Amazon Basic Care Migraine Relief

Description

Acetaminophen, Aspirin (NSAID), and Caffeine Tablets USP are formulated as capsule-shaped tablets, each containing 250 mg of acetaminophen, 250 mg of aspirin, and 65 mg of caffeine. This combination serves as a pain reliever and pain reliever aid. The product is packaged in a container of 200 coated caplets.

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 not to exceed 2 tablets within a 24-hour period unless specifically directed by a healthcare professional. For individuals under 18 years of age, it is recommended to consult a doctor prior to 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 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. 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, if combined with other medications containing acetaminophen, or if consumed alongside 3 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. The likelihood of this adverse effect increases in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, and those concurrently taking blood thinners (anticoagulants) or steroid medications. The risk is also heightened for individuals using other NSAIDs (including aspirin, ibuprofen, or naproxen), consuming 3 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 conditions.

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 contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

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 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 symptoms could indicate the onset of Reye’s syndrome.

Severe skin reactions have been reported in patients using acetaminophen, which may manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients should discontinue use and seek medical assistance immediately. Additionally, aspirin may provoke severe allergic reactions, including hives, facial swelling, asthma (wheezing), and shock. Patients experiencing any signs of an allergic reaction should stop using the product and seek medical help right away.

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 three or more alcoholic drinks daily while using this product.

Stomach bleeding is another serious risk, particularly for patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, or those taking blood thinners or steroid medications. The risk of stomach bleeding increases with the concurrent use of other NSAIDs, including aspirin, ibuprofen, or naproxen, and with excessive alcohol consumption or prolonged use beyond the recommended duration.

Common Adverse Reactions Patients may also experience medication overuse headaches if this product is used for 10 or more days per month. Furthermore, the recommended dose contains caffeine equivalent to that found in a cup of coffee. Patients should limit the intake of other caffeine-containing medications, foods, or beverages, as excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Monitoring and Consultation Patients are advised to stop using the product 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, or having bloody or black stools), persistent stomach pain, worsening migraines after the first dose, new or unexpected symptoms, or ringing in the ears or loss of hearing.

Drug Interactions

Concurrent use of this product with any other drug 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 Amazon Basic Care Migraine Relief (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 of severe stomach bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). This risk is further heightened in individuals with a history of stomach ulcers or bleeding problems, those who are concurrently using blood-thinning medications (anticoagulants) or steroid drugs, and patients taking other NSAIDs, whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen.

Healthcare providers should exercise caution when prescribing this product to geriatric patients, especially if they consume three or more alcoholic drinks daily while using the medication. It is essential to monitor these patients closely for any signs of gastrointestinal bleeding and to consider dose modifications or alternative therapies as appropriate. Additionally, adherence to the recommended dosage and duration of treatment is critical to minimize the risk of adverse effects in this 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 fetal outcomes or complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a qualified healthcare provider if deemed necessary.

Lactation

Lactating mothers are advised to consult a health professional before using this medication while breastfeeding. 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 provided 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. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 elevate 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, significant health risks are associated with the consumption of this product, particularly concerning liver function.

Risk of Severe Liver Damage Healthcare professionals should be aware that severe liver damage may occur if a patient ingests more than 2 tablets within a 24-hour period, which is the established maximum daily dosage. Additionally, the risk of liver damage is heightened when this product is taken concurrently with other medications that contain acetaminophen.

Furthermore, patients who consume 3 or more alcoholic beverages daily while using this product are also at an increased risk for severe liver damage.

Recommended Actions In the event of suspected overdosage, it is imperative to assess the patient's liver function and consider immediate medical intervention. Healthcare providers should monitor for symptoms indicative of liver impairment and initiate appropriate management procedures as necessary.

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 relevant information regarding non-teratogenic effects is provided in the insert. Additionally, there is no relevant information available concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), and shock. Severe skin reactions associated with acetaminophen have also been noted, including skin reddening, blisters, and rash.

Additionally, severe liver damage has been reported, particularly in cases of overdose or when used concurrently with other acetaminophen-containing products. Stomach bleeding has been observed, especially in individuals over 60 years of age, those with a history of stomach ulcers or bleeding problems, and those taking blood thinners or other nonsteroidal anti-inflammatory drugs (NSAIDs).

Medication overuse headache has been documented, which may worsen if the product is used for 10 or more days per month. Symptoms of caffeine overuse, including nervousness, irritability, sleeplessness, and rapid heart rate, have also been reported. Users are advised that new or unexpected symptoms may occur, and they should seek medical attention if these arise.

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 that this product should not be used 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 allergic reactions or if they notice signs 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 stop use and seek medical advice.

Healthcare providers should also counsel patients to stop using the product and consult a doctor if they develop new or unexpected symptoms, experience ringing in the ears, or notice any loss of hearing. It is important to advise patients to consult a healthcare professional before using this product 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 also be advised to seek medical advice if they have a fever accompanied by a stiff neck, headaches that begin after a head injury, or if they experienced their first headache after the age of 50.

Patients with daily headaches, migraines severe enough to require bed rest, liver disease, or a history of stomach problems such as heartburn should be encouraged to consult a doctor before use. Additionally, those with high blood pressure, heart disease, liver cirrhosis, kidney disease, or who are taking diuretics should seek medical advice prior to using this product. Patients with asthma or those who have experienced serious side effects from pain relievers or fever reducers should also be advised to consult a healthcare professional.

Finally, patients should be encouraged to discuss their current medications with a doctor or pharmacist, especially if they are taking prescription drugs for diabetes, gout, or arthritis, or if they are under care for any serious condition. It is crucial for patients to inform their healthcare provider about any other medications or products they are using that contain aspirin, acetaminophen, or other pain relievers or fever reducers.

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 and safety.

After each use, the cap must be closed tightly to prevent contamination and ensure the integrity of the product. Users are advised to read all product information thoroughly before use and to retain the packaging for future reference, as it contains 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 Amazon Basic Care Migraine Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)