Quality Choice Menthol Cough Drops

Description

The product is identified by the National Drug Code (NDC) 83324-265-30. It is formulated as a liquid dosage form, specifically containing 30 drops per unit.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with the common cold. Additionally, it provides temporary relief from occasional minor irritation or sore throat.

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

Dosage and Administration

For adults and children aged 5 years and older, the recommended dosage is to dissolve 1 drop slowly in the mouth. This may be repeated every 2 hours as needed.

For children under 5 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

Use of this product is contraindicated in the following situations:

Patients should discontinue use and consult a healthcare professional if cough persists for more than one week, recurs, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious underlying condition. Additionally, if a sore mouth does not show improvement within 7 days, medical advice should be sought. Patients experiencing persistent or worsening irritation, pain, or redness should also stop use and consult a healthcare provider.

Warnings and Precautions

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

Patients should discontinue use and seek medical advice if any of the following occur: a cough that persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache, as these may signify a serious underlying condition; a sore mouth that does not show improvement within seven days; or if irritation, pain, or redness persists or worsens.

Before initiating treatment, it is advisable for patients to consult a healthcare provider 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).

In the event of any severe or concerning symptoms, patients should seek emergency medical assistance as 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 symptoms such as headache, rash, swelling, nausea, or vomiting, warrants prompt consultation with a healthcare professional. These symptoms may indicate a serious underlying condition.

Common adverse reactions necessitate immediate medical attention if they occur. Patients should stop using the medication and consult a doctor if a cough persists for more than 1 week, recurs, or is accompanied by fever, rash, or a persistent headache, as these may also signify a serious condition. Additionally, if a sore mouth does not improve within 7 days, or if irritation, pain, or redness persists or worsens, medical advice should be sought.

Before using this medication, patients are advised to consult a healthcare provider 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 safe and effective use of the product.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Quality Choice Menthol Cough Drops (menthol cough drops). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 5 years of age should consult a healthcare professional before use. For children aged 5 years and older, the recommended dosage is to dissolve 1 drop slowly in the mouth, with the option to repeat every 2 hours as needed.

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.

Pregnancy

There is no information available regarding the use of Quality Choice Menthol Cough Drops during pregnancy. As such, the safety of this product in pregnant patients has not been established, and no specific dosage modifications or special precautions are recommended for use in this population. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential risks and benefits before recommending this product during pregnancy.

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

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 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 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 initiate supportive care and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the substance involved in the overdose.

Overall, vigilance and prompt intervention are critical in managing any suspected overdose situation effectively.

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 medication out of reach of children to prevent accidental ingestion.

Patients should be instructed to stop using the medication 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 7 days, or if irritation, pain, or redness persists or worsens, patients should seek medical advice.

It is also important for healthcare providers to remind patients to consult a doctor before using this medication 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 available in various package configurations, identified by their respective National Drug Code (NDC) numbers. Specific storage and handling instructions are not provided; therefore, standard practices for pharmaceutical products should be followed. It is recommended to store the product in a controlled environment, ensuring that it is kept at appropriate temperature ranges to maintain its integrity. Containers should be suitable for pharmaceutical storage, and any special handling requirements should be adhered to as per general guidelines for similar products.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)