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Migrenol

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This product has been discontinued

Active ingredients
  • Acetaminophen 500 mg
  • Caffeine 6 mg
Other brand names
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2014
Label revision date
November 14, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 500 mg
  • Caffeine 6 mg
Other brand names
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2014
Label revision date
November 14, 2018
Manufacturer
Four Ventures Enterprises, Inc.
Registration number
part343
NDC root
69293-565
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

You can use this medication for the temporary relief of occasional headaches and minor aches and pains. It is effective in alleviating discomfort from headaches, muscular aches, toothaches, and even premenstrual and menstrual cramps. This makes it a versatile option for managing various types of mild pain you might experience in your daily life.

Uses

You can use this medication for the temporary relief of occasional headaches and minor aches and pains. It is effective for various types of discomfort, including headaches, muscular aches, toothaches, and cramps associated with premenstrual and menstrual symptoms.

This medication is designed to help you feel more comfortable during those times when you experience these common aches and pains.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take 2 tablets every 6 hours as needed. However, make sure not to exceed 8 tablets in a 24-hour period to avoid potential side effects.

It's important to note that this medication is not suitable for children under 12 years of age, so please do not use this adult product for younger children. Always follow these guidelines to ensure safe and effective use of the medication.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

You should be aware of some important side effects and warnings associated with this product. It is crucial not to use it alongside any other medications that contain acetaminophen, as this can lead to severe liver damage. If you have a history of allergic reactions to pain relievers or fever reducers, you should avoid this product. Additionally, if you have liver disease, consult your doctor before using it.

While using this product, you may experience drowsiness, so it's advisable to avoid alcohol and be cautious if you're taking sedatives or tranquilizers. If you notice any signs of an allergic reaction, new symptoms, or if your pain or fever worsens or lasts longer than the specified time frames (10 days for pain and 3 days for fever), stop using the product and seek medical advice immediately.

Warnings and Precautions

It's important to use this product safely. Do not take it with any other medications that contain acetaminophen, and avoid it if you have ever had an allergic reaction to pain relievers or fever reducers. If you have liver disease, please consult your doctor before using this product. Additionally, if you are taking sedatives or tranquilizers, check with your doctor or pharmacist first.

Be aware that drowsiness may occur, so it's best to avoid alcohol while using this product. If you experience any allergic reactions, new symptoms, or if your pain worsens or lasts longer than 10 days, or if your fever gets worse or lasts more than 3 days, stop using the product and contact your doctor immediately. These could be signs of a more serious condition. Remember, taking more than 8 tablets in 24 hours, combining it with other acetaminophen-containing drugs, or consuming 3 or more alcoholic drinks daily while using this product can lead to severe liver damage.

Overdose

Taking more than 8 tablets in a 24-hour period, using other medications that contain acetaminophen, or consuming 3 or more alcoholic drinks daily while using this product can lead to severe liver damage. It's important to be aware of these risks to protect your health.

If you suspect an overdose, look for signs such as unusual tiredness, nausea, vomiting, or yellowing of the skin or eyes. If you notice any of these symptoms or believe you have taken too much, seek immediate medical help. Always prioritize your safety and consult a healthcare professional if you have any concerns about your medication use.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to consult with a healthcare professional before using this medication. They can provide guidance on whether it is safe for you and your baby. Always prioritize your health and the health of your child by seeking professional advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

It's important to be cautious when considering medications for children. If your child is under 12 years old, you should not use this adult product, as it can provide more than the recommended dose. Taking too much can lead to serious health issues, including liver damage. Always consult with a healthcare professional for appropriate alternatives that are safe for your child's age and weight.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach for your individual health needs, especially since older adults may have different responses to medications compared to younger individuals. Always keep an open line of communication with your doctor about any changes in health or medication effects.

Renal Impairment

If you have kidney issues, it's important to know that there are no specific guidelines provided for dosage adjustments, special monitoring, or safety considerations related to your condition. This means that the information available does not outline any changes you may need to make regarding your treatment or any additional precautions you should take.

Always consult with your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your kidney health. They can provide guidance tailored to your specific situation.

Hepatic Impairment

If you have liver disease, it’s important to consult your doctor before using this product. This medication contains acetaminophen, which can be harmful to your liver. You should be aware that taking more than 8 tablets in a 24-hour period, using it alongside other medications that also contain acetaminophen, or consuming 3 or more alcoholic drinks daily while using this product can lead to severe liver damage.

