Excedrin

Description

Excedrin Migraine is a combination medication formulated to provide relief from migraine headaches. It contains a blend of active ingredients that work synergistically to alleviate pain and associated symptoms. The specific chemical composition and molecular weight of the active components contribute to its efficacy in treating migraines. The dosage form is typically available in tablet form, designed for oral administration. The tablets are characterized by their distinct appearance, which aids in identification. Inactive ingredients included in the formulation serve various roles, such as stabilizing the active components and enhancing the overall product quality.

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 should take 2 caplets with a full glass of water. The maximum dosage is 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.

Patients should not 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, 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 currently experiencing or recovering from chickenpox or flu-like symptoms should refrain from using this product. If any behavioral changes accompanied by nausea and vomiting occur during use, it is imperative to consult a physician, 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 manifest as skin reddening, blisters, or rash. Should any skin reaction occur, the use of the product must be discontinued immediately, and medical assistance should be sought without delay.

Aspirin, also present in this formulation, can provoke severe allergic reactions. Symptoms may include hives, facial swelling, asthma (wheezing), and in extreme cases, shock.

This product contains acetaminophen, and it is crucial to adhere to the recommended dosage. Severe liver damage may result from exceeding 2 caplets within a 24-hour period, which is the maximum daily allowance, particularly when combined with other medications containing acetaminophen or when consuming three or more alcoholic beverages daily during treatment.

Additionally, this product includes a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of severe stomach bleeding. The likelihood of such an event increases in individuals aged 60 or older, those with a history of stomach ulcers or bleeding disorders, and patients concurrently using blood thinners (anticoagulants) or steroid medications. Caution is advised for those taking other prescription or nonprescription NSAIDs (such as aspirin, ibuprofen, or naproxen) or for individuals who exceed the recommended duration or dosage.

Healthcare professionals should advise patients to limit the intake of caffeine-containing medications, foods, or beverages while using this product, as excessive caffeine consumption may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

In the event of an overdose, immediate medical attention is essential. Patients or caregivers should contact a Poison Control Center without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should discontinue use and consult a physician 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 a 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 should be aware of several serious adverse reactions and warnings associated with its use. Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product due to the risk of Reye’s syndrome, a rare but serious illness. If patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these symptoms may indicate the onset of Reye’s syndrome.

Severe skin reactions may occur with acetaminophen, which can manifest as skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), or shock. Additionally, there is a significant risk of severe liver damage if patients exceed the maximum daily dosage of 2 caplets within 24 hours, particularly when combined with other medications containing acetaminophen or when consuming three or more alcoholic drinks daily.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The risk is heightened in patients who are 60 years or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (such as aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily, or take the medication for longer than directed.

Patients should discontinue use and seek medical attention if they experience any signs of an allergic reaction, such as difficulty breathing 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. Furthermore, 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 be vigilant for symptoms such as ringing in the ears or loss of hearing.

Before using this product, patients are advised to consult a healthcare professional if they have never had migraines diagnosed, if they experience headaches that differ from their usual migraines, if they have the worst headache of their life, or if they have fever and stiff neck. Additional caution is warranted for those with headaches following head injury, exertion, coughing, or bending, as well as for individuals experiencing their first headache after age 50, daily headaches, or migraines severe enough to require bed rest. Patients with liver disease, a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, kidney disease, or those taking diuretics or with asthma should also seek medical advice prior to use. Lastly, patients who have experienced serious side effects from pain relievers or fever reducers, or who experience vomiting with their migraine headache, should consult a doctor before using this product.

Drug Interactions

The concurrent use of this product with caffeine-containing medications, foods, or beverages should be limited. Excessive caffeine intake may lead to adverse effects such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Co-administration with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated. Additionally, the use of this product alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen, naproxen, or similar agents, is not recommended.

