Signature Care Migraine Relief

Description

Acetaminophen, aspirin (NSAID), and caffeine tablets are formulated as a pain reliever and pain reliever aid. Each tablet is capsule-shaped and coated for ease of swallowing. The product is supplied in a container containing 100 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 are instructed to take 2 caplets with a full 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.

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.

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 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 may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin reaction, the user must discontinue use immediately and seek medical assistance.

Additionally, aspirin, another component of this product, may provoke a severe allergic reaction characterized by hives, facial swelling, asthma (wheezing), or shock. Immediate medical attention is warranted if any of these symptoms occur.

Liver Warning The presence of acetaminophen in this product necessitates caution, as severe liver damage can occur under certain conditions. Users should not exceed two caplets within a 24-hour period, which is the maximum daily dosage. Caution is also advised when using this product in conjunction with other medications containing acetaminophen, or when consuming three or more alcoholic drinks daily.

Stomach Bleeding Warning This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in individuals aged 60 or older, those with a history of stomach ulcers or bleeding problems, and those taking anticoagulants or steroid medications. Users should also avoid concurrent use of other NSAIDs, including aspirin, ibuprofen, or naproxen, and limit alcohol consumption to fewer than three drinks daily while using this product. Prolonged use beyond the recommended duration may also elevate the risk of stomach bleeding.

Medication Overuse Headache Warning Frequent use of this product, defined as ten or more days per month, may exacerbate headaches.

Caffeine Warning The recommended dosage of this product contains approximately the same amount of caffeine as a standard cup of coffee. Users 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.

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

Discontinuation of Use Users 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, having bloody or black stools, or experiencing persistent stomach pain; if migraines are not alleviated or worsen 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 should be aware of several serious and common adverse reactions associated with its use.

Warnings 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 not use this product in such cases. If changes in behavior accompanied by nausea and vomiting occur, it is crucial to consult a healthcare professional, as these may be early signs 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 immediately. Aspirin, another component of this product, may also cause 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. Additionally, the presence of an NSAID in this formulation increases 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. Patients should also be cautious if they consume three or more alcoholic drinks daily or take the medication for longer than directed.

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

Stop Use and Ask a Doctor If Patients should seek medical attention immediately if they experience any signs of an allergic reaction or symptoms indicative 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 relieved or worsens after the first dose, or if new or unexpected symptoms arise, medical consultation is advised. Patients should also report any ringing in the ears or loss of hearing.

Additional Adverse Reactions or Important Notes Before using this product, patients should consult a healthcare professional if they have never had migraines diagnosed, experience headaches that differ from their usual migraines, have the worst headache of their life, or present with fever and stiff neck. Other considerations include headaches following head injury, exertion, coughing, or bending, experiencing their first headache after age 50, having daily headaches, or suffering from 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 prior to use.

Drug Interactions

The concomitant use of caffeine-containing medications, foods, or beverages should be limited while taking this product. Excessive caffeine intake may lead to adverse effects such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients are advised to consult a healthcare professional prior to using this product if they are currently taking anticoagulants (blood thinners) or steroid medications. Additionally, it is recommended that individuals seek guidance from a doctor or pharmacist before using this product in conjunction with any other medications.

Particular caution should be exercised if the patient is using other products that contain aspirin, acetaminophen, or any other pain reliever or fever reducer. It is essential to ensure that there is no overlap in active ingredients to avoid potential overdose or increased risk of side effects.

Packaging & NDC

Below are the non-prescription pack sizes of Signature Care Migraine Relief (acetaminophen, aspirin, 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, a rare but serious illness. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is essential to consult a doctor, as these may be early signs of Reye’s syndrome.

For pediatric patients under 18 years of age, it is advised to seek medical guidance before use. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay, as prompt attention is critical for both children and adults, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients, specifically those aged 60 years and older, should consult a healthcare provider prior to using this medication. This precaution is essential to ensure the safe and effective use of the treatment in this population, as age-related physiological changes may influence drug metabolism and response. Careful consideration and monitoring are advised when prescribing this medication to geriatric patients to mitigate potential risks and optimize therapeutic outcomes.

Pregnancy

Pregnant patients and women 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, aspirin should only be used in this period if explicitly directed by a healthcare provider. Caution is advised to ensure the safety of both the mother and the unborn child.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. 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 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 underlying 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, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed the maximum daily dosage of 2 caplets within a 24-hour period. Additionally, patients must avoid concomitant use with other medications containing acetaminophen and limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product.

Prior to use, patients with known liver disease or those with conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease should consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during treatment.

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 observable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide comprehensive care as needed.

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 non-teratogenic effects have been specified. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse events reported voluntarily or through surveillance programs. Instances of allergic reactions have been documented, with recommendations for individuals to seek medical assistance promptly.

Reports of gastrointestinal bleeding have been noted, characterized by symptoms such as feeling faint, vomiting blood, experiencing bloody or black stools, and persistent stomach pain.

Additionally, there have been cases where migraines were not alleviated or worsened following the initial dose. New or unexpected symptoms have also been reported, alongside occurrences of tinnitus or hearing loss.

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 quick medical attention is necessary for both adults and children, even if they do not exhibit any 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 packaging details, which are essential for proper handling and storage. It is recommended to store the product at a temperature range of 20°C to 25°C (68°F to 77°F) to maintain its efficacy.

After each use, it is crucial to close the cap 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 healthcare professional prior to use. It is particularly critical 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 Signature Care Migraine Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)