To protect your liver, always follow your healthcare provider's advice regarding dosage and usage. Monitoring your liver function is crucial, so keep your doctor informed about any changes in your health.

Drug Interactions

It's important to be cautious when using this medication. You should avoid taking it alongside any other products that contain acetaminophen, as this can lead to serious health issues. Additionally, if you are using sedatives or tranquilizers, it's essential to consult with your doctor or pharmacist before starting this medication to ensure your safety.

While there are no specific interactions with laboratory tests noted, discussing all your current medications and any upcoming tests with your healthcare provider is crucial. This helps to prevent any potential complications and ensures that your treatment is as effective and safe as possible.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature, ideally between 20°C to 25°C (68°F to 77°F). It's important to protect it from light and keep the container tightly closed when not in use. Always keep the product out of reach of children to prevent accidental ingestion or misuse. Once opened, please remember to discard the product to maintain safety and quality.

Additional Information

You should take this medication orally, with the recommended dosage for adults and children aged 12 and over being 2 tablets every 6 hours. However, do not exceed 8 tablets in a 24-hour period.

Before using this product, it's important to consult with a doctor if you have liver disease or if you are taking sedatives or tranquilizers. Additionally, if you are pregnant or breastfeeding, make sure to speak with a healthcare professional before use.

FAQ

What is the primary use of this drug?

This drug provides temporary relief of occasional headaches and minor aches and pains, including muscular aches, toothache, and menstrual cramps.

What should adults and children 12 years and over do for dosing?

Adults and children 12 years and over should take 2 tablets every 6 hours, not exceeding 8 tablets in 24 hours.

Is this product safe for children under 12 years?

No, this adult product should not be used in children under 12 years of age.

What should I do if I have liver disease?

You should ask a doctor before using this product if you have liver disease.

What are the warnings associated with this drug?

Do not use this product with any other product containing acetaminophen or if you have had an allergic reaction to pain relievers. Seek medical help if an allergic reaction occurs or if symptoms worsen.

What should I avoid while using this product?

You should avoid alcoholic drinks and consult a doctor if you are taking sedatives or tranquilizers, as drowsiness may occur.

What are the storage instructions for this drug?

Store at room temperature, between 20°C to 25°C (68°F to 77°F), protect from light, and keep the container tightly closed.

What should I do if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using this product.

Packaging Info

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

Packaging configurations for Migrenol.
Details

Drug Information (PDF)

This file contains official product information for Migrenol, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Migrenol is a pharmaceutical formulation that combines acetaminophen, aspirin, and caffeine. Each tablet contains 250 mg of acetaminophen, 250 mg of aspirin, and 65 mg of caffeine. The inactive ingredients include corn starch, D&C Yellow No. 10, FD&C Red No. 40, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and talc. The tablets are characterized as round, biconvex, and are coated with a yellow film. The SPL code for this product is 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of occasional headaches and minor aches and pains associated with various conditions, including headache, muscular aches, toothache, and premenstrual and menstrual cramps.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and older are advised to take 2 tablets every 6 hours as needed. The maximum dosage should not exceed 8 tablets within a 24-hour period.

This product is not recommended for use in children under 12 years of age. Healthcare professionals should ensure that this product is not administered to this age group.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

The use of this product is contraindicated in patients who are currently taking any other medications that contain acetaminophen, as this may lead to an increased risk of severe liver damage. Additionally, individuals with a history of allergic reactions to any pain reliever or fever reducer should not use this product.

Healthcare professionals should advise patients to consult a doctor prior to use if they have liver disease, as this condition may exacerbate the risks associated with acetaminophen. Furthermore, it is essential to recommend that patients seek guidance from a doctor or pharmacist if they are concurrently using sedatives or tranquilizers, as these medications may interact with the product.

Patients should be informed that drowsiness is a common side effect of this product. Therefore, it is advisable to avoid the consumption of alcoholic beverages while using this medication, as alcohol can further increase the risk of drowsiness and potential liver damage.

Patients must be instructed to discontinue use and consult a doctor if any of the following occur: an allergic reaction, the emergence of new symptoms, worsening pain that persists beyond 10 days, or a fever that lasts more than 3 days. These symptoms may indicate a serious underlying condition that requires immediate medical attention.

