Exchange Select Cough Drops

Description

Menthol Cough Drop is a pharmaceutical formulation designed to provide symptomatic relief from cough and throat irritation. It contains menthol as the active ingredient, which acts as a topical analgesic and provides a cooling sensation. The product is typically presented in a lozenge form, allowing for convenient oral administration. The appearance of the cough drop is generally characterized by a translucent or semi-translucent structure, often with a characteristic mint flavor. The formulation may include various inactive ingredients to enhance stability and palatability.

Uses and Indications

This drug is indicated for the temporary relief of cough due to a cold. Additionally, it provides temporary relief from occasional minor irritation, pain, sore mouth, and sore throat.

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

Dosage and Administration

Adults and children aged 2 years and older should dissolve one lozenge slowly in the mouth. This process may be repeated every 2 hours as needed or as directed by a healthcare professional.

For children under 2 years of age, it is recommended to consult a doctor before administration.

Contraindications

There are no specific contraindications identified for this product. However, it is essential to adhere to the recommended dosage guidelines, as exceeding the recommended dosage may lead to adverse effects.

Warnings and Precautions

If a patient experiences a severe sore throat that persists for more than two days, or if it is accompanied or followed by symptoms such as fever, headache, rash, swelling, nausea, or vomiting, it is imperative to consult a healthcare professional promptly.

Healthcare providers should advise patients to discontinue use and seek medical attention under the following circumstances: if a cough persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache, as these may indicate a serious underlying condition. Additionally, if symptoms of a sore mouth do not improve within seven days, or if there is ongoing irritation, pain, or redness that persists or worsens, patients should be instructed to contact their doctor for further evaluation.

Monitoring for these symptoms is essential to ensure patient safety and to facilitate timely intervention when necessary.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions include severe sore throat, which, if it persists for more than 2 days or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, necessitates prompt consultation with a healthcare provider.

Common adverse reactions may include symptoms related to cough and sore throat. Patients should discontinue use and seek medical advice if a cough persists for more than 1 week, recurs, or is accompanied by fever, rash, or a persistent headache, as these may indicate a serious underlying condition. Additionally, if sore mouth symptoms do not improve within 7 days, or if irritation, pain, or redness persists or worsens, patients are advised to stop use and consult a doctor.

Before using this medication, patients should consult a healthcare professional if they have a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus). These considerations are important to ensure the safe and effective use of the medication.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Exchange Select Cough Drops (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older are instructed to dissolve the lozenge slowly in the mouth and may repeat the dosage every 2 hours as needed or as directed by a healthcare professional. For children under 2 years of age, it is recommended to consult a doctor before use.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. Consequently, the safety concerns, dosage modifications, or special precautions for pregnant patients remain undefined. Healthcare professionals should exercise caution when prescribing this product to women of childbearing potential and consider the lack of information when assessing the potential risks and benefits for pregnant patients. It is advisable to monitor any emerging data that may inform the safety profile of this product in the context of pregnancy.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised.

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 patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols tailored to the substance involved. Continuous assessment and supportive measures should be prioritized to ensure patient safety and mitigate potential complications associated with 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 compound in these areas.

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. Patients should be instructed to stop using the product and consult a doctor if their cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition. Additionally, if symptoms of a sore mouth do not improve within seven days, or if irritation, pain, or redness persists or worsens, patients should seek medical advice.

While using this product, it is important for patients to adhere strictly to the recommended dosage and not exceed it. Healthcare providers should also encourage patients to consult a doctor prior to use if they have a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus). This guidance will help ensure safe and effective use of the product.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring that it is kept away from excessive heat and direct sunlight to maintain its integrity.

Additionally, healthcare professionals should inspect the primary bag seal prior to use; the product must not be utilized if the seal has been torn or broken, as this may compromise the safety and efficacy of the product. Proper handling and storage conditions are crucial for preserving the quality of the product.

Additional Clinical Information

The medication is administered orally, with specific instructions for different age groups. Adults and children aged 2 years and older should dissolve the lozenge slowly in the mouth, with the option to repeat every 2 hours as needed or as directed by a healthcare professional. For children under 2 years of age, it is advised to consult a doctor before administration.

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

Drug Information (PDF)

This file contains official product information for Exchange Select Cough Drops, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)