Aspirin/Acetaminophen/Caffeine

Description

Acetaminophen, in combination with Aspirin (a nonsteroidal anti-inflammatory drug) and Caffeine, serves as a pain reliever and pain reliever aid. This formulation is designed to provide relief comparable to the active ingredients found in Excedrin® Extra Strength. The product is available in a dosage form of 100 caplets. It is important to note that this medication is not intended for households with young children.

Uses and Indications

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

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

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the recommended dosage. Patients must not exceed the directed amount. Each dose should be taken with a full glass of water to ensure proper administration.

For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 6 hours. It is imperative that patients do not exceed a total of 8 caplets within a 24-hour period.

For children under 12 years of age, it is essential to consult a physician 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 prohibited. 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.

Aspirin, a component of this product, may lead to severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma (wheezing). Similarly, acetaminophen may cause severe skin reactions, including skin reddening, blisters, or rash. In the event of a skin reaction, the use of the product should be discontinued, and medical assistance should be sought without delay.

This product contains acetaminophen, which poses a risk of severe liver damage if taken in conjunction with other acetaminophen-containing medications, if the maximum daily dosage of 8 caplets is exceeded, or if consumed with three or more alcoholic drinks daily. Additionally, the presence of an NSAID in this product increases the risk of severe stomach bleeding, particularly in individuals aged 60 or older, those who take the medication for longer than directed, individuals with a history of stomach ulcers or bleeding problems, and those concurrently using blood thinners, steroids, or other NSAIDs. Alcohol consumption of three or more drinks daily while using this product further elevates this risk.

Caffeine is also present in the recommended dose of this product, which is comparable to the caffeine content of a cup of coffee. It is advisable to limit the intake of other caffeine-containing medications, foods, or beverages, as excessive caffeine may lead to symptoms such as 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, a history of stomach problems (such as heartburn), high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma. Additionally, patients taking diuretics or prescription medications for diabetes, gout, or arthritis should seek guidance from a healthcare provider or pharmacist before using this product. It is also recommended that patients under care for any serious condition discuss the use of this product with their healthcare provider.

In the event of an accidental overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should discontinue use and consult a doctor if they experience any signs of stomach bleeding, such as feeling faint, having bloody or black stools, or vomiting blood. Additionally, if stomach pain persists, an allergic reaction occurs, or if symptoms such as ringing in the ears, loss of hearing, worsening pain, or fever lasting more than three days develop, medical advice should be sought. Any new symptoms that arise should also be reported to a healthcare professional, as they may indicate a serious condition.

Side Effects

Patients using this product should be aware of several potential adverse reactions, which can range from serious to common.

Serious adverse reactions include the risk of Reye’s syndrome, particularly in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. If patients exhibit changes in behavior accompanied by nausea and vomiting, they should consult a healthcare professional immediately, as these may be early signs of this rare but serious illness.

Allergic reactions can also occur, with aspirin potentially causing severe reactions such as hives, facial swelling, shock, and asthma (wheezing). Acetaminophen may lead to severe skin reactions, including skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use and seek medical assistance promptly.

Liver damage is another serious concern associated with this product, particularly due to its acetaminophen content. Severe liver damage may occur if patients take this product in conjunction with other medications containing acetaminophen, exceed the maximum daily dosage of 8 caplets, or consume three or more alcoholic drinks daily while using this product.

The product also contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. This risk is heightened in patients aged 60 or older, those who take the medication for longer than directed, individuals with a history of stomach ulcers or bleeding problems, and those concurrently using blood thinners or other NSAIDs. Additionally, consuming three or more alcoholic drinks daily while using this product may further elevate this risk.

Patients should be cautious regarding 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 symptoms such as nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Patients are advised to stop use and consult a healthcare professional if they experience any signs of stomach bleeding, such as feeling faint, having bloody or black stools, or vomiting blood. Other symptoms warranting medical attention include persistent stomach pain, allergic reactions, ringing in the ears or loss of hearing, worsening pain lasting more than 10 days, fever lasting more than 3 days, redness or swelling in a painful area, or the emergence of any new symptoms, which could indicate a serious condition.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated. Patients should consult a healthcare professional if there is uncertainty regarding the presence of acetaminophen in other medications.

Pharmacodynamic interactions are significant when this medication is used concurrently with anticoagulants or steroid drugs, as the risk of severe gastrointestinal bleeding is increased. Caution is advised, and monitoring for signs of gastrointestinal bleeding should be considered in patients receiving these combinations.

Additionally, the concomitant use of this medication with other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen, also elevates the risk of severe stomach bleeding. Patients should be advised against using multiple NSAIDs simultaneously.

For patients taking prescription medications for diabetes, gout, or arthritis, it is recommended to consult a healthcare provider or pharmacist prior to initiating this medication to avoid potential interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen, Aspirin, 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, it is important to consult a doctor, 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.

This product should be kept out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or contact a Poison Control Center (1-800-222-1222). Prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding when using this product. This risk is further heightened in individuals who have a history of stomach ulcers or bleeding problems, those who are concurrently taking anticoagulants or steroid medications, and patients who are using other nonsteroidal anti-inflammatory drugs (NSAIDs), whether prescription or nonprescription. Additionally, consumption of three or more alcoholic drinks daily while using this product may exacerbate the risk of gastrointestinal complications.

Healthcare providers should exercise caution when prescribing this product to geriatric patients. Close monitoring for signs of gastrointestinal bleeding is recommended, and dosage adjustments may be necessary based on the individual patient's health status and concurrent medications. It is essential to ensure that elderly patients are informed of the potential risks associated with the use of this product, particularly in the context of their overall treatment regimen.

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 prior to 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 while breastfeeding.

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 under certain conditions. Specifically, patients with compromised liver function should be aware that the following precautions are critical to minimize the risk of hepatotoxicity:

• Patients must not exceed the maximum daily dosage of 8 caplets within a 24-hour period.

• Concurrent use of other medications containing acetaminophen should be avoided to prevent cumulative dosing.

• Consumption of 3 or more alcoholic drinks per day while using this product is contraindicated, as it may significantly increase the risk of liver damage.

Monitoring of liver function may be warranted in patients with existing liver disease or those who are at risk for hepatic impairment. It is essential for these patients to adhere strictly to the recommended guidelines to ensure their safety while using this product.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the management of overdose cases may vary depending on the specific substance involved and the clinical presentation of the patient. Therefore, it is essential to conduct a thorough assessment and provide appropriate interventions based on the patient's condition and the guidance of poison control experts.

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 important safety considerations associated with the use of this product.

Reports indicate that acetaminophen may lead to severe skin reactions, characterized by symptoms such as skin reddening, blisters, and rash. Additionally, there is a warning regarding the potential for severe liver damage, particularly when the product is taken in conjunction with other medications containing acetaminophen, when exceeding the maximum daily dosage of 8 caplets, or when consumed alongside three or more alcoholic drinks daily.

The presence of an NSAID in this product raises concerns about the risk of severe stomach bleeding. This risk is heightened in individuals aged 60 or older, those who take the medication for longer than directed, individuals with a history of stomach ulcers or bleeding problems, and those concurrently using blood thinners or other NSAIDs, as well as those consuming three or more alcoholic drinks daily.

Users are advised to discontinue use and consult a healthcare professional if they experience an allergic reaction, ringing in the ears, loss of hearing, worsening pain lasting more than 10 days, fever persisting beyond 3 days, redness or swelling in the painful area, or the emergence of any new symptoms, as these may indicate a serious condition.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be informed not to use the medication if they have ever experienced an allergic reaction to acetaminophen, aspirin, or any other pain reliever or fever reducer.

It is important to counsel patients against using this medication in conjunction with any other drug that contains acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist for clarification.

Patients should be instructed to stop using the medication and seek medical advice if they experience any signs of stomach bleeding, such as feeling faint, having bloody or black stools, or vomiting blood. Additionally, they should be advised to discontinue use and consult a doctor if they experience stomach pain that does not improve.

In the event of an allergic reaction, patients should be informed to stop using the medication and seek immediate medical assistance. They should also be made aware that if they experience ringing in the ears or loss of hearing, they should stop use and consult a doctor.

Patients should be cautioned to stop using the medication and seek medical advice if their pain worsens or persists for more than 10 days, or if their fever worsens or lasts for more than 3 days. They should also be advised to consult a doctor if the painful area becomes red or swollen, or if any new symptoms arise, as these may indicate a serious condition.

Healthcare providers should recommend that patients 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 applies to them. Patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also be advised to seek medical advice prior to use.

Furthermore, patients with asthma or those taking a diuretic should be encouraged to consult a doctor before using the medication. It is also advisable for patients to speak with a doctor or pharmacist if they are taking a prescription drug for diabetes, gout, or arthritis, or if they are taking any other medication or are under a doctor’s care for any serious condition.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Acetaminophen, Aspirin, Caffeine, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)