Migraine Relief

Description

QUALITY CHOICE® is a formulation designed for migraine relief, containing a combination of acetaminophen, aspirin (a nonsteroidal anti-inflammatory drug), and caffeine. Each package contains 24 coated caplets, which are capsule-shaped tablets. The product is identified by the National Drug Code (NDC) 83324-099-24 and is comparable to the active ingredients found in EXCEDRIN® MIGRAINE. It serves as a pain reliever and pain reliever aid.

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 caplets with a full glass of water. The maximum dosage should not exceed 2 caplets within a 24-hour period unless otherwise directed by a healthcare professional.

For individuals under 18 years of age, it is advised to consult a doctor prior to use. If symptoms persist or worsen, patients should seek medical advice. It is important to adhere strictly to the recommended dosage and not exceed the directed amount.

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 have or are recovering from chickenpox or flu-like symptoms should not use this product. If behavioral changes accompanied by nausea and vomiting occur during use, it is imperative to consult a physician, as these symptoms may indicate the onset of Reye’s syndrome, a rare but serious condition.

Acetaminophen, a component of this product, has the potential to cause severe skin reactions. Symptoms may include skin reddening, blisters, or rash. Should any skin reaction occur, the use of the product must be discontinued immediately, and medical assistance should be sought.

This product contains acetaminophen, and severe liver damage may result from exceeding the maximum daily dosage of 2 caplets within a 24-hour period, using it concurrently with other medications containing acetaminophen, or consuming three or more alcoholic drinks daily while using this product.

Additionally, the product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The risk of such complications is heightened 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 the product.

Prolonged use of this product, particularly for 10 or more days per month, may exacerbate headaches. The recommended dosage contains approximately the same amount of caffeine as a standard cup of coffee. Therefore, 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.

General precautions include avoiding use in individuals with a known allergy to acetaminophen, aspirin, or any other pain reliever or fever reducer. It is also crucial not to combine this product with any other medications containing acetaminophen, whether prescription or over-the-counter. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is recommended.

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 essential for both adults and children, even if no signs or symptoms are initially apparent.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any allergic reactions occur, or if symptoms indicative of stomach bleeding arise, 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, or if new or unexpected symptoms develop, medical consultation is warranted. Patients should also be informed to report any occurrences of tinnitus or hearing loss.

Side Effects

Patients using this product should be aware of several serious and common adverse reactions associated with its use.

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. If patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these symptoms could indicate the onset of Reye's syndrome.

Severe skin reactions may occur due to acetaminophen, with symptoms including skin reddening, blisters, and rash. If any skin reaction is observed, patients should discontinue use and seek medical assistance promptly. Additionally, aspirin may provoke severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock.

The product contains acetaminophen, which poses a risk of severe liver damage if patients exceed the maximum daily dosage of 2 caplets within 24 hours, use it in conjunction with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using this product.

As this product contains a nonsteroidal anti-inflammatory drug (NSAID), there is a risk of severe stomach bleeding, particularly in patients aged 60 or older, those with a history of stomach ulcers or bleeding problems, or those taking blood thinners or other NSAIDs. The risk is also heightened with excessive alcohol consumption or prolonged use beyond the recommended duration.

Patients may experience medication overuse headaches if this product is utilized for 10 or more days per month. Furthermore, the recommended dose contains caffeine equivalent to that of a cup of coffee; thus, patients should limit the intake of other caffeine-containing products to avoid symptoms such as nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Patients are advised 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, or having bloody or black stools), if their migraine is not relieved or worsens after the first dose, or if new or unexpected symptoms arise. Additionally, patients should seek medical attention if they experience ringing in the ears or loss of hearing.

Before using this product, patients should consult a doctor if they have never had migraines diagnosed by a healthcare professional, if they have a headache that differs from their usual migraines, or if they have the worst headache of their life. Other conditions that warrant consultation include fever and stiff neck, headaches following head injury or exertion, new headaches after age 50, daily headaches, severe migraines requiring bed rest, liver disease, a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are taking diuretics or have asthma. Patients should also inform their healthcare provider of any serious conditions or if they are taking prescription medications for diabetes, gout, or arthritis, or any other products containing aspirin or acetaminophen.

