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Quality Choice Menthol Cough Drops

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Active ingredient
Menthol 5.4 mg
Other brand names
Dosage form
Lozenge
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2024
Label revision date
December 22, 2025
Active ingredient
Menthol 5.4 mg
Other brand names
Dosage form
Lozenge
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2024
Label revision date
December 22, 2025
Manufacturer
Chain Drug Marketing Association, Inc.
Registration number
M012
NDC root
83324-265

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If you are a consumer or patient please visit this version.

Drug Overview

You may find this medication helpful if you're experiencing a cough due to a cold or if you have occasional minor irritation or soreness in your throat. It is designed to provide temporary relief from these symptoms, helping you feel more comfortable.

The product comes in a package containing 30 drops, making it easy to use when you need it. If you're looking for a way to soothe your throat and ease your cough, this medication could be a suitable option for you.

Uses

If you're dealing with a cough caused by a cold, this medication can help provide temporary relief. It’s also effective for easing occasional minor throat irritation or soreness. You can use it to feel more comfortable while you recover from your cold symptoms.

Rest assured, this medication does not have any known teratogenic effects, meaning it does not cause developmental issues in a fetus.

Dosage and Administration

If you or your child is 5 years old or older, you can take this medication by dissolving 1 drop slowly in your mouth. You can repeat this every 2 hours if needed. However, if your child is under 5 years old, it’s important to consult a doctor before using this medication. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to be aware of certain situations when using this medication. You should stop using it and consult your doctor if your cough lasts more than a week, keeps coming back, or is accompanied by fever, rash, or a persistent headache, as these may indicate a more serious health issue. Additionally, if you notice that a sore in your mouth isn't improving after 7 days, or if you experience ongoing irritation, pain, or redness, it's crucial to seek medical advice.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, always prioritize your health and safety by following these guidelines.

Side Effects

If you experience a severe sore throat that lasts more than two days or is accompanied by symptoms like headache, rash, swelling, nausea, or vomiting, it's important to consult a doctor, as these could indicate a serious issue. Additionally, if your cough persists for more than a week, recurs, or is accompanied by fever, rash, or a persistent headache, seek medical advice, as these may also signal a serious condition.

You should stop using the medication and contact a doctor if your sore mouth does not improve within seven days, or if you notice any irritation, pain, or redness that persists or worsens. Before using this medication, consult your doctor if you have a chronic cough related to smoking, asthma, or emphysema, or if your cough is accompanied by excessive mucus.

Warnings and Precautions

If you experience a severe sore throat that lasts more than two days or is accompanied by symptoms like headache, rash, swelling, nausea, or vomiting, it’s important to consult a doctor right away, as these could indicate a serious issue.

You should also stop taking the medication and contact your doctor if your cough persists for more than a week, returns frequently, or is accompanied by fever, rash, or a persistent headache. Additionally, if a sore mouth does not improve within seven days, or if you notice ongoing irritation, pain, or redness, seek medical advice.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical attention.

In case of an emergency, call your local emergency services or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or special precautions have not been clearly outlined.

Before taking any medication, including this one, you should consult with your healthcare provider to discuss potential risks and benefits. They can help you make informed decisions that prioritize your health and the health of your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your baby. Since the effects on nursing infants have not been thoroughly studied, exercising caution is advised. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

If you have a child under 5 years old, it's important to consult with a doctor before using this medication. For children aged 5 years and older, you can give them one drop to dissolve slowly in their mouth, repeating this every two hours as needed. Always ensure you follow these guidelines to keep your child safe and healthy.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

You can feel confident that there are no specific storage or handling instructions for this product or device. This means you can store it in a standard environment without worrying about special conditions.

For safety, always handle the product with clean hands and ensure that any surfaces you use are clean. If you have any questions about how to use or dispose of the product, please consult the accompanying materials or your healthcare provider for guidance.

Additional Information

No further information is available.

FAQ

What is the primary use of this medication?

This medication temporarily relieves cough due to cold and occasional minor irritation or sore throat.

How should adults and children over 5 years use this medication?

Adults and children 5 years and over should dissolve 1 drop slowly in the mouth and can repeat this every 2 hours as needed.

What should I do if my cough persists?

Stop use and ask a doctor if your cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.

Are there any contraindications for this medication?

No specific contraindications are mentioned for this medication.

What should I do if I have a severe sore throat?

Consult a doctor promptly if your sore throat is severe, persists for more than 2 days, or is accompanied by headache, rash, swelling, nausea, or vomiting.

Is this medication safe to use during pregnancy?

No specific information regarding the safety of this medication during pregnancy is provided, so consult a doctor.

Can nursing mothers use this medication?

Nursing mothers should consult a doctor before using this product, as there is a potential for excretion in breast milk.

What should I do if my sore mouth does not improve?

Stop use and ask a doctor if your sore mouth does not improve in 7 days.

Is there any information on drug interactions?

No drug interactions information is provided for this medication.

What is the packaging information for this medication?

The package contains 30 drops, and the NDC (National Drug Code) is 83324-265-30.

Packaging Info

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.

Packaging configurations for Quality Choice Menthol Cough Drops.
Details

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)

Description

No description information is available for the specified drug.

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

Adults and children aged 5 years and older should dissolve 1 drop slowly in the mouth. This process may be repeated every 2 hours as needed. For children under 5 years of age, it is advised to consult a physician before administration.

Contraindications

Use is contraindicated in patients who experience a cough that persists for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious underlying condition. Additionally, discontinue use and consult a healthcare professional if a sore mouth does not improve within 7 days. Patients should also seek medical advice if irritation, pain, or redness persists or worsens.

Warnings and Precautions

If a patient experiences a severe sore throat that 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, as these may indicate a serious underlying condition.

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 symptoms may suggest a serious health issue. Additionally, if a sore mouth does not show improvement within seven days, or if irritation, pain, or redness persists or worsens, medical consultation is advised.

While no specific emergency medical instructions are provided, healthcare professionals should remain vigilant for any signs of severe adverse reactions in their patients.

General precautions and laboratory tests relevant to the safe use of the medication have not been specified; however, healthcare providers should exercise clinical judgment and consider appropriate monitoring based on individual patient circumstances and the clinical context.

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

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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.

Packaging configurations for Quality Choice Menthol Cough Drops.
Details

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 specific information available regarding the use of this medication 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 using this medication.

Lactation

Lactating 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 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

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Monitoring of vital signs and laboratory parameters may be warranted to assess the patient's condition and guide further management.

Healthcare professionals should also consider consulting a poison control center or a medical toxicologist for additional guidance on the management of potential overdosage scenarios.

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, with specific NDC numbers assigned for identification. Storage and handling instructions are not explicitly provided; therefore, standard practices for pharmaceutical products should be followed. It is advisable to store the product in a controlled environment, ensuring that it is kept away from extreme temperatures and humidity. Proper container requirements should be adhered to, and any special handling needs should be assessed based on the product's characteristics and intended use.

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)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Quality Choice Menthol Cough Drops, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.