Excedrin

Description

NDC 0067-2039-24, EXCEDRIN® MIGRAINE is a combination medication containing Acetaminophen, Aspirin (NSAID), and Caffeine, formulated as a pain reliever and pain reliever aid. The product is presented in a tamper-evident bottle containing 24 capsule-shaped tablets. It is essential to note that the product should not be used if the inner foil seal imprinted with “SEALED for YOUR PROTECTION” is broken or missing. EXCEDRIN® MIGRAINE is distributed by GSK Consumer Healthcare, located in Warren, NJ 07059. ©2017 GSK or its licensor. For more information, visit www.excedrin.com.

Uses and Indications

This drug is indicated for the treatment of migraine.

There are no teratogenic effects associated with this medication. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Adults are instructed to take 2 caplets with a glass of water. It is essential not to exceed the recommended dosage of 2 caplets 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. If symptoms persist or worsen, patients should 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, 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 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 symptoms may indicate the onset of this rare but serious condition.

Allergy Alerts This product contains acetaminophen, which may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. If any of these symptoms occur, the use of the product should be discontinued immediately, and medical assistance should be sought.

Additionally, aspirin, another component of this product, may cause severe allergic reactions characterized by hives, facial swelling, asthma (wheezing), and shock. Immediate medical attention is required if any of these symptoms manifest.

Liver Warning The presence of acetaminophen in this product necessitates caution, as severe liver damage may occur under certain conditions. This includes exceeding the maximum daily dosage of 2 caplets within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Stomach Bleeding Warning As this product contains a nonsteroidal anti-inflammatory drug (NSAID), there is a risk of severe stomach bleeding. The likelihood of this adverse effect increases in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily, or exceed the recommended duration or dosage of the product.

Medication Overuse Headache Warning Frequent use of this product, specifically for 10 or more days per month, may lead to worsening headaches.

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

Emergency Medical Help In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Discontinuation and Consultation Users should stop using the product and consult a healthcare professional 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.

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 to discontinue use and consult a doctor if they observe changes in behavior accompanied by nausea and vomiting, as these may be early signs 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 of these symptoms occur, patients should stop use immediately and seek medical assistance.

Aspirin, another component of this product, may cause severe allergic reactions, including hives, facial swelling, asthma (wheezing), or shock. Patients experiencing any signs of an allergic reaction should seek medical help right away.

Liver damage is a significant risk associated with this product due to its acetaminophen content. Severe liver damage may occur if patients exceed the maximum daily dosage of 2 caplets in 24 hours, use other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Stomach bleeding is another serious concern, particularly for patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, or those taking blood thinners or other NSAIDs. Symptoms of stomach bleeding include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Patients should stop use and consult a doctor if any of these symptoms occur.

Common Adverse Reactions Patients may experience headaches that worsen with prolonged use of this product, particularly if used for 10 or more days per month, leading to medication overuse headaches.

Caffeine, present in the recommended dose of this product, may cause nervousness, irritability, sleeplessness, and occasionally rapid heartbeat if patients consume excessive amounts of caffeine from other sources.

Additional Considerations Patients are advised to seek medical advice before using this product if they have never had migraines diagnosed by a healthcare professional, experience headaches that differ from their usual migraines, or have other specific medical conditions such as liver disease, high blood pressure, or a history of stomach problems.

In the event of an overdose, it is critical for patients to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Caution is advised when using this product in conjunction with other medications containing acetaminophen, whether prescription or nonprescription, due to the potential for cumulative effects.

The concomitant use of this product with anticoagulants or steroid medications may increase the risk of gastrointestinal bleeding. Healthcare professionals should monitor patients closely for signs of bleeding and consider dosage adjustments as necessary.

Similarly, the use of this product alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen, may also elevate the risk of stomach bleeding. It is recommended that healthcare providers assess the necessity of concurrent NSAID therapy and adjust dosages accordingly.

Additionally, patients are advised to limit the intake of caffeine-containing medications, foods, or beverages while using this product to prevent excessive caffeine consumption, which may lead to adverse effects.

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

Packaging & NDC

Below are the non-prescription pack sizes of Excedrin (acetaminophen, aspirin (nsaid) 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. If pediatric patients experience changes in behavior accompanied by nausea and vomiting while using this product, it is essential to consult a doctor, as these symptoms may indicate the onset of Reye’s syndrome, a rare but serious condition. For individuals under 18 years of age, it is advised to seek medical guidance before use. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the heightened susceptibility to gastrointestinal complications.

It is advisable to monitor these patients closely 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 ratio 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 concerning, as it may lead to adverse effects on fetal outcomes or complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin in the final three months of pregnancy if explicitly directed by a healthcare provider.

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 its use in lactating individuals.

Renal Impairment

Patients with renal impairment should consult their healthcare provider prior to use, particularly if they have a history of high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the severity of renal impairment.

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 caplets 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 any history of liver dysfunction should consult their healthcare provider. Furthermore, individuals with high blood pressure, heart disease, liver cirrhosis, or kidney disease are also advised to seek medical advice prior to use to ensure safe administration and monitoring of their condition. Regular assessment of liver function may be warranted in these patients to mitigate the risk of adverse effects.

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 noticeable 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

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical help or contact a Poison Control Center in the event of an overdose, 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 a history of allergic reactions to acetaminophen, aspirin, or any other pain reliever or fever reducer. It is essential to avoid concurrent use with any other drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to 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 indicative of stomach bleeding, such as 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, patients should be advised to discontinue use and seek medical advice.

Healthcare providers should also counsel patients to stop use and consult a doctor if new or unexpected symptoms arise, or if they experience ringing in the ears or loss of hearing. It is important to recommend that patients consult a doctor before use 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. Patients should also be advised to seek medical advice if they have a fever and 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, severe migraines requiring bed rest, liver disease, or a history of stomach problems such as heartburn should be encouraged to consult a doctor before use. Additionally, those with high blood pressure, heart disease, liver cirrhosis, or kidney disease, as well as patients taking diuretics or those with asthma, should also seek medical advice prior to use.

Healthcare providers should recommend that patients who have experienced serious side effects from pain relievers or fever reducers, or who have vomiting associated with their migraine headache, consult a doctor. Furthermore, patients taking prescription drugs for diabetes, gout, or arthritis, or those under a doctor’s care for any serious condition, should be advised to speak with a doctor or pharmacist before using this medication. Lastly, patients should be reminded to consult a doctor or pharmacist if they are taking any other drug or product that contains aspirin, acetaminophen, or any other pain reliever or fever reducer.

Storage and Handling

The product is supplied in a configuration that includes specific packaging details, which are essential for proper handling and storage. It is recommended to store the product at a controlled room temperature of 20°-25°C (68°-77°F) to maintain its efficacy.

After each use, it is crucial to close the cap tightly to prevent contamination and ensure the integrity of the product. Users are advised to read all product information thoroughly before use and to retain the packaging for reference to important information regarding the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. It is particularly crucial to avoid aspirin during the last trimester of pregnancy unless explicitly directed by a physician, 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)