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Doloneuro-Tropas

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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 2025
Label revision date
April 14, 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 2025
Label revision date
April 14, 2025
Manufacturer
OPMX LLC
Registration number
M013
NDC root
69729-795
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

DOLONEURO-TROPAS is a medication designed to help relieve pain associated with inflammation from conditions like rheumatism and arthritis. It acts as an analgesic (pain reliever), providing temporary relief from minor aches and pains, including headaches and muscle discomfort.

This medication comes in a box of 24 caplets, making it convenient for managing pain when needed. If you're experiencing discomfort due to inflammation, DOLONEURO-TROPAS may be a suitable option to consider for alleviating your symptoms.

Uses

You can use this medication to temporarily relieve minor aches and pains. It is effective for headaches, muscular aches, and pain caused by inflammation from conditions like rheumatism and arthritis. If you're experiencing general pain, this medication may also help alleviate your discomfort.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication.

Dosage and Administration

When taking this medication, it’s important to follow 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.

For children under 12 years of age, it’s best to consult with a doctor before giving them this medication. This way, you can ensure they receive the appropriate care and dosage tailored to their needs. Always remember to stick to the guidelines to avoid any potential risks.

What to Avoid

You should avoid using this medication alongside any other drug that contains acetaminophen, whether it's a prescription or over-the-counter product. It's important to consult with your doctor or pharmacist if you're unsure about the medications you are taking to ensure your safety. Mixing these drugs can lead to serious health issues, so always double-check before combining treatments.

Side Effects

Taking this product can lead to some serious side effects, particularly concerning your liver. You should avoid taking more than 6 caplets in a 24-hour period, using it with other medications that contain acetaminophen, or consuming 3 or more alcoholic drinks daily while using this product, as these actions can increase the risk of severe liver damage.

Additionally, be cautious with caffeine while using this product, as too much can lead to nervousness, irritability, sleeplessness, and sometimes a rapid heartbeat. If you have liver disease or are taking blood thinners like warfarin, consult your doctor or pharmacist before use. It's important to stop using the product and seek medical advice if you notice any new symptoms, if your symptoms worsen, or if pain or fever persists beyond the specified time frames.

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 suspect an overdose, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222, even if you don't notice any symptoms. You should also stop using the product and call your doctor if you experience any 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. You can contact a Poison Control Center at 1-800-222-1222 for guidance. 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 the outcome.

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 are considering this medication for your child, it's important to know that children under 12 years old should consult a doctor before use. For those aged 12 and older, the recommended dosage is 2 caplets every 6 hours, but be sure not to exceed 6 caplets in a 24-hour period. Always follow these guidelines to ensure safe and effective use.

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 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 you understand how to manage your treatment effectively while considering your kidney 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 substances. You should avoid using any other products that contain acetaminophen, whether they are prescription or over-the-counter, as this can lead to serious health issues. If you are taking warfarin, a blood-thinning medication, make sure to consult with your doctor or pharmacist to ensure it's safe to use this product alongside it.

Additionally, be mindful of your caffeine intake while using this medication. Consuming too much caffeine from medications, foods, or drinks can lead to feelings of nervousness, irritability, trouble sleeping, and even a rapid heartbeat. Always discuss your current medications and any dietary habits with your healthcare provider 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 immediately or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is crucial for both adults and children, even if there are no noticeable signs or symptoms.

FAQ

What is DOLONEURO-TROPAS used for?

DOLONEURO-TROPAS is used to treat pain of inflammation caused by conditions such as rheumatism, arthritis, and general pain, as well as to temporarily relieve minor aches and pains 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, you should ask a doctor before use.

Are there any contraindications for using DOLONEURO-TROPAS?

You should not use DOLONEURO-TROPAS with any other drug containing acetaminophen. Always ask a doctor or pharmacist if you are unsure about using it with other medications.

What are the liver warnings associated with this product?

Severe liver damage may occur if you take more than 6 caplets in 24 hours, use it with other drugs containing acetaminophen, 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 at 1-800-222-1222 immediately.

