Excedrin

Description

EXCEDRIN is a formulation indicated for migraine relief, comprising active ingredients of acetaminophen (250 mg), aspirin (250 mg), and caffeine (65 mg). The product is presented in the form of capsule-shaped tablets, with a total count of 24 caplets per bottle. It is distributed by Haleon, located in Warren, NJ 07059. The packaging features a tamper-evident bottle, and it is advised not to use the product if the inner foil seal imprinted with “SEALED for YOUR PROTECTION” is broken or missing. The copyright notice indicates ©2023 Haleon or its licensor, with trademarks owned by or licensed to the Haleon 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 instructed to take 2 caplets orally with a glass of water. The maximum dosage should not exceed 2 caplets within a 24-hour period unless otherwise directed by a healthcare professional. In cases where symptoms persist or worsen, it is advised to consult a doctor.

For individuals under 18 years of age, it is recommended to seek guidance from a healthcare provider 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 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 can include skin reddening, blisters, and rash. If any skin reaction occurs, 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 such reactions occur.

Liver Warning The presence of acetaminophen in this product necessitates caution, as severe liver damage may result from exceeding the maximum daily dosage of 2 caplets within a 24-hour period, using other medications containing acetaminophen concurrently, or consuming 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, particularly in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, and those taking anticoagulants or steroid medications. The risk is also heightened when combined with other NSAIDs (such as aspirin, ibuprofen, or naproxen) or when exceeding the recommended dosage or duration of use. Alcohol consumption of three or more drinks daily while using this product further increases the risk.

Medication Overuse Headache Warning Prolonged use of this product, specifically for 10 or more days per month, may exacerbate 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 treatment, as excessive caffeine consumption may lead to 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 a Poison Control Center without delay. 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. 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 allergic reactions may occur, particularly in patients sensitive to acetaminophen or aspirin. Symptoms of a severe skin reaction to acetaminophen may include skin reddening, blisters, and rash. If any of these symptoms develop, patients should discontinue use and seek medical assistance promptly. Aspirin may cause severe allergic reactions characterized by hives, facial swelling, asthma (wheezing), or shock, necessitating immediate medical attention.

Patients should be aware of the potential for severe liver damage associated with acetaminophen, particularly 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 product contains an NSAID, which may increase 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 regarding 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 using the product 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.

Additional Considerations 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.

Patients should consult a healthcare professional before using this product if they have never had migraines diagnosed, experience headaches that differ from their usual migraines, or have other specific medical conditions, including liver disease, high blood pressure, or a history of stomach problems.

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 elevate 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 increase the risk of stomach bleeding. It is recommended that healthcare providers assess the necessity of concurrent NSAID therapy and monitor for gastrointestinal complications.

Additionally, it is advisable to limit the intake of caffeine-containing medications, foods, or beverages while using this product to prevent excessive caffeine consumption, which could 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) , 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, a rare but serious illness. If pediatric patients exhibit changes in behavior accompanied by nausea and vomiting while using this product, it is essential to consult a doctor, as these may be early signs of Reye’s syndrome.

For individuals under 18 years of age, it is advised to seek medical guidance before use. Quick medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients.

Monitoring for signs of gastrointestinal bleeding is advised, and consideration should be given to the potential need for dose adjustments or alternative therapies in this population. Regular assessment of the patient's overall health status and concurrent medications is recommended to mitigate risks associated with NSAID use in elderly patients.

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 or 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 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 concomitant use with other medications containing acetaminophen and limit alcohol consumption to fewer than 3 drinks per day while using this product.

Prior to use, patients with known liver disease, including liver cirrhosis, should consult their healthcare provider. Furthermore, individuals with high blood pressure, heart disease, or kidney disease are also advised to seek medical advice before using this product. Regular 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 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, it is essential to monitor the patient closely and provide appropriate care as directed by medical guidelines.

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 specific non-teratogenic effects have been identified in the available data. Additionally, there are no specific details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

No specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

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 package that should be stored at a controlled room temperature of 20°-25°C (68°-77°F). It is essential to close the cap tightly after each use to maintain product integrity. Additionally, users are advised to keep the box for important information related to the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid the use of aspirin at 20 weeks of gestation or later 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)