Acetaminophen Aspirin and Caffeine

Description

AUROHEALTH Migraine Relief is a combination medication formulated as tablets containing Acetaminophen, Aspirin (NSAID), and Caffeine. Each tablet delivers 250 mg of Acetaminophen, 250 mg of Aspirin, and 65 mg of Caffeine. The product is packaged in a bottle containing 8 tablets, designated under NDC 58602-817-02. This formulation is indicated for the relief of migraine pain.

Uses and Indications

This drug is indicated for the treatment of migraine.

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

Dosage and Administration

Adults should take 2 tablets with a full glass of water. It is imperative that patients do not exceed the recommended dosage. Specifically, no more than 2 tablets should be taken within a 24-hour period unless otherwise directed by a healthcare professional.

In cases where symptoms persist or worsen, patients are advised to consult their doctor for further evaluation and guidance. For individuals under 18 years of age, it is recommended to seek advice from a healthcare provider before use.

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. 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 This product contains acetaminophen, which has been associated with severe skin reactions. Symptoms may include skin reddening, blisters, or rash. Should any skin reaction occur, the use of this product must be discontinued immediately, and medical assistance should be sought without delay. Additionally, aspirin may provoke a severe allergic reaction characterized by hives, facial swelling, asthma (wheezing), or shock.

Liver Warning The presence of acetaminophen in this product necessitates caution, as severe liver damage can occur if more than 2 tablets are taken within a 24-hour period, which is the maximum recommended daily dosage. This risk is further heightened when used in conjunction with other medications containing acetaminophen or when consuming three or more alcoholic beverages 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. The likelihood of this adverse effect increases in individuals aged 60 or older, those with a history of stomach ulcers or bleeding disorders, and those concurrently taking anticoagulants or steroid medications. The risk is also elevated for individuals using other NSAIDs (including aspirin, ibuprofen, or naproxen), consuming three or more alcoholic drinks daily, or exceeding the recommended duration or dosage of this product.

Medication Overuse Headache Warning Prolonged 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 attention is crucial. Contact a Poison Control Center or seek medical help right away (1-800-222-1222). Prompt intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Discontinuation of Use Patients should stop using this 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, or having bloody or black stools; persistent stomach pain; a migraine that is not alleviated or worsens after the first dose; the emergence of new or unexpected symptoms; or symptoms such as 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.

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 arise, patients should discontinue use and seek medical attention promptly. Aspirin may provoke severe allergic reactions characterized by hives, facial swelling, asthma (wheezing), or shock, necessitating immediate medical intervention.

Liver damage is a significant concern associated with this product 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 3 or more alcoholic drinks daily while using this product.

Additionally, the product contains an NSAID, which may lead to 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 of stomach bleeding is also heightened if patients consume 3 or more alcoholic drinks daily or exceed the recommended dosage.

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, as excessive caffeine may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients are instructed to stop use 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 occur, or if they experience ringing in the ears or loss of hearing.

Drug Interactions

Co-administration of this product with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

Pharmacodynamic interactions are significant with anticoagulants and corticosteroids. The concomitant use of this product with blood-thinning agents (anticoagulants) or steroid medications increases the risk of severe gastrointestinal bleeding. Healthcare professionals should monitor patients closely for signs of gastrointestinal bleeding and consider alternative therapies where appropriate.

Additionally, the use of this product alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen, and naproxen, is associated with an elevated risk of severe stomach bleeding. It is advisable to avoid the concurrent use of these medications to mitigate this risk.

Patients are also advised to limit the intake of caffeine-containing medications, foods, or beverages while using this product. Excessive caffeine consumption 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 the onset of Reye’s syndrome, a rare but serious condition.

For pediatric patients under 18 years of age, it is advised to consult a doctor before use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. This risk is further compounded in individuals with liver disease. Therefore, it is essential for healthcare providers to exercise caution when prescribing medications that may exacerbate this risk in geriatric patients.

Additionally, elderly patients with pre-existing conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease should be closely monitored. Consultation with a healthcare provider is strongly advised for these individuals to ensure safe and effective management of their conditions, as well as to evaluate the appropriateness of any prescribed therapies.

Given these considerations, careful assessment and potential dosage adjustments may be necessary to mitigate risks associated with treatment in the geriatric 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 or 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 healthcare 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

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, as it may significantly heighten the risk of severe liver damage. Regular assessment of liver function is recommended for patients with hepatic impairment to ensure safe use of this medication.

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 conditions that can lead to significant hepatic injury.

Maximum Daily Dosage Taking more than 2 tablets within a 24-hour period exceeds the maximum recommended daily amount and poses a risk for liver toxicity.

Concomitant Use with Acetaminophen The risk of 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 prevent potential overdose.

Alcohol Consumption Consumption of 3 or more alcoholic drinks daily while using this product significantly increases the likelihood of liver damage. It is advisable to counsel patients on the dangers of combining alcohol with this medication.

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 irreversible liver damage.

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

Reports have been received regarding severe skin reactions, including skin reddening, blisters, and rash, associated with the use of acetaminophen. Additionally, there have been reports of severe allergic reactions linked to aspirin, which include hives, facial swelling, asthma (wheezing), and shock.

Cases of severe liver damage have been documented in relation to acetaminophen overdose or misuse. Furthermore, incidents of stomach bleeding have been reported in patients using NSAIDs, particularly among those with risk factors such as age over 60, a history of stomach ulcers, or concurrent use of anticoagulants or other NSAIDs.

There have also been reports of medication overuse headaches in patients utilizing this product for 10 or more days per month. New or unexpected symptoms occurring after the use of the product have been noted, along with reports of ringing in the ears or loss of hearing associated with its use.

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 at 1-800-222-1222 without delay. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if they do not exhibit any noticeable signs or symptoms of overdose. This proactive approach can significantly impact the outcome in such situations.

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 at 20 weeks of gestation or later 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)