Menthol

Description

The product is identified by SPL Code 34089-3 and is presented as a white to off-white, round, biconvex tablet. It is debossed with "R" on one side and "34089" on the opposite side. Each tablet contains 500 mg of Acetaminophen. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, stearic acid, povidone, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, iron oxide red, and iron oxide yellow.

Uses and Indications

This drug is indicated for the relief of temporary pain associated with various conditions, including arthritis, neck and back pains, stiffness, muscle soreness, cramps, sprains and strains, and tendonitis.

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

Dosage and Administration

The prescribing information for the medication includes specific dosage instructions that are detailed in the accompanying image format (Directions_Therapain Plus.jpg). Healthcare professionals are advised to refer to this image for comprehensive guidance on the appropriate dosage and administration techniques.

As the route, method, and frequency of administration are not explicitly stated in the provided text, it is essential for healthcare professionals to consult the image for these critical details to ensure safe and effective use of the medication.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional under the following circumstances:

• If excessive skin irritation develops.

• If the condition worsens.

• If symptoms persist for more than 7 days.

In these cases, medical advice should be sought to ensure appropriate management.

Warnings and Precautions

For external use only. In the event of accidental ingestion, it is imperative to contact poison control immediately.

Healthcare professionals should advise patients to discontinue use and seek medical consultation if any of the following occur: excessive skin irritation, worsening of the condition, or if symptoms persist for more than 7 days. In such cases, it is essential to stop using the product and consult a physician for further evaluation and management.

While no specific emergency medical help instructions are provided, it is advisable for patients to seek immediate medical attention if they experience severe reactions or other concerning symptoms.

Currently, there are no additional general precautions or specific laboratory tests recommended for monitoring the safe use of this product. However, healthcare providers should remain vigilant and assess the patient's response to treatment regularly.

Side Effects

Patients should be aware that this product is for external use only. In the event of accidental ingestion, it is imperative to contact poison control immediately.

In clinical use, patients are advised to discontinue use and consult a healthcare professional if excessive skin irritation develops, if the condition worsens, or if symptoms persist for more than 7 days. These actions are crucial to ensure patient safety and to address any potential adverse reactions effectively.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Menthol (therapain plus spray). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. This precaution is essential to ensure safety and prevent accidental ingestion.

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 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 is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the effects on breastfed infants are not well characterized. It is advisable to weigh the potential benefits against any unknown risks when considering treatment options for lactating patients.

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 event of an overdosage, it is crucial to note that the product is intended for external use only. Should accidental ingestion occur, immediate action is required. Healthcare professionals are advised to contact poison control without delay to ensure appropriate management and intervention.

Symptoms of overdosage may vary depending on the amount ingested and the individual's response. Prompt recognition of these symptoms is essential for effective treatment.

Management of overdosage should focus on supportive care and symptomatic treatment. Healthcare providers should monitor the patient closely and provide necessary interventions as guided by poison control recommendations.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to discontinue use of the product and consult a doctor if they experience excessive skin irritation. Patients should also be informed to seek medical advice if their condition worsens or if symptoms persist for more than 7 days. It is important for patients to understand that prolonged use without improvement may require further evaluation by a healthcare professional.

Storage and Handling

The product is supplied in packaging that ensures its integrity and safety. It should be stored at room temperature, away from direct light exposure to maintain its efficacy. Additionally, it is essential to keep the product out of reach of children to prevent accidental ingestion or misuse. Proper handling and storage conditions are crucial for preserving the quality of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)