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Cough Drops

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Active ingredient
Menthol 7.5 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 2023
Label revision date
February 9, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Menthol 7.5 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 2023
Label revision date
February 9, 2025
Manufacturer
The Kroger CO
Registration number
M012
NDC root
59450-716
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

You may find this medication helpful if you're experiencing a cough due to a cold or minor throat irritation. It is designed to temporarily relieve these symptoms, providing you with some comfort during your recovery. While the specific name of the drug isn't mentioned, its purpose is clear: to ease the discomfort associated with coughing and sore throat.

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 dealing with 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

If you are an adult or a child aged 12 years and older, you can take this medication by dissolving one drop slowly in your mouth. You may repeat this every two hours as needed, or follow your doctor's instructions for use.

However, if you are caring for a child under 12 years old, it’s important to note that this medication is not recommended for them. Always consult with a healthcare professional if you have any questions or concerns about using this medication.

What to Avoid

It's important to be aware of certain guidelines when using this medication. If you notice that symptoms related to a sore mouth do not improve within 7 days, or if you experience any irritation, pain, or redness that persists or worsens, you should stop using the product and consult your doctor.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always prioritize your health and seek professional advice if you have any concerns.

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 consult a doctor right away, as these symptoms may indicate a serious condition. You should not use this medication for more than 2 days or give it to children under 12 years of age.

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 call your doctor. Additionally, before using this product, check with your doctor if you have a severe sore throat that lasts more than 2 days or is accompanied by difficulty breathing, fever, headache, rash, swelling, nausea, or vomiting.

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 hesitate to get help right away. Your health and safety are the top priority.

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 help them take the medication by having them dissolve one drop slowly in their 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

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, it’s important to consult with a healthcare provider before starting the medication. 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 and what steps to take for your safety.

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. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

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 follow any specific instructions provided to avoid contamination or mishandling. Proper storage and careful handling are key to ensuring that the product remains safe and effective for your use.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

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. Children under 12 years should not use it.

How should I take 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, pain, 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.

Is this drug safe to use 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 for this drug.

What should I do if I experience severe throat symptoms?

Consult a doctor if you have a severe throat accompanied by difficulty in breathing or that 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 combination formulation featuring honey and lemon flavor. It contains active ingredients specifically designed to provide relief for cough and sore throat symptoms. Additionally, the formulation incorporates various inactive ingredients that enhance the overall characteristics of the product.

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 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

Use is contraindicated in patients who experience sore mouth symptoms that do not improve within 7 days, or if irritation, pain, or redness persists or worsens. In such cases, it is advised to stop use and consult a healthcare professional.

Warnings and Precautions

Severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, and vomiting, may indicate a serious condition. Healthcare professionals should advise patients to consult a doctor promptly in such cases. It is crucial to limit the use of this medication to no more than 2 days and to avoid administering it to children under 12 years of age.

Patients should be instructed to discontinue use and seek medical advice if symptoms of a sore mouth do not improve within 7 days, or if there is a persistence or worsening of irritation, pain, or redness.

Before recommending this medication, healthcare providers should inquire about the presence of any of the following conditions: a severe sore throat that is accompanied by difficulty in breathing or lasts longer than 2 days; or a sore throat associated with fever, headache, rash, swelling, nausea, or vomiting. These symptoms may necessitate further evaluation and intervention.

Emergency medical assistance should be sought if any severe reactions occur, although specific instructions for such situations are not provided in the current guidelines.

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 more 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 prior to use if they have a severe sore throat that is accompanied by difficulty in breathing or lasts longer than 2 days. Additionally, a sore throat accompanied by fever, headache, rash, swelling, nausea, or vomiting warrants consultation with a healthcare provider before use.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 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, which may be repeated 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.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient 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 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular monitoring of renal function may be warranted in patients with reduced kidney function 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 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 information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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 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 effectiveness. Proper storage conditions are crucial to ensure the product remains within its specified temperature range and is protected from moisture.

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.