Excedrin

Description

EXCEDRIN EXTRA STRENGTH HEADACHE is a combination pain reliever formulated to alleviate headache symptoms. Each caplet contains 250 mg of acetaminophen, 250 mg of aspirin (a nonsteroidal anti-inflammatory drug), and 65 mg of caffeine. The product is presented in a tamper-evident bottle containing 24 caplets. A safety seal warning indicates that the product should not be used if the inner safety seal imprinted with “SEALED for YOUR PROTECTION” is broken or missing. This product is distributed by Haleon, located in Warren, NJ 07059. All trademarks are owned by or licensed to the Haleon group of companies, and the copyright for this product is held by ©2023 Haleon or its licensor.

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 taken orally every 6 hours, with a maximum limit of 8 caplets within a 24-hour period. It is essential to consume each dose with a full glass of water to ensure proper administration.

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 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, a rare but serious illness. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional immediately, as these may be early indicators of Reye’s syndrome.

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, and medical assistance should be sought without delay.

Additionally, aspirin, another component of this product, may provoke a severe allergic reaction characterized by hives, facial swelling, asthma (wheezing), or shock. Immediate medical attention is warranted if any of these symptoms manifest.

Liver Warning The presence of acetaminophen in this product necessitates caution, as severe liver damage may occur under certain conditions. This includes exceeding the maximum daily dosage of 8 caplets within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of 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, or those taking anticoagulants or steroid medications. The risk is further heightened with the use of other NSAIDs (including aspirin, ibuprofen, or naproxen) or if the product is taken in excess or for an extended duration. Alcohol consumption of three or more drinks daily while using this product also increases the risk of stomach bleeding.

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 symptoms such as 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 a Poison Control Center should be contacted. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Discontinuation of Use Healthcare professionals should advise patients to stop using this product and seek medical advice 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; 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 persists for more than 3 days; or the emergence of any new symptoms. These may indicate a serious condition requiring further evaluation.

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 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 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.

Patients should also be aware of the risk of severe liver damage associated with acetaminophen, particularly if they exceed the maximum daily dosage of 8 caplets, use other acetaminophen-containing products, or consume three or more alcoholic drinks daily while using this product.

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. Patients should be cautioned against exceeding the recommended dosage or duration of use, as well as against concurrent alcohol consumption.

Common Adverse Reactions Patients may experience symptoms related to 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.

Monitoring and Consultation 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, 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 lasting more than 3 days, or any new symptoms. These may indicate a serious condition requiring medical evaluation.

Drug Interactions

Co-administration of this product with other drugs containing acetaminophen, whether prescription or nonprescription, should be approached with caution due to the potential risk of severe liver damage.

When used concurrently with anticoagulants or steroid medications, there is an increased risk of gastrointestinal bleeding. Therefore, careful monitoring is advised in patients receiving these combinations.

The use of other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen, and naproxen, should be avoided while taking this product to prevent additive adverse effects.

Additionally, it is recommended to limit the intake of caffeine-containing medications, foods, or beverages during treatment with this product to prevent excessive caffeine exposure.

No specific interactions with laboratory tests 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

Pediatric patients, particularly children and teenagers, should not use this product if they have or are recovering from chicken pox or flu-like symptoms 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 essential to consult a healthcare professional, 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 before use.

Geriatric Use

Elderly patients may be at an increased risk for severe stomach bleeding when using this product, as it contains a nonsteroidal anti-inflammatory drug (NSAID). The likelihood of experiencing such adverse effects is notably higher in individuals aged 60 years and older.

It is essential for geriatric patients to consult with a healthcare provider prior to using this medication, particularly if they have pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Careful consideration and monitoring are advised to ensure the safe use of this product in the elderly population.

Pregnancy

Pregnant patients and those 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 and complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a healthcare provider if deemed necessary.

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 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. It is important to note that this product contains acetaminophen, which carries a risk of severe liver damage. Patients with compromised liver function must be particularly cautious, as exceeding the maximum daily dosage of 8 caplets within a 24-hour period can lead to significant hepatic injury.

Additionally, the risk of liver damage is heightened when acetaminophen is taken in conjunction with other medications containing acetaminophen or when consuming three or more alcoholic beverages daily while using this product. Therefore, careful monitoring of liver function and adherence to recommended dosages is essential for patients with liver disease.

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 comprehensive care as needed.

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 or additional nonclinical toxicology details are available in the provided data. Furthermore, there are no specific findings related to animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified 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 associated with aspirin, which may manifest as hives, facial swelling, asthma (wheezing), and shock.

Cases of liver damage have been reported in patients taking acetaminophen, particularly among those exceeding the recommended dosage or using it in conjunction with other acetaminophen-containing products. Furthermore, postmarketing data indicate an increased risk of stomach bleeding associated with the use of NSAIDs, especially in patients over 60 years of age, those with a history of stomach ulcers or bleeding problems, and those taking anticoagulants or other NSAIDs.

Reports of caffeine-related adverse effects, such as nervousness, irritability, sleeplessness, and rapid heart rate, have also been noted in the postmarketing experience.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed to discontinue use and consult a doctor if they experience any signs of an allergic reaction, and to seek medical help without delay. Additionally, they should be informed to stop use and contact a healthcare professional if they notice any symptoms indicative of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain.

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

Healthcare providers should remind patients to consult a doctor before using the medication if they have liver disease, a history of stomach problems such as heartburn, or if the stomach bleeding warning is applicable 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, those taking diuretics or who have asthma should consult a doctor before use.

Lastly, patients should be encouraged to speak with their doctor or pharmacist before using the medication if they are taking prescription drugs 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 a secure packaging that includes an inner safety seal imprinted with “SEALED for YOUR PROTECTION.” It is essential to inspect this seal before use; the product should not be utilized if the seal is broken or missing.

For optimal storage, the product must be kept at a temperature range of 20°-25°C (68°-77°F). After each use, the cap should be closed tightly to maintain the integrity of the product. Additionally, it is advisable to retain the original box for reference to important information regarding 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 of age, consultation with a doctor is recommended before administration.

Clinicians should counsel patients on important safety information. Pregnant or breastfeeding individuals should seek advice from a healthcare professional prior to use, particularly noting that aspirin should generally be avoided after 20 weeks of pregnancy unless specifically directed by a physician due to potential risks to the unborn child and 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)