Excedrin

Description

Excedrin Migraine is a combination medication formulated to provide relief from migraine pain. Each dosage form contains Acetaminophen, Aspirin (a nonsteroidal anti-inflammatory drug), and Caffeine, which work synergistically to alleviate headache symptoms. The product is available in a package containing 50 capsule-shaped tablets. The National Drug Code (NDC) for this formulation is 0067-2040-04.

Uses and Indications

This drug is indicated for the treatment of migraine. There are no teratogenic effects associated with its use, and no nonteratogenic effects have been reported.

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the recommended dosage. For adults, the prescribed dosage is 2 caplets taken with a full glass of water. Patients must not exceed 2 caplets within a 24-hour period unless specifically directed by a healthcare provider.

For individuals under 18 years of age, it is essential to consult a doctor 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, concurrent use with any other medication containing acetaminophen, whether prescription or nonprescription, is contraindicated. If there is uncertainty regarding the presence of acetaminophen in a medication, 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.

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 any of these symptoms occur.

This product contains acetaminophen, and users should be aware of the potential for severe liver damage. Such damage may result from exceeding the maximum daily dosage of 2 caplets within a 24-hour period, concurrent use with other acetaminophen-containing medications, or consumption of three or more alcoholic drinks daily while using this product.

The presence of an NSAID in this formulation raises the risk of severe stomach bleeding, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding disorders, users of blood thinners or steroids, and those consuming three or more alcoholic beverages daily. Additionally, the risk increases with prolonged use or higher dosages than recommended.

Users should be cautious of medication overuse headaches, which may occur if this product is utilized for 10 or more days per month. Furthermore, the recommended dosage contains caffeine equivalent to that found in a cup of coffee. It is advisable 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.

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, present with fever and stiff neck, or have headaches that began after a head injury, exertion, coughing, or bending. Additional caution is warranted for those over 50 years of age experiencing their first headache, individuals with daily headaches, severe migraines requiring bed rest, liver disease, a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, kidney disease, or those taking diuretics or experiencing adverse effects from pain relievers or fever reducers.

In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center contacted, as prompt intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Users must discontinue use and contact a healthcare provider if they experience any allergic reactions, signs of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or persistent stomach pain), if their migraine is not alleviated or worsens after the first dose, if new or unexpected symptoms arise, or if they experience 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. If patients exhibit changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these may be early signs of Reye’s syndrome.

Severe skin reactions have been reported in patients allergic to acetaminophen, which may manifest as skin reddening, blisters, or rash. In such cases, patients should discontinue use and seek medical assistance promptly. Similarly, aspirin may provoke severe allergic reactions, including hives, facial swelling, asthma (wheezing), and shock, necessitating immediate medical attention.

Patients should be aware of the risk of severe liver damage associated with acetaminophen, particularly if they exceed the maximum daily dosage of 2 caplets, use other acetaminophen-containing products, or consume three or more alcoholic drinks daily while using this product. Additionally, the presence of an NSAID in this product raises the risk of 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.

Common Adverse Reactions Medication overuse headaches may occur if this product is used for 10 or more days per month. Patients should also be cautious about caffeine intake, as the recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee. Excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients are advised to stop use and consult a doctor if they experience any signs 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, or if new or unexpected symptoms arise, medical advice should be sought. Symptoms such as ringing in the ears or loss of hearing should also prompt a consultation with a healthcare professional.

Precautions Before using this product, patients should consult a doctor 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. Other conditions that warrant medical consultation include fever and stiff neck, headaches following head injury, daily headaches, severe migraines requiring bed rest, liver disease, and a history of stomach problems. Patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, or those taking diuretics or with asthma should also seek medical advice prior to use.

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

Limitations on the use of caffeine-containing medications, foods, or beverages are advised while taking this product. Excessive caffeine intake may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients are advised to consult a healthcare professional prior to using this product if they are concurrently taking anticoagulants or steroid medications. Additionally, it is recommended that individuals seek medical advice if they are using other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, or naproxen.

Those taking any medications that contain acetaminophen, whether prescription or nonprescription, should also consult a healthcare provider before use. If there is uncertainty regarding the presence of acetaminophen in a medication, it is advisable to ask a doctor or pharmacist for clarification.

Furthermore, individuals on prescription medications for diabetes, gout, or arthritis should seek medical guidance before using this product.

Patients should discontinue use and consult a healthcare professional if they experience any signs of stomach bleeding, which may include symptoms such as feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain.

Packaging & NDC

Below are the non-prescription pack sizes of Excedrin (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. 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, specifically those aged 60 years and older, should consult a healthcare provider prior to using this medication. This precaution is essential to ensure the safe and effective use of the treatment in this population, as age-related physiological changes may influence drug metabolism and response. Careful consideration and monitoring are advised when prescribing to geriatric patients to mitigate potential risks and optimize therapeutic outcomes.

Pregnancy

Pregnant patients and women who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during pregnancy, particularly at 20 weeks gestation or later, is associated with potential risks. Specifically, it may lead to adverse effects on the unborn child and complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a qualified 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 at 20 weeks of pregnancy or later 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 during lactation.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have conditions such as 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 a history of liver disease, high blood pressure, heart disease, liver cirrhosis, or kidney disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during treatment.

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 at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No non-teratogenic effects have been specified. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Severe allergic reactions, including anaphylaxis, have been reported in the postmarketing experience. Additionally, cases of liver injury have been documented, with some instances necessitating liver transplantation. There have been reports of gastrointestinal bleeding, particularly among patients with a history of ulcers or those concurrently using anticoagulants. Instances of medication overuse headache have also been noted in patients who frequently use this product. Furthermore, adverse reactions related to the skin, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported.

Patient Counseling

Healthcare providers should advise patients 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.

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 medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the contents of a medication, they should be encouraged to consult a doctor or pharmacist.

Patients must be instructed to discontinue use and consult a healthcare professional 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 alleviated or worsens after the first dose, or if new or unexpected symptoms arise, patients should seek medical advice. They should also be aware that ringing in the ears or loss of hearing warrants immediate consultation.

Before initiating treatment, patients should be encouraged to discuss their medical history with their healthcare provider, particularly if they have never had migraines diagnosed, if they experience headaches that differ from their usual migraines, or if they have the worst headache of their life. Patients presenting with fever and a stiff neck, headaches following head injury, or those who experienced their first headache after age 50 should also seek medical advice prior to use.

Patients with daily headaches, migraines severe enough to require bed rest, liver disease, or a history of stomach problems such as heartburn should consult their healthcare provider before using this medication. Furthermore, individuals with high blood pressure, heart disease, liver cirrhosis, or kidney disease, as well as those taking diuretics or who have asthma, should also discuss their conditions with their healthcare provider before use.

Patients should be advised to inform their healthcare provider if they have experienced serious side effects from pain relievers or fever reducers, or if they experience vomiting with their migraine headache. It is also important for patients to consult a doctor or pharmacist if they are taking prescription medications for diabetes, gout, arthritis, or are under care for any serious condition, as well as if they are taking any other drugs or 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 future reference to important information.

Additional Clinical Information

No further data are available.

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)