Migraine Relief

Description

Harris Teeter™ Migraine Relief is formulated as a combination of acetaminophen, aspirin (a nonsteroidal anti-inflammatory drug), and caffeine. Each dosage form consists of 100 coated, capsule-shaped tablets. The product is designed to provide effective relief from migraine pain. The National Drug Code (NDC) for this formulation is 72036-305-03. This product is comparable to the active ingredients found in Excedrin® Migraine.

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 are instructed to take 2 caplets with a glass of water. It is essential not to exceed the recommended dosage of 2 caplets within a 24-hour period unless otherwise directed by a healthcare professional. In cases where symptoms persist or worsen, patients should consult their doctor for further evaluation and guidance.

For individuals under 18 years of age, it is advised to seek the counsel of a doctor before administration.

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 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 Reye’s syndrome, a rare but serious condition.

This product contains acetaminophen, which 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.

Severe liver damage may result from the use of this product if the following conditions are met: 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.

Additionally, this product contains a nonsteroidal anti-inflammatory drug (NSAID), which may lead to severe stomach bleeding. The risk of such an event 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, specifically 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 while using this product, as excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Individuals with a known allergy to acetaminophen, aspirin, or any other pain reliever or fever reducer should refrain from using this product. It is also crucial to avoid concurrent use with any other medications containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare provider or pharmacist is recommended.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is advised. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Patients should discontinue use and contact 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 a migraine is not alleviated or worsens 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.

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 exhibit changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these may be early signs of Reye's syndrome.

Severe skin reactions have been reported in patients taking acetaminophen, with symptoms including skin reddening, blisters, and rash. If any skin reaction occurs, patients are advised to stop use and seek medical help right away. Additionally, aspirin may cause severe allergic reactions, which can manifest as hives, facial swelling, asthma (wheezing), or shock.

The product contains acetaminophen, and patients should be aware that severe liver damage may occur if they exceed the maximum daily amount of 2 caplets in 24 hours, use it in conjunction with other drugs containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Patients should also be cautious of the risk of severe stomach bleeding associated with the NSAID component of this product. The likelihood of stomach bleeding is increased in patients who are 60 years or older, have a history of stomach ulcers or bleeding problems, take blood thinners or steroid drugs, use other NSAIDs, or consume alcohol excessively while using this product.

Medication overuse headaches may occur if this product is used for 10 or more days per month, and patients should limit their intake of caffeine-containing medications, foods, or beverages, as excessive caffeine may lead to 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, having bloody or black stools, or persistent stomach pain), 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.

It is important for patients to avoid using this product if they have a history of allergic reactions to acetaminophen, aspirin, or any other pain reliever/fever reducer. Prior to use, patients should consult a doctor if they have never had migraines diagnosed by a health professional, experience headaches that differ from their usual migraines, have the worst headache of their life, present with fever and stiff neck, have headaches following head injury, exertion, coughing, or bending, experience their first headache after age 50, have daily headaches, or have a migraine severe enough to require bed rest. Patients with liver disease, a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, kidney disease, or those taking diuretics or with asthma should also seek medical advice before using this product.

Drug Interactions

Co-administration of this product with other drugs containing acetaminophen, whether prescription or nonprescription, should be approached with caution due to the potential for cumulative effects.

When used concurrently with anticoagulants or steroid medications, there is an increased risk of gastrointestinal bleeding. Healthcare professionals should monitor patients closely for signs of bleeding and consider dosage adjustments as necessary.

The concomitant use of this product with other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to aspirin, ibuprofen, and naproxen, also heightens the risk of stomach bleeding. It is advisable to limit the use of these medications to mitigate this risk.

Additionally, the intake of caffeine-containing medications, foods, or beverages should be restricted while using this product to avoid potential adverse effects.

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

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 due to the risk of Reye's syndrome. For individuals under 18 years of age, it is advised to consult a healthcare professional before 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 health status and concurrent medications. Careful assessment of the risk-benefit ratio is essential in this population to ensure safe and effective treatment.

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 pregnancy unless specifically 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 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 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.

It is also advised that patients limit alcohol consumption to fewer than 3 drinks per day while using this product, as excessive alcohol intake can exacerbate the potential for liver damage.

Before initiating treatment, patients with known liver disease should consult a healthcare professional to assess the appropriateness of this product for their condition. Regular monitoring of liver function may be warranted in these patients to ensure safety and efficacy.

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 health consequences. 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 associated with the use of the medications. Reports have indicated severe skin reactions, which include skin reddening, blisters, and rash, in association with acetaminophen. Additionally, severe allergic reactions have been reported in connection with aspirin, manifesting as hives, facial swelling, asthma (wheezing), and shock. These events were reported voluntarily or through surveillance programs and are documented in the postmarketing safety data.

Patient Counseling

Healthcare providers should advise patients to keep the 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 allergic reactions, as immediate medical assistance is necessary. They should also 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 patient's migraine is not relieved or worsens after the first dose, or if new or unexpected symptoms arise, they should seek medical advice. Additionally, patients should report any occurrences of ringing in the ears or loss of hearing.

Before initiating treatment, healthcare providers should encourage patients to consult a doctor if they have never had migraines diagnosed by a health professional, if they experience a headache that differs from their usual migraines, or if they have the worst headache of their life. Patients presenting with fever and a stiff neck, headaches that begin after or are caused by head injury, exertion, coughing, or bending, or those who experienced their first headache after the age of 50 should also seek medical advice. Furthermore, patients with daily headaches, migraines severe enough to require bed rest, liver disease, or a history of stomach problems such as heartburn should be advised to consult a healthcare professional. Those with high blood pressure, heart disease, liver cirrhosis, or kidney disease, as well as individuals taking diuretics or who have asthma, should also discuss their conditions with their doctor. Patients who have experienced serious side effects from pain relievers or fever reducers, or who have vomiting associated with their migraine headache, should be encouraged to seek medical guidance.

Lastly, healthcare providers should recommend that patients consult a doctor or pharmacist before use if they are taking prescription medications for diabetes, gout, or arthritis, are under a doctor's care for any serious condition, are taking any other drugs, or are using any products that contain aspirin, acetaminophen, or other pain relievers or 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 advised to retain the original packaging for important information related to the product.

Additional Clinical Information

No further data are available.

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)