Nerve Reverse Pain Relief

Description

The drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. Each tablet is debossed with "XYZ" on one side and "123" on the opposite side. It contains 500 mg of the active ingredient. The formulation includes several inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc, hypromellose, titanium dioxide, polyethylene glycol, and iron oxides (red and yellow).

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of the muscles and joints associated with conditions such as arthritis, simple backache, sprains, bruises, and strains.

Limitations of Use: This medication is intended for short-term use and should not be used as a substitute for more comprehensive treatment of underlying conditions.

Dosage and Administration

For adults and children aged two years and older, the recommended application is to the affected area not more than three to four times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under two years of age, it is advised to consult a physician prior to use to determine the appropriate course of action and ensure safety.

Contraindications

There are no specific contraindications listed for this product. However, it is advised not to bandage tightly, as this may lead to complications such as impaired circulation or tissue damage.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury. In the event that symptoms persist for more than seven days, the product should be discontinued, and a physician should be consulted for further evaluation and management.

In cases of accidental ingestion, it is essential to seek medical advice promptly. Users are advised against applying a tight bandage over the treated area, as this may lead to adverse effects or hinder the product's efficacy.

Pregnant or breastfeeding individuals should consult their physician prior to using this product to ensure safety for both the mother and child.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only, and contact with the eyes should be avoided. In clinical practice, if symptoms persist for more than seven days, it is advised to discontinue use and consult a physician.

Additionally, the product should be kept out of reach of children. In the event of accidental ingestion, patients should seek medical advice immediately. It is also important to avoid tightly bandaging the area where the product is applied.

For pregnant or breastfeeding individuals, it is recommended to contact a physician prior to use to ensure safety for both the mother and child.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Nerve Reverse Pain Relief (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged two years and older may apply the medication to the affected area no more than three to four times daily. For children under two years of age, it is advised to consult a physician prior to use.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should contact their physician prior to using this medication. It is essential for healthcare providers to evaluate the potential risks and benefits associated with the use of this medication during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised.

Lactation

Lactating mothers are advised to contact their physician prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating patients.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. 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, it is imperative that healthcare professionals take immediate action. If the product is ingested, the individual should be advised to consult a physician without delay.

Prompt medical evaluation is essential to assess the severity of the situation and to initiate appropriate management strategies. Symptoms of overdosage may vary depending on the specific substance involved, and healthcare providers should be prepared to monitor for any adverse effects that may arise.

Management of overdosage should include supportive care and symptomatic treatment as necessary. It is crucial to follow established protocols for the specific substance in question, which may involve decontamination procedures or the administration of antidotes if applicable.

Healthcare professionals are encouraged to report any cases of overdosage to the relevant authorities to contribute to ongoing safety monitoring and to enhance the understanding of the substance's risk profile.

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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients that if the product is swallowed, they should consult a physician immediately. It is important to emphasize the need for prompt medical attention in such cases to ensure patient safety.

Additionally, healthcare providers should instruct patients not to bandage the area tightly. This precaution helps prevent potential complications and ensures proper circulation and healing.

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 room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged two years or older being three to four times daily to the affected area. For children under two years of age, it is advised to consult a physician prior to use. 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 Nerve Reverse Pain Relief, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)