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 associated hepatotoxicity.

The concomitant use of blood thinners (anticoagulants) or steroid medications increases the risk of severe gastrointestinal bleeding. Patients should be closely monitored for signs of gastrointestinal distress or bleeding if these medications are used together.

This product should not be taken alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen, as this may elevate the risk of adverse effects, particularly gastrointestinal complications.

Caution is advised regarding the intake of caffeine-containing medications, foods, or beverages during treatment with this product, as excessive caffeine may exacerbate side effects.

Patients taking prescription medications for diabetes, gout, or arthritis should consult with a healthcare professional prior to using this product to ensure safe and effective use, as interactions may alter therapeutic outcomes or increase the risk of adverse effects.

Packaging & NDC

Below are the non-prescription pack sizes of Migraine Relief (acetaminophen, aspirin and caffeine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients, including children and teenagers, should not use this product if they have or are recovering from chicken pox or flu-like symptoms. It is important for healthcare professionals to advise that if any changes in behavior accompanied by nausea and vomiting occur during the use of this product, a doctor should be consulted. These symptoms may indicate the onset of Reye’s syndrome, a rare but serious condition. For patients under 18 years of age, it is recommended to seek medical advice prior to use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the potential for heightened adverse effects.

It is advisable to closely monitor elderly patients for signs of gastrointestinal bleeding and to evaluate the necessity of dosage adjustments based on individual patient factors. Careful assessment of the risk-benefit ratio is essential in this population to ensure safe and effective use of the medication.

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 development and complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin under the guidance of a qualified healthcare provider.

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, 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 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 exercise caution when using this product, which contains acetaminophen. 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 may 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 alcohol can exacerbate the potential for liver damage.

It is recommended that patients with liver disease consult a healthcare professional prior to using this product to ensure safe and appropriate use. Regular monitoring of liver function may be warranted in these patients to detect any potential adverse effects early.

Overdosage

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

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious adverse effects. Therefore, vigilance and timely action are essential in managing overdose situations effectively.

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

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. Instances of liver damage due to excessive acetaminophen intake have been reported.

Additionally, stomach bleeding has been observed, particularly in individuals over 60 years of age or those with a history of stomach ulcers or bleeding problems. Medication overuse headaches have been documented in patients with prolonged use. New or unexpected symptoms occurring after use have been reported, along with cases of ringing in the ears or loss of hearing.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. In the event of an overdose, patients must seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed to stop using the medication and consult a doctor if they experience any signs of an allergic reaction, and to seek medical assistance without delay. Additionally, they should be made aware of the signs of stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. If a migraine is not relieved or worsens after the first dose, patients should also stop use and consult a doctor.

Patients should be encouraged to report any new or unexpected symptoms, as well as any occurrences of ringing in the ears or loss of hearing. It is important for healthcare providers to ask patients if they have never had migraines diagnosed by a health professional, or if they have a headache that differs from their usual migraines. Patients should be advised to seek medical advice if they experience the worst headache of their life, have a fever accompanied by a stiff neck, or if headaches begin after or are caused by head injury, exertion, coughing, or bending.

Patients over the age of 50 who experience their first headache should also consult a doctor. Those with daily headaches or migraines severe enough to require bed rest should seek medical advice before using the medication. 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 advised to consult a doctor prior to use.

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 before using this medication. If patients experience vomiting with their migraine headache, they should consult a doctor. Lastly, patients should be encouraged to speak with a doctor or pharmacist if they are taking prescription drugs for diabetes, gout, or arthritis, are under care for any serious condition, or are taking any other medications or products that contain aspirin, acetaminophen, or other pain relievers/fever reducers.

Storage and Handling

The product is supplied in a container that requires careful handling to maintain its integrity. It should be stored at a controlled room temperature of 20º to 25ºC (68º to 77ºF). After each use, it is essential to close the cap tightly to prevent contamination and ensure the product remains effective. Additionally, it is advisable to retain the original box for important information related to 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 specifically 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 Migraine Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)