Sore No More Plus Cbd 500mg Cool Therapy

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. Each tablet is debossed with "SN" on one side and "500" on the opposite side, containing 500 mg of the active ingredient. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, and iron oxides (red and yellow).

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints, including those resulting from strains, bruises, and sprains.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended dosage is to apply the gel to the affected area no more than 3 to 4 times daily. The gel should be rubbed in thoroughly until fully absorbed.

For children under 2 years of age, it is advised to consult a healthcare professional before use.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

For external use only. This product is contraindicated for application on wounds or damaged skin and should not be used in conjunction with any heat sources.

Pregnant or breastfeeding individuals are advised to consult a healthcare professional prior to use to ensure safety for both the mother and child.

When utilizing this product, it is essential to avoid tightly bandaging the area of application and to prevent contact with the eyes to mitigate the risk of adverse effects.

Additionally, this product should be kept out of reach of children to prevent accidental ingestion or misuse.

Side Effects

Patients should be aware that this product is for external use only and should not be applied to wounds or damaged skin. The use of this product in conjunction with a heat source is contraindicated.

In clinical practice, it is advised that pregnant or breastfeeding individuals consult a healthcare professional prior to use. While using this product, patients should avoid tightly bandaging the area of application and ensure that the product does not come into contact with the eyes. Additionally, it is important to keep this product out of reach of children to prevent accidental ingestion or misuse.

These precautions are essential to minimize the risk of adverse reactions and ensure safe usage.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Sore No More Plus Cbd 500mg Cool Therapy (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this product out of reach of children and to use it for external purposes only. When applying the product, caregivers should avoid bandaging tightly and ensure that it does not come into contact with the eyes.

For children aged 2 years and older, the recommended dosage is to apply the product to the affected area no more than 3 to 4 times daily, ensuring thorough rubbing until the gel is fully absorbed. For children under 2 years of age, consultation with a doctor is necessary prior to use.

Geriatric Use

There is no specific information available 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 use. It is essential to evaluate the potential risks and benefits of treatment during pregnancy and lactation, as the effects on fetal outcomes and nursing infants are not fully established. Healthcare providers should consider individual patient circumstances and available data when advising on the use of this medication in pregnant or breastfeeding individuals.

Lactation

Lactating mothers are advised to consult a healthcare 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the insert text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with reduced kidney function. Regular monitoring of renal function may be warranted in these patients, although specific guidelines are not outlined.

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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on 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 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 limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are provided in the insert for SORE NO MORE PLUS CBD 500MG COOL THERAPY.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young individuals.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability while maintaining safety standards. It is essential to store the product at room temperature to preserve its efficacy.

To ensure safety, the product should be kept out of reach of children. It is important to note that the product should not be applied to wounds or damaged skin, and care should be taken to avoid contact with the eyes.

Once opened, the product must be discarded to prevent any potential contamination or degradation.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 2 years and older being 3 to 4 times daily. Patients should apply the gel to the affected area and rub it in thoroughly until fully absorbed. For children under 2 years of age, consultation with a doctor is advised prior to 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 Sore No More Plus Cbd 500mg Cool Therapy, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)