Excedrin Extra Strength

Description

EXCEDRIN® EXTRA STRENGTH is a combination medication that contains Acetaminophen, Aspirin (a nonsteroidal anti-inflammatory drug), and Caffeine. This formulation is designed to provide effective relief from pain. Each packet contains two caplets, which are intended for oral administration.

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

For adults and children aged 12 years and over, the recommended dosage is 2 caplets every 6 hours, with a maximum of 8 caplets within a 24-hour period. For children under 12 years of age, it is advised to consult a physician for appropriate dosing.

Each dose should be taken with a full glass of water to ensure proper administration and absorption.

Healthcare professionals should emphasize the importance of adhering to the recommended dosage and caution patients against exceeding the directed amount.

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 have or are recovering from chickenpox or flu-like symptoms should not use this product. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a physician, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

This product contains acetaminophen, which has the potential to cause severe skin reactions. Symptoms may include skin reddening, blisters, and rash. Should any skin reaction occur, the user must discontinue use immediately and seek medical assistance.

Severe liver damage may result from the consumption of this product if the user exceeds the maximum daily dosage of 8 caplets within a 24-hour period, takes it in conjunction with other medications containing acetaminophen, or consumes three or more alcoholic drinks daily while using this product.

Additionally, this product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The risk of such an event is heightened in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily, or exceed the recommended duration or dosage.

The recommended dose of this product contains approximately the same amount of caffeine as a standard 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.

Healthcare professionals should advise patients to consult a physician prior to use if they have liver disease, if the stomach bleeding warning is applicable, if they have a history of stomach issues such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, individuals taking diuretics or those with asthma should seek medical advice before use. It is also recommended to consult a doctor or pharmacist if the patient is taking prescription medications for diabetes, gout, or arthritis, or if they are under medical care for any serious condition.

In the event of an overdose, immediate medical attention is crucial. Users should contact a Poison Control Center or seek emergency medical help right away, as prompt intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should discontinue use and contact a physician 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), ringing in the ears or loss of hearing, redness or swelling in a painful area, worsening pain lasting more than 10 days, fever that worsens or lasts more than three days, or any new symptoms, as these may indicate a serious condition.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which may 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 not to use this product under these circumstances. If changes in behavior accompanied by nausea and vomiting occur, it is essential to consult a healthcare professional, as these may be early signs of Reye's syndrome.

Severe skin reactions have been associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. If any skin reaction occurs, patients should discontinue use and seek medical assistance immediately. Additionally, aspirin may provoke severe allergic reactions, including hives, facial swelling, asthma (wheezing), or shock, necessitating prompt medical attention.

This product contains acetaminophen, and patients should be aware that severe liver damage may occur if they exceed the maximum daily dosage of 8 caplets, use other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

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. The risk is further heightened if patients consume three or more alcoholic drinks daily or exceed the recommended duration or dosage.

Common Adverse Reactions Patients should limit the use of caffeine-containing medications, foods, or beverages while taking this product, as excessive caffeine intake may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients are advised to stop use and consult a healthcare professional 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

Concurrent use of nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and nonprescription agents such as aspirin, ibuprofen, and naproxen, may elevate the risk of gastrointestinal bleeding. Caution is advised when combining these medications, and monitoring for signs of bleeding should be considered.

The concomitant administration of anticoagulants or steroid medications may similarly increase the risk of gastrointestinal bleeding. Healthcare providers should evaluate the necessity of dosage adjustments and closely monitor patients for any adverse effects.

Patients are advised 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, insomnia, and, in some cases, tachycardia.

It is imperative to avoid the use of any other products containing acetaminophen, whether prescription or nonprescription, to prevent the risk of overdose and associated complications.

No specific laboratory test interactions have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Excedrin Extra Strength (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 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.

For dosing, adults and children aged 12 years and older are advised 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 recommended to consult a doctor for appropriate dosing guidance.

This product should be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay. Quick medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor elderly patients for any signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit profile is essential in this population to ensure safe and effective use of the medication.

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 fetal outcomes 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 healthcare 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 its use in lactating mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have 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. The presence of liver disease may increase the risk of adverse effects associated with acetaminophen, which is a component of this product.

Severe liver damage may occur if patients exceed the maximum recommended dosage of 8 caplets within a 24-hour period. Additionally, patients should avoid concurrent use of other medications containing acetaminophen, as this can further elevate the risk of liver injury. It is also advised that patients limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product, as alcohol can exacerbate the potential for liver damage.

Monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy while using this product.

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 essential 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 crucial in managing overdose situations effectively.

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 revealed reports of severe skin reactions associated with acetaminophen, including symptoms such as skin reddening, blisters, and rash. Additionally, there have been reports of severe allergic reactions linked to aspirin, which may manifest as hives, facial swelling, asthma (wheezing), and shock.

Cases of liver damage have been documented, particularly in individuals exceeding the recommended dosage of acetaminophen or using multiple acetaminophen-containing products concurrently. Furthermore, postmarketing data indicate an increased risk of stomach bleeding associated with the use of NSAIDs, especially in individuals over 60 years of age, those with a history of stomach ulcers or bleeding problems, and those consuming alcohol while using the product.

Reports of nervousness, irritability, sleeplessness, and rapid heart rate have been associated with excessive caffeine intake from this product.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients must be instructed to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be cautioned against using the medication if they have a history of allergic reactions to acetaminophen, aspirin, or any other pain reliever or fever reducer. It is important to inform patients not to use this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the contents of a drug, they should be encouraged to consult a doctor or pharmacist.

Patients should be instructed to stop using the medication and seek medical advice 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, patients should be advised to discontinue use and consult a doctor if they experience ringing in the ears, loss of hearing, redness or swelling in the painful area, worsening pain lasting more than 10 days, or a fever that worsens or lasts more than 3 days. They should also be informed to seek medical attention if any new symptoms arise, as these may indicate a serious condition.

Before initiating treatment, patients should be encouraged to consult a doctor if they have liver disease, a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients taking diuretics or those with asthma should also seek medical advice prior to use. Furthermore, patients should be advised to consult a doctor or pharmacist if they are taking prescription medications for diabetes, gout, or arthritis, or if they are on any other medications or under a doctor's care for any serious condition.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20° to 25°C (68° to 77°F) to maintain its efficacy and stability. Proper storage conditions should be ensured to prevent exposure to extreme temperatures.

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 of age, consultation with a healthcare provider is recommended before use.

Clinicians should counsel patients regarding the use of this medication during pregnancy and breastfeeding. It is crucial to seek medical advice before use, particularly in the last trimester of pregnancy, as aspirin may pose risks to the unborn child or lead to complications during delivery. Additionally, patients should be informed to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt attention is essential for both adults and children, regardless of the presence of symptoms.

Drug Information (PDF)

This file contains official product information for Excedrin Extra Strength, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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