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 dosage form is a lozenge, typically presented in a solid form for oral administration. The product is characterized by its distinct menthol flavor and is intended for use in adults and children over a specified age.

Uses and Indications

This drug is indicated for the temporary relief of cough due to cold and for the occasional alleviation of 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 is accompanied by 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 advice if any of the following occur: a cough that persists for more than one week, a cough that tends to recur, or if it is accompanied by fever, rash, or a persistent headache. Additionally, if a sore mouth does not show improvement within seven days, or if there is ongoing irritation, pain, or redness that persists or worsens, patients should be instructed to stop taking the medication and contact their doctor.

While no specific emergency medical instructions are provided, it is essential for healthcare professionals to remain vigilant and assess the need for immediate intervention based on the patient's clinical presentation.

Currently, there are no specific general precautions or laboratory tests indicated for monitoring in relation to the use of this medication. However, healthcare providers should maintain a comprehensive understanding of the patient's overall health status and any concurrent medications that may necessitate additional monitoring or precautions.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. 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 professional.

Common adverse reactions warranting attention include persistent cough, which should prompt patients to stop use and seek medical advice if it lasts more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. Additionally, if a sore mouth does not improve within 7 days, or if irritation, pain, or redness persists or worsens, patients are advised to discontinue use and consult a doctor.

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, or if their cough is accompanied by excessive phlegm (mucus). These considerations are important to ensure the safe and effective use of the product.

Drug Interactions

No specific drug interactions have been identified for this medication. 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

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no information available regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients and to weigh the potential risks and benefits. Women of childbearing potential should be counseled accordingly.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. The effects on breastfed infants have not been established, and further research may be necessary to determine safety and efficacy in this population.

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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider general principles of management for suspected cases of drug overdosage.

Recommended Actions In the event of an overdosage, it is essential to assess the patient's clinical status promptly. Healthcare providers should initiate supportive care and monitor vital signs closely. The management of overdosage may include the following steps:

1. Assessment: Evaluate the patient's symptoms and history of exposure to the drug.

2. Supportive Care: Provide symptomatic treatment as necessary, which may include intravenous fluids, oxygen supplementation, or other interventions based on the patient's condition.

3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific management strategies tailored to the drug involved.

Potential Symptoms While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for signs of toxicity that may arise from excessive dosing of medications. Symptoms can vary widely depending on the pharmacological properties of the drug and may include, but are not limited to, neurological, cardiovascular, or gastrointestinal manifestations.

In summary, due to the lack of specific overdosage information, healthcare professionals should rely on established protocols for managing suspected overdosage cases, ensuring that patient safety remains the top priority.

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. 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. Additionally, if a sore mouth does 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 to the recommended dosage and not exceed it. Healthcare providers should also encourage patients to consult a doctor before using the product 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).

Storage and Handling

The product is supplied in a configuration that includes a primary bag. It is essential to store the product at room temperature, ensuring that it is kept away from excessive heat and direct sunlight. Healthcare professionals should inspect the primary bag prior to use; the product must not be utilized if the seal of the primary bag is torn or broken.

Additional Clinical Information

The medication is administered orally, with specific instructions for different age groups. For adults and children aged 2 years and older, the lozenge should be dissolved 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)