Dolo - Neurobion Acetaminophen Max

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including minor pain of arthritis, muscular aches, backache, premenstrual and menstrual cramps, the common cold, headache, and toothache. 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 are advised to take 2 tablets every 8 hours with water. The tablets should be swallowed whole and must not be crushed, chewed, split, or dissolved. The maximum recommended dosage is 6 caplets within a 24-hour period. Additionally, the use of this medication should not exceed 10 days unless directed by a healthcare professional.

For individuals under 18 years of age, it is recommended to consult a doctor prior to use.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center (1-800-222-1222) is advised. Prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the guidelines. Healthcare professionals should advise patients that the maximum daily dosage is limited to 6 caplets within a 24-hour period. Patients must be cautioned against concurrent use with other medications containing acetaminophen, as well as the consumption of three or more alcoholic drinks daily while using this product.

In addition to liver-related warnings, there is an allergy alert associated with acetaminophen. Severe skin reactions may occur, presenting as skin reddening, blisters, or rash. Should any of these symptoms manifest, patients are instructed to discontinue use immediately and seek medical assistance.

This product should not be used in the following circumstances:

• In conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. Patients uncertain about the contents of their medications should consult a healthcare provider.

• By individuals with a known allergy to acetaminophen or any inactive ingredients present in the formulation.

Healthcare professionals should recommend that patients consult a doctor prior to use if they have a history of liver disease. Additionally, patients taking the anticoagulant warfarin should seek advice from a healthcare provider or pharmacist before using this product.

Patients are advised to discontinue use and contact their healthcare provider if any of the following occur:

• Pain worsens or persists for more than 10 days.

• Fever intensifies or lasts longer than 3 days.

• New symptoms develop.

• Redness or swelling is observed.

These symptoms may indicate a serious underlying condition requiring further evaluation.

In the event of an overdose, immediate medical attention is essential. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily dosage of 6 caplets within 24 hours, use it concurrently with other medications 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, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

It is advised that patients consult a healthcare professional prior to using this product if they have a history of liver disease or are currently taking the anticoagulant warfarin. Additionally, patients should stop using the product and consult a doctor if pain worsens or persists beyond 10 days, if fever intensifies or lasts more than 3 days, if new symptoms arise, or if there is any redness or swelling, as these may indicate a serious underlying condition.

Patients who are pregnant or breastfeeding should seek guidance from a healthcare professional before using this product. It is also crucial to avoid using this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription, and to refrain from use if allergic to acetaminophen or any of the inactive ingredients present in the formulation.

Drug Interactions

Patients taking the anticoagulant warfarin should consult with a healthcare professional prior to initiating treatment with this medication. The interaction between this drug and warfarin may necessitate careful monitoring of coagulation parameters to ensure therapeutic efficacy and minimize the risk of adverse effects. Adjustments to the dosage of warfarin may be required based on the clinical judgment of the healthcare provider.

Packaging & NDC

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

Pediatric Use

Pediatric patients should be kept out of reach of children. For individuals under 18 years of age, it is advised to consult a healthcare professional prior to use. In the event of an overdose, prompt medical attention is essential for both children and adults, even if no signs or symptoms are immediately apparent.

Geriatric Use

There is no specific information regarding the use of Dolo-NeuroBion Acetaminophen Max Extended-Release 650 mg in geriatric patients. The prescribing information does not indicate any dosage adjustments, safety concerns, or special precautions that are specifically applicable to elderly patients.

Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the absence of data on this population. Monitoring for efficacy and safety is recommended, as elderly patients may have different pharmacokinetic and pharmacodynamic responses compared to younger adults.

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 on 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

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. The maximum recommended dosage is 6 caplets in a 24-hour period; exceeding this limit may lead to significant hepatic injury.

Additionally, patients should be aware that combining this product with other medications containing acetaminophen can also result in severe liver damage. It is crucial for patients to avoid the concurrent use of multiple acetaminophen-containing products.

Furthermore, the consumption of 3 or more alcoholic drinks daily while using this product may increase the risk of severe liver damage.

Patients with known liver disease are advised to consult a healthcare professional prior to using this product to assess the potential risks and determine appropriate use. Regular monitoring of liver function may be warranted in these individuals to ensure safety and efficacy.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage associated with the use of this product, which contains acetaminophen.

Maximum Daily Dosage Healthcare professionals should advise patients that the maximum recommended dosage is 6 caplets within a 24-hour period. Exceeding this limit significantly increases the risk of liver injury.

Concurrent Use with Other Medications It is essential to note that taking acetaminophen in conjunction with other medications that also contain acetaminophen can lead to severe liver damage. Healthcare providers should carefully review a patient's medication history to prevent unintentional overdosing.

Alcohol Consumption Patients should be cautioned against the consumption of 3 or more alcoholic drinks daily while using acetaminophen. This combination can exacerbate the risk of liver damage, necessitating close monitoring and patient education regarding safe alcohol consumption levels.

In the event of suspected overdosage, immediate medical attention is warranted. Healthcare professionals should initiate appropriate management procedures, which may include monitoring liver function and considering the use of antidotes as indicated.

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

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is essential to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. It is crucial to communicate that prompt medical attention is necessary for both adults and children, even if no signs or symptoms of overdose are apparent. This information is vital for ensuring the safety and well-being of patients and their families.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

Patients should be advised that the medication is administered orally, with adults instructed to take 2 tablets every 8 hours with water. It is important to swallow the tablets whole and not to crush, chew, split, or dissolve them. Patients should not exceed 6 caplets in a 24-hour period and should not use the medication for more than 10 days unless directed by a healthcare professional.

Clinicians should counsel patients who are pregnant or breastfeeding to consult a health professional before use. Additionally, the medication should be kept out of reach of children. In the event of an overdose, patients must seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are present.

Drug Information (PDF)

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

View product document (PDF)