Pain Reliever

Description

The product associated with SPL Code 34089-3 does not have specific details available regarding its chemical name, physical characteristics, or inactive ingredients. Further information may be required to provide a comprehensive description of the drug's properties and formulation.

Uses and Indications

This drug is indicated for the treatment of specific medical conditions as determined by healthcare professionals. There are no known teratogenic effects associated with this drug, and it has not been reported to cause any nonteratogenic effects.

Limitations of use have not been specified; therefore, healthcare providers should evaluate the appropriateness of this drug based on individual patient needs and clinical guidelines.

Dosage and Administration

Adults and children over 12 years of age should apply a generous amount of the product directly to the affected area. The application should be followed by a thorough massage into the skin until the product is completely absorbed. This process may be repeated as necessary, with a maximum frequency of four times daily.

The product is intended for topical application only, and care should be taken to ensure proper technique during administration to achieve optimal results.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounds or damaged skin. Healthcare professionals should advise patients to use the product strictly as directed, ensuring that contact with the eyes is avoided. It is also important to instruct patients not to apply tight bandages over the treated area.

Patients should be informed to discontinue use and seek medical advice if any of the following occur: the presence of redness, the development of irritation, worsening of the condition, or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, medical consultation is recommended.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients should be aware that this product is intended for external use only and should not be applied to wounds or damaged skin. It is crucial to use the product only as directed, avoiding contact with the eyes, and not to bandage the area tightly.

In the event of adverse reactions, patients are advised to discontinue use and consult a healthcare professional if any of the following occur: redness at the application site, development of irritation, worsening of the condition, or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, it is recommended to seek medical advice.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients over 12 years of age may apply a generous amount of the product directly to the affected area, massaging it into the skin until thoroughly absorbed. This application may be repeated as necessary, but should not exceed four times daily.

It is important to keep the product out of reach of younger children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a Poison Control Center for guidance.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should be aware that no specific information regarding the use of this product during pregnancy is provided in the prescribing information. There are no statements indicating whether the product is contraindicated in pregnancy or any associated risks to the fetus. Additionally, no dosage modifications or special precautions regarding the use of this product during pregnancy are mentioned. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to 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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may be beneficial in guiding the management of the overdose.

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

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to seek medical help or contact a Poison Control Center immediately. It is essential for patients to understand the importance of these precautions to ensure their safety and the safety of others.

Storage and Handling

The product is supplied in packaging that includes a lot number and expiration date, which can be located on the crimp or on the box. It is essential to store the product at room temperature to maintain its integrity and effectiveness. Proper handling should be observed to ensure the product remains within the specified storage conditions.

Additional Clinical Information

The product is administered topically, with a recommendation to apply a generous amount directly to the affected area and massage until thoroughly absorbed. Patients may repeat this application as necessary, but should not exceed four times daily.

Clinicians should counsel patients that the product is for external use only and must not be applied to wounds or damaged skin. Patients are advised to use the product only as directed, avoiding contact with the eyes and not bandaging tightly. They should discontinue use and consult a doctor if redness occurs, irritation develops, the condition worsens, or symptoms persist beyond seven days. Additionally, if symptoms resolve and then recur within a few days, medical advice should be sought. It is important to keep the product out of reach of children, and in the event of ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

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

View product document (PDF)