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Migrafein Forte

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Active ingredients
  • Acetaminophen 500 mg
  • Caffeine 65 mg
Other brand names
Drug classes
Central Nervous System Stimulant, Methylxanthine
Dosage form
Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
December 3, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 500 mg
  • Caffeine 65 mg
Other brand names
Drug classes
Central Nervous System Stimulant, Methylxanthine
Dosage form
Tablet, Film Coated
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 2023
Label revision date
December 3, 2024
Manufacturer
OPMX LLC
Registration number
M013
NDC root
69729-148
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

Migrafein FORTE is a medication available in the form of 40 caplets, designed to temporarily relieve minor aches and pains. It is particularly effective for headaches and muscular aches, helping you feel more comfortable when experiencing these common discomforts.

This medication works by targeting the sources of pain, providing you with relief when you need it most. If you're dealing with headaches or muscle soreness, Migrafein FORTE may be a helpful option to consider.

Uses

You can use this medication to temporarily relieve minor aches and pains, such as headaches and muscular aches. It’s designed to help you feel more comfortable when you're experiencing these common discomforts.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

When using this medication, it's important to stick to the recommended dosage to ensure your safety and effectiveness. If you are an adult or a child aged 12 years and older, you should take 2 caplets every 6 hours. However, make sure not to exceed 6 caplets in a 24-hour period.

If the patient is a child under 12 years old, it's best to consult a doctor before administering the medication. This way, you can ensure that the child receives the appropriate care and dosage tailored to their needs. Always follow these guidelines closely for the best results.

What to Avoid

It's important to be cautious when using this medication. You should not use it in combination with any other drug that contains acetaminophen (a common pain reliever found in many over-the-counter and prescription medications). If you're unsure whether a medication contains acetaminophen, please consult your doctor or pharmacist before taking it.

Additionally, be aware that this medication is classified as a controlled substance, which means it has the potential for abuse or misuse. This can lead to dependence (a condition where your body becomes reliant on a substance). Always follow your healthcare provider's instructions and avoid using this medication in ways not prescribed.

Side Effects

Taking this medication can lead to some side effects, particularly concerning your liver and caffeine intake. It's important to be aware that severe liver damage may occur if you exceed six caplets in a 24-hour period, combine it with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product. Additionally, too much caffeine can result in feelings of nervousness, irritability, sleeplessness, and sometimes a rapid heartbeat.

If you have liver disease or are taking the blood-thinning medication warfarin, consult your doctor or pharmacist before using this product. You should also stop using it and seek medical advice if you notice any new symptoms, if your symptoms do not improve or worsen, if the painful area becomes red or swollen, if pain lasts more than 10 days, or if a fever persists for more than three days.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you exceed 6 caplets in 24 hours, take it with other acetaminophen-containing medications, or consume 3 or more alcoholic drinks daily while using it. Additionally, the recommended dose has about as much caffeine as a cup of coffee, so it's wise to limit other caffeine sources to avoid nervousness, irritability, sleeplessness, or rapid heartbeat.

Before using this product, consult your doctor if you have liver disease or are taking the blood thinner warfarin. If you experience an overdose, seek emergency medical help or contact a Poison Control Center immediately, even if you don't notice any symptoms. You should also stop using the product and call your doctor if you develop new symptoms, if your symptoms worsen or do not improve, if the painful area becomes red or swollen, if pain lasts more than 10 days, or if fever lasts more than 3 days.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center. Quick action is crucial for both adults and children, even if you don’t see any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and get checked out by a medical professional.

Pregnancy Use

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

If you have a child under 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 and older, as well as adults, the recommended dosage is 2 caplets every 6 hours, but you should not exceed 6 caplets in a 24-hour period. Always follow these guidelines to ensure safe use for your child.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help determine the best course of action based on your kidney function and overall health.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using this product, which contains acetaminophen. To avoid severe liver damage, do not take more than 6 caplets in a 24-hour period, and be careful not to combine it with other medications that also contain acetaminophen. Additionally, limit your alcohol intake to fewer than 3 drinks per day while using this product, as drinking more can increase the risk of liver damage.

