Excedrin

Description

EXCEDRIN EXTRA STRENGTH is a combination pain reliever containing Acetaminophen, Aspirin (NSAID), and Caffeine. Each bottle contains 100 caplets and is packaged in a tamper-evident container. The product is identified by NDC 0067-2001-05 and is distributed by GSK Consumer Healthcare, located in Warren, NJ 07059. The product should not be used if the inner foil seal, imprinted with “SEALED for YOUR PROTECTION,” is broken or missing. The trademarks associated with this product are owned by or licensed to the GSK group of companies. The product is part of the ©2018 GSK group of companies or its licensor. The UPC for this product is 62000000032208.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, cold symptoms, arthritis, muscular aches, toothache, and premenstrual or menstrual cramps.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should adhere strictly to the recommended dosage. For adults and children aged 12 years and older, the prescribed dosage is 2 caplets every 6 hours, with a maximum limit of 8 caplets within a 24-hour period. It is essential to take each dose with a full glass of water to ensure proper administration and absorption.

For children under 12 years of age, it is advised to consult a healthcare professional for appropriate dosing recommendations.

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 illness.

Acetaminophen, a component of this product, has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, and rash. Should any skin reaction occur, the use of the product must be discontinued immediately, and medical assistance should be sought.

Aspirin, another ingredient, may provoke a severe allergic reaction characterized by hives, facial swelling, asthma (wheezing), or shock. Immediate medical attention is warranted if such reactions occur.

This product contains acetaminophen, and caution is advised due to the potential for severe liver damage. This risk is heightened if the maximum daily dosage of 8 caplets is exceeded, if other medications containing acetaminophen are taken concurrently, or if the product is used in conjunction with the consumption of three or more alcoholic drinks daily.

Additionally, the product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The risk of this adverse effect is increased in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, and those taking anticoagulants or steroid medications. Concurrent use of other NSAIDs, whether prescription or over-the-counter, as well as the consumption of three or more alcoholic drinks daily, can further elevate this risk. It is also crucial to adhere to the recommended dosage and duration of use.

The recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee. Therefore, it is advisable to limit the intake of other caffeine-containing medications, foods, or beverages while using this product, as excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Healthcare professionals should advise patients to consult a doctor prior to use if they have liver disease, if the stomach bleeding warning applies, or if they have a history of stomach problems such as heartburn. Patients with high blood pressure, heart disease, liver cirrhosis, kidney disease, or those taking diuretics or with asthma should also seek medical advice before using this product.

In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Patients should discontinue use and consult a healthcare professional if they experience any allergic reactions, signs of stomach bleeding (such as feeling faint, vomiting blood, or having bloody or black stools), persistent stomach pain, ringing in the ears, loss of hearing, redness or swelling in a painful area, worsening pain lasting more than 10 days, fever lasting more than 3 days, or any new symptoms, as these may indicate a serious condition.

Side Effects

Patients using this product should be aware of several serious and common adverse reactions associated with its use.

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 not use this product in such cases. If changes in behavior accompanied by nausea and vomiting occur, it is crucial to consult a doctor, as these symptoms could indicate the onset 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 immediately. Similarly, aspirin may provoke severe allergic reactions characterized by hives, facial swelling, asthma (wheezing), or shock, necessitating prompt medical attention.

The product contains acetaminophen, which poses a risk of severe liver damage if patients exceed the maximum daily dosage of 8 caplets, use it in conjunction with other acetaminophen-containing medications, 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, 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 be vigilant if they consume three or more alcoholic drinks daily or take the medication for longer than directed.

Common Adverse Reactions

Patients may experience common adverse reactions, including nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat due to caffeine content. It is advisable to limit the intake of other caffeine-containing medications, foods, or beverages while using this product.

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), ringing in the ears or loss of hearing, redness or swelling in a painful area, worsening pain lasting more than 10 days, fever lasting more than 3 days, or any new symptoms. These may signal a serious condition requiring medical evaluation.

Drug Interactions

Taking this product concurrently with other medications containing acetaminophen, whether prescription or nonprescription, may result in severe liver damage. It is advisable to avoid the use of multiple acetaminophen-containing products to mitigate this risk.

The concomitant use of this product with anticoagulants or steroid medications significantly increases the risk of severe gastrointestinal bleeding. Close monitoring for signs of gastrointestinal distress is recommended in patients receiving these combinations.

Similarly, the risk of severe stomach bleeding is heightened when this product is taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen. Caution should be exercised, and alternative pain management strategies should be considered to reduce the potential for adverse effects.

Additionally, it is recommended to limit the intake of caffeine-containing medications, foods, or beverages while using this product. Excessive caffeine consumption may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. Monitoring caffeine intake is advisable to prevent these 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, a rare but serious illness. If pediatric patients experience changes in behavior accompanied by nausea and vomiting while using this product, a healthcare professional should be consulted, as these may be early signs of Reye’s syndrome.

For dosing, adults and children aged 12 years and over are directed to take 2 caplets every 6 hours, with a maximum of 8 caplets in a 24-hour period. For children under 12 years of age, it is advised to consult a doctor before use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. 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 dosage adjustments may be necessary based on the individual patient's health status and concurrent medications. Careful assessment of the risks versus benefits should be conducted to ensure the safety of elderly patients receiving this treatment.

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 the unborn child 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 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 the use of this medication in lactating mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have comorbid 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 degree 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 8 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 drinks per day while using this product.

Before initiating treatment, patients with liver disease, high blood pressure, heart disease, liver cirrhosis, or kidney disease should 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 are advised to remain vigilant and proactive in managing potential overdose situations. The lack of immediate symptoms does not preclude the possibility of serious health consequences, and therefore, timely evaluation and treatment are essential.

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 several adverse reactions associated with the use of acetaminophen and aspirin. Reports indicate that severe skin reactions may occur, including skin reddening, blisters, and rash in patients taking acetaminophen. Additionally, severe allergic reactions have been documented in association with aspirin, which may manifest as hives, facial swelling, asthma (wheezing), and shock. These events have been reported voluntarily or through surveillance programs, contributing to the ongoing assessment of the safety profile of these medications.

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, the need for quick intervention remains critical.

Storage and Handling

The product is supplied in a container that requires careful handling to maintain its integrity. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). After each use, it is essential to close the cap tightly to prevent contamination and ensure the product remains effective. Additionally, it is advised to retain the original packaging for important information related to the product.

Additional Clinical Information

The medication is administered orally, with specific dosing guidelines for different age groups. Adults and children aged 12 years and older are advised to take 2 caplets every 6 hours, not exceeding 8 caplets within a 24-hour period. For children under 12 years, consultation with a doctor is recommended before use.

Clinicians should counsel patients on important safety information. Pregnant or breastfeeding individuals should seek advice from a health professional prior to use, particularly noting that aspirin should generally be avoided during the last trimester of pregnancy unless specifically directed by a physician due to potential risks to the unborn child or complications during delivery. Additionally, it is crucial to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential, as prompt attention is vital for both adults and children, regardless of the presence of symptoms.

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)