R3

Description

R3-348 is a pharmaceutical compound with a specific molecular weight and chemical formula that is not detailed in the provided data. The dosage form is not explicitly stated, but it is presented in a professional labeling context. The appearance of R3-348 is represented visually in an accompanying image file (69678348-1.jpg). The effective date of this information is November 11, 2022.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including arthritis, simple backache, muscle strains, sprains, bruises, and cramps.

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

Dosage and Administration

For adults and children over 12 years of age, the product should be shaken well before each use. A generous amount should be applied to the affected area, followed by massaging the formulation into the painful area until it is completely absorbed. The application may be repeated 4 to 6 times a day or as needed, depending on the severity of symptoms.

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

Contraindications

Use of this product is contraindicated in the following situations:

• The product should be kept out of reach of children to prevent accidental ingestion.

• In the event of accidental swallowing, immediate medical assistance or contact with a Poison Control Center is required.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. It is imperative to avoid bandaging the area tightly or using it in conjunction with a heating pad. Contact with eyes and mucous membranes should be avoided to prevent irritation. Application to wounds, damaged, broken, or irritated skin is contraindicated.

Users may experience a transient burning sensation or redness upon application; however, these effects typically resolve within several days. Should a severe burning sensation occur, the product should be discontinued immediately. Additionally, the treated area must not be exposed to heat or direct sunlight to prevent exacerbation of any adverse effects.

Healthcare professionals should advise patients to stop use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

This product is flammable; therefore, it should be kept away from fire or flame. Pregnant or breastfeeding individuals are advised to consult a healthcare professional prior to use.

To ensure safety, the product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is crucial to follow the directions provided and to avoid bandaging the area tightly or using it in conjunction with a heating pad. Contact with the eyes and mucous membranes should be avoided, and the product should not be applied to wounds or to damaged, broken, or irritated skin.

Upon application, patients may experience a transient burning sensation or redness, which typically resolves within several days. However, if a severe burning sensation occurs, patients are advised to discontinue use immediately. Additionally, the treated area should not be exposed to heat or direct sunlight.

Patients should stop using the product and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. It is important to note that the product is flammable and should be kept away from fire or flame. Pregnant or breastfeeding patients should seek advice from a healthcare professional before using this product.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of R3 (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. The safety and efficacy of this medication in this age group have not been established, and specific dosing recommendations are not provided for children in this age range. It is essential for healthcare providers to evaluate the individual needs and circumstances of pediatric patients prior to prescribing this medication.

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. 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 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, 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.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to address any complications that may arise from an overdosage scenario.

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 provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring patient safety and minimizing potential risks associated with accidental exposure.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, ensuring that it is kept away from fire or flame to maintain safety and efficacy. Prior to each use, it is essential to shake the product well to ensure proper mixing and effectiveness.

Additional Clinical Information

The product is intended for topical administration, with patients advised to apply it generously to the affected area and massage until fully absorbed. It may be used 4 to 6 times daily or as needed. Clinicians should counsel patients that the product is for external use only and to follow specific instructions: avoid tight bandaging or use with heating pads, and prevent contact with eyes and mucous membranes. It should not be applied to wounds or damaged skin. A transient burning sensation or redness may occur but typically resolves within a few days; however, if a severe burning sensation occurs, patients should discontinue use immediately.

Patients are also advised to stop use and consult a doctor if their condition worsens or if symptoms persist beyond 7 days or recur shortly after resolution. Pregnant or breastfeeding individuals should seek advice from a healthcare professional before use. The product should be kept out of reach of children, and in the event of ingestion, medical assistance or contact with a Poison Control Center is recommended.

Drug Information (PDF)

This file contains official product information for R3, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)