Before using this product, please consult your doctor if you have liver disease. They can provide guidance tailored to your specific health needs and help ensure your safety while using this medication.

Drug Interactions

It's important to be cautious when taking this medication. You should avoid using it alongside any other products that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure about combining it with other medications, it's best to consult with your doctor or pharmacist. Additionally, if you are taking warfarin, a blood-thinning medication, you should speak with your healthcare provider before using this product.

While using this medication, try to limit your intake of caffeine from medications, foods, or drinks. Too much caffeine can lead to feelings of nervousness, irritability, trouble sleeping, and sometimes a rapid heartbeat. Always discuss your current medications and any concerns with your healthcare provider to ensure your safety and well-being.

Storage and Handling

To ensure the best quality and safety of your product, store it at a controlled room temperature between 20°-25°C (68°-77°F). This temperature range helps maintain the product's effectiveness.

When handling the product, be sure to check the safety seal under the cap. If the seal is broken or missing, do not use the product, as this indicates it may have been tampered with. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally. For adults and children aged 12 years and older, the recommended dose is 2 caplets every 6 hours, with a maximum of 6 caplets in a 24-hour period. If the patient is under 12 years old, consult a doctor for the appropriate dosage.

If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this medication. Always keep it out of reach of children. In case of an overdose, seek medical help or contact a Poison Control Center immediately, as prompt attention is crucial for both adults and children, even if no symptoms are present.

FAQ

What is Migrafein FORTE used for?

Migrafein FORTE temporarily relieves minor aches and pain due to headaches and muscular aches.

What is the recommended dosage for adults and children over 12?

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

What should I do if I am under 12 years old?

If you are under 12 years old, ask a doctor before use.

Are there any warnings associated with Migrafein FORTE?

Yes, do not exceed the recommended dosage, and avoid using it with other drugs containing acetaminophen. Severe liver damage may occur if you do.

What should I do if I experience new symptoms while using Migrafein FORTE?

Stop use and ask a doctor if any new symptoms occur, if symptoms do not improve, or if pain lasts more than 10 days.

Can I use Migrafein FORTE if I have liver disease?

You should ask a doctor before use if you have liver disease.

Is it safe to use Migrafein FORTE while pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately.

What are the side effects of Migrafein FORTE?

Possible side effects include nervousness, irritability, sleeplessness, and rapid heartbeat due to caffeine.

How should I store Migrafein FORTE?

Store at controlled room temperature between 20°-25°C (68°-77°F).

Packaging Info

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

Packaging configurations for Migrafein Forte.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Migrafein FORTE is available in the form of 40 caplets. The product is identified by the National Drug Code (NDC) 69729-148-40.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with headache and muscular aches.

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

Dosage and Administration

Healthcare professionals should advise patients to adhere strictly to the recommended dosage guidelines. For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 6 hours, with a maximum of 6 caplets within a 24-hour period.

For children under 12 years of age, it is essential to consult a physician before administration to determine the appropriate dosage. It is imperative that patients do not exceed the recommended dosage to avoid potential adverse effects.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or nonprescription. This is due to the potential risk of acetaminophen overdose, which can lead to severe liver damage. Healthcare professionals should advise patients to consult a doctor or pharmacist before combining this product with any other medications to ensure safety.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage under certain conditions. Healthcare professionals should advise patients to adhere strictly to the following guidelines to mitigate this risk:

  • The maximum recommended dosage is 6 caplets within a 24-hour period. Exceeding this limit may lead to severe liver injury.

  • Patients should avoid concurrent use with other medications that contain acetaminophen to prevent unintentional overdose.

  • Consumption of three or more alcoholic drinks daily while using this product is contraindicated, as it significantly increases the risk of liver damage.

