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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)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
October 2, 2025
Drug Information (PDF)
Prescribing information, PDF file
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
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2023
Label revision date
October 2, 2025
Manufacturer
Perrigo Direct Inc.
Registration number
M012
NDC root
50804-590
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 if you have occasional minor irritation and soreness in your throat. It is designed to provide temporary relief from these symptoms, helping you feel more comfortable as you recover.

Uses

If you're dealing with a cough that often comes with a cold, this medication can help provide temporary relief. It’s also effective for easing occasional minor throat irritation and soreness. You can use it to feel more comfortable while you recover from your cold symptoms.

Rest assured, this medication does not have any known teratogenic effects, meaning it does not cause developmental issues in a fetus.

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.

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. While there are no specific contraindications or concerns regarding abuse, misuse, or dependence, you should stop using the medication and consult your doctor if your sore mouth symptoms do not improve within 7 days. Additionally, if you experience any irritation, pain, or redness that persists or worsens, seek medical advice promptly. Your health and safety are paramount, so don't hesitate to reach out to a healthcare professional 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 medication and seek medical advice. Before using this product, 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 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.

If your sore mouth symptoms do not improve within 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, speak with your doctor if you have a severe sore throat that makes it hard to breathe or lasts longer than 2 days, or if your sore throat is accompanied by fever, headache, rash, swelling, nausea, or vomiting.

Overdose

If you suspect an accidental overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that require prompt attention.

Always err on the side of caution—if you notice anything concerning after taking medication, don’t hesitate to reach out for assistance. 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 be cautious when considering this medication for children. You should not use it in children under 12 years of age. For those 12 years and older, the recommended dosage is to dissolve 1 drop slowly in the mouth, which can be repeated every 2 hours as needed or as directed by a doctor.

Additionally, be aware that this medication should not be used for more than 2 days. Always consult with a healthcare professional if you have any questions or concerns about its use in 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 for personalized advice. 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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

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

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 detailed recommendations available for how your liver health might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and appropriate for your liver condition. They can help you understand how to manage your health effectively while considering your liver function.

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 share your complete list of medications and any health conditions you have to receive the best care possible.

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 this drug