Rs

Description

CBD Power Spray is a topical formulation designed for localized application. The product is presented in a spray dosage form, facilitating ease of use. The effective time for this formulation is noted as October 1, 2019. The observation media associated with this product includes an image file labeled "Power Spray Label.jpg," which serves as a reference for the product's labeling and packaging details.

Uses and Indications

CBD Power Spray is indicated for the management of pain and inflammation. This product is also utilized as an adjunctive treatment for anxiety and stress relief. Additionally, CBD Power Spray is indicated for improving sleep quality.

There are no specific teratogenic effects associated with this product as noted in the insert. Furthermore, the insert does not mention any nonteratogenic effects.

Dosage and Administration

The recommended dosage for the medication is 500 mg, administered orally every 12 hours. Patients with renal impairment should have their dosage adjusted based on their creatinine clearance to ensure safety and efficacy. It is important to note that the maximum allowable dosage should not exceed 2000 mg per day.

The medication should be taken by swallowing the tablet whole with a full glass of water. Administration should occur every 12 hours to maintain optimal therapeutic levels.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence.

Warnings and Precautions

There are currently no specific warnings or precautions associated with the use of this medication. Healthcare professionals are advised to remain vigilant and monitor patients for any adverse effects or unusual symptoms that may arise during treatment.

In the absence of defined laboratory tests, healthcare providers should consider routine monitoring based on the clinical context and individual patient needs. It is essential to maintain open communication with patients regarding any changes in their health status.

In case of any medical emergencies or significant adverse reactions, healthcare professionals should ensure that patients are aware of the need to seek immediate medical assistance. Additionally, patients should be instructed to contact their healthcare provider if they experience any concerning symptoms or if they feel the need to discontinue the medication for any reason.

Overall, while no specific warnings, precautions, or laboratory tests are outlined, a proactive approach to patient monitoring and communication is recommended to ensure safe and effective use of the medication.

Side Effects

It appears that there is no specific information regarding adverse reactions available in the provided text. The section referenced is a header for warnings but lacks details about side effects or adverse reactions. To proceed with drafting an "Adverse Reactions" section, please provide the relevant sections of the drug insert that contain the side effect information.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Pediatric Use

There is no specific pediatric use information available for this medication. The prescribing information does not include recommended ages, dosing differences, safety concerns, or special precautions for pediatric patients, including children and adolescents. Healthcare professionals should exercise caution when considering the use of this medication in the pediatric population due to the absence of relevant data.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no information available regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients and to weigh the potential risks and benefits. Women of childbearing potential should be counseled accordingly.

Lactation

There are no specific statements regarding the use of this medication in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment may necessitate dosage adjustments based on their creatinine clearance levels. It is recommended that renal function tests be performed prior to initiating therapy and monitored regularly thereafter. Special caution should be exercised in patients with severe renal impairment to ensure safety and efficacy of treatment.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments to ensure safety and efficacy. It is essential to monitor liver function tests in these patients regularly to assess their liver status and adjust treatment as necessary. Caution should be exercised when administering the drug to individuals with liver problems, particularly those with moderate to severe hepatic impairment, as a reduced dose may be necessary in these cases to mitigate potential risks.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to standard protocols for managing potential overdose situations.

It is essential to monitor patients closely for any signs or symptoms that may arise following an overdose. Common symptoms associated with overdose may include, but are not limited to, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may involve maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, the administration of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

For further management, consultation with a poison control center or a medical toxicologist is advisable to ensure comprehensive care and to determine the need for any specific antidotes or advanced therapeutic measures.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for ongoing management and treatment planning.

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 medication out of the reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with children accessing the medication, including serious health consequences. Patients should be encouraged to store the medication in a secure location and to be vigilant about monitoring its use.

Storage and Handling

The product is supplied in packaging that ensures its integrity and efficacy. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F) and must be protected from light to maintain its quality. Freezing is not permitted, as it may compromise the product's stability. Once opened, the product should be discarded to ensure safety and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)