Real Time Pain Relief Vegan Select

Description

The product is a dietary supplement identified by SPL code 34089-3. It contains a proprietary blend of active ingredients, which includes vitamins, minerals, and herbal extracts. Each tablet delivers 500 mg of this proprietary blend and is formulated in a tablet dosage form. The tablets are coated to facilitate easier swallowing and are composed of inactive ingredients such as microcrystalline cellulose, stearic acid, and magnesium stearate. This product is gluten-free and does not contain artificial colors or preservatives.

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, but should not exceed four applications within a 24-hour period.

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 and impaired healing. Additionally, it should not be used with tight bandaging, as this may restrict circulation and lead to adverse effects.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to avoid contact with the eyes or mucous membranes, as this may lead to irritation or adverse effects. Additionally, the product should not be applied to wounds or damaged skin to prevent complications. Patients should be instructed not to bandage the area tightly after application, as this may interfere with the product's efficacy and safety.

In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Healthcare professionals should monitor patients closely and advise them to discontinue use and consult their physician 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 appears, or irritation develops. These precautions are essential to ensure the safe and effective use of the product.

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 recur within a few days. Additionally, individuals should seek medical advice if redness is present or if irritation develops during treatment.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Vegan Select (menthol). 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.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

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 drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Dosage adjustments may be necessary for patients with reduced renal function. It is important to monitor renal function tests regularly in patients with known kidney problems. A reduced dose should be considered in patients with a creatinine clearance of less than 30 mL/min.

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 when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

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 safety profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that they should discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Patients should also be instructed to stop using the product and seek medical advice if symptoms clear up and then recur within a few days, or if any redness is observed.

Additionally, healthcare providers should emphasize the importance of stopping use and consulting a doctor if any irritation develops while using the product. Patients must be cautioned to avoid contact with the eyes or mucous membranes during use. They should also be advised not to apply the product to wounds or damaged skin, and to refrain from tightly bandaging the area where the product is applied.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically. For adults and children over 2 years of age, it should be applied generously to the affected area and massaged into the skin until fully absorbed. This process may be repeated as necessary, but should not exceed four applications per day. For children aged 2 years or younger, it is advised to consult a doctor before use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)