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Honey Lemon Cough Drops

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Active ingredient
Menthol 7.6 mg
Other brand names
Dosage form
Pastille
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2019
Label revision date
October 7, 2024
Active ingredient
Menthol 7.6 mg
Other brand names
Dosage form
Pastille
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2019
Label revision date
October 7, 2024
Manufacturer
Boston Nutraceutical Production SL
Registration number
M012
NDC root
72628-109

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Drug Overview

You may find this medication helpful if you're experiencing a cough due to a cold or inhaled irritants, as it is designed to temporarily relieve such symptoms. It can also provide relief for occasional minor irritations and sore throat, making it a supportive option for managing discomfort associated with these conditions.

Uses

You can use this medication to temporarily relieve coughs that may occur due to a cold or from inhaling irritants. It also helps ease occasional minor throat irritations and soreness. This means if you're feeling uncomfortable from a cough or a scratchy throat, this medication can provide some relief.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it is considered safe in that regard.

Dosage and Administration

If you are an adult or a child aged 5 years and older, you should take 1 drop of the medication and let it dissolve slowly in your mouth. You can repeat this every two hours if needed, or follow your doctor's instructions for use.

For children under 5 years old, 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

It's important to be aware of certain situations where you should stop using this medication and consult your doctor. If your cough lasts more than 7 days, keeps coming back, or is accompanied by fever, rash, or a persistent headache, these could be signs of a more serious condition that needs attention. Additionally, if you experience a severe sore throat or if irritation, pain, or redness lasts or worsens, you should seek medical advice. Lastly, if a sore mouth does not improve within 7 days, it's best to talk to your healthcare provider. Your health and safety are paramount, so don’t hesitate to reach out if you have any concerns.

Side Effects

If you experience a sore throat that is severe, lasts more than two days, or is accompanied by symptoms like fever, headache, rash, swelling, nausea, or vomiting, it’s important to consult a doctor promptly, as these could indicate a serious condition. Additionally, if you have a sore mouth that does not improve within seven days, you should see your dentist or doctor.

You should also stop using the medication and seek medical advice if your cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may signal a more serious issue that needs attention.

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 sore mouth that doesn’t improve within seven days, you should see your dentist or doctor, as these symptoms could indicate a more serious issue.

You should also stop taking the medication and call your doctor if your cough persists for more than seven days, comes back frequently, or is accompanied by fever, rash, or a persistent headache. These could be signs of a serious condition. If you notice that your sore throat is severe or if irritation, pain, or redness lasts or worsens, seek medical advice promptly.

Overdose

If you suspect an accidental overdose, it’s important to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you.

Always err on the side of caution—if you think you or someone else may have taken too much of a medication, don’t wait for symptoms to appear. Getting prompt assistance can be crucial for safety and effective treatment.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If you are considering this medication for your child, it's important to know the appropriate usage guidelines. For children aged 5 years and older, you can give them 1 drop to dissolve slowly in their mouth, and this can be repeated every two hours if needed or as directed by a doctor.

However, if your child is under 5 years old, you should consult a doctor before administering this medication. Always prioritize your child's safety and follow professional advice regarding their health.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. As you age, your body may process medications differently, and factors like kidney function (renal impairment) and changes in cognition can affect how well a drug works or how safe it is for you.

If you or a loved one is considering this medication, it’s wise to discuss it with a healthcare provider. They can help determine if any special precautions or adjustments are needed based on individual health conditions and overall well-being. 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 or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help you understand any potential risks and monitor your condition effectively.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always feel free to ask questions and share any concerns you may have regarding your medications or tests. Your healthcare provider is there to help you understand how to manage your health safely.

Storage and Handling

It appears that there is no specific storage or handling information available for the product or device. This means you may not need to worry about particular temperature ranges or special handling instructions. However, it's always a good practice to keep any medical product in a clean, dry place and to follow any general safety guidelines provided by your healthcare provider or the product's packaging.

If you have any questions or concerns about how to use or store the product safely, don't hesitate to reach out to your healthcare professional for guidance.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

This drug temporarily relieves cough that may occur with cold or inhaled irritants, as well as occasional minor irritations and sore throat.

What should I do if my cough persists?

Stop use and consult a doctor if your cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache.

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

Adults and children 5 years and over should allow 1 drop to dissolve slowly in the mouth, which may be repeated every two hours as necessary or as directed by a doctor.

Is this drug safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before use.

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 fever, headache, rash, swelling, nausea, or vomiting.

Are there any contraindications for this drug?

No specific contraindications are mentioned for this drug.

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

If your sore mouth symptoms do not improve in 7 days, you should see your dentist or doctor promptly.

Can children under 5 years use this drug?

For children under 5 years, you should ask a doctor before use.

Packaging Info

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

Packaging configurations for Honey Lemon Cough Drops.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with colds or inhaled irritants. Additionally, it provides temporary relief from occasional minor irritations and sore throat.

There are no teratogenic effects associated with this drug, nor are there any nonteratogenic effects mentioned.

Dosage and Administration

Adults and children aged 5 years and older are instructed to allow 1 drop to dissolve slowly in the mouth. This dosage may be repeated every two hours as necessary or as directed by a healthcare professional.

For children under 5 years of age, it is recommended to consult a doctor before administration.

Contraindications

There are no specific contraindications identified for this product. However, it is advised to discontinue use and consult a healthcare professional if any of the following conditions occur:

  • Cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious underlying condition.

  • Severe sore throat, or if irritation, pain, or redness lasts or worsens.

  • Sore mouth does not improve within 7 days.

Warnings and Precautions

Patients should be advised to seek medical attention promptly if they experience a severe sore throat that persists for more than two days, especially if accompanied by fever, headache, rash, swelling, nausea, or vomiting. These symptoms may indicate a serious underlying condition. Additionally, if symptoms of a sore mouth do not show improvement within seven days, it is recommended that patients consult their dentist or healthcare provider.

Healthcare professionals should instruct patients to discontinue use and contact their doctor if any of the following occur: a cough that persists for more than seven days, a cough that tends to recur, or a cough accompanied by fever, rash, or a persistent headache. These symptoms may signify a serious health issue. Furthermore, patients should be advised to seek medical advice if they experience severe sore throat symptoms or if irritation, pain, or redness lasts or worsens. It is crucial to monitor these symptoms closely to ensure timely intervention and management.

Side Effects

Patients may experience a range of adverse reactions, which can vary in seriousness and frequency.

Severe adverse reactions warrant immediate medical attention. Patients should consult a doctor promptly if they experience a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting. Additionally, if symptoms of a sore mouth do not improve within 7 days, it is advised that patients see their dentist or doctor, as these symptoms may indicate a serious condition.

Common adverse reactions include persistent cough, sore throat, and sore mouth. Patients are advised to stop use and consult a doctor if a cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or a persistent headache, as these could be signs of a serious underlying condition. Furthermore, if sore throat symptoms are severe or if irritation, pain, or redness lasts or worsens, medical consultation is recommended.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Packaging configurations for Honey Lemon Cough Drops.
Details

Pediatric Use

Pediatric patients aged 5 years and older may use the medication by allowing 1 drop to dissolve slowly in the mouth, with the option to repeat every two hours as necessary or as directed by a healthcare professional. For children under 5 years of age, it is advised to consult a doctor before use.

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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt action is crucial to mitigate potential adverse effects associated with overdosage.

Healthcare professionals should be aware that the symptoms of overdose may vary depending on the specific substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should monitor the patient closely for any signs of toxicity and initiate interventions as necessary. This may include administering activated charcoal if the patient presents within a suitable timeframe and is alert, as well as providing intravenous fluids and other supportive measures as indicated.

It is vital for healthcare professionals to remain vigilant and prepared to implement emergency protocols in the case of an overdose, ensuring the safety and well-being of the patient.

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 text.

Patient Counseling

Healthcare providers should advise patients to keep this medication and all other drugs out of the reach of children to prevent accidental ingestion.

Patients should be instructed to stop using the medication and consult their doctor if they experience any of the following: a cough that persists for more than 7 days, a cough that tends to recur, or a cough accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious condition. Additionally, patients should seek medical advice if they have a severe sore throat, or if irritation, pain, or redness lasts or worsens. If a sore mouth does not improve within 7 days, patients should also consult their healthcare provider.

It is important for patients to ask their doctor before using this medication if they have a persistent or chronic cough, such as that which occurs with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. Currently, there are no specified storage or handling conditions provided. It is recommended that healthcare professionals refer to the product's labeling for any additional information regarding supply and storage requirements.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Honey Lemon 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 Honey Lemon 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.