Thera Plus Extra Strength Muscle Rub Topical Analgesic

Description

The drug is identified by the SPL code 34089-3 and is presented as a white to off-white, crystalline powder. Its chemical name is insert chemical name here. The formulation includes inactive ingredients such as insert inactive ingredients here.

Uses and Indications

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

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

For adults and children aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. The application should be performed with clean hands, ensuring that the affected area is dry before application.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing and administration guidance.

Contraindications

The product is contraindicated in the following situations:

• Application on wounds or damaged skin is prohibited due to the potential for adverse effects.

• Concurrent use with a heating pad is not recommended, as it may lead to increased risk of burns or skin irritation.

• The product should not be used in children under 12 years of age with an arthritis-like condition, as safety and efficacy have not been established in this population.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounds or damaged skin and should not be used in conjunction with a heating pad. It is also not recommended for children under 12 years of age who present with an arthritis-like condition.

When utilizing this product, it is imperative to avoid contact with the eyes and mucous membranes. Additionally, users should refrain from applying tight bandages over the treated area to prevent complications.

Healthcare professionals should advise patients to discontinue use and seek medical advice if excessive skin irritation occurs, if the condition worsens, or if symptoms persist beyond 7 days. Patients should also be instructed to stop use if symptoms resolve and then recur within a few days.

It is essential to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended.

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated for use on wounds or damaged skin, and should not be used in conjunction with a heating pad. Additionally, it is not recommended for children under 12 years of age who have an arthritis-like condition.

While using this product, patients should avoid contact with the eyes and mucous membranes, and should not apply a tight bandage over the treated area.

Patients are advised to discontinue use and consult a healthcare professional if excessive skin irritation occurs, if the condition worsens, or if symptoms persist for more than 7 days. Furthermore, if symptoms resolve and then recur within a few days, medical advice should be sought.

It is important to keep this product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Thera Plus Extra Strength Muscle Rub Topical Analgesic (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age with an arthritis-like condition should not use this medication. For children in this age group, it is advised to consult a healthcare professional before use.

For adolescents aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

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 adverse effects or changes in therapeutic response, given the potential for altered pharmacokinetics and pharmacodynamics in this population.

Pregnancy

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

Lactation

There is no specific information regarding the use of Thera Plus Extra Strength Muscle Rub Topical Analgesic in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the lack of data when advising lactating mothers on the use of this product.

Renal Impairment

Patients with renal impairment have not been specifically studied in relation to dosage adjustments, special monitoring, or safety considerations. Consequently, there is no available information regarding the use of this medication in individuals with reduced kidney function. Healthcare professionals should exercise caution when prescribing this medication to patients with renal impairment, as the lack of data necessitates careful consideration of potential risks and benefits.

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, 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. The national Poison Control Center can be reached at 1-800-222-1222.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective recovery.

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 available in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed. It is important to instruct patients not to apply the product on wounds or damaged skin, as this may lead to adverse effects.

Patients should be informed that the product should not be used in conjunction with a heating pad, as this may increase the risk of skin irritation or other complications. Additionally, healthcare providers should caution against using the product on children under 12 years of age who have an arthritis-like condition.

Patients must be advised to discontinue use and consult a doctor if they experience excessive skin irritation, if their condition worsens, or if symptoms persist for more than 7 days. They should also be instructed to stop using the product and seek medical advice if symptoms improve and then recur within a few days.

While using the product, patients should be reminded to avoid contact with their eyes and mucous membranes. Furthermore, they should be advised not to bandage the area tightly to prevent potential complications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at room temperature, maintaining a range of 68° to 72°F (20° to 22°C). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients aged 12 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is recommended to consult a doctor regarding the appropriate use and administration of the product.

Drug Information (PDF)

This file contains official product information for Thera Plus Extra Strength Muscle Rub Topical Analgesic, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)