Stressa Back and Neck Pain Relieving

Description

Stressa™ is an all-natural back and neck pain relieving oil formulated to provide soothing relief for tense and sore muscles. The product is presented in a dosage form of 8 fluid ounces (240 mL).

Uses and Indications

This drug is indicated for the temporary relief of pain associated with simple backache, strains, bruises, and sprains.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is performed with clean hands and that the affected area is dry before applying the medication.

For children under 2 years of age, it is advised to consult a healthcare professional prior to use to determine the appropriate course of action.

Contraindications

Use is contraindicated in the following situations:

• The product should be kept out of reach of children to prevent accidental ingestion or misuse.

• Tight bandaging is contraindicated as it may lead to complications such as impaired circulation or skin damage.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes during application. Additionally, it is important to instruct patients not to bandage the area tightly after use, as this may lead to adverse effects.

Patients should be closely monitored for any changes in their condition. If symptoms worsen or persist for more than 7 days, or if symptoms resolve and then recur within a few days, patients are advised to discontinue use and consult a healthcare provider for further evaluation.

It is crucial to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Side Effects

Patients should be aware that this product is for external use only. It is important to avoid contact with the eyes during application. Additionally, patients are advised not to bandage the area tightly after use.

In the event that conditions worsen or symptoms persist for more than 7 days, patients should discontinue use and consult a healthcare professional. If symptoms resolve and then recur within a few days, it is also recommended to seek medical advice.

This product should be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should consult a doctor prior to use. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

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

There is no specific information regarding the use of Stressa Back and Neck Pain Relieving Oil during pregnancy. The drug insert does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when considering the use of this product in pregnant women, as the potential risks and effects on fetal outcomes are not established. It is advisable to weigh the benefits against any unknown risks when recommending this product to women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in lactating mothers. Additionally, there are no known data on excretion in breast milk or effects on breastfed infants. Healthcare professionals should consider the absence of specific guidance when advising lactating mothers about the use of this medication.

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 this drug. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children to prevent accidental ingestion. In the event that the product is swallowed, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, they should be instructed to stop using the product and seek medical advice if symptoms resolve but then reoccur within a few days.

It is important to caution patients to avoid contact with their eyes while using this product. Furthermore, they should be advised not to bandage the area tightly when applying the product to ensure proper usage and minimize the risk of adverse effects.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity. The container must be kept tightly closed to prevent contamination and degradation. Additionally, the product should be protected from light exposure to ensure optimal stability. Once opened, the product must be discarded after use to ensure safety and efficacy.

Additional Clinical Information

For patients aged 2 years and older, the medication should be applied to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)