Excedrin

Description

EXCEDRIN EXTRA STRENGTH is a combination medication containing Acetaminophen, Aspirin (a nonsteroidal anti-inflammatory drug), and Caffeine as active ingredients. The product is formulated as GELTABS, with a total count of 20 GELTABS per bottle. The packaging is designed to be tamper-evident, ensuring product integrity. Users are advised not to use the product if the inner foil seal imprinted with “SEALED for YOUR PROTECTION” is broken or missing. EXCEDRIN EXTRA STRENGTH is distributed by GSK Consumer Healthcare, located in Warren, NJ 07059. Copyright ©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 geltabs every 6 hours, with a maximum of 8 geltabs within a 24-hour period. It is essential to consume a full glass of water with each dose 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 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 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 geltabs is exceeded, if other medications containing acetaminophen are taken concurrently, or if the product is used while consuming three or more alcoholic drinks daily.

Additionally, the presence of an NSAID in this product raises the 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 increased for individuals using other NSAIDs (including aspirin, ibuprofen, or naproxen), consuming three or more alcoholic drinks daily, or exceeding the recommended duration or dosage of the product.

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.

Before using this product, individuals should consult a healthcare provider if they have liver disease, if the stomach bleeding warning applies, or if they have a history of stomach problems such as heartburn. Additional caution is warranted for those with high blood pressure, heart disease, liver cirrhosis, kidney disease, or those taking diuretics. Patients with asthma or those on prescription medications for diabetes, gout, or arthritis should also seek medical advice prior to use.

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

Users should discontinue the product and consult a healthcare professional if any allergic reactions occur, or if symptoms indicative of stomach bleeding arise, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. Other concerning symptoms include 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 the emergence of any new symptoms, as these may signal a serious condition.

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. Patients should be advised to discontinue use and consult a doctor if they experience changes in behavior accompanied by nausea and vomiting, 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 allergic reaction to acetaminophen may include skin reddening, blisters, and rash. If any of these symptoms develop, patients should stop using the product and seek medical attention immediately. Similarly, aspirin may cause severe allergic reactions characterized by hives, facial swelling, asthma (wheezing), or shock.

Patients should be aware of the risk of severe liver damage associated with acetaminophen, particularly if they exceed the maximum daily dosage of 8 geltabs, 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. This risk is heightened in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, individuals taking anticoagulants or steroid drugs, and those consuming three or more alcoholic drinks daily. Patients should be vigilant for signs of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

Common Adverse Reactions:

Patients may also experience less severe but common reactions. These include nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat, particularly if the recommended dose is exceeded or if caffeine-containing medications, foods, or beverages are consumed concurrently.

Patients are advised to stop using the product and consult a doctor if they experience any new symptoms, ringing in the ears, loss of hearing, or if pain worsens or lasts longer than 10 days. Additionally, if fever persists or worsens beyond three days, medical advice should be sought.

Precautions:

Before using this product, patients should consult a doctor if they have liver disease, a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are taking diuretics or have asthma.

Drug Interactions

The concurrent 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 guidance from a doctor or pharmacist if they are using other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, or naproxen.

Furthermore, individuals taking prescription medications for diabetes, gout, or arthritis should also consult a healthcare provider before using this product to ensure safety and efficacy.

It is imperative to avoid the concurrent use of this product with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, patients should seek clarification from a healthcare professional.

Packaging & NDC

Below are the non-prescription pack sizes of Excedrin (acetaminophen, asprin, caffeine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product due to the risk of Reye’s syndrome, a rare but serious illness. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is essential to consult a doctor, as these may be early signs of Reye’s syndrome.

For children under 12 years of age, it is advised to consult a doctor before use. For adults and children aged 12 years and older, the recommended dosage is 2 geltabs every 6 hours, with a maximum of 8 geltabs in a 24-hour period. Quick medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

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 drug 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

Pregnant patients and women 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 prior to 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 a healthcare professional prior to use, particularly if they have underlying 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 consult a healthcare professional prior to using this product. It is important to note that this product contains acetaminophen, which carries a risk of severe liver damage under certain conditions. Specifically, patients with compromised liver function should be aware that exceeding the maximum daily dosage of 8 geltabs within a 24-hour period may lead to significant hepatic injury.

Additionally, patients should avoid concurrent use of other medications containing acetaminophen, as this can further increase the risk of liver damage. Consumption of three or more alcoholic drinks per day while using this product is also contraindicated, as it may exacerbate the potential for severe liver injury. Monitoring of liver function may be warranted in patients with existing liver disease to ensure safety and prevent adverse effects.

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 needed.

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 relevant information is available regarding non-teratogenic effects. Additionally, there is no pertinent data provided in the nonclinical toxicology section or in the animal pharmacology and toxicology section.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include skin reddening, blisters, rash, hives, and facial swelling. Respiratory symptoms such as asthma (wheezing) and severe reactions including shock have also been noted.

Additionally, reports of auditory symptoms such as ringing in the ears or loss of hearing have been documented. Observations of painful areas that are red or swollen, as well as reports of pain worsening or persisting for more than 10 days, have been received. Instances of fever worsening or lasting for more than 3 days have also been reported.

Any appearance of new symptoms should be evaluated, as they may indicate a serious condition. In cases of allergic reactions, immediate medical assistance is advised.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical help or contact a Poison Control Center in the event of an overdose, emphasizing that 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 important to instruct patients to avoid using this medication in conjunction with any other products 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 should be instructed to discontinue use and consult a doctor if they experience any signs of an allergic reaction, as well as to seek immediate medical assistance. They should also be made aware of the signs of stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. In such cases, patients should stop using the medication and contact a healthcare professional.

Additionally, patients should be advised to stop use and consult a doctor if they experience ringing in the ears, loss of hearing, or if a painful area becomes red or swollen. They should also be informed to seek medical advice if their pain worsens or persists for more than 10 days, or if their fever worsens or lasts longer than 3 days. Patients should be encouraged to report any new symptoms, as these may indicate a serious condition.

Healthcare providers should recommend that patients consult a doctor before using this medication if they have liver disease, a history of stomach problems such as heartburn, or if the stomach bleeding warning applies to them. Patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also be advised to seek medical guidance prior to use. Furthermore, patients taking diuretics or those with asthma should be encouraged to discuss their situation with a healthcare professional before using this medication.

Storage and Handling

The product is supplied in a tamper-evident bottle. It is essential to ensure that the inner foil seal, marked with “SEALED for YOUR PROTECTION,” remains intact; do not use the product if this seal is broken or missing.

For optimal storage, the product should be maintained at a temperature range of 20°-25°C (68°-77°F). After each use, the cap must be closed tightly to preserve the integrity of 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 instructed to take 2 geltabs every 6 hours, not exceeding 8 geltabs within a 24-hour period. For children under 12 years, it is recommended to consult a doctor for appropriate dosing.

Clinicians should counsel patients on important safety information. Pregnant or breastfeeding individuals should seek advice from a health professional before 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, the medication should be kept out of reach of children, and in the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential, as prompt attention is critical 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)