Pain Release

Description

Saje® Natural Wellness Pain Release is a topical analgesic mist formulated for the relief of pain. This product is presented in a dosage form of 3.4 fluid ounces (100 milliliters).

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 dosing frequency for the medication is not more than three to four times daily. It is important to note that this medication is not recommended for use in children under 12 years of age. Healthcare professionals should ensure that patients adhere to the prescribed dosing regimen to optimize therapeutic outcomes while minimizing the risk of adverse effects.

Contraindications

Use is contraindicated in patients with a history of epilepsy due to the potential for exacerbating seizures. Additionally, the product should not be administered to individuals with high blood pressure, as it may pose significant health risks in this population.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to avoid ingestion of the product. In the event of accidental swallowing, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

This product is contraindicated in individuals with epilepsy. Additionally, it should not be used in patients with high blood pressure due to potential adverse effects.

Patients should be instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Monitoring of the patient's condition is essential to ensure safety and efficacy during treatment.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days.

Drug Interactions

The use of this medication is contraindicated in patients with a history of epilepsy, as it may exacerbate seizure activity. Additionally, it should not be administered to individuals with high blood pressure due to potential adverse effects on cardiovascular stability.

No specific drug or laboratory test interactions have been identified. Therefore, routine monitoring for drug interactions or laboratory test alterations is not necessary.

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 are not recommended to use this product. For adolescents 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, medical assistance should be sought immediately, or contact a Poison Control Center.

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 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 has not been evaluated. Therefore, 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 during 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

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

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 information regarding overdosage, healthcare professionals are advised to exercise caution and consider general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, it is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the substance involved in the overdose.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and follow-up care.

Nonclinical Toxicology

If pregnant or breast-feeding, the use of this product is contraindicated due to potential teratogenic effects. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings available regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the 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 for patients to understand the potential risks associated with ingestion and the need for prompt action.

Patients should be instructed to discontinue use of 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. This guidance is crucial to ensure that patients are aware of when to seek further medical evaluation.

Additionally, healthcare providers should emphasize the importance of avoiding contact with the eyes while using this product. Patients should be made aware of the potential consequences of eye contact and encouraged to take precautions to prevent such incidents.

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 under appropriate conditions to maintain its integrity and efficacy.

Storage should be conducted in a controlled environment, ensuring that the temperature remains within the specified range. Containers must be kept sealed and protected from light and moisture to prevent degradation.

Special handling requirements include adherence to recycling protocols; healthcare professionals are encouraged to recycle packaging materials where possible to support environmental sustainability.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 3 to 4 times daily for adults and children aged 12 years and older. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, 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)