Chest Comfort

Description

Chest Comfort is an antitussive (cough suppressant) balm with a net weight of 1.91 oz (54.1 g). This formulation is designed to provide relief from cough symptoms.

Uses and Indications

This drug is indicated for the topical application in adults and children aged 12 years and older. It is to be applied in a thick layer to the throat and chest. For enhanced efficacy, the area may be covered with a warm, dry cloth if desired. It is recommended that clothing around the throat and chest be loose to facilitate the inhalation of vapors.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

The recommended dosage for the medication is up to three times daily, or as directed by a healthcare professional. For children under 12 years of age, it is advised to consult a doctor prior to administration to determine the appropriate dosage and ensure safety.

Contraindications

Use of this product is contraindicated in patients with a history of epilepsy due to the potential for exacerbating seizures. Additionally, it should not be used in individuals with high blood pressure, as it may pose further cardiovascular risks.

The product should not be heated, microwaved, or used near an open flame. It is also contraindicated to add the product to hot water or any container where water is being heated, as this may lead to splattering and result in burns.

Warnings and Precautions

For external use only. This product must not be ingested or placed in the nostrils, as doing so may lead to serious adverse effects. It is important to note that the product is flammable; therefore, it should be kept away from fire or flame to prevent any risk of ignition.

General precautions should be observed to ensure safety. The product must be kept out of reach of children. In the event that the product is swallowed, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Healthcare professionals should instruct patients to discontinue use and consult a physician if a cough persists for more than one week, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache. A persistent cough may indicate an underlying serious condition that requires further evaluation and management.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. This product is intended for external use only and should not be ingested or placed in the nostrils. It is also flammable; therefore, it should be kept away from fire or flame.

Patients are advised to discontinue use and consult a healthcare professional if a cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or a persistent headache. A persistent cough may indicate a serious underlying condition that requires medical evaluation.

Before using this product, patients should seek medical advice if they have a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema. Additionally, individuals with a cough accompanied by excessive phlegm (mucus) should also consult a healthcare provider prior to use.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and adults aged 12 years and older, the product is to be applied in a thick layer on the throat and chest. It is essential to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

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

Pregnant patients and those who are breastfeeding should not use this product. The potential risks associated with the use of this product during pregnancy or lactation have not been established, and its safety in these populations has not been evaluated. Therefore, healthcare professionals are advised to consider alternative treatments for women who are pregnant or nursing.

Lactation

Lactating mothers are advised against the use of this product while breastfeeding. There is no available data on the excretion of the product in human milk or its effects on breastfed infants. Therefore, caution is warranted, and alternative treatments should be considered for lactating mothers.

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

There is no information available regarding hepatic impairment, including dosage adjustments, special monitoring, or precautions for patients with compromised liver function. Therefore, no specific recommendations can be made for the use of this medication in patients with hepatic impairment. It is advised that healthcare professionals exercise caution and consider individual patient factors when prescribing to this population.

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.

Additionally, it is recommended to consult local poison control centers or toxicology experts for guidance on specific management protocols and interventions that may be appropriate based on the clinical scenario.

Documentation of the incident, including the substance involved, estimated dose, time of exposure, and any symptoms observed, is crucial for effective management and follow-up care.

Nonclinical Toxicology

If pregnant or breast-feeding, the use of this product is contraindicated due to potential teratogenic effects. No information is available regarding non-teratogenic effects. Additionally, there are no data provided concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert.

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 be instructed to seek medical help or contact a Poison Control Center immediately. 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 tightly sealed container to ensure integrity. It should be stored at room temperature, away from heat sources, to maintain its efficacy. Additionally, it is recommended to recycle the container where possible to promote environmental sustainability.

Additional Clinical Information

Patients aged 12 years and older are instructed to apply the product in a thick layer to the throat and chest, with a maximum frequency of three times daily or as directed by a healthcare professional.

Clinicians should counsel patients on the following important safety information: the product is for external use only and should not be ingested or placed in the nostrils. It is flammable and must be kept away from fire or flame. Patients should consult a doctor prior to use if they have a persistent or chronic cough associated with conditions such as smoking, asthma, or emphysema. They should discontinue use and seek medical advice if the cough persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache. Additionally, the product is not recommended for use during pregnancy or breastfeeding, and it should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is advised.

Drug Information (PDF)

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

View product document (PDF)