Can I take DOLONEURO-TROPAS if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using DOLONEURO-TROPAS.

What should I do if I experience new symptoms while taking this medication?

You should stop using DOLONEURO-TROPAS and ask a doctor if any new symptoms occur, if symptoms do not improve, or if pain lasts for more than 10 days.

How should I store DOLONEURO-TROPAS?

Store DOLONEURO-TROPAS at a controlled room temperature of 20°-25°C (68°-77°F).

Packaging Info

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

Packaging configurations for Doloneuro-Tropas.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

DOLONEURO-TROPAS is an analgesic/pain reliever indicated for the temporary relief of mild pain and discomfort associated with conditions such as rheumatism, arthritis, inflammation, and general pain. The product is available in a box containing 24 caplets. It is exclusively distributed by OPMX, located in Chula Vista, CA 91910, with a contact number of 619-600-5632. The National Drug Code (NDC) for this product is 69729-795-24.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, and pain resulting from inflammation due to rheumatism, arthritis, and general inflammatory processes.

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

Dosage and Administration

Healthcare professionals are advised 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 imperative to consult a physician for appropriate dosing recommendations. It is essential to ensure that the maximum dosage is not exceeded to avoid potential adverse effects.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other drug containing acetaminophen, whether prescription or nonprescription. Due to the potential for acetaminophen overdose, it is essential to consult a healthcare professional, such as 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 advise patients to adhere strictly to the maximum daily dosage to mitigate these risks.

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 adverse effects such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

General precautions should be taken into account. 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 is crucial. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help without delay, regardless of the presence of symptoms, as prompt intervention is essential 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. These actions are important to ensure patient safety and effective management of their condition.

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.

Patients are advised to limit the use of caffeine-containing medications, foods, or beverages during treatment, as excessive caffeine intake may lead to symptoms such as nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

It is contraindicated to use this product with any other drug containing acetaminophen, whether prescription or nonprescription. Patients should consult a doctor or pharmacist if they are uncertain about the use of other medications alongside this product.

Patients with a history of liver disease should seek medical advice before using this product. Additionally, those taking the blood-thinning medication warfarin should 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.

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 and potential hepatotoxicity.

Patients taking the anticoagulant warfarin should consult with a healthcare professional, such as a doctor or pharmacist, prior to using this product. The combination may necessitate careful monitoring of coagulation parameters to avoid potential alterations in anticoagulant efficacy.

Additionally, it is advisable to limit the intake of caffeine-containing medications, foods, or beverages while using this product. Excessive caffeine consumption may lead to adverse effects, including nervousness, irritability, insomnia, and, in some cases, tachycardia. Monitoring for these symptoms is recommended to ensure patient safety and comfort.

Packaging & NDC

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

Packaging configurations for Doloneuro-Tropas.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and adults 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 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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in 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 currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically studied in relation to dosage adjustments, special monitoring, or safety considerations. Consequently, there is no available information regarding the use of this medication in individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 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 at 1-800-222-1222. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the severity of symptoms may vary based on the specific substance involved in the overdose. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual’s clinical presentation. Continuous evaluation and appropriate interventions should be initiated as necessary to mitigate potential complications associated with the overdose.

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 for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial to emphasize that prompt medical attention is necessary 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 recommended that patients 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 any new symptoms arise. Additionally, patients should be advised to stop using the medication and seek medical advice if their symptoms do not improve or if they worsen. It is important to inform patients to stop use and contact a doctor if the area experiencing pain becomes red or swollen, if the pain intensifies, or if it persists for more than 10 days. Furthermore, patients should be cautioned to stop use and consult a doctor if a fever worsens or lasts for more than 3 days.

Patients with liver disease should be advised to consult a doctor before using this medication. Lastly, those taking the blood-thinning medication warfarin should be encouraged to speak with a doctor or pharmacist prior to use.

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 must 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 at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable symptoms.

Drug Information (PDF)

This file contains official product information for Doloneuro-Tropas, 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 Doloneuro-Tropas, 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.