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Neo-Lubrina Fuerte

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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
69729-149
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

Neo-Lubrina Fuerte is a medication available in the form of 24 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 product works by targeting the sources of pain, providing you with relief so you can go about your daily activities with less interruption. If you're dealing with minor aches, Neo-Lubrina Fuerte 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 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 (a common pain reliever found in many over-the-counter and prescription medications). If you're unsure whether a medication contains acetaminophen, please consult with your doctor or pharmacist before taking it.

Additionally, be aware that this medication may have potential for abuse or misuse, which 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 and important warnings to be aware of. Severe liver damage may occur if you exceed the maximum daily limit of 6 caplets, take it with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product. Additionally, too much caffeine can cause nervousness, irritability, sleeplessness, and occasionally a rapid heartbeat.

It's crucial to avoid using this medication with any other acetaminophen-containing products. If you have liver disease or are taking the blood thinner warfarin, consult your doctor or pharmacist before use. You should stop taking the medication and seek medical advice if you notice any new symptoms, if your symptoms worsen or do not improve, or if you experience redness or swelling in a painful area. In case of overdose, seek immediate medical help, as prompt attention is essential for both adults and children.

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 any new symptoms, notice that your symptoms are not improving or are worsening, or if you have pain that is red, swollen, or lasts more than 10 days, stop taking the product and contact your doctor. In case of an overdose, seek emergency medical help or contact a Poison Control Center immediately, even if you don't see any symptoms.

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, acting quickly can make a significant difference in ensuring safety and health.

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

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, it’s wise to discuss any medications with a healthcare provider, especially considering factors like kidney function and changes in cognition (thinking and memory).

Always ensure that your doctor is aware of your age and any other health conditions you may have, as this can help them make the best decisions regarding your treatment. Regular check-ins can help monitor how well the medication is working and whether any adjustments are needed for safety and effectiveness.

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, especially regarding potential interactions with other drugs. 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, make sure to discuss this with your healthcare provider before using this product.

While using this medication, you should also limit your intake of caffeine from medications, foods, or drinks. Consuming too much caffeine can lead to side effects like nervousness, irritability, trouble sleeping, and sometimes a rapid heartbeat. Always keep an open line of communication with your healthcare provider about any medications or tests you are undergoing to ensure your safety and well-being.

Storage and Handling

To ensure the best performance 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. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using it. Always keep this medication 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 apparent.

FAQ

What is Neo-Lubrina Fuerte used for?

Neo-Lubrina Fuerte 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 Neo-Lubrina Fuerte?

Yes, do not exceed the recommended dosage, and avoid using it with other drugs containing acetaminophen or if you have liver disease.

What are the potential side effects of taking too much caffeine with this product?

Too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.

What should I do in case of an overdose?

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

Is it safe to use Neo-Lubrina Fuerte during pregnancy or breastfeeding?

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

What should I do if my symptoms do not improve?

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

How should I store Neo-Lubrina Fuerte?

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

Packaging Info

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

Packaging configurations for Neo-Lubrina Fuerte.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Neo-Lubrina Fuerte is available in the form of 24 caplets. The product is identified by the National Drug Code (NDC) 69729-149-24.

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 is contraindicated in patients who are concurrently taking any other drug containing 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 the maximum daily dosage of 6 caplets within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of 3 or more alcoholic drinks daily while using this product.

Caution is advised regarding caffeine intake, as the recommended dose of this product contains approximately the same amount of caffeine as a standard cup of coffee. Healthcare professionals should counsel patients to limit the use 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 include advising patients to consult a healthcare provider prior to use if they have a history of liver disease. Additionally, patients taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist before using this product.

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 signs or symptoms are initially apparent.

Patients are instructed to discontinue use and consult a healthcare provider if any new symptoms arise, if existing symptoms do not improve or worsen, if the painful area becomes red or swollen, if pain intensifies or persists for more than 10 days, or if fever worsens or lasts for more 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 the product in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product. Patients are advised to avoid using this product with any other drug containing acetaminophen, whether prescription or nonprescription, and should consult a doctor or pharmacist if uncertain about concurrent medications.

Excessive caffeine intake may lead to adverse reactions such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. Patients should be cautious regarding their overall caffeine consumption while using this product.

Patients with liver disease should seek medical advice before using this product. Additionally, those taking the blood-thinning medication warfarin are advised to consult a healthcare professional prior to use.

Patients are instructed to discontinue use and consult a doctor 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 imperative to seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is crucial 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 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 potential interactions.

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 advised to ensure patient safety.

Packaging & NDC

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

Packaging configurations for Neo-Lubrina Fuerte.
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 adverse effects or changes in therapeutic response, 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 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 absence of guidance necessitates careful clinical judgment and monitoring.

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 consuming three or more alcoholic drinks daily refrain from 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. 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 are advised to remain vigilant and proactive in managing potential overdose situations. The importance of rapid response cannot be overstated, as early intervention may significantly influence the outcome.

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 provided in the insert for NEO-LUBRINA FUERTE (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 the importance of prompt medical attention 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 essential for patients to consult with a doctor or pharmacist before combining this medication with any other drugs if they are uncertain.

Patients should be instructed 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, they should 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.

Healthcare providers should also recommend that patients consult a doctor prior to use if they have a history of liver disease. Furthermore, patients taking the blood-thinning medication warfarin should be advised to speak with a doctor or pharmacist before using this product.

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 safety seal under the cap is intact; the product should not be used if the tamper-evident seal 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. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center, as prompt attention is crucial for both adults and children, even if no symptoms are apparent.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Neo-Lubrina Fuerte, 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 Neo-Lubrina Fuerte, 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.

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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.