Caffeine is also present in this product, approximately equivalent to the amount found in a standard cup of coffee. It is advisable to limit the intake of other caffeine-containing medications, foods, or beverages during treatment, as excessive caffeine consumption may result in adverse effects such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

General precautions should be taken into account prior to use. Patients with a history of liver disease should consult a healthcare provider before starting this product. Additionally, individuals taking the anticoagulant warfarin should seek advice from a doctor or pharmacist to ensure safe concurrent use.

In the event of an overdose, immediate medical assistance is crucial. Patients or caregivers should contact a Poison Control Center or seek emergency medical help without delay, regardless of the presence of symptoms, as prompt intervention is vital for both adults and children.

Patients are advised to discontinue use and consult a healthcare professional if any new symptoms arise, if existing symptoms do not improve or worsen, if the painful area becomes red or swollen, if pain persists for more than 10 days, or if fever worsens or lasts longer than 3 days.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 6 caplets within a 24-hour period, particularly when used in conjunction with other medications containing acetaminophen or when consuming three or more alcoholic drinks daily while using this product.

Excessive caffeine intake may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. Patients are advised to avoid using this product alongside any other drug containing acetaminophen, whether prescription or nonprescription, and should consult a healthcare professional if uncertain about concurrent medication use.

Patients with a history of liver disease should seek medical advice before using this product. Additionally, individuals taking the anticoagulant warfarin are encouraged to consult a doctor or pharmacist prior to use.

Patients should discontinue use and seek medical attention if they experience any new symptoms, if symptoms do not improve or worsen, if the painful area becomes red or swollen, if pain persists for more than 10 days, or if fever worsens or lasts for more than 3 days.

Drug Interactions

Concurrent use of this product with any other medications containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose.

Patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using this product in conjunction with other medications if there is uncertainty regarding potential interactions.

Particular caution is warranted for patients taking warfarin, a blood-thinning medication. It is recommended that these patients seek medical advice before using this product to avoid potential alterations in anticoagulant effects.

Additionally, the consumption of caffeine-containing medications, foods, or beverages should be limited while using this product. Excessive caffeine intake may lead to adverse effects, including nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. Monitoring for these symptoms is advisable to ensure patient safety.

Packaging & NDC

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

Packaging configurations for Migrafein Forte.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 2 caplets every 6 hours, with a maximum of 6 caplets in a 24-hour period.

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 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 have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

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 6 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 with compromised liver function refrain from consuming 3 or more alcoholic drinks daily while using this product, as alcohol can exacerbate the potential for liver damage.

Before initiating treatment, patients with liver disease should consult a healthcare professional to assess the appropriateness of this product for their specific condition. 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 without delay. 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, vigilance and timely action are essential in managing overdose situations effectively.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert for Migrafein FORTE (acetaminophen, caffeine tablet, film coated).

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, emphasizing that prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this medication in conjunction with any other products containing acetaminophen, whether prescription or nonprescription. It is important for patients to consult with a doctor or pharmacist before combining this medication with any other drugs if they are uncertain.

Healthcare providers should instruct patients to discontinue use and consult a doctor if they experience any new symptoms, if their symptoms do not improve or worsen, or if the area of pain becomes red or swollen. Additionally, patients should be advised to stop using the medication and seek medical advice if their pain intensifies or persists for more than 10 days, or if their fever worsens or lasts longer than 3 days.

Patients with a history of liver disease should be encouraged to consult a doctor prior to using this medication. Furthermore, those taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist before use to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at a controlled room temperature of 20°-25°C (68°-77°F) to maintain its integrity and efficacy.

It is essential to ensure that the product is tamper evident; therefore, it must not be used if the imprinted safety seal under the cap is broken or missing. Proper handling and storage conditions are crucial to ensure the product remains safe for use.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 6 hours, with a maximum of 6 caplets in a 24-hour period. For children under 12 years, it is advised to consult a doctor for appropriate dosing.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is important to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center, as prompt attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

This file contains official product information for Migrafein Forte, 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 Migrafein Forte, 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.