Medicated Chest Rub

Description

GOODSENSE® is a medicated chest rub formulated as a topical analgesic, nasal decongestant, and cough suppressant. It is designed for external application to relieve symptoms associated with colds and respiratory conditions. The product is comparable to the active ingredients found in Vicks® VapoRub®*. Each container has a net weight of 3.53 ounces (100 grams) and is identified by NDC# 50804-078-01.

Uses and Indications

This drug is indicated for the temporary relief of cough due to the common cold when applied to the chest and throat. Additionally, it is indicated for the temporary relief of minor aches and pains when applied to muscles and joints.

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

Dosage and Administration

For adults and children aged 2 years and older, a thick layer of the product should be applied to the chest and throat to alleviate cough symptoms, or it may be rubbed onto sore, aching muscles or joints. If desired, the application can be covered with a warm, dry cloth to enhance comfort. It is recommended to keep clothing loose around the throat and chest area to facilitate the inhalation of vapors. This application may be repeated up to three times daily or as directed by a healthcare professional.

The product is contraindicated for use in children under 2 years of age.

Contraindications

The product is contraindicated for oral administration. It should not be applied with tight bandages, in the nostrils, or on wounds or damaged skin due to the potential for adverse effects. Heating, including microwaving or adding to hot water, is also contraindicated as it may cause splattering and result in burns.

Warnings and Precautions

For external use only; direct contact with the eyes should be avoided. This product is contraindicated for oral ingestion, application with tight bandages, use in the nostrils, or on wounds and damaged skin.

Healthcare professionals should advise patients to consult a physician prior to use if they have a cough accompanied by excessive phlegm (mucus) or a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema.

During the application of this product, it is imperative to avoid heating, microwaving, or adding it to hot water or any container that may involve heating water. Such actions may lead to splattering and potential burns.

Patients should be instructed to discontinue use and seek medical advice if muscle aches and pains worsen, persist for more than 7 days, or resolve only to recur within a few days. Additionally, if a cough lasts longer than 7 days, tends to recur, or is accompanied by fever, rash, or a persistent headache, these may indicate a serious underlying condition requiring further evaluation.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made at 800-222-1222.

Side Effects

Patients using this product should be aware of several important warnings and precautions. This product is intended for external use only and should not come into contact with the eyes. It is contraindicated for oral use, application with tight bandages, use in nostrils, or on wounds or damaged skin.

Before using this product, patients should consult a healthcare professional if they have a cough that occurs with excessive phlegm (mucus) or if they experience a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema.

While using this product, patients are advised against heating, microwaving, or adding it to hot water or any container that may involve heating water, as this may cause splattering and result in burns.

Patients should discontinue use and seek medical advice if muscle aches and pains worsen, persist for more than 7 days, or if they resolve and then recur within a few days. Additionally, if a cough lasts more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache, these may indicate a serious condition requiring medical attention.

For pregnant or breastfeeding patients, it is recommended to consult a healthcare professional prior to use. Furthermore, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made at 800-222-1222.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Medicated Chest Rub (camphor (synthetic) , eucalyptus oil, and menthol, unspecified form). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should not use this product. For children aged 2 years and older, the recommended application involves rubbing a thick layer on the chest and throat to alleviate cough symptoms, or applying it to sore, aching muscles or joints. Care should be taken to ensure that the product is used appropriately in this age group to avoid any potential safety concerns.

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, given the lack of targeted data.

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an overdose, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. It is recommended to contact a Poison Control Center at 800-222-1222 for expert guidance on managing the situation.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdose.

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 question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 800-222-1222 for further assistance. It is essential for patients to understand the importance of these precautions to ensure their safety and the safety of others.

Storage and Handling

The product is supplied in a container that must be stored at a temperature range of 15 to 30°C (59 to 86°F). It is imperative that the integrity of the packaging is maintained; therefore, the product should not be used if the seal on the jar is broken or missing.

Additional Clinical Information

The product is administered topically, with specific instructions for adults and children aged 2 years and older. Patients should apply a thick layer to the chest and throat to alleviate cough or to sore, aching muscles or joints. It is recommended to cover the application site with a warm, dry cloth if desired and to keep clothing loose around the throat and chest to facilitate the inhalation of vapors. This application may be repeated up to three times daily or as directed by a healthcare professional.

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

Drug Information (PDF)

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

View product document (PDF)