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Menthol Cough Suppressant Oral Anesthetic Cough Drops

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Active ingredient
Menthol, Unspecified Form 5.4 mg
Other brand names
Dosage form
Lozenge
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
December 23, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Menthol, Unspecified Form 5.4 mg
Other brand names
Dosage form
Lozenge
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2024
Label revision date
December 23, 2024
Manufacturer
Xiamen Kang Zhongyuan Biotechnology Co. , Ltd.
Registration number
M012
NDC root
83698-110
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Cough drops are a type of medication designed to temporarily relieve coughs caused by colds, as well as soothe minor irritation, pain, sore mouth, and sore throat. They work by coating the throat and providing a soothing effect, which can help ease discomfort associated with these symptoms.

If you're experiencing a cough or throat irritation, using cough drops can be a simple and effective way to find relief. They are easy to use and can be a helpful addition to your self-care routine when you're feeling under the weather.

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 or your child is 2 years old or older, you can take the medication in the form of a lozenge. Simply let the lozenge dissolve 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 with a doctor before giving them this medication. Always ensure you follow the recommended guidelines for safe and effective use.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with it. This means that, based on the available information, there are no known reasons to avoid taking this medication. Always remember to follow your healthcare provider's guidance and reach out if you have any questions or concerns about your treatment.

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 from conditions like 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 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 consult a doctor, as these could be signs of a more serious issue. Also, if symptoms in your mouth do not improve within seven days, or if you notice 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's important to follow the recommended dosage when using this product. Taking more than the advised amount can lead to an overdose, which may cause serious health issues.

If you suspect an overdose, look for signs such as unusual drowsiness, confusion, or difficulty breathing (respiratory depression). If you notice any of these symptoms, seek immediate medical help or contact your local poison control center. Always prioritize your safety by adhering to the dosage guidelines provided.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific warnings or dosage changes related to the use of this product during pregnancy. The information available does not indicate whether the product is contraindicated (not recommended) for pregnant individuals or if there are any risks to your developing baby.

As always, it's best to consult with your healthcare provider before using any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If your child is under 2 years old, it's important to consult 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 follow your doctor's instructions.

Be aware that there is 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

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

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 the medication 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. They can provide guidance tailored to your specific needs.

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 need to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medication or health status with your healthcare provider to avoid any potential issues and to get the best care possible.

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. If the seal is torn or broken, do not use the product, as this could compromise its safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

For adults and children aged 2 years and older, you should dissolve the lozenge slowly in your mouth and can repeat this every 2 hours as needed or as directed by your doctor. If your child is under 2 years old, it's important to consult a doctor before use.

Currently, there is no additional information available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is the primary use of this product?

This product 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 child is under 2 years old?

If your child is under 2 years of age, you should ask a doctor before use.

Are there any warnings associated with sore throat?

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

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.

Are there any contraindications for this product?

No specific contraindications are listed for this product.

Is this product safe to use during pregnancy?

There are no specific warnings or contraindications regarding the use of this product during pregnancy mentioned.

Can nursing mothers use this product?

There are no specific warnings or recommendations regarding the use of this product in nursing mothers.

How should I store this product?

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

Is there a choking hazard associated with this product?

Yes, there is a choking hazard for small parts for children under 4, so children should always be seated and supervised while eating.

Packaging Info

Below are the non-prescription pack sizes of Menthol Cough Suppressant Oral Anesthetic Cough Drops (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Menthol Cough Suppressant Oral Anesthetic Cough Drops.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Cough drops are a pharmaceutical formulation designed to provide symptomatic relief from cough and throat irritation. They are typically presented in a lozenge form, allowing for easy administration and dissolution in the oral cavity. The active ingredients may include various soothing agents, while the specific composition can vary by manufacturer. Cough drops are often flavored to enhance palatability, and they may contain sweeteners and other excipients to aid in the formulation's stability and effectiveness.

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

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 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

Patients should be advised to seek medical attention if they experience a severe sore throat that persists for more than two days, particularly if it is accompanied by fever, headache, rash, swelling, nausea, or vomiting. These symptoms may indicate a more serious underlying condition that requires prompt evaluation.

Healthcare professionals should instruct patients to consult a physician prior to using this product if they have a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema. Additionally, patients with a cough that is accompanied by excessive phlegm (mucus) should also seek medical advice before use.

During the use of this product, it is imperative that patients adhere strictly to the recommended dosage. Exceeding the advised dosage may lead to adverse effects.

Patients must discontinue use and consult a healthcare provider if any of the following occur: a cough that persists for more than one week, a cough that tends to recur, or a cough accompanied by fever, rash, or persistent headache. Such symptoms may indicate a serious condition that warrants further investigation. Furthermore, if sore mouth symptoms do not show improvement within seven days, or if irritation, pain, or redness persists or worsens, patients should seek medical advice promptly.

Side Effects

Patients may experience a range of adverse reactions while using 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 provider. Additionally, patients should seek medical advice before using this 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.

Common adverse reactions may include sore throat symptoms that do not improve within 7 days, as well as irritation, pain, or redness that persists or worsens. Patients are advised to stop using the product and consult a doctor if their cough lasts longer than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious underlying condition. It is also important for patients to adhere to the recommended dosage to avoid potential complications.

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 Menthol Cough Suppressant Oral Anesthetic Cough Drops (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Menthol Cough Suppressant Oral Anesthetic Cough Drops.
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 that there is 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

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

Pregnancy

The available data does not indicate any specific warnings, precautions, or dosage modifications regarding the use of this product during pregnancy. Additionally, there is no information provided that contraindicates the use of this product in pregnant patients or suggests any risks to the fetus. Healthcare professionals should consider the absence of documented risks while evaluating the use of this product in women of childbearing potential. As with any medication, the benefits and risks should be carefully weighed in the context of individual patient circumstances.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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 the lack of specific guidance when treating patients with renal impairment.

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 overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of potential risks and benefits.

Overdosage

Exceeding the recommended dosage of this product may lead to serious health consequences. Healthcare professionals are advised to monitor patients closely for any signs of overdosage.

Symptoms of Overdosage

Potential symptoms associated with overdosage may vary depending on the specific product and individual patient factors. It is crucial for healthcare providers to be vigilant and assess patients for any unusual or severe reactions following an overdose.

Recommended Actions

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare professionals should initiate appropriate management procedures, which may include supportive care and symptomatic treatment. It is essential to consult relevant clinical guidelines and toxicology resources for specific interventions tailored to the product in question.

Conclusion

To mitigate the risk of overdosage, adherence to the recommended dosage is imperative. Continuous education and awareness among healthcare professionals regarding the potential risks associated with exceeding the prescribed limits are essential for patient safety.

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.

Patient Counseling

Healthcare providers should advise patients to keep this medication and all other drugs out of the reach of children. It is essential to emphasize the importance of proper storage to prevent accidental ingestion or misuse. Patients should be informed about the potential risks associated with leaving medications accessible to children and encouraged to take necessary precautions to ensure safety.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring that it is kept away from excessive heat and direct sunlight to maintain its integrity.

Additionally, healthcare professionals should inspect the primary bag seal prior to use; the product must not be utilized if the seal has been torn or broken, as this may compromise the safety and efficacy of the product. Proper handling and storage conditions are crucial for preserving the quality of the product.

Additional Clinical Information

For patients 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 healthcare professional. For children under 2 years of age, it is advised to consult a doctor before use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Menthol Cough Suppressant Oral Anesthetic 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 Menthol Cough Suppressant Oral Anesthetic 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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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.