Publix Super Markets Inc

Description

Migrainerelief is a combination medication consisting of acetaminophen, aspirin (a nonsteroidal anti-inflammatory drug), and caffeine, formulated as capsule-shaped coated tablets. Each package contains 50 coated caplets, designed for the relief of migraine pain. The product is identified by the National Drug Code (NDC) 56062-305-02 and is intended for use as a pain reliever and pain reliever aid. This formulation 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, 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 a medication, 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 beverages 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.

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 during treatment, as excessive caffeine consumption may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients should refrain from using this product if they have a known allergy to acetaminophen, aspirin, or any other pain reliever or fever reducer. It is also crucial to avoid concurrent use 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.

Patients should discontinue use and contact a healthcare provider 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.

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 are advised to discontinue use and seek medical assistance promptly. Additionally, aspirin may provoke a severe allergic reaction characterized by hives, facial swelling, asthma (wheezing), or shock, necessitating immediate medical attention.

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.

Furthermore, 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 blood thinners, steroids, or other NSAIDs. Patients who consume three or more alcoholic drinks daily or take the medication for longer than directed are also at increased risk.

Patients should be cautious of medication overuse headaches, which may worsen if this product is used for 10 or more days per month. The recommended dose contains caffeine equivalent to a cup of coffee; therefore, patients are advised to limit the intake of other caffeine-containing products to avoid symptoms such as nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Patients are instructed 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.

Before using this product, patients should seek medical advice if they have never had migraines diagnosed by a healthcare professional, experience headaches that differ from their usual migraines, have the worst headache of their life, have fever and stiff neck, or have headaches that began after a head injury, exertion, coughing, or bending. Additional caution is warranted for patients over 50 experiencing their first headache, those with daily headaches, severe migraines requiring bed rest, liver disease, or a history of stomach problems. Patients with high blood pressure, heart disease, liver cirrhosis, or kidney disease, as well as those taking diuretics or with asthma, should also consult a doctor prior to use.

Lastly, patients taking prescription medications for diabetes, gout, or arthritis, or those under a doctor's care for any serious condition, should seek advice before using this product, especially if they are taking any other drugs or products containing aspirin, acetaminophen, or other pain relievers/fever reducers.

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 closely monitor patients for signs of gastrointestinal distress and consider dosage adjustments as necessary.

Similarly, the use of this product alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including but not limited to 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.

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

Packaging & NDC

Below are the non-prescription pack sizes of Publix Super Markets Inc (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 to consult a doctor if any changes in behavior accompany nausea and vomiting, as these symptoms may indicate the onset of Reye’s syndrome, a rare but serious condition. For individuals under 18 years of age, it is advised to seek medical guidance 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 any 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 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 prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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, 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 acetaminophen is taken concurrently with other medications containing acetaminophen or if patients consume 3 or more alcoholic drinks daily while using this product.

It is recommended that patients with liver disease consult a healthcare professional prior to use. Furthermore, individuals with high blood pressure, heart disease, liver cirrhosis, or kidney disease should also seek medical advice before using this product to ensure safe and appropriate use. Monitoring of liver function may be warranted in these populations to prevent potential adverse effects.

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 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 medical evaluation 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

No specific postmarketing experience details are available in the provided text. As such, there are no reported adverse events or case reports to summarize.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients must be instructed to 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 cautioned against using the medication if they have a history of allergic reactions to acetaminophen, aspirin, or any other pain reliever or fever reducer. It is important to inform patients not to use this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

Patients should be instructed to stop using the medication and seek medical advice if they experience any signs of an allergic reaction or if they notice 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, patients should be advised to consult a doctor.

Healthcare providers should also inform patients to discontinue use and seek medical attention if new or unexpected symptoms arise, or if they experience ringing in the ears or loss of hearing. Patients should be encouraged to consult a doctor before using the medication 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 are experiencing the worst headache of their life.

Furthermore, patients should be advised to seek medical advice if they have a fever accompanied by a stiff neck, if headaches begin after or are caused by head injury, exertion, coughing, or bending, or if they experienced their first headache after the age of 50. Those with daily headaches or migraines severe enough to require bed rest should also consult a doctor before use.

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 seek medical advice prior to using the medication. Additionally, patients taking diuretics, those with asthma, or those who have experienced serious side effects from pain relievers or fever reducers should consult a doctor before use.

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 a doctor’s care for any serious condition. Lastly, patients should be reminded to consult a doctor or pharmacist before using any other product that contains aspirin, acetaminophen, or any other pain reliever or fever reducer.

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, users are advised to retain the box 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 the use of aspirin at 20 weeks of gestation or later 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 Publix Super Markets Inc, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)