Excedrin

Description

NDC 0067-2000-10. EXCEDRIN® EXTRA STRENGTH is a combination pain reliever containing Acetaminophen, Aspirin (NSAID), and Caffeine. Each package contains 10 caplets, which are supplied in a tamper-evident bottle. The product should not be used if the inner foil seal imprinted with “SEALED for YOUR PROTECTION” is broken or missing. EXCEDRIN® is distributed by GSK Consumer Healthcare, located in Warren, NJ 07059. ©2015 GSK or its licensor. For more information, visit www.excedrin.com.

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 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, 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 another 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.

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

Similarly, aspirin may provoke a severe allergic reaction characterized by hives, facial swelling, wheezing, or shock. Healthcare professionals should be alerted to these potential reactions.

Liver Warning This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 8 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. Monitoring liver function may be warranted in patients at risk.

Stomach Bleeding Warning As this product contains a nonsteroidal anti-inflammatory drug (NSAID), it may increase the risk of severe stomach bleeding. The risk is heightened in individuals aged 60 or older, those with a history of stomach ulcers or bleeding disorders, and patients taking anticoagulants or steroid medications. Caution is advised for those using other NSAIDs, including prescription and nonprescription options such as aspirin, ibuprofen, or naproxen. Additionally, the risk of stomach bleeding may increase with the consumption of three or more alcoholic drinks daily or with prolonged use beyond the recommended duration.

Caffeine Warning The recommended dosage of this product contains approximately the same amount of caffeine as a standard cup of coffee. Patients should limit the intake of other 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.

Emergency Medical Help In the event of an overdose, immediate medical attention is crucial. Patients or caregivers should contact a Poison Control Center or seek emergency medical help without delay, regardless of the presence of symptoms.

Discontinuation of Use If any skin reactions occur, the product should be discontinued immediately, and medical assistance should be sought.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which can be serious.

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. It is crucial that these individuals do not use this product. If patients exhibit changes in behavior accompanied by nausea and vomiting while using this product, they should consult a healthcare professional immediately, as these symptoms could indicate the onset of Reye’s syndrome.

Severe skin reactions have been reported in patients taking acetaminophen, which may manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, patients are advised to discontinue use and seek medical attention promptly. Similarly, aspirin may provoke a severe allergic reaction characterized by hives, facial swelling, asthma (wheezing), or shock. Patients experiencing these symptoms should seek immediate medical assistance.

The product contains acetaminophen, which poses a risk of severe liver damage if patients exceed the maximum daily dosage of 8 caplets within 24 hours, 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 a nonsteroidal anti-inflammatory drug (NSAID) in this product raises the risk of severe stomach bleeding, particularly in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, or are consuming three or more alcoholic drinks daily. The risk is also heightened if patients take other NSAIDs, whether prescription or over-the-counter, or exceed the recommended duration or dosage.

Patients should also be aware that the recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee. 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.

Drug Interactions

The concomitant use of caffeine-containing medications, foods, or beverages should be limited while taking this product. 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. This precaution is essential to avoid potential interactions that may affect the efficacy or safety of either treatment.

Additionally, individuals taking other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, or naproxen, should seek guidance from a healthcare provider before use. The combination of these medications may increase the risk of adverse effects.

For patients on prescription medications for diabetes, gout, or arthritis, it is recommended to consult a healthcare professional before using this product. This is to ensure that there are no contraindications or interactions that could compromise treatment outcomes.

Lastly, individuals taking any other medications or those under a physician's care for serious medical conditions should also seek advice from a healthcare provider prior to use. This ensures comprehensive safety and monitoring of potential drug interactions.

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 changes in behavior accompanied by nausea and vomiting occur 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, it is advised to consult a doctor before use. It is important not to exceed the recommended dosage.

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 this medication to geriatric patients to mitigate potential risks and optimize therapeutic outcomes.

Pregnancy

The use of this medication is contraindicated during pregnancy. There is currently no established risk to the fetus; however, due to the lack of sufficient data, pregnant patients should avoid using this medication. Women of childbearing potential are advised to consult a healthcare professional prior to use if they are pregnant or planning to become pregnant.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

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 consult a healthcare professional prior to use of this product. This is particularly important for individuals with liver disease, high blood pressure, heart disease, liver cirrhosis, or kidney disease.

The product contains acetaminophen, which carries a risk of severe liver damage. Patients with compromised liver function must be cautious not to exceed the maximum daily dosage of 8 caplets within a 24-hour period. Additionally, patients should avoid concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than 3 drinks per day while using this product to mitigate the risk of liver injury. Regular monitoring of liver function may be warranted in patients with significant hepatic impairment.

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

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified several important safety considerations associated with the use of this product.

Severe skin reactions have been reported in association with acetaminophen use, with symptoms including skin reddening, blisters, and rash. Users are advised to discontinue use and seek medical assistance immediately if any skin reaction occurs.

Aspirin has been associated with the potential for severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), or shock.

The product contains acetaminophen, and there is a risk of severe liver damage if the maximum daily dosage of 8 caplets is exceeded within a 24-hour period, particularly when used in conjunction with other acetaminophen-containing medications or in individuals with pre-existing liver disease.

Additionally, the product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. This risk is heightened in individuals who exceed the recommended dosage, have a history of stomach ulcers or bleeding problems, or possess conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Finally, the recommended dose of this product contains a caffeine amount comparable to that found in a cup of coffee. Users are advised to limit the intake of other 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.

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 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 medical intervention remains critical.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at a controlled room temperature of 20° to 25°C (68° to 77°F) to maintain its integrity and efficacy.

After each use, it is essential to close the cap tightly to prevent contamination and preserve the product's quality. Users should also ensure that the inner foil seal, which is imprinted with “SEALED for YOUR PROTECTION,” remains intact. The product should not be used if this seal is broken or missing, as this may indicate potential compromise of the product's safety and effectiveness.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 6 hours, with a maximum of 8 caplets in a 24-hour period. For children under 12 years, it is advised to consult a doctor for appropriate dosing.

Patients should be counseled to drink a full glass of water with each dose and to read all product information prior to use, ensuring they retain the packaging for important information.

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)