Relaxium

Description

Flexium Full Body Pain Relief is a pharmaceutical formulation designed for the alleviation of pain. The product is presented in a topical dosage form, specifically as a cream. It is characterized by its unique blend of active ingredients that target various types of pain throughout the body. The cream exhibits a smooth texture and is intended for external application. The formulation is designed to provide localized relief, making it suitable for use on multiple areas of discomfort.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints, including those related to arthritis, simple backache, strains, and sprains.

Limitations of Use: There are no teratogenic or nonteratogenic effects associated with this drug.

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. It is important to ensure that the area is clean and dry prior to application. The product should be applied gently and evenly, taking care to cover the entire affected area without excessive rubbing. Healthcare professionals should advise patients to wash their hands after application, unless the hands are the treated area.

Contraindications

Use of Flexium is contraindicated in individuals with a known allergy to any of its ingredients.

Contact with the eyes or mucous membranes should be avoided. Application to wounds, damaged skin, or irritated skin is prohibited. Bandaging of the application site is not recommended. Additionally, Flexium should not be used in conjunction with heating pads or devices. The product must not be punctured or incinerated, and it should be stored at temperatures not exceeding 120°F.

Warnings and Precautions

For external use only. This product is not intended for ingestion. In the event of accidental swallowing, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then reoccur within a few days. Monitoring of the patient's condition is essential to ensure appropriate management and to prevent potential complications.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur within a few days.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. 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 Relaxium (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 12 years and older may apply the medication to the affected area no more than 3 to 4 times daily. It is important to keep the product out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a Poison Control Center for guidance.

Geriatric Use

There is no specific information regarding the use of RELAXIUM menthol spray in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when administering this product to elderly patients, as the absence of data necessitates careful monitoring and consideration of individual patient factors. It is advisable to assess the overall health status and any comorbidities of geriatric patients prior to use, given the lack of established guidelines for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Additionally, contacting a poison control center can provide valuable guidance on the management of overdose cases.

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

Patients should be informed to stop using the product and consult their doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur within a few days.

When using this product, patients must avoid any contact with the eyes or mucous membranes. In the event of accidental contact with the eyes, they should flush the area with cold water. It is important to instruct patients not to apply the product to wounds or damaged skin, or to irritated skin. Additionally, they should not bandage the area after application.

Patients should wash their hands with cool water after using the product. They should also be cautioned against using the product in conjunction with a heating pad or any heating device.

Inform patients that the contents of the product are under pressure and that they should not puncture or incinerate the container. Patients should be made aware that they should not use the product if they are allergic to any ingredient in Flexium. Finally, advise patients to store the product at temperatures not exceeding 120° F.

Storage and Handling

The product is supplied in a pressurized container. It is essential to store the product at temperatures not exceeding 120°F to maintain its integrity and effectiveness. Due to the pressurized nature of the contents, it is critical to avoid puncturing or incinerating the container to prevent potential hazards. Proper handling and storage conditions are vital to ensure safety and efficacy.

Additional Clinical Information

For patients aged 12 years and older, the product should be applied to the affected area no more than 3 to 4 times daily. Clinicians should counsel patients to avoid contact with the eyes or mucous membranes, and to flush with cold water if the product accidentally comes into contact with the eyes. It is important not to apply the product to wounds, damaged, or irritated skin, and to avoid bandaging the area after application. Patients should wash their hands with cool water after use and refrain from using the product with heating pads or devices. Additionally, the product is under pressure; therefore, it should not be punctured or incinerated, and should not be used by individuals allergic to any of its ingredients. Storage should be at temperatures not exceeding 120°F.

Drug Information (PDF)

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

View product document (PDF)