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Sugar Free Honey Lemon Cough Drops

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Active ingredient
Menthol 7.6 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
November 30, 2024
Active ingredient
Menthol 7.6 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
November 30, 2024
Manufacturer
American Sales
Registration number
M012
NDC root
41520-045

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Drug Overview

CareOne SF Honey Lemon Cough Drops are designed to temporarily relieve coughs that may occur with a cold, as well as provide relief from occasional minor throat irritation and soreness. These soothing drops can help make you feel more comfortable when you're experiencing these common symptoms.

Uses

You can use this medication to temporarily relieve cough that may occur with a cold, as well as to ease occasional minor irritation and sore throat. It’s designed to help you feel more comfortable when you're experiencing these common symptoms.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

For adults and children aged 5 years and older, you should take 1 drop of the medication and let it dissolve slowly in your mouth. If needed, you can repeat this every 2 hours, but it's best to follow your doctor's advice on how often to take it.

If your child is under 5 years old, it's important to consult with a doctor before giving them this medication. Remember, the medication is taken orally, meaning it should dissolve in your mouth for it to work effectively.

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.

Side Effects

If you experience a sore throat that is severe, 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, as these symptoms could indicate a serious condition. Additionally, if your sore mouth symptoms do not improve within seven days, you should see a dentist or doctor.

You should also stop using the medication and seek medical advice if your cough persists for more than seven days, tends to come back, or is accompanied by fever, rash, or a persistent headache. If your sore throat is severe or if irritation, pain, or redness lasts or worsens, it’s advisable to contact a healthcare professional. If you have a chronic cough due to smoking, asthma, or emphysema, or if your cough comes with excessive mucus, consult 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 you have a sore mouth that doesn’t improve within seven days, please see your dentist or doctor, as these symptoms could indicate a more serious issue.

You should also stop taking this medication and call your doctor if your cough lasts more than seven days, keeps coming back, or is accompanied by fever, rash, or a persistent headache. Severe sore throat symptoms or worsening irritation, pain, or redness should also prompt you to seek medical advice. Remember, taking these precautions can help ensure your health and safety.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there are no specific signs or symptoms listed for an overdose, you should be aware of general warning signs such as extreme drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms or feel something is wrong, seek medical help right away.

In case of an overdose, contacting a healthcare professional or poison control center is crucial. They can provide guidance on what steps to take next. Always err on the side of caution—if you are unsure, it’s better to seek help immediately.

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 your child is 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 a healthcare professional. Always ensure you follow the guidance provided by your doctor 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 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 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 your medication is safe and effective for you.

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 keep your healthcare team informed about all the medications and supplements you use, as well as any lab tests you may undergo. This way, they can provide the best care tailored to you.

Storage and Handling

It appears that there is no specific storage or handling information available for the product or device you are inquiring about. 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 concerns or questions about how to use or store the product safely, please consult with your healthcare professional for personalized advice.

Additional Information

No further information is available.

FAQ

What is CareOne SF Honey Lemon Cough Drops used for?

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

How should I take CareOne SF Honey Lemon Cough Drops?

Adults and children 5 years and over should allow 1 drop to dissolve slowly in the mouth, which may be repeated 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.

Are there any warnings associated with 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 SF Honey Lemon Cough Drops during pregnancy or breastfeeding?

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

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

Stop use and ask a doctor if your sore throat is severe, or if irritation, pain, or redness lasts or worsens.

Packaging Info

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

Packaging configurations for Sugar Free Honey Lemon Cough Drops.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

CareOne SF Honey Lemon Cough Drops are formulated to provide symptomatic relief for coughs. Each drop is designed to deliver a soothing effect, featuring a honey lemon flavor profile. The product is available in a package containing 25 drops.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with a cold, as well as for the alleviation of occasional minor irritation and sore throat.

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

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 2 hours as necessary or as directed by a healthcare professional. For children under 5 years of age, it is recommended to consult a doctor prior to administration.

The route of administration is oral, with the method involving the slow dissolution of 1 drop in the mouth. The frequency of administration can be every 2 hours as needed, or as specifically directed by a healthcare provider.

Contraindications

There are no specific contraindications listed 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, tends to recur, 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

Patients should be advised to seek medical attention promptly 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 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 a cough persists for more than seven days, recurs, or is associated with fever, rash, or a persistent headache, as these may also be indicative of a serious health issue. Furthermore, any severe sore throat or worsening irritation, pain, or redness should prompt immediate medical consultation. It is crucial for patients to be aware of these warning signs to ensure timely intervention and management of potential complications.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions warrant immediate medical attention and include severe sore throat, particularly if it persists for more than two days or is accompanied by symptoms such as fever, headache, rash, swelling, nausea, or vomiting. In such cases, patients are advised to consult a doctor promptly, as these symptoms may indicate a serious condition.

Common adverse reactions include sore throat, irritation, pain, or redness that lasts or worsens. Patients should discontinue use and seek medical advice if these symptoms become severe or do not improve within seven days. Additionally, if a cough persists for more than seven days, tends to recur, or is accompanied by fever, rash, or persistent headache, patients should also consult a healthcare professional, as these may be signs of a serious underlying condition.

Patients with a history of persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should seek medical advice before using this medication. Furthermore, those experiencing a cough accompanied by excessive phlegm (mucus) are also advised to consult a doctor prior to use.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Sugar Free 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. 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 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Overall, vigilance and prompt intervention are critical in managing any suspected overdose scenario.

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

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. This reporting helps to enhance the understanding of the safety profile of the product.

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 be informed to seek medical advice if they experience a severe sore throat, or if irritation, pain, or redness lasts or worsens. They should also be counseled to contact a healthcare professional if a sore mouth does not show improvement within 7 days.

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

Storage and Handling

The product is supplied in various package configurations, although specific NDC numbers or packaging details were not provided. There are no specific storage or handling conditions outlined in the available information. Therefore, it is recommended that healthcare professionals refer to the product's official labeling for any additional details regarding supply and storage requirements.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Sugar Free 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 Sugar Free 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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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.