Pain Release

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the topical treatment of affected areas in adults and children aged 12 years and older.

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

Dosage and Administration

The recommended dosage for the medication is not to exceed 3 to 4 times daily. For children under 12 years of age, it is imperative to consult a healthcare professional prior to administration to determine the appropriate dosage and ensure safety.

Healthcare professionals should assess the individual needs of the patient and adjust the frequency of administration accordingly, while adhering to the maximum dosage limits. Proper evaluation and guidance are essential for pediatric patients to avoid potential adverse effects.

Contraindications

Use of this product is contraindicated in the following situations:

• Application on wounds or damaged skin is prohibited due to the risk of exacerbating the condition or causing further injury.

• The product should not be used in individuals with epilepsy, as it may trigger seizures.

• Patients with high blood pressure should avoid this product, as it may pose additional health risks.

Warnings and Precautions

For external use only, this product is flammable and should be kept away from fire or flame to prevent any risk of ignition.

General precautions must be observed to ensure safe use. The product should not be applied to wounds or damaged skin, as this may exacerbate the condition or lead to adverse effects. Additionally, individuals with epilepsy should refrain from using this product, as it may pose a risk of triggering seizures. Those with high blood pressure are also advised against its use due to potential complications.

Patients are instructed to stop using the product and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately to ensure appropriate care is provided.

Side Effects

Patients should be aware that the product is for external use only and is flammable; it should be kept away from fire or flame.

In clinical practice, it is advised that patients discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. These precautions are important to ensure patient safety and effective management of their condition.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Pain Release (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. For adolescents and adults aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily. It is important to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

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 individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should not use this product. The potential risks associated with the use of this product during pregnancy or lactation have not been established, and its safety in these populations is not confirmed. Healthcare professionals are advised to consider alternative treatments for women who are pregnant or nursing.

Lactation

Lactating mothers are advised against the use of this product while breastfeeding. There is no available data on the excretion of this product in human milk or its effects on breastfed infants. Therefore, caution is warranted, and alternative treatments should be considered for lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Should an overdose occur, the following general recommendations should be considered:

Recommended Actions Immediate medical attention is advised in the event of suspected overdosage. Healthcare providers should assess the patient's condition and initiate appropriate interventions based on the clinical presentation.

Potential Symptoms While specific symptoms related to this product's overdosage are not detailed, healthcare professionals should be aware that overdose may lead to a range of adverse effects. Symptoms can vary widely depending on the substance involved and may include, but are not limited to, cardiovascular, neurological, and gastrointestinal manifestations.

Management Procedures Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should monitor vital signs and provide necessary interventions to stabilize the patient. In cases where the specific antidote or treatment protocol is known, it should be administered as per established guidelines.

In summary, while no specific overdosage information is available for this product, healthcare professionals should be prepared to act swiftly and effectively in the event of an overdose, utilizing their clinical judgment and available resources to ensure patient safety.

Nonclinical Toxicology

The available nonclinical data indicates significant concerns regarding the use of this product. Both teratogenic and non-teratogenic effects have been identified, leading to a strong recommendation against its use.

No additional relevant information is available regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the drug insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients not to apply the product on wounds or damaged skin to prevent further complications.

Patients should be informed that the product is contraindicated for individuals with epilepsy and those with high blood pressure. They should be cautioned to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

While using the product, patients must be reminded to avoid contact with the eyes to prevent irritation or injury. Additionally, they should be advised against tightly bandaging the area where the product is applied to ensure proper circulation and avoid adverse effects.

Storage and Handling

The product is available in various packaging configurations, with specific NDC numbers provided for identification. It is essential to store the product within the recommended temperature range to ensure its efficacy and safety.

Proper storage conditions must be maintained, and the product should be kept in a suitable container to prevent contamination. Special handling requirements may apply, and healthcare professionals are advised to follow these guidelines closely to ensure optimal product integrity.

Additionally, the organization supports recycling initiatives and encourages the recycling of packaging materials wherever possible.

Additional Clinical Information

Patients should be advised that the product is to be administered no more than 3 to 4 times daily. In the event that the product is swallowed, it is crucial to seek medical assistance or contact a Poison Control Center immediately. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)