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Mejoral

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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
March 19, 2025
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
March 19, 2025
Manufacturer
OPMX LLC
Registration number
M013
NDC root
69729-154
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

Mejoral is a medication that contains 500 mg of acetaminophen (a common pain reliever) and 65 mg of caffeine (a stimulant that can enhance the effects of pain relief). It is designed to temporarily relieve minor aches and pains, including those caused by headaches and muscular aches.

You can find Mejoral in a package of 24 caplets, making it a convenient option for managing discomfort from headaches or migraines, as well as muscle pain.

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 will help ensure that the child receives the appropriate care and dosage. 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, whether it's a prescription or over-the-counter medication. If you're unsure about the medications you're taking, please consult with your doctor or pharmacist before using this product.

Additionally, be aware that this medication may be 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 the drug). 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, and it's important to be aware of them. You may experience nervousness, irritability, sleeplessness, or even a rapid heartbeat, especially if you consume too much caffeine while using this product. Additionally, severe liver damage can occur if you exceed the maximum daily dose of 6 caplets, take it with other medications containing acetaminophen, or consume three or more alcoholic drinks daily.

If you notice any new symptoms, if your symptoms worsen, or if you experience redness or swelling in a painful area, it's crucial to stop using the medication and consult a doctor. Also, seek medical help immediately in case of an overdose, even if you don't see any symptoms, as prompt attention is vital. If you have liver disease or are taking blood thinners like warfarin, be sure to talk to your doctor before using this medication.

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 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 persists for 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 the safety and well-being of 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, it’s important to consult with a healthcare provider before starting the medication. 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 may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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° and 25°C (68° to 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 speak with a healthcare professional before using this medication. Always keep it out of reach of children. In the event 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 Mejoral?

Mejoral is a medication that contains 500 mg of Acetaminophen and 65 mg of Caffeine, available in 24 caplets.

What does Mejoral relieve?

Mejoral 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.

Can children under 12 use Mejoral?

Children under 12 years should ask a doctor before use.

What should I avoid while taking Mejoral?

Do not use Mejoral with any other drug containing acetaminophen and limit caffeine intake to avoid side effects like nervousness and sleeplessness.

What are the liver warnings associated with Mejoral?

Severe liver damage may occur if you take more than 6 caplets in 24 hours, use it with other acetaminophen-containing drugs, or consume 3 or more alcoholic drinks daily while using this product.

What should I do in case of an overdose?

In case of overdose, get medical help or contact a Poison Control Center immediately, as quick medical attention is critical.

Should I consult a doctor before using Mejoral?

Yes, consult a doctor if you have liver disease or are taking the blood-thinning drug warfarin.

Is Mejoral safe to use during pregnancy or breastfeeding?

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

How should Mejoral be stored?

Store Mejoral at controlled room temperature between 20°-25°C (68°-77°F) and do not use if the safety seal under the cap is broken or missing.

Packaging Info

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

Packaging configurations for Mejoral.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Mejoral is a combination medication formulated to provide relief from headache, migraines, and muscular aches. Each caplet contains 500 mg of acetaminophen and 65 mg of caffeine. The product is available in a dosage form of 24 caplets, with each caplet designed to deliver effective analgesic properties. The National Drug Code (NDC) for Mejoral is 69729-154-24.

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.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 6 caplets within a 24-hour period, using other medications that also contain acetaminophen, or consuming 3 or more alcoholic drinks daily while using this product. Healthcare professionals should counsel patients on these risks to ensure safe usage.

The recommended dosage of this product is comparable to the caffeine content 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 lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

General precautions should be observed. Patients with liver disease should consult a healthcare provider prior to use. Additionally, individuals taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before using this product to avoid potential interactions.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. Prompt medical attention is crucial for both adults and children, even if no symptoms are initially apparent.

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, use this product in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product. Patients are advised to limit the use of caffeine-containing medications, foods, or beverages while taking this product, as excessive caffeine intake may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients should not use this product with any other drug containing acetaminophen, whether prescription or nonprescription, and are encouraged to consult a doctor or pharmacist if there is uncertainty regarding the use of other medications. Individuals with liver disease should seek medical advice before using this product. Additionally, patients taking the blood-thinning medication warfarin should consult a healthcare professional prior to use.

Patients are instructed to discontinue use and seek medical advice if any new symptoms arise, 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. In the event of an overdose, it is critical for patients to obtain medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

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 any uncertainty regarding potential interactions.

Particular caution is warranted for patients taking warfarin, a blood-thinning medication. It is recommended that individuals consult their healthcare provider before using this product to assess the risk of increased bleeding.

Additionally, the use of caffeine-containing medications, foods, or beverages should be limited while taking 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 advised to ensure patient safety.

Packaging & NDC

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

Packaging configurations for Mejoral.
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

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 limit alcohol consumption to fewer than 3 alcoholic drinks per day while using this product, as alcohol can exacerbate the potential for liver damage.

Before initiating treatment, patients with known liver disease should consult a healthcare professional to assess the appropriateness of this product for their condition. Regular monitoring of liver function may be warranted in these patients 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 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, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 using this medication alongside 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 use 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 crucial to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is recommended. Quick medical attention is essential for both adults and children, even if no signs or symptoms of overdose are apparent.

Drug Information (PDF)

This file contains official product information for Mejoral, 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 Mejoral, 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.