Patients taking anticoagulants or steroid medications should consult a healthcare professional prior to using this product. Furthermore, individuals on prescription medications for diabetes, gout, or arthritis are advised to seek medical advice before use. It is also recommended that patients under medical care for any serious condition or those taking any other medications consult their healthcare provider to ensure safety and efficacy.

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

Pediatric patients, including children and teenagers, should not use this product if they have or are recovering from chicken pox or flu-like symptoms. It is important to consult a doctor if any changes in behavior accompany nausea and vomiting, 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 prior to use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding when using this product. It is essential for healthcare providers to exercise caution and consider the individual health status of geriatric patients before prescribing.

Prior to use, it is advisable for elderly patients to consult a healthcare professional if they have a history of high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, those with a history of stomach problems, such as heartburn, or previous occurrences of stomach ulcers or bleeding should seek medical advice before initiating treatment.

Elderly patients who are currently taking anticoagulant or steroid medications should also consult their doctor, as these drugs may interact with the product and increase the risk of adverse effects.

Furthermore, it is recommended that the use of this product be limited in patients who consume three or more alcoholic drinks daily, as alcohol can exacerbate the risk of gastrointestinal complications. Regular monitoring and appropriate dose modifications may be necessary to ensure the safety and efficacy of treatment in this population.

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. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless explicitly 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, including those with liver disease, may require careful consideration regarding the use of this medication. It is essential to evaluate the severity of liver function when determining the appropriate dosage and monitoring parameters.

For patients with compromised liver function, particularly those with liver cirrhosis, dosage adjustments may be necessary to mitigate the risk of adverse effects. Additionally, patients with concurrent conditions such as high blood pressure, heart disease, or kidney disease should be monitored closely, as these factors may further complicate the management of their treatment.

Regular assessment of liver function is recommended to ensure the safe administration of the medication in this population. Monitoring should include liver enzyme levels and other relevant laboratory values to detect any potential deterioration in liver function. Adjustments to therapy should be made based on these evaluations to optimize patient safety and therapeutic 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 adverse effects. 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 additional adverse events reported voluntarily or through surveillance programs. These events include skin reddening, blisters, rash, hives, and facial swelling. Respiratory symptoms such as asthma and wheezing have also been noted. In rare instances, cases of shock have been reported.

Patient Counseling

Patients should be advised to seek immediate medical assistance 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.

It is important to inform patients that they should not use this medication if they have a history of allergic reactions to acetaminophen, aspirin, or any other pain reliever or fever reducer. Additionally, patients must be cautioned against using this medication in conjunction with any other products containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should consult a healthcare professional.

Patients should be instructed to discontinue use 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. They should also stop use and seek medical advice if their migraine is not alleviated or worsens after the first dose, or if they develop new or unexpected symptoms, including ringing in the ears or loss of hearing.

Before initiating treatment, patients should be encouraged to discuss their medical history with their healthcare provider, particularly if they have never had migraines diagnosed by a health professional, if they experience headaches that differ from their usual migraines, or if they have the worst headache of their life. Patients should also consult their doctor if they have a fever accompanied by a stiff neck, headaches that begin after a head injury, or if they are over the age of 50 and experiencing their first headache.

Furthermore, patients should be advised to seek medical guidance if they have daily headaches, migraines severe enough to require bed rest, liver disease, or if the stomach bleeding warning applies to them. Those with a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma should also consult their healthcare provider before use.

Patients taking diuretics, experiencing vomiting with their migraine headache, or those under a doctor's care for any serious condition should be encouraged to discuss their situation with their healthcare provider. Lastly, patients should be reminded to consult a doctor or pharmacist before using this medication if they are taking any other drugs, particularly prescription medications for diabetes, gout, or arthritis, or any other products containing aspirin, acetaminophen, or other pain relievers or fever reducers.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a controlled room temperature ranging from 20° to 25°C (68° to 77°F) to maintain its efficacy.

After each use, the cap must be closed tightly to ensure the integrity of the product. Users are advised to read all product information thoroughly before use and to retain the packaging for 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)