It is critical to highlight the liver warning associated with this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the recommended dosage of more than 8 tablets within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product. Regular monitoring of liver function may be warranted in patients at risk.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. It is contraindicated to use this product in conjunction with any other product containing acetaminophen or in individuals who have a history of allergic reactions to any pain reliever or fever reducer.

Patients with liver disease should consult a doctor before using this product. Additionally, those taking sedatives or tranquilizers are advised to seek guidance from a healthcare professional prior to use, as drowsiness may occur. It is recommended to avoid alcoholic beverages while using this product due to the increased risk of adverse effects.

Patients are instructed to discontinue use and consult a doctor if they experience an allergic reaction, if new symptoms arise, if pain worsens or persists beyond 10 days, or if fever intensifies or lasts more than 3 days. These symptoms may indicate a serious underlying condition.

The product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 8 tablets within a 24-hour period, using it alongside other medications containing acetaminophen, or consuming 3 or more alcoholic drinks daily while using this product.

Drug Interactions

The concomitant use of this product with any other formulation containing acetaminophen is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

When considering the use of this product in patients who are concurrently taking sedatives or tranquilizers, it is advisable to consult a healthcare professional, such as a doctor or pharmacist, prior to use. This is to ensure safe administration and to monitor for potential additive sedative effects, which may increase the risk of respiratory depression or excessive sedation.

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

Packaging & NDC

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

Packaging configurations for Migrenol.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this adult product, as it may provide more than the recommended dose. The use of this product in this age group poses a risk of liver damage. Caution is advised when considering treatment options for pediatric patients, and alternative formulations specifically designed for children should be utilized to ensure safety and efficacy.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. 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 administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with a risk of severe liver damage. It is imperative that patients with liver disease consult their healthcare provider prior to use.

The maximum recommended dosage for patients is limited to 8 tablets within a 24-hour period. Additionally, patients should avoid concomitant use of other medications containing acetaminophen, as this may further increase the risk of liver injury. Consumption of 3 or more alcoholic drinks daily while using this product is also contraindicated, as it may exacerbate the potential for severe liver damage.

Monitoring of liver function is advised for patients with compromised liver function who are prescribed this product, to ensure safety and mitigate the risk of adverse effects.

Overdosage

In cases of overdosage, severe liver damage may occur under specific circumstances. It is critical for healthcare professionals to be aware of the following risk factors associated with acetaminophen use.

Risk Factors for Severe Liver Damage

Severe liver damage can result from the ingestion of more than 8 tablets within a 24-hour period. Additionally, the concomitant use of other medications containing acetaminophen significantly increases the risk of hepatotoxicity. Furthermore, chronic consumption of three or more alcoholic drinks daily while using this product can exacerbate the potential for liver injury.

Recommended Actions

In the event of suspected overdosage, immediate medical attention is warranted. Healthcare providers should assess the patient's condition and consider the administration of N-acetylcysteine (NAC) as an antidote, particularly if the overdosage is identified within a critical time frame. Monitoring liver function tests and providing supportive care are essential components of management.

Potential Symptoms

Patients may present with symptoms indicative of liver damage, which can include nausea, vomiting, loss of appetite, confusion, jaundice, and abdominal pain. Early recognition and intervention are crucial to mitigate the risk of severe hepatic injury.

Healthcare professionals are advised to educate patients on the importance of adhering to recommended dosages and to be vigilant about the potential interactions with other medications and alcohol consumption.

Nonclinical Toxicology

Pregnant or breastfeeding individuals are advised to consult a health professional prior to use due to potential teratogenic effects. There are no specific non-teratogenic effects or detailed nonclinical toxicology data available. Additionally, no specific information regarding animal pharmacology and toxicology has been provided.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young children.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, specifically within the range of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light exposure to ensure its efficacy. Additionally, the product should be kept out of reach of children, and any unused portion should be discarded after opening to prevent potential safety risks.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 2 tablets every 6 hours, not to exceed 8 tablets within a 24-hour period.

Clinicians should counsel patients to consult a doctor prior to use if they have liver disease, are taking sedatives or tranquilizers, or if they are pregnant or breastfeeding. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Migrenol, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Migrenol, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.