Dolo- Neurobion

Description

NeuroB-1 and NeuroB-2 are presented in a packaging format that includes visual representations for identification. The effective date of this packaging is September 11, 2023. The images associated with the packaging are in JPEG format, with NeuroB-1 referenced as "55959171Nlbl-3.jpg" and NeuroB-2 as "55959171Nlbl-4.jpg."

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including the common cold, toothache, headache, muscular aches, backache, premenstrual and menstrual cramps, and minor pain of arthritis. Additionally, it is indicated for the temporary reduction of fever.

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

Dosage and Administration

Adults and children aged 12 years and over are advised to take 2 tablets every 6 hours as needed for symptom relief. The maximum dosage should not exceed 6 tablets within a 24-hour period, unless otherwise directed by a healthcare professional. Additionally, this medication should not be used for more than 10 consecutive days unless specifically instructed by a doctor.

For children under 12 years of age, it is recommended to consult a healthcare professional for appropriate dosing guidance.

Contraindications

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

Warnings and Precautions

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

Healthcare professionals should be aware of the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blistering, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product should not be used in conjunction with any other medications containing acetaminophen, whether prescription or over-the-counter. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a doctor or pharmacist is advised. Additionally, individuals with known allergies to acetaminophen or any inactive ingredients in this formulation should refrain from use.

Prior to administration, it is essential to consult a healthcare provider if the patient has liver disease. Furthermore, patients taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before using this product.

Patients should be instructed to discontinue use and consult a healthcare professional if any of the following occur: worsening pain or pain lasting more than 10 days, fever that worsens or persists for more than 3 days, the emergence of new symptoms, or the presence of redness or swelling. These symptoms may indicate a serious underlying condition.

For individuals who are pregnant or breastfeeding, it is crucial to seek guidance from a healthcare professional before using this product.

In the event of an overdose, immediate medical attention is necessary. Patients should contact a Poison Control Center at 1-800-222-1222 without delay, as prompt medical intervention is vital for both adults and children, even in the absence of noticeable signs or symptoms.

Side Effects

Severe liver damage may occur in patients who exceed the recommended dosage of more than 8 tablets in 24 hours, use the product in conjunction with other drugs containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blistering, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients who are unsure if a drug contains acetaminophen are advised to consult a doctor or pharmacist. Additionally, individuals with a known allergy to acetaminophen or any inactive ingredients in this product should refrain from use.

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

Patients are advised to stop using the product and consult a doctor if pain worsens or persists for more than 10 days, if fever worsens or lasts more than 3 days, if new symptoms arise, or if redness or swelling occurs, as these may indicate a serious condition.

In the case of overdose, it is crucial for patients to seek medical help or contact a Poison Control Center immediately (1-800-222-1222). Prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

If pregnant or breastfeeding, patients should consult a health professional before use.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent. The combination may increase the risk of bleeding due to potential pharmacodynamic interactions.

Additionally, this medication should not be used in conjunction with any other products containing acetaminophen, whether prescription or over-the-counter. Co-administration may lead to an increased risk of acetaminophen-related hepatotoxicity. If there is uncertainty regarding the presence of acetaminophen in other medications, patients are advised to seek guidance from a healthcare provider.

Packaging & NDC

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

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 tablets every 6 hours as needed, with a maximum of 6 tablets in a 24-hour period, unless otherwise directed by a physician. Treatment should not exceed 10 days without medical advice.

In cases of overdose, prompt medical attention is essential for both adults and pediatric patients, even if no signs or symptoms are immediately apparent.

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.

Due to the lack of available data, it is advisable to closely monitor elderly patients for any potential adverse effects or changes in therapeutic response. Individualized assessment and consideration of the patient's overall health status, comorbidities, and concurrent medications are recommended to ensure safe and effective use in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

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 individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this medication. It is essential for individuals with liver disease to receive appropriate guidance, as their liver function may affect the pharmacokinetics and safety profile of the drug. Monitoring of liver function may be necessary to ensure safe and effective use in this population.

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 intervention is crucial for both adults and children, even in the absence of noticeable 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 teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients about the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center at 1-800-222-1222 without delay. It is crucial to emphasize that quick medical attention is necessary for both adults and children, even if they do not exhibit any signs or symptoms of overdose. This proactive approach can significantly impact the outcome in such situations.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product within the temperature range of 20°-25°C (68°-77°F) to maintain its efficacy and safety.

Additionally, it is important to ensure that the seal under the cap remains intact; the product should not be used if this seal is broken or missing, as this may compromise the integrity of the product. Proper handling and storage conditions are vital to ensure the product's quality and effectiveness.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)