Goodsense Extra Strength Cold and Hot Medicated

Description

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

Uses and Indications

This drug is indicated for use in adults and children aged 12 years and older. For children under 12 years of age, consultation with a healthcare professional is recommended prior to use.

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

Dosage and Administration

There is currently no specific dosage or administration information available for this medication. Healthcare professionals are advised to refer to the prescribing information or clinical guidelines for detailed instructions regarding the appropriate dosage, route of administration, and frequency of use. It is essential to consider individual patient factors and clinical judgment when determining the appropriate treatment regimen.

Contraindications

Use is contraindicated in the following situations:

• Application on wounds or damaged skin is prohibited due to the risk of exacerbating injury or infection.

• Concurrent use with a heating pad is not recommended, as it may lead to increased risk of burns or skin irritation.

• The product should not be used in children under 12 years of age with arthritis-like conditions, as safety and efficacy have not been established in this population.

Warnings and Precautions

For external use only. It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222.

General precautions must be observed to ensure safe use. This product should not be applied to wounds or damaged skin, nor should it be used in conjunction with a heating pad. Additionally, it is contraindicated for use in children under 12 years of age who present with arthritis-like conditions.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens or symptoms persist beyond 7 days; symptoms resolve only to reappear within a few days; or if excessive skin irritation develops.

In cases of ingestion, it is crucial to seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if the condition worsens or if symptoms persist for more than 7 days. Additionally, if symptoms clear up and then recur within a few days, or if excessive skin irritation occurs, medical advice should be sought.

Before using this product, patients are advised to consult a doctor if there is any redness over the affected area.

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 Goodsense Extra Strength Cold and Hot Medicated (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients with arthritis-like conditions under 12 years of age should not use this medication. For children in this age group, it is essential to consult a healthcare professional before administration.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

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, consultation with a poison control center or a medical toxicologist is encouraged to guide further management and treatment options.

Documentation of the incident, including the amount and timing of the substance involved, is crucial for ongoing assessment and 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 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 of swallowing, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be instructed not to use the product on wounds or damaged skin, and to avoid using it in conjunction with a heating pad. It is important to inform patients that this product should not be used on children under 12 years of age who have arthritis-like conditions.

Healthcare providers should counsel patients to stop using the product and consult a doctor if any of the following occur: the condition worsens or symptoms persist for more than 7 days; symptoms improve and then recur within a few days; or if excessive skin irritation develops.

When using this product, patients should be reminded to use it only as directed and to avoid contact with the eyes or mucous membranes. They should not bandage the area tightly and should discontinue use at least 1 hour before taking a bath or shower, as well as avoid using it immediately after bathing.

Lastly, patients should be encouraged to consult a doctor before use if there is any redness over the affected area.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, within the range of 20-25°C (68-77°F). Care should be taken to ensure that the product is kept in a suitable container to maintain its integrity. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The route of administration for the medication is topical. For adults and children aged 12 years or older, the patch should not be worn for more than 8 hours and may be applied to the affected area no more than three times daily. For children under 12 years of age, it is advised to consult a doctor 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 Goodsense Extra Strength Cold and Hot Medicated, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)