Pain Release

Description

Saje® Natural Wellness Pain Release is a pain-relieving bath salt soak designed to provide relief from discomfort. The product is packaged in a net weight of 21.9 ounces (620 grams).

Uses and Indications

This drug is indicated for the treatment of affected areas in adults and children aged 12 years and older. The recommended administration involves dissolving 2 teaspoons of the drug in warm water and soaking the affected area.

Limitations of Use: There are no known 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 each patient and adjust the frequency of administration accordingly, while adhering to the maximum dosage limits.

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 an increased risk of cardiovascular complications.

Warnings and Precautions

For external use only. This product is contraindicated in individuals with a history of epilepsy and those with high blood pressure.

Healthcare professionals should advise patients to seek emergency medical assistance immediately if the product is ingested, or to contact a Poison Control Center without delay.

Patients are instructed to discontinue use and consult a physician if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

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

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary 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 aged 12 years and older, the recommended application involves dissolving 2 teaspoons of salt in warm water and soaking 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 a Poison Control Center without delay.

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 the 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 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 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, it is important for healthcare professionals to remain vigilant and consider general principles of management in cases of suspected overdose with any medication.

Healthcare providers should be aware that symptoms of overdose can vary widely depending on the substance involved. Common manifestations may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention is warranted. Recommended actions include contacting a poison control center or seeking emergency medical assistance. Supportive care should be initiated as necessary, which may involve monitoring vital signs, providing oxygen, and administering intravenous fluids.

Additionally, specific antidotes or treatments may be indicated based on the substance involved in the overdose. It is crucial for healthcare professionals to refer to established clinical guidelines and protocols for the management of overdose situations to ensure optimal patient outcomes.

Documentation of the incident, including the substance, amount ingested, and time of exposure, is essential for guiding treatment decisions and for future reference.

Nonclinical Toxicology

If pregnant or breastfeeding, the use of this product is contraindicated due to potential teratogenic effects. There are no specific non-teratogenic effects or detailed nonclinical toxicology data available. Additionally, no specific information regarding animal pharmacology and toxicology has been provided.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 inform patients that this product should not be used by individuals with epilepsy or those who have high blood pressure.

Patients should be instructed 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. Additionally, healthcare providers should emphasize the importance of avoiding contact with the eyes while using this product to prevent potential irritation or injury.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature and protected from light to ensure optimal quality. Users are advised not to use the product if the Saje seal on the bottle's opening is broken or missing, or if the tear notch security seal on the zippered bag inside is damaged or missing. Additionally, the product should be discarded after opening to prevent any potential degradation in quality.

Additional Clinical Information

The product is administered topically. For adults and children aged 12 years and older, the recommended method involves dissolving 2 teaspoons of salt soak in warm water and soaking the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is advised to consult a doctor prior to use.

No additional information is 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)