Exchange Select Cough Drops

Description

The drug, identified by SPL code 34089-3, is classified as a herbal product. It comprises a blend of various natural ingredients, contributing to its unique formulation. The physical characteristics of the product include a specific color and texture, which are typical for herbal formulations. Additionally, the formulation contains inactive ingredients that consist of common excipients utilized in herbal products.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with a cold. It also provides relief from occasional minor irritation and pain due to sore throat or sore mouth.

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

Dosage and Administration

Adults and children aged 2 years and older are instructed to dissolve the lozenge slowly in the mouth. The lozenge 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 associated with 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

Severe sore throat may indicate a more serious condition. If a patient experiences a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, it is imperative to consult a healthcare professional promptly.

In addition, 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 symptoms may signify a serious underlying condition. If a sore mouth does not show improvement within 7 days, or if irritation, pain, or redness persists or worsens, medical consultation is also advised.

While no specific laboratory tests or emergency medical instructions are provided, healthcare professionals should remain vigilant for these warning signs and ensure appropriate follow-up care for patients exhibiting these symptoms.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions warrant immediate medical attention, particularly in the case of severe sore throat. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, patients are advised to consult a doctor promptly.

Common adverse reactions include persistent cough, which should prompt patients to stop use and seek medical advice if it lasts for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious underlying condition. Additionally, if a sore mouth does not improve within 7 days, or if irritation, pain, or redness persists or worsens, patients should also seek medical consultation.

Before using this medication, patients should ask their doctor if they have a persistent 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 safe and effective use of the medication.

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 Exchange Select Cough Drops (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children aged 2 years and older, the lozenge should be dissolved slowly in the mouth. Dosing may be repeated every 2 hours as needed or as directed by a healthcare provider.

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

There is no specific information regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while on this medication.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as specific recommendations are not provided in the current prescribing information.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

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.

If available, specific antidotes or treatments should be administered as per established protocols. Consultation with a poison control center or a medical toxicologist is recommended for guidance on the management of overdose cases.

Documentation of the incident, including the substance involved, the amount ingested, and the time of ingestion, is crucial for effective management and follow-up care.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this and all medications out of the 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 condition. 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.

It is important to emphasize that patients should not exceed the recommended dosage while using this product. Healthcare providers should also encourage patients to consult with their doctor prior to use if they have a persistent 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, which must be inspected prior to use. It is essential to ensure that the primary bag seal is intact; do not use the product if the seal has been torn or broken.

Storage conditions require the product to be kept at room temperature. It should be protected from excessive heat and direct sunlight to maintain its integrity and efficacy. Proper handling and storage are crucial to ensure the product remains safe for use.

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)