Real Time Pain Relief Maxx

Description

The product is identified by the SPL Code 34089-3 and is packaged in a 4 oz bottle.

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 2 years of age, the recommended dosage involves applying a generous amount of the product to the affected area. The application should be followed by a gentle massage into the painful area until the product is thoroughly absorbed into the skin. This process may be repeated as necessary, with a maximum frequency of four times daily.

For children aged 2 years or younger, it is advised to consult a physician before use.

Contraindications

The product is contraindicated for application to wounds or damaged skin due to the potential for irritation or adverse reactions. Additionally, it should not be used with tight bandaging, as this may compromise circulation and lead to further complications.

Warnings and Precautions

For external use only. This product is intended solely for topical application and should not be ingested.

It is imperative that this product is used only as directed. Healthcare professionals should advise patients to avoid contact with the eyes and mucous membranes, as exposure may lead to irritation or adverse effects. Additionally, the product should not be applied to wounds or damaged skin, and care should be taken to avoid tight bandaging of the treated area to prevent complications.

Patients should be instructed to discontinue use and seek medical advice if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, redness is observed, or if any irritation develops. These signs may indicate a need for reevaluation of the treatment plan.

Furthermore, it is crucial 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 should be made without delay.

Side Effects

Patients should be aware that this product is for external use only. It is essential to use the product strictly as directed and to avoid contact with the eyes or mucous membranes. The product should not be applied to wounds or damaged skin, and it is advised not to bandage the area tightly.

In the event that the condition worsens, symptoms persist for more than 7 days, or symptoms clear up and then recur within a few days, patients are advised to stop use and consult a healthcare professional. Additionally, if redness or irritation develops, it is important to discontinue use and seek medical advice.

For pregnant or breastfeeding individuals, it is recommended to consult a health professional prior to use. Furthermore, this product should be kept out of reach of children. In case of accidental ingestion, immediate medical assistance should be sought or contact with a Poison Control Center should be made.

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 Real Time Pain Relief Maxx (menthol 1.5%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients over 2 years of age may apply the medication generously to the affected area, massaging it into the skin until thoroughly absorbed. This application may be repeated as necessary, but should not exceed four times daily. For pediatric patients 2 years of age or younger, it is advised 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, given the lack of targeted data.

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 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 this drug. 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, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention.

Prompt action is crucial in mitigating potential adverse effects associated with overdosage. The symptoms may vary depending on the specific substance involved; therefore, a thorough assessment and appropriate treatment plan should be initiated based on the clinical presentation and guidance from poison control experts.

Nonclinical Toxicology

There is no information available regarding teratogenic effects associated with the substance. However, it is advised that individuals who are pregnant or breastfeeding consult a health professional prior to use.

No additional data is provided concerning nonclinical toxicology or animal pharmacology and 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. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a doctor if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms clear up and then recur within a few days, redness is present, or if irritation develops.

When using this product, patients must be reminded to use it only as directed. They should avoid contact with the eyes and mucous membranes, and it is important not to apply the product to wounds or damaged skin. Additionally, patients should be cautioned against tightly bandaging the area where the product is applied.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring that it is protected from light exposure. Freezing the product is strictly prohibited, as it may compromise its integrity.

To maintain optimal conditions, the container must be kept tightly closed when not in use. Additionally, it is important to discard the product after opening to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically, with instructions for adults and children over 2 years to apply generously to the affected area and massage until fully absorbed. This application may be repeated as necessary, not exceeding four times daily. For children aged 2 years or younger, consultation with a doctor is advised prior to use.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before using the product. It is also important to keep the product out of reach of children; if ingested, medical assistance or contact with a Poison Control Center should be sought immediately. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)