Migraine Relief

Description

Restore U is a formulation designed for migraine relief, containing a combination of acetaminophen, aspirin (a nonsteroidal anti-inflammatory drug), and caffeine. Each dosage form consists of 24 coated caplets, which are capsule-shaped tablets. The product is identified by the National Drug Code (NDC) 57344-205-01 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 or nonteratogenic effects associated with this medication.

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.

Patients are cautioned not to exceed the recommended dosage. If 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 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 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, and rash. Should any skin reaction occur, the user must discontinue use immediately and seek medical assistance.

Severe liver damage may result from the consumption of this product if the user exceeds the maximum daily dosage of 2 caplets within a 24-hour period, combines it with other medications containing acetaminophen, or consumes 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 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 cup of coffee; therefore, it is advisable to limit the intake of other caffeine-containing medications, foods, or beverages to avoid potential side effects such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional prior to use. Notably, the use of aspirin after 20 weeks of pregnancy should be avoided unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

In the event of an overdose, immediate medical attention is crucial. Users should contact a Poison Control Center at 1-800-222-1222 without delay, as prompt intervention is vital for both adults and children, even in the absence of noticeable symptoms.

Users should discontinue use and seek medical advice 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 experiencing persistent stomach pain), if their migraine is not alleviated or worsens after the first dose, if new or unexpected symptoms arise, or if they experience ringing in the ears or loss of hearing.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which may be serious.

Serious adverse reactions include the potential for 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 healthcare professional 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 severe skin reactions associated with acetaminophen may include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use and seek medical assistance promptly. Aspirin may provoke severe allergic reactions characterized by hives, facial swelling, asthma (wheezing), and 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 the product.

Additionally, the presence of an NSAID in this product raises the 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 anticoagulants, steroids, or other NSAIDs. The risk is further heightened if patients consume three or more alcoholic drinks daily or exceed the recommended duration or dosage.

Patients may also experience medication overuse headaches if the product is used for 10 or more days per month.

Caffeine, present in the recommended dose of this product, is comparable to that found in a cup of coffee. Patients are advised to 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.

Patients should stop using the product and seek medical advice 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

Taking this product concurrently with other medications containing acetaminophen, whether prescription or nonprescription, is not advised due to the potential for increased risk of hepatotoxicity.

The concomitant use of this product with anticoagulants or steroid medications may elevate the risk of severe gastrointestinal bleeding. Healthcare professionals should monitor patients closely for signs of gastrointestinal distress and consider dosage adjustments as necessary.

Additionally, the use of this product alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, ibuprofen, and naproxen, is associated with an increased risk of severe stomach bleeding. Caution is warranted, and alternative pain management strategies should be considered.

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. Monitoring for these symptoms is recommended to ensure patient safety.

No specific laboratory test interactions 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. For individuals under 18 years of age, it is advised to consult a healthcare professional prior to use.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing medications that may exacerbate this risk in this population.

Monitoring for gastrointestinal adverse effects is recommended, and dosage adjustments should be considered based on the individual patient's health status and concurrent medications. Careful assessment of the benefits and risks is crucial when treating geriatric patients to ensure their safety and well-being.

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 if deemed necessary.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication if they are pregnant or breastfeeding. It is particularly important to avoid the use of aspirin at 20 weeks of pregnancy or later unless specifically directed by a healthcare provider, 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.

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, the risk of liver damage increases if patients take this product concurrently with other medications containing acetaminophen or consume three or more alcoholic drinks daily while using this product.

It is advised that patients with liver disease consult a healthcare professional prior to use. This recommendation extends to individuals with high blood pressure, heart disease, liver cirrhosis, or kidney disease, as these conditions may further complicate the safe use of this product. Regular monitoring of liver function may be warranted in patients with compromised liver function 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 intervention is essential 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 crucial 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

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 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 seek medical attention if they notice signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Additionally, if a migraine is not relieved or worsens after the first dose, or if new or unexpected symptoms arise, patients should contact their healthcare provider. They should also report any occurrences of ringing in the ears or loss of hearing.

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

Patients should be encouraged to ask a doctor or pharmacist before using the medication if they are taking prescription drugs for diabetes, gout, or arthritis, are under a doctor’s care for any serious condition, are taking any other medications, 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 package that should be stored at a controlled room temperature of 20º to 25ºC (68º to 77ºF). It is essential to close the cap tightly after each use to maintain product integrity. Additionally, the box should be retained 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 aspirin use 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.

Patients should be instructed to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center contacted at 1-800-222-1222. Prompt medical attention is essential for both adults and children, even if no symptoms are apparent.

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)