Coralite Extra Strength Cool and Hot

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for use in adults and children aged 12 years and older. It is recommended for administration for a maximum duration of 8 hours and should not be used more than 3 times a day. For children aged 12 years, consultation with a healthcare professional is advised prior to use.

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

Dosage and Administration

No dosage and administration information is available for this product. Healthcare professionals are advised to consult the prescribing information or relevant clinical guidelines for specific dosing recommendations and administration techniques.

Contraindications

The product should not be used in the following situations:

Tight bandaging or the use of heating pads in conjunction with this product is contraindicated, as it may lead to adverse effects. Additionally, application to wounds or damaged skin is prohibited to prevent potential complications and ensure safety.

Warnings and Precautions

For external use only. It is imperative that this product is kept out of reach of children to prevent accidental ingestion. In the event of swallowing, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

No specific laboratory tests are recommended for monitoring during the use of this product. However, healthcare professionals should remain vigilant regarding the safety and proper use of the product in their practice.

Side Effects

Patients should be aware that the product is intended for external use only. Adverse reactions associated with the use of this product may vary in severity and frequency.

In clinical trials, participants reported a range of adverse reactions, although specific data on the frequency and seriousness of these reactions were not provided. Postmarketing experiences may also reveal additional adverse reactions that were not observed during clinical trials.

It is essential for patients to monitor for any unexpected effects and to consult healthcare professionals if they experience any adverse reactions while using the product.

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 Coralite Extra Strength Cool and Hot (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

For pediatric patients aged 12 years and older, it is recommended to consult a healthcare professional prior to use. The application of the patch involves peeling off the protective backing and adhering the sticky side to the affected area. The patch is indicated for use for a maximum duration of 8 hours and should not be applied more than three times a day.

It is essential to keep the product out of reach of younger children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 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 consider general principles of management for potential overdose situations.

It is essential to monitor patients closely for any signs or symptoms that may arise following an overdose. Common symptoms 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 include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, contacting a poison control center or a medical toxicologist for guidance on specific management strategies is advisable. Additionally, healthcare professionals should be prepared to implement advanced life support measures if the patient's condition warrants such intervention.

Documentation of the incident, including the amount and timing of the substance involved, is crucial for ongoing management and treatment decisions.

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 use of the compound in these contexts.

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 to prevent accidental ingestion. In the event that the product is swallowed, patients should seek medical help or contact a Poison Control Center immediately.

When using this product, it is essential for patients to use it only as directed. They should be informed not to bandage tightly or use the product in conjunction with a heating pad, as this may lead to adverse effects. Additionally, patients should be cautioned to avoid contact with their eyes and mucous membranes, as this could cause irritation or injury. It is also important to instruct patients not to apply the product to wounds or damaged skin to prevent complications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, ensuring that the temperature does not exceed 86°F (30°C). Proper storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The product is administered topically and should be applied for a maximum of 8 hours, not exceeding three applications per day. Clinicians should advise patients to use the product only as directed and to avoid tight bandaging or the use of heating pads during application.

Patients who are pregnant or breastfeeding should consult a healthcare professional prior to use. It is important to avoid contact with eyes and mucous membranes, and the product should not be applied to wounds or damaged skin. Additionally, it 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 Coralite Extra Strength Cool and Hot, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)