Acetaminophen Aspirin and Caffeine

Description

Acetaminophen, Aspirin (NSAID), and Caffeine Tablets USP are formulated to provide effective pain relief. Each tablet contains 250 mg of Acetaminophen, 250 mg of Aspirin, and 65 mg of Caffeine. This combination is designed to enhance the analgesic effects of the pain relievers. The product is available in a package containing 24 tablets.

Uses and Indications

This drug is indicated for the acute treatment of migraine.

There are no teratogenic effects associated with this medication. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Adults are advised to take 2 tablets with a full glass of water. The maximum dosage should not exceed 2 tablets within a 24-hour period unless otherwise directed by a healthcare professional.

For individuals under 18 years of age, it is recommended to consult a doctor prior to use.

Patients should adhere strictly to the directed dosage and should not exceed the recommended amount. In the event that symptoms persist or worsen, it is important to seek medical advice.

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 condition.

Allergy Alerts 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 this product must be discontinued immediately, and medical assistance should be sought without delay.

Aspirin, another ingredient, 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 This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding the maximum daily dosage of 2 tablets 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 potential risk for severe stomach bleeding. The likelihood of this adverse effect increases in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, 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 of this product.

Medication Overuse Headache Warning Frequent use of this product, specifically for 10 or more days per month, may exacerbate headache symptoms.

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 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 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.

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), if migraine symptoms 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 doctor immediately, as these may be early signs of this rare but serious illness.

Allergic reactions are also a concern. Acetaminophen may lead to severe skin reactions, which can manifest as skin reddening, blisters, or 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 characterized by hives, facial swelling, asthma (wheezing), or shock, necessitating immediate medical attention.

Liver damage is another serious risk associated with this product, particularly due to its acetaminophen content. Severe liver damage may occur if patients exceed the maximum daily dosage of 2 tablets within 24 hours, use other medications containing acetaminophen, 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 with a history of stomach ulcers or bleeding problems, individuals taking anticoagulants or steroid medications, and those consuming three or more alcoholic drinks daily. Patients should be cautious if they take other NSAIDs, whether prescription or over-the-counter, and should not exceed the recommended duration of use.

Additionally, patients may experience medication overuse headaches 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, as excessive caffeine may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients should stop using the product and consult a doctor 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), if their migraine is not relieved or worsens after the first dose, if new or unexpected symptoms arise, or if they experience ringing in the ears or loss of hearing.

Drug Interactions

Concurrent use of this product with any other medication containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose.

Pharmacodynamic interactions are significant when this product is used alongside anticoagulants or steroid medications. The concomitant use of these agents increases the risk of gastrointestinal bleeding. Similarly, the use of this product with other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen, and naproxen, also heightens the risk of stomach bleeding.

Caution is advised regarding the consumption of caffeine-containing medications, foods, or beverages during treatment with this product. Excessive caffeine intake may lead to adverse effects such as nervousness, irritability, insomnia, and, in some cases, tachycardia.

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

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen Aspirin and Caffeine (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. If any 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 an early sign of Reye’s syndrome, a rare but serious condition.

For pediatric patients under 18 years of age, it is advised to seek medical guidance before use. In the event of an overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, are at an increased risk for stomach bleeding when using this product. This risk is further heightened in individuals with a history of stomach ulcers or bleeding problems. Caution is advised for geriatric patients who are concurrently taking anticoagulants or steroid medications, as well as those using other nonsteroidal anti-inflammatory drugs (NSAIDs), including prescription and over-the-counter options such as aspirin, ibuprofen, or naproxen.

Additionally, the risk of stomach bleeding may be exacerbated in elderly patients who consume three or more alcoholic drinks daily while using this product. It is essential for healthcare providers to monitor these patients closely and consider dose adjustments or alternative therapies if necessary. Prolonged use or exceeding the recommended dosage can also increase the likelihood of adverse effects, including gastrointestinal complications. Therefore, careful adherence to dosing guidelines is crucial in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of aspirin after 20 weeks of gestation unless explicitly directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully evaluate the potential benefits and risks when considering the use of this medication in pregnant patients.

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 gestation 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 may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to this population, as the absence of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

Hepatic Impairment

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

It is also critical for patients with compromised liver function to limit alcohol consumption. Specifically, the intake of 3 or more alcoholic drinks per day while using this product is contraindicated due to the heightened risk of severe liver damage. Regular assessment of liver function is recommended for patients with hepatic impairment to ensure safety and efficacy during treatment.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of this product.

Risk of Severe Liver Damage Healthcare professionals should be aware that severe liver damage may occur if a patient exceeds the maximum recommended dosage of 2 tablets within a 24-hour period. This threshold is critical for maintaining patient safety and preventing adverse effects.

Additionally, the risk of severe liver damage is heightened when this product is taken concurrently with other medications that contain acetaminophen. It is essential for healthcare providers to evaluate a patient's medication regimen to avoid potential interactions that could exacerbate liver toxicity.

Furthermore, patients who consume three or more alcoholic drinks daily while using this product are at an increased risk for severe liver damage. Clinicians should counsel patients on the dangers of alcohol consumption during treatment and consider this factor when assessing overall risk.

In the event of suspected overdosage, immediate medical attention is warranted. Healthcare professionals should monitor liver function and provide appropriate management based on the severity of the symptoms presented.

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 were identified in the available data. Additionally, there are no specific details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the text.

Postmarketing Experience

No specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, as 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 essential to avoid concurrent use with any other medications 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 must be instructed to discontinue use and consult a healthcare professional 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, if a migraine is not alleviated or worsens after the first dose, patients should be advised to stop use and seek medical advice.

Healthcare providers should also inform patients to stop using the medication and consult a doctor if new or unexpected symptoms arise, or if they experience ringing in the ears or loss of hearing. It is important to encourage patients to discuss their migraine history with a healthcare professional, particularly if they have never had a migraine diagnosed, if they have a headache that differs from their usual migraines, or if they are experiencing the worst headache of their life.

Patients should be advised to seek medical advice before using this medication if they have a fever accompanied by a stiff neck, headaches that begin after or are caused by head injury, exertion, coughing, or bending, or if they experienced their first headache after the age of 50. Those with daily headaches or migraines severe enough to require bed rest should also consult a healthcare provider prior to use.

Furthermore, patients with liver disease, a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease should be encouraged to discuss their conditions with a healthcare professional before using this medication. Patients taking diuretics, those with asthma, or individuals who have experienced serious side effects from pain relievers or fever reducers should also seek medical advice prior to use.

Lastly, patients should be reminded to consult a doctor or pharmacist if they are taking any prescription drugs for diabetes, gout, or arthritis, if they are under a doctor’s care for any serious condition, or if they are taking any other medications or products that contain aspirin, acetaminophen, or any other pain reliever or fever reducer.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a controlled room temperature ranging from 20° to 25°C (68° to 77°F) to maintain its efficacy.

After each use, the cap must be closed tightly to ensure the integrity of the product. Users are advised to read all product information thoroughly before use and to retain the packaging for important information regarding the product.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is particularly crucial to avoid the use of aspirin after 20 weeks 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)