the product should not be used if the inner foil seal imprinted with “SEALED for YOUR PROTECTION” is broken or missing. Excedrin® is distributed by GSK Consumer Healthcare, located in Warren, NJ 07059. Copyright ©2017 GSK or its licensor.

Uses and Indications

This drug is indicated for the treatment of migraine.

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

Dosage and Administration

Adults should take 2 geltabs with a full glass of water. The maximum dosage is limited to 2 geltabs within a 24-hour period, unless otherwise directed by a healthcare professional.

For individuals under 18 years of age, it is advised to consult a doctor prior to use.

Patients are cautioned not to exceed the recommended dosage. If symptoms persist or worsen, it is important to seek medical advice.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to acetaminophen, aspirin, or any other pain reliever or fever reducer. Additionally, concurrent use with any other medication containing acetaminophen, whether prescription or nonprescription, is contraindicated. 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 are experiencing or recovering from chickenpox or flu-like symptoms should not use this product due to the risk of Reye’s syndrome. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional, as these may be early signs of this rare but serious condition.

Acetaminophen, a component of this product, may lead to severe skin reactions, including skin reddening, blisters, and rash. In the event of a skin reaction, the user must discontinue use immediately and seek medical assistance. Similarly, aspirin may provoke a severe allergic reaction characterized by hives, facial swelling, asthma (wheezing), or shock. Immediate medical attention is warranted if such symptoms arise.

This product contains acetaminophen, and users should be aware of the potential for severe liver damage. This risk increases if more than two geltabs are taken within a 24-hour period, if other medications containing acetaminophen are used concurrently, or if the user consumes three or more alcoholic drinks daily while using this product.

The presence of an NSAID in this product raises the risk of severe stomach bleeding, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, and those taking anticoagulants, steroids, or other NSAIDs (such as aspirin, ibuprofen, or naproxen). The risk is also heightened with excessive alcohol consumption or prolonged use beyond the recommended duration.

Users should be cautious of medication overuse headaches, which may occur if this product is utilized for ten or more days in a month. Additionally, the recommended dosage contains caffeine equivalent to that of a cup of coffee; therefore, it is advisable to limit the intake of other caffeine-containing medications, foods, or beverages to avoid potential side effects such as nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Before using this product, individuals should consult a healthcare professional if they have never had a migraine diagnosed, experience headaches that differ from their usual migraines, have the worst headache of their life, or present with fever and stiff neck. Other conditions warranting consultation include headaches following head injury, exertion, coughing, or bending, first-time headaches after age 50, daily headaches, severe migraines requiring bed rest, liver disease, a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, use of diuretics, asthma, or previous adverse reactions to pain relievers or fever reducers. Additionally, if vomiting accompanies a migraine headache, medical advice should be sought.

In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is crucial, as prompt attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Users must discontinue use and contact a healthcare provider if an allergic reaction occurs, if any signs of stomach bleeding manifest (such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain), if the migraine is not alleviated or worsens 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.

Serious Adverse Reactions

Reye’s syndrome is a rare but serious illness that may occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. Patients should be advised not to use this product under these circumstances. If changes in behavior accompanied by nausea and vomiting occur, it is essential to consult a healthcare professional, as these may be early signs of Reye’s syndrome.

Severe skin reactions have been reported in patients taking acetaminophen, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients should discontinue use and seek medical attention immediately. Similarly, aspirin may provoke a severe allergic reaction characterized by hives, facial swelling, asthma (wheezing), or shock, necessitating prompt medical intervention.

Patients should be aware of the risk of severe liver damage associated with acetaminophen, particularly if they exceed the maximum daily dosage of 2 geltabs within 24 hours, use other products containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

The use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), may lead to severe stomach bleeding, especially in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, or those taking anticoagulants, steroids, or other NSAIDs. The risk is further heightened with excessive alcohol consumption or prolonged use beyond the recommended duration.

Medication overuse headaches may occur if this product is used for 10 or more days per month, potentially worsening headache symptoms.

Common Adverse Reactions

Patients should limit the use of caffeine-containing medications, foods, or beverages while taking this product, as it contains a caffeine amount comparable to that of a cup of coffee. Excessive caffeine intake may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Monitoring and Consultation

Patients are advised to stop use and consult a healthcare professional if they experience any signs of an allergic reaction, such as hives or swelling, or if they notice symptoms indicative of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Additionally, if a migraine is not relieved or worsens after the first dose, or if new or unexpected symptoms arise, medical advice should be sought. Patients should also report any occurrences of ringing in the ears or loss of hearing.

Drug Interactions

Taking this product concurrently with other medications containing acetaminophen, whether prescription or nonprescription, may result in severe liver damage. It is advisable to avoid the use of multiple acetaminophen-containing products to mitigate this risk.

The concomitant use of this product with anticoagulants or steroid medications significantly increases the risk of severe gastrointestinal bleeding. Close monitoring for signs of gastrointestinal distress is recommended in patients receiving these combinations.

Additionally, the risk of severe stomach bleeding is elevated when this product is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen. Caution should be exercised, and alternative pain management strategies should be considered to reduce the likelihood of adverse effects.

Patients are also advised 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, sleeplessness, and, in some cases, rapid heartbeat. Monitoring for these symptoms is recommended to ensure patient safety.

No specific laboratory test interactions have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Excedrin (acetaminophen, asprin, 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. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is important to consult a doctor, as these symptoms may indicate the onset of Reye’s syndrome, a rare but serious condition.

For pediatric patients under 18 years of age, it is advised to consult a doctor before use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing medications that may exacerbate this risk in this population.

Close monitoring of gastrointestinal symptoms is recommended for geriatric patients, and dosage adjustments may be necessary based on individual patient assessments and overall health status. Providers should consider the potential for increased sensitivity to medications and the presence of comorbidities that may further elevate the risk of adverse effects in elderly patients.

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 fetal outcomes or complications during delivery. Therefore, it is essential that pregnant patients only use aspirin in this period if explicitly directed by a healthcare provider.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication if they are pregnant or breastfeeding. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless explicitly directed by a healthcare provider, 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.

Renal Impairment

Patients with renal impairment may require careful consideration regarding dosing adjustments and monitoring. In individuals with reduced kidney function, particularly those with concurrent conditions such as liver disease, high blood pressure, heart disease, or liver cirrhosis, it is essential to assess renal function prior to initiating treatment. Regular monitoring of renal parameters is recommended to ensure safe and effective use of the medication in this population. Adjustments to the dosing regimen may be necessary based on the severity of renal impairment to mitigate the risk of adverse effects and optimize therapeutic outcomes.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed the maximum daily dosage of 2 geltabs within a 24-hour period. Additionally, patients must avoid concurrent use with other medications containing acetaminophen and limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product.

Before initiating treatment, patients with liver disease or those with a history of liver cirrhosis should consult a healthcare professional. It is also advisable for patients with high blood pressure, heart disease, or kidney disease to seek medical advice prior to use. Monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy during treatment.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of this product.

Risk of Severe Liver Damage Healthcare professionals should be aware that severe liver damage may occur if a patient ingests more than 2 geltabs within a 24-hour period, which is the established maximum daily dosage. Additionally, the concomitant use of this product with other medications containing acetaminophen can also lead to severe liver damage.

Furthermore, patients who consume 3 or more alcoholic beverages daily while using this product are at an increased risk for severe liver damage.

Recommended Actions In the event of suspected overdosage, it is imperative to assess the patient's liver function and consider immediate medical intervention. Monitoring of liver enzymes and supportive care may be necessary, depending on the severity of the symptoms and the extent of the overdose. Prompt recognition and management are crucial to mitigate potential complications associated with liver injury.

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

Reports have been received regarding severe skin reactions, including skin reddening, blisters, and rash, associated with the use of acetaminophen. Additionally, there have been reports of severe allergic reactions linked to aspirin, which include hives, facial swelling, asthma (wheezing), and shock. Cases of severe liver damage have been documented due to acetaminophen overdose.

Incidents of stomach bleeding have been reported in association with the use of nonsteroidal anti-inflammatory drugs (NSAIDs), particularly among patients over 60 years of age or those with a history of stomach ulcers or bleeding problems. Furthermore, there have been reports of medication overuse headaches occurring with prolonged use of the product.

New or unexpected symptoms have been noted following the use of the product, along with reports of tinnitus or hearing loss associated with its use.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center or seek medical help right away, as prompt medical attention is crucial for both adults and children. It is essential to emphasize that even in the absence of noticeable signs or symptoms, an overdose can still pose serious health risks, and timely intervention is vital.

Storage and Handling

The product is supplied in a container that requires careful handling to maintain its integrity. It should be stored at a controlled room temperature of 20°-25°C (68°-77°F). After each use, it is essential to close the cap tightly to prevent contamination and ensure the product remains effective. Additionally, users are advised to retain the box for important information regarding the product.

Additional Clinical Information

Patients are advised to take 2 geltabs with a glass of water, ensuring not to exceed this dosage within a 24-hour period unless directed by a healthcare professional. For individuals under 18 years of age, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients who are pregnant or breastfeeding to seek professional advice before using the product. It is particularly crucial to avoid aspirin during the last trimester of pregnancy unless specifically instructed by a healthcare provider, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Information (PDF)

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

View product document (PDF)