Joint and Muscle Pain Relief

Description

This product is indicated for the relief of joint and muscle pain. It is formulated to provide effective analgesic properties, targeting discomfort associated with musculoskeletal conditions. The active ingredients work synergistically to alleviate pain and improve mobility, making it suitable for individuals experiencing acute or chronic pain in these areas.

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, 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 dosage is to apply the medication 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 physician before use.

The medication should be applied directly to the affected area, ensuring that the application does not exceed the specified frequency of 3 to 4 times daily for the appropriate age group.

Contraindications

The product is contraindicated for use on wounds or damaged skin due to the potential for irritation and impaired healing. Additionally, contact with the eyes should be avoided to prevent adverse effects. It is also contraindicated to apply a tight bandage over the area of application, as this may lead to increased local irritation or other complications.

Warnings and Precautions

For external use only. It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay. This product should not be applied to wounds or damaged skin to prevent adverse effects.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens, irritation develops, or symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days.

In cases of ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if the condition worsens, irritation occurs, or if symptoms persist for more than 7 days or clear up and then recur within a few days.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

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

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 and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 context of overdosage, there is currently no specific information available regarding the effects or management of an overdose for this medication. Healthcare professionals are advised to monitor patients closely for any unusual symptoms or adverse reactions that may arise.

In the absence of detailed overdosage data, it is recommended that standard supportive care measures be implemented. This may include symptomatic treatment and monitoring of vital signs. If an overdose is suspected, healthcare providers should consider contacting a poison control center or seeking guidance from a medical toxicologist for further management strategies.

As always, maintaining a thorough understanding of the patient's medical history and current medications is essential in managing any potential overdosage scenarios effectively.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been provided in the insert. Additionally, there is no nonclinical toxicology data or animal pharmacology and toxicology information available in the insert.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

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

Patients should be informed not to use the product on wounds or damaged skin. They should be counseled to stop using the product and consult a doctor if their condition worsens or if irritation occurs. Additionally, patients should be advised to discontinue use and seek medical advice if symptoms persist for more than 7 days or if symptoms clear up and then recur within a few days.

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

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 in a cool, dry place, ensuring it is protected from light exposure to maintain its integrity and efficacy. Proper storage conditions are crucial for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)