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Leader Cough Drops Vanilla Honey

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Active ingredient
Menthol, Unspecified Form 2.5 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 26, 2025
Active ingredient
Menthol, Unspecified Form 2.5 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 26, 2025
Manufacturer
Xiamen Kang Zhongyuan Biotechnology Co. , Ltd.
Registration number
M012
NDC root
83698-692

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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 minor irritation, pain, a sore mouth, or a sore throat. It is designed to provide temporary relief from these symptoms, making you feel more comfortable as you recover.

While the specific name of the drug isn't mentioned, its purpose is clear: to ease discomfort associated with common cold symptoms and throat irritation. If you're dealing with these issues, this medication could be a supportive option for you.

Uses

You can use this medication to temporarily relieve a cough caused by a cold. It also helps with occasional minor irritation, pain, and soreness in your mouth and throat. This means if you're feeling discomfort in these areas, this medication may provide some relief.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication. Always consult with a healthcare professional if you have any questions or concerns about using this product.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you should dissolve the lozenge slowly in your mouth. You can repeat this process every 2 hours as needed, or follow your doctor's instructions for use.

For children under 2 years of age, it’s important to consult a doctor before using this medication. Always ensure you follow the recommended guidelines for safe and effective use.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or risks of abuse or misuse associated with this medication. Additionally, there are no concerns regarding dependence (a condition where the body becomes reliant on a substance).

Since there are no "do not take" or "do not use" instructions provided, it suggests that this medication is generally safe for use as directed. However, always consult with your healthcare provider for personalized advice and to ensure it’s appropriate for your individual health needs.

Side Effects

If you experience a severe sore throat that lasts more than two days or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, it's important to consult a doctor right away. Additionally, if you have a chronic cough due to smoking, asthma, or emphysema, or if your cough comes with excessive mucus, you should speak with a healthcare professional before using this product.

While using this medication, be sure to follow the recommended dosage. If your cough lasts more than a week, keeps coming back, or is accompanied by fever, rash, or a persistent headache, stop using the product and consult a doctor, as these could be signs of a more serious condition. Also, if symptoms in your mouth do not improve within seven days, or if you experience ongoing irritation, pain, or redness, seek medical advice.

Warnings and Precautions

If you experience a severe sore throat that lasts more than two days or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, it’s important to consult a doctor right away. Additionally, if you have a chronic cough due to smoking, asthma, or emphysema, or if your cough comes with excessive mucus, please ask your doctor before using this product.

While using this medication, make sure not to exceed the recommended dosage. If your cough lasts more than a week, keeps coming back, or is accompanied by fever, rash, or a persistent headache, stop using the product and contact your doctor, as these could be signs of a more serious condition. Also, if symptoms in your mouth do not improve after seven days, or if you experience 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 always important to be aware of the signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital right away. Having the medication packaging or details about the dosage taken can be very helpful for medical professionals. Always remember, when in doubt, it’s better to err on the side of caution and get help.

Pregnancy Use

When considering the use of LEADER COUGH DROPS VANILLA HONEY (menthol lozenge) during pregnancy, it's important to note that there is no specific information available regarding its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this product on you and your developing baby are not well understood.

If you are pregnant or planning to become pregnant, it’s always best to consult with your healthcare provider before using any medication, including over-the-counter products like cough drops. They can help you weigh the potential risks and benefits based on your individual health needs.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk and your nursing infant are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding. They can help you weigh the potential risks and benefits to ensure the safety of both you and your baby.

Pediatric Use

If you have a child under 2 years old, it's important to consult with a doctor before using this medication. For children aged 2 years and older, you can give them the lozenge, but make sure they dissolve it slowly in their mouth. They can repeat this every 2 hours as needed or as directed by a healthcare professional.

Please be aware of a choking hazard for children under 4 years old due to small parts. Always ensure that your child is seated and supervised while they are eating to prevent any accidents.

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 there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you without any special considerations. However, always consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective based on your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

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

To ensure the best performance and safety of your product, store it at room temperature, away from excessive heat and direct sunlight. This helps maintain its effectiveness.

When handling the product, be sure to check the primary bag seal before use; do not use it if the seal is torn or broken, as this could compromise safety. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally. For adults and children aged 2 years and older, dissolve the lozenge slowly in your mouth and repeat every 2 hours as needed or as directed by your doctor. If the patient is under 2 years of age, consult a doctor for guidance.

FAQ

What is the primary use of this drug?

This drug temporarily relieves cough due to a cold, as well as occasional minor irritation, pain, sore mouth, and sore throat.

How should adults and children over 2 years use this product?

Adults and children 2 years and over should dissolve the lozenge slowly in the mouth and can repeat every 2 hours as needed or as directed by a doctor.

What should I do if my sore throat is severe?

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

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What should I do if my cough persists?

You should stop using the product 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.

Is this drug safe for children under 2 years?

You should ask a doctor before using this product for children under 2 years of age.

How should I store this drug?

Store the drug at room temperature, away from excessive heat or sunlight, and do not use if the primary bag seal has been torn or broken.

Are there any warnings I should be aware of?

Yes, do not exceed the recommended dosage, and consult a doctor if symptoms do not improve or worsen.

Packaging Info

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

Packaging configurations for Leader Cough Drops Vanilla Honey.
Details

Drug Information (PDF)

This file contains official product information for Leader Cough Drops Vanilla Honey, 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 due to a cold and for the alleviation of occasional minor irritation, pain, sore mouth, and sore throat.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended method of administration is to dissolve the 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 advised to consult a doctor before administration.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

Severe sore throat symptoms warrant immediate medical attention. If a sore throat is severe, 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.

Prior to using this product, individuals should seek medical advice if they have a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema. Additionally, those experiencing a cough accompanied by excessive phlegm (mucus) should also consult a doctor.

During the use of this product, it is crucial not to exceed the recommended dosage.

Users should discontinue use and consult a healthcare provider if any of the following occur: a cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or a persistent headache, as these may indicate a serious underlying condition. Furthermore, if symptoms of a sore mouth do not improve within seven days, or if irritation, pain, or redness persists or worsens, medical advice should be sought.

Side Effects

Patients using this product may experience a range of adverse reactions. 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. Additionally, patients should seek medical advice if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, or emphysema, or if it is accompanied by excessive phlegm.

Common adverse reactions may include sore throat symptoms that do not improve within 7 days. Patients are advised to discontinue use and consult a doctor if their cough persists 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. Furthermore, if symptoms of sore mouth, irritation, pain, or redness persist or worsen, medical advice should be sought.

It is crucial for patients to adhere to the recommended dosage and to be vigilant about any worsening symptoms during the course of treatment.

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 Leader Cough Drops Vanilla Honey (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Leader Cough Drops Vanilla Honey.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children aged 2 years and older, the recommended administration involves dissolving the lozenge slowly in the mouth, with the option to repeat every 2 hours as needed or as directed by a physician.

It is important to note a choking hazard associated with small parts for children under 4 years of age. Therefore, children should always be seated and supervised while consuming the lozenge to minimize the risk of choking.

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

Pregnancy

There is no specific information regarding the use of LEADER COUGH DROPS VANILLA HONEY (menthol lozenge) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when recommending this product to women of childbearing potential and consider the lack of data on potential fetal impacts. It is advisable to weigh the benefits against any potential risks when considering the use of this product in pregnant patients.

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.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established 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 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. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on clinical judgment.

For further guidance, healthcare professionals may refer to established protocols for managing drug overdosage or consult a poison control center.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication and all other drugs out of the reach of children. It is important to emphasize the potential risks associated with accidental ingestion by young children and to encourage patients to store medications in a secure location.

Storage and Handling

The product is supplied in a configuration that ensures optimal integrity and usability. It should be stored at room temperature, away from excessive heat and direct sunlight to maintain its efficacy. Healthcare professionals are advised to inspect the primary bag seal prior to use; the product should not be utilized if the seal has been torn or broken, as this may compromise the product's safety and effectiveness.

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 Leader Cough Drops Vanilla Honey, 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 Leader Cough Drops Vanilla Honey, 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.