Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Cough Drops

Last content change checked dailysee data sync status

Active ingredient
Menthol 5.8 mg
Other brand names
Dosage form
Pastille
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
October 7, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Menthol 5.8 mg
Other brand names
Dosage form
Pastille
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 2022
Label revision date
October 7, 2024
Manufacturer
Topco Associates LLC
Registration number
M012
NDC root
76162-014
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

This medication is designed to temporarily relieve cough that may occur with a cold, as well as occasional minor irritation and sore throat. It works by soothing your throat and reducing the urge to cough, helping you feel more comfortable during your illness. If you're experiencing these symptoms, this drug may provide the relief you need.

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 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 12 years and older, you should dissolve one drop of the medication slowly in your mouth. You can repeat this every two hours as needed, or follow your doctor's instructions for use.

It's important to note that this medication is not recommended for children under 12 years old, so please avoid using it for younger children. Always consult with a healthcare professional if you have any questions or concerns about the dosage or administration.

What to Avoid

If you experience sore mouth symptoms, it's important to monitor your condition closely. You should stop using the product and consult a doctor if your symptoms do not improve within 7 days, or if you notice any irritation, pain, or redness that persists or worsens. This guidance helps ensure your safety and well-being.

Side Effects

If you experience a severe or persistent sore throat along with a high fever, headache, nausea, or vomiting, it’s important to consult a doctor right away, as these symptoms may indicate a serious condition. You should not use this medication for more than two days or give it to children under 12 years of age.

Additionally, if your sore mouth symptoms do not improve within seven days, or if you notice any irritation, pain, or redness that persists or worsens, stop using the product and seek medical advice. Before using this medication, talk to your doctor if you have a severe sore throat that makes it hard to breathe or lasts longer than two days, or if your sore throat is accompanied by fever, headache, rash, swelling, nausea, or vomiting.

Warnings and Precautions

If you experience a severe or persistent sore throat along with a high fever, headache, nausea, or vomiting, it’s important to seek medical attention right away, as these symptoms could indicate a serious condition. You should not use this medication for more than 2 days, and it is not recommended for children under 12 years of age.

Additionally, if your sore mouth symptoms do not improve after 7 days, or if you notice any irritation, pain, or redness that gets worse, stop using the medication and contact your doctor for further advice. Your health and safety are important, so don’t hesitate to reach out for help if you have concerns.

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

It's important to know that this medication should not be given to children under 12 years of age. For those who are 12 years and older, you can use it by dissolving one drop slowly in the mouth. This can be repeated every two hours as needed or as directed by a doctor. Always consult with a healthcare professional if you have any questions or concerns about using this medication for your child.

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. If you or a loved one is an older adult, be sure 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 are essential to ensure safety and effectiveness.

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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool and dry place. This helps maintain its effectiveness and prevents any potential damage. When handling the product, be sure to do so with clean hands and in a sterile field (a clean area free from germs) to avoid contamination.

If you have any specific disposal instructions, please follow them carefully to ensure safe and responsible disposal. Keeping these guidelines in mind will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What does this drug temporarily relieve?

This drug temporarily relieves cough as may occur with a cold and occasional minor irritation and sore throat.

Who can use this drug?

Adults and children 12 years and over can use this drug. It is not recommended for children under 12 years of age.

How should I use this drug?

Dissolve 1 drop slowly in your mouth every 2 hours as needed or as directed by a doctor.

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

Stop use and consult a doctor if sore mouth symptoms do not improve in 7 days or if irritation, pains, or redness persists or worsens.

Are there any warnings associated with this drug?

Yes, if you have a severe or persistent sore throat accompanied by high fever, headache, nausea, or vomiting, consult a doctor promptly. Do not use for more than 2 days.

Is it safe to use this drug during pregnancy or breastfeeding?

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

Are there any contraindications for this drug?

No specific contraindications are mentioned in the provided text.

What should I do if I experience severe side effects?

Consult a doctor immediately if you experience severe side effects such as difficulty in breathing or if your sore throat lasts more than 2 days.

How should I store this drug?

Store the drug in a cool and dry place.

Packaging Info

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

Packaging configurations for Cough Drops.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product, identified by SPL code 34089-3, is a cherry-flavored cough drop formulated to provide symptomatic relief. Each cough drop contains 10 mg of menthol as the active ingredient. The formulation includes several inactive ingredients: sugar, glucose syrup, citric acid, natural and artificial flavors, color added, sodium citrate, gum arabic, menthol, and water.

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

Adults and children aged 12 years and older are instructed to dissolve 1 drop slowly in the mouth. This may be repeated every 2 hours as needed or as directed by a healthcare professional.

The product is not recommended for use in children under 12 years of age.

Contraindications

There are no specific contraindications identified for this product. However, it is advised to discontinue use and consult a healthcare professional if symptoms of a sore mouth do not improve within 7 days, or if irritation, pain, or redness persists or worsens.

Warnings and Precautions

Severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, and vomiting, may indicate a serious condition. In such cases, it is imperative to consult a healthcare professional promptly. This product should not be used for more than 2 days, and it is contraindicated for administration to children under 12 years of age.

Patients are advised to discontinue use and seek medical advice if symptoms of a sore mouth do not show improvement within 7 days. Additionally, if any irritation, pain, or redness persists or worsens, it is essential to stop taking the product and consult a healthcare provider. Monitoring for these symptoms is crucial to ensure patient safety and effective management of any underlying conditions.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, and vomiting. Such symptoms may indicate a serious condition, and patients are advised to consult a doctor promptly. It is important to note that the product should not be used for more than 2 days, and it is contraindicated for children under 12 years of age.

Common adverse reactions necessitate immediate cessation of use and consultation with a healthcare professional if sore mouth symptoms do not improve within 7 days, or if irritation, pain, or redness persists or worsens.

Patients should also seek medical advice before using this product if they have a severe sore throat that is accompanied by difficulty in breathing or lasts more than 2 days. Additionally, a sore throat accompanied by fever, headache, rash, swelling, nausea, or vomiting warrants consultation with a healthcare provider prior to use.

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

Packaging configurations for Cough Drops.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is to dissolve 1 drop slowly in the mouth, with the option to repeat every 2 hours as needed or as directed by a healthcare professional.

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, given the lack of targeted data for 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 safe use during pregnancy and lactation.

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 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 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 this patient population.

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 intervention 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. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where specific antidotes are available, their administration should be considered based on the clinical scenario.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the best possible outcomes for affected individuals.

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

Postmarketing experience has been gathered through voluntary reports and surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events or concerns regarding the product. For inquiries or to report an adverse event, individuals may contact the designated helpline at 1-800-423-0139.

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 a doctor if symptoms of a sore mouth do not improve within 7 days, or if they experience any irritation, pain, or redness that persists or worsens.

Additionally, healthcare providers should encourage patients to seek medical advice before using the medication if they have a severe throat condition that is accompanied by difficulty in breathing or lasts more than 2 days. Patients should also be advised to consult a doctor if they have a sore throat that is accompanied by fever, headache, rash, swelling, nausea, or vomiting.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product in a cool and dry place to maintain its integrity and efficacy. Proper storage conditions are crucial to ensure the product remains effective throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for 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 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.

Learn more in our Editorial Policy

Last AI update:

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.