Acetaminophen/Aspirin/Caffeine

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the treatment of migraine.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

Adults are instructed to take 2 caplets orally with a glass of water. It is essential that no more than 2 caplets are taken within a 24-hour period unless otherwise directed by a healthcare professional. If symptoms persist or worsen, patients should consult their doctor for further evaluation.

For individuals under 18 years of age, it is recommended to seek advice from a doctor prior to administration. Care should be taken to adhere strictly to the recommended dosage and administration guidelines, ensuring that the maximum dosage is not exceeded.

Contraindications

Use is contraindicated in patients with a history of allergic reactions to acetaminophen, aspirin, or any other pain reliever/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 avoid using 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 may be early indicators of this rare but serious condition.

Allergy Alerts This product contains acetaminophen, which has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, or rash. Should any of these symptoms arise, the use of the product must be discontinued immediately, and medical assistance should be sought.

Additionally, aspirin 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 occur.

Liver Warning The presence of acetaminophen in this product necessitates caution, as severe liver damage can occur under certain conditions. This includes exceeding the maximum daily dosage of 2 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 also heightened with the concurrent use of other NSAIDs (such as aspirin, ibuprofen, or naproxen), excessive alcohol consumption, or prolonged use beyond the recommended duration.

Medication Overuse Headache Warning Frequent use of this product, defined as 10 or more days per month, may lead to worsening headaches.

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 result in nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Emergency Medical Help In the event of an overdose, immediate medical assistance or contact with a Poison Control Center is essential. Prompt medical attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Discontinuation and Consultation Users should stop using the product and consult a healthcare professional 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), if migraines are not alleviated or worsen after the first dose, if new or unexpected symptoms arise, or if there is ringing in the ears or loss of hearing.

Side Effects

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

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 condition.

Allergic reactions are also a concern. Acetaminophen, one of the active ingredients, may lead to severe skin reactions characterized by symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use and seek medical assistance promptly. Similarly, aspirin may provoke severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or even shock. Immediate medical attention is warranted if any of these symptoms occur.

Liver damage is another serious risk associated with this product, particularly due to its acetaminophen content. Patients should be cautious not to exceed the maximum daily dosage of 2 caplets within 24 hours, avoid concurrent use with other acetaminophen-containing medications, and limit alcohol consumption to fewer than three drinks per day 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 with a history of stomach ulcers or bleeding problems, individuals taking blood thinners or steroids, 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, and seek medical attention if these occur.

Additionally, patients should be aware of the potential for medication overuse headaches, which may worsen if the product is used for 10 or more days per month.

Caffeine content in the recommended dose is comparable to that of a cup of coffee. Patients are advised to limit the intake of other caffeine-containing medications, foods, or beverages to avoid symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients should discontinue use and consult a healthcare provider if they experience any allergic reactions, if their migraine is not relieved or worsens after the first dose, or if new or unexpected symptoms arise, including ringing in the ears or loss of hearing.

Drug Interactions

Taking this product concurrently with other medications containing acetaminophen, whether prescription or nonprescription, is not advised due to the potential for increased risk of adverse effects.

The concomitant use of this product with anticoagulants or steroid medications may elevate the risk of severe gastrointestinal bleeding. Similarly, the use of this product alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen, and naproxen, is associated with an increased likelihood of severe stomach bleeding. It is recommended that healthcare providers monitor patients closely for signs of gastrointestinal complications when these combinations are necessary.

Additionally, the intake of caffeine-containing medications, foods, or beverages should be limited while using this product. Excessive caffeine consumption may lead to symptoms such as nervousness, irritability, insomnia, and, in some cases, tachycardia.

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

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen, Aspirin 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 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 pediatric patients under 18 years of age, it is advised to seek medical guidance before use. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay, as prompt medical attention is critical for both children and adults, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients.

Monitoring for signs of gastrointestinal bleeding is advised, and consideration should be given to the potential need for dose adjustments or alternative therapies in this population. Regular assessment of the patient's overall health status and concurrent medications is recommended to mitigate risks associated with NSAID use in elderly patients.

Pregnancy

Pregnant patients are advised to consult a healthcare professional before using this medication. The use of aspirin during the last trimester of pregnancy is particularly cautioned against unless explicitly directed by a physician. This is due to the potential risks associated with aspirin, which may lead to adverse effects on fetal outcomes or complications during delivery. Therefore, careful consideration and professional guidance are essential for women of childbearing potential when contemplating the use of this medication during pregnancy.

Lactation

Lactating mothers are advised to consult a health 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 individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. As such, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, given the absence of detailed guidance on its use in this population. Regular monitoring of renal function may be prudent in these cases, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the maximum daily dosage of 2 caplets within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product, as excessive alcohol intake can exacerbate the potential for liver damage. Regular assessment of liver function may be warranted in these patients to ensure safety and efficacy during treatment.

Overdosage

In cases of overdosage, severe liver damage may occur under specific circumstances. It is critical for healthcare professionals to be aware of the following risk factors associated with the use of this product.

Maximum Daily Dosage Taking more than 2 caplets within a 24-hour period exceeds the maximum recommended daily dosage and significantly increases the risk of liver injury.

Concurrent Use with Acetaminophen The risk of severe liver damage is further heightened when this product is used in conjunction with other medications that contain acetaminophen. Healthcare providers should carefully evaluate a patient's medication regimen to avoid potential interactions.

Alcohol Consumption Consumption of 3 or more alcoholic drinks daily while using this product can also lead to severe liver damage. It is advisable to counsel patients on the risks associated with alcohol intake during treatment.

Recommended Actions In the event of suspected overdosage, immediate medical attention is warranted. Healthcare professionals should monitor liver function and consider appropriate interventions based on the severity of the symptoms presented. Early recognition and management are crucial to mitigate the risk of long-term liver damage.

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

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Severe skin reactions, including skin reddening, blisters, and rash, have been reported in association with acetaminophen. Additionally, severe allergic reactions such as hives, facial swelling, asthma (wheezing), and shock have been linked to aspirin use.

Liver damage has been noted in cases of excessive acetaminophen intake or concurrent use with alcohol. Furthermore, severe stomach bleeding has been associated with NSAID use, particularly in individuals over 60 years of age, those with a history of stomach ulcers or bleeding problems, and patients taking anticoagulants or other NSAIDs.

Medication overuse headaches may occur with prolonged use of this product. New or unexpected symptoms have also been reported during the course of treatment. Additionally, instances of ringing in the ears or loss of hearing have been documented.

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 medical attention is crucial for both adults and children. It is essential to emphasize that even if patients do not observe any signs or symptoms of an overdose, they should not hesitate to seek help.

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 ranging from 20° to 25°C (68° to 77°F). To ensure the integrity of the product, the cap must be closed tightly after each use. Additionally, the product should not be used if the foil inner seal located under the cap is opened or missing, as this may compromise its safety and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to consult a health professional prior to use if they are pregnant or breastfeeding. It is particularly crucial to avoid aspirin during the last trimester of pregnancy unless explicitly directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Drug Information (PDF)

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

View product document (PDF)