Excedrin

Description

Excedrin Migraine is a combination medication formulated as coated capsule-shaped tablets containing Acetaminophen, Aspirin (NSAID), and Caffeine. Each tablet has a molecular weight of 300 mg. It is indicated as a pain reliever and pain reliever aid. The product is distributed by GSK Consumer Healthcare, located in Warren, NJ 07059. The National Drug Code (NDC) for this formulation is 0067-8201-03. ©2020 GSK or licensor. Trademarks are owned by or licensed to the GSK group of companies.

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 advised to take 2 caplets with a full glass of water. It is important not to exceed the recommended dosage of 2 caplets within a 24-hour period unless specifically directed by a healthcare professional. In cases where symptoms persist or worsen, patients should consult their doctor for further evaluation and guidance.

For individuals under 18 years of age, it is recommended to seek advice from a healthcare provider before use.

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 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 may be early signs of this rare but serious illness.

Acetaminophen, one of the active ingredients, may lead to severe skin reactions, including skin reddening, blisters, and rash. In the event of a skin reaction, the product should be discontinued immediately, and medical assistance should be sought. Additionally, 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 caution is advised due to the potential for severe liver damage. Such damage may occur if the maximum daily dosage of 2 caplets is exceeded within a 24-hour period, if it is taken concurrently with other medications containing acetaminophen, or if the user consumes 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 problems, or those taking anticoagulants or steroid medications. The risk is also heightened for individuals consuming three or more alcoholic drinks daily, taking other NSAIDs, or using the product for longer than directed.

Headaches may worsen if this product is used for 10 or more days per month, indicating a potential medication overuse headache. Furthermore, the recommended dosage contains caffeine equivalent to that found in a cup of coffee. Users should limit the intake of other caffeine-containing medications, foods, or beverages, as excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.

Healthcare professionals should advise patients to consult a doctor before using this product if they have never had a migraine diagnosed, experience headaches that differ from their usual migraines, or have the worst headache of their life. Additional caution is warranted for individuals with fever and stiff neck, headaches following head injury or exertion, new headaches after age 50, daily headaches, or migraines severe enough to require bed rest. Patients with liver disease, a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or those taking diuretics or experiencing asthma should also seek medical advice prior to use.

In the event of an overdose, immediate medical help should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Quick medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Patients should 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 relieved 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 may be serious.

Warnings include the risk of Reye’s syndrome, particularly 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, they should consult a doctor immediately, as these may be early signs of this rare but serious illness.

Severe skin reactions have been associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients are advised to discontinue use and seek medical assistance promptly. Aspirin, another component of this product, may provoke severe allergic reactions characterized by hives, facial swelling, asthma (wheezing), or shock.

The product contains acetaminophen, and patients should be aware of the potential for severe liver damage if they exceed the maximum daily dosage of 2 caplets within 24 hours, use other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. Additionally, the presence of an NSAID in the formulation raises the risk of severe stomach bleeding, particularly in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, or those taking anticoagulants, steroids, or other NSAIDs. Patients should also be cautious if they consume three or more alcoholic drinks daily or take the product for longer than directed.

Medication overuse headaches may occur if this product is used for 10 or more days per month. Furthermore, the recommended dose contains caffeine equivalent to that of a cup of coffee, and patients should limit the intake of other caffeine-containing products to avoid symptoms such as nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Patients are advised to stop use and consult a doctor if they experience any signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, or having bloody or black stools), or if their migraine is not relieved or worsens after the first dose. New or unexpected symptoms, as well as ringing in the ears or loss of hearing, should also prompt a consultation with a healthcare professional.

Before using this product, patients should seek medical advice if they have never had migraines diagnosed, experience headaches that differ from their usual migraines, have the worst headache of their life, or present with fever and stiff neck. Additional caution is warranted for patients with headaches following head injury, exertion, coughing, or bending, those experiencing their first headache after age 50, or those with daily headaches. Patients with severe migraines requiring bed rest, liver disease, a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease should also consult a doctor prior to use.

Pregnant or breastfeeding patients should seek professional guidance before using this product, particularly regarding the use of aspirin during the last three months of pregnancy, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Interactions

The concomitant 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.

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

Furthermore, individuals should inquire with a healthcare provider before using this product if they are taking any medications that contain acetaminophen, whether prescription or over-the-counter. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a doctor or pharmacist is advised.

Patients who are prescribed medications for diabetes, gout, or arthritis should also seek medical advice before using this product. Lastly, individuals under the care of a healthcare professional for any serious medical condition should consult their doctor prior to use.

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 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 with their healthcare provider prior to using this medication. It is essential for geriatric patients to discuss their overall health status and any concurrent medications to ensure safe and effective use. Careful consideration and monitoring may be warranted in this population to mitigate potential risks associated with the medication.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication. It is particularly important to avoid the use of aspirin during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child and lead to complications during delivery. The potential fetal impacts and associated risks necessitate careful consideration and professional guidance for women of childbearing potential.

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 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 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.

Prior to use, patients with liver disease, liver cirrhosis, high blood pressure, heart disease, or kidney disease should consult their healthcare provider. Monitoring of liver function may be warranted in patients with compromised liver function 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 at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary based on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and intervention may be necessary to address any complications that arise from the overdose.

It is vital to maintain open communication with poison control and other medical professionals throughout the management process to ensure optimal care and outcomes for the patient.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No relevant information is available regarding non-teratogenic effects, nonclinical toxicology, or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse events reported voluntarily or through surveillance programs.

Allergic reactions have been documented, and individuals are advised to seek medical assistance immediately if such reactions occur. Additionally, signs indicative of stomach bleeding have been reported, including feelings of faintness, vomiting blood, the presence of bloody or black stools, and persistent stomach pain that does not improve.

Reports also indicate that some patients may experience worsening or unrelieved migraine symptoms following the initial dose. Furthermore, new or unexpected symptoms have been noted, along with instances of tinnitus or hearing loss.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) 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 the medication if they have a history of allergic reactions to acetaminophen, aspirin, or any other pain reliever or fever reducer. It is essential to caution patients against using this medication in conjunction with any other drug that contains 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 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 patient's migraine is not alleviated or worsens after the first dose, they should stop use and seek medical advice.

Healthcare providers should also inform patients to stop using the medication and consult a doctor if they experience new or unexpected symptoms, or if they notice 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 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 consult a doctor if they have fever and 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 before use. It is important to discuss any history of liver disease, stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, or kidney disease with a healthcare provider prior to use. Patients taking diuretics, those with asthma, or those who have experienced serious side effects from pain relievers or fever reducers should also consult their doctor before use.

Finally, patients should be advised to speak with a doctor or pharmacist if they are taking any prescription drugs for diabetes, gout, or arthritis, if they are under a doctor's care for any serious condition, or if they are taking any other medications or products that contain aspirin, acetaminophen, or any other pain reliever or fever reducer.

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 temperature range of 20°-25°C (68°-77°F) to maintain its integrity and efficacy.

After each use, the cap must be closed tightly to prevent contamination and ensure the product remains effective. Users are advised to read all product information thoroughly before use and to retain the packaging for future reference, as it contains 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, particularly emphasizing the importance of avoiding aspirin during the last trimester of pregnancy unless specifically directed by a physician, due to potential risks to the unborn child and complications during delivery.

Patients should be instructed to keep the medication out of reach of children. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even if no symptoms are apparent.

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)