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Honey Lemon Cough Drops

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Active ingredient
Menthol 7.5 mg
Other brand names
Dosage form
Lozenge
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2016
Label revision date
December 7, 2025
Active ingredient
Menthol 7.5 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 2016
Label revision date
December 7, 2025
Manufacturer
American Sales
Registration number
M012
NDC root
41520-011

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Drug Overview

CareOne Honey Lemon Cough Drops are designed to temporarily relieve coughs that may occur with a cold, as well as soothe occasional minor throat irritation and soreness. These drops combine the soothing flavors of honey and lemon to help provide comfort when you're feeling under the weather.

Uses

You can use this medication to temporarily relieve a cough that often comes with a cold. It also helps ease occasional minor irritation and soreness in your throat. This can make you feel more comfortable while you recover from your cold symptoms. Rest assured, there are no known harmful effects on developing babies (teratogenic effects) associated with this medication.

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 2 hours if needed, or follow your doctor's instructions for use.

For children under 5 years old, it’s important to consult a doctor before giving them this medication. Always ensure you follow the recommended guidelines for safe and effective use.

What to Avoid

If you are using this medication, it's important to know when to stop and consult your doctor. You should discontinue use and seek medical advice if your cough lasts more than 7 days, comes back frequently, or is accompanied by fever, rash, or a persistent headache, as these may indicate a more serious issue. Additionally, if you experience a severe sore throat or if irritation, pain, or redness lasts or worsens, you should also stop using the medication and talk to your doctor. Lastly, if a sore mouth does not improve within 7 days, please reach out to your healthcare provider. Your health and safety are paramount, so don’t hesitate to seek help 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 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 using the medication and seek medical advice if your cough persists for more than seven days, recurs frequently, or is accompanied by fever, rash, or a persistent headache. If you have a chronic cough due to conditions like smoking, asthma, or emphysema, or if your cough comes with excessive mucus, it’s advisable to talk to your doctor before using this medication.

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 symptoms in your mouth do not improve within seven days, you should see your dentist or doctor, as these could indicate a more serious issue.

You should also stop using the medication and contact your doctor if your cough persists for more than seven days, tends to come back, or is accompanied by fever, rash, or a persistent headache. Severe sore throat symptoms or worsening irritation, pain, or redness should also prompt a call to your healthcare provider. Taking these precautions can help ensure your health and safety.

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 an overdose, it’s crucial to seek immediate medical help.

In case of an emergency, call your local emergency number 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 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 and any medications you may consider.

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 1 drop to let dissolve slowly in their mouth. This can be repeated every 2 hours if needed, or as directed by your doctor. Always follow your healthcare provider's advice to ensure the safety and effectiveness of the treatment for your child.

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 considering this medication, it’s important to consult with a healthcare provider. 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 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 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 monitor your liver function and determine the best approach for your treatment.

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 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 avoid any potential issues and ensure the best possible care.

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 any special requirements.

For safety, always handle the product with clean hands and ensure that any surfaces you use are clean. If you have any questions about proper use or safety, don’t hesitate to reach out for more information.

Additional Information

No further information is available.

FAQ

What is CareOne Honey Lemon Cough Drops used for?

CareOne Honey Lemon Cough Drops temporarily relieve cough associated with a cold, as well as occasional minor irritation and sore throat.

How should I use CareOne Honey Lemon Cough Drops?

For adults and children 5 years and over, allow 1 drop to dissolve slowly in your mouth, and you may repeat this every 2 hours as necessary or as directed by a doctor.

What should I do if my cough persists?

Stop use and ask a doctor if your cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache, as these could indicate a serious condition.

Are there any warnings for sore throat?

Yes, 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.

Can children under 5 years use these cough drops?

Children under 5 years should ask a doctor before use.

Is it safe to use CareOne Honey Lemon Cough Drops if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using CareOne Honey Lemon Cough Drops.

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

If your sore throat is severe or does not improve in 7 days, you should see your dentist or doctor promptly.

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

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with a cold. Additionally, it provides temporary relief from occasional minor irritation and 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 allow 1 drop to dissolve slowly in the mouth. This dosage may be repeated every 2 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 administration.

Contraindications

There are no specific contraindications identified for this product. However, healthcare professionals should advise patients to discontinue use and consult a physician under the following circumstances:

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

  • If sore throat is severe, or if irritation, pain, or redness lasts or worsens.

  • If sore mouth does not improve within 7 days.

Warnings and Precautions

Severe sore throat symptoms warrant immediate medical attention. Healthcare professionals should advise patients to consult a doctor promptly if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting. Additionally, if symptoms related to a sore mouth do not show improvement within seven days, patients should be referred to a dentist or physician, as these symptoms may indicate a serious underlying condition.

Patients should be instructed to discontinue use and seek medical advice if the following conditions arise: 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 suggest the presence of a serious health issue. Furthermore, if a sore throat is severe or if irritation, pain, or redness lasts or worsens, patients should be advised to stop use and consult a healthcare provider. Lastly, if sore mouth symptoms do not improve within seven days, it is essential for patients to seek medical evaluation.

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 fever, headache, rash, swelling, nausea, or vomiting, necessitates prompt consultation with a healthcare provider. Additionally, if symptoms of a sore mouth do not improve within 7 days, patients are advised to seek medical attention from a dentist or doctor, as these symptoms may indicate a serious condition.

Common adverse reactions warranting attention include a persistent cough that lasts more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may also suggest the presence of a serious underlying condition. Patients should discontinue use and consult a healthcare professional if they experience severe sore throat, or if irritation, pain, or redness persists or worsens.

Before using this medication, patients should consult a doctor 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).

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known 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 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 under 5 years of age should consult a healthcare professional before use. For children aged 5 years and older, the recommended dosage is 1 drop to be allowed to dissolve slowly in the mouth. This dosage may be repeated every 2 hours as necessary or as directed by a healthcare provider.

Geriatric Use

There is no specific information available 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.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug 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 absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, remain observant for potential overdose symptoms, and implement appropriate management strategies in the event of an overdose.

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

Adverse events have been reported voluntarily and through surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events by calling 1-800-245-2898, available Monday through Friday from 9 AM to 4 PM EST.

Patient Counseling

Healthcare providers should advise patients to keep the 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 7 days, tends to recur, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious condition. Additionally, patients should seek medical advice if they experience a severe sore throat or if irritation, pain, or redness lasts or worsens. It is also important to inform patients that if their sore mouth does not improve within 7 days, they should contact their healthcare provider.

Before using the medication, patients should be encouraged to ask a doctor 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). This information is crucial for ensuring safe and effective use of the medication.

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 at appropriate temperature ranges to maintain its integrity. Containers should be kept sealed and protected from light and moisture to prevent degradation. Special handling requirements are not specified, but general precautions should be taken to ensure the product's quality and safety during storage and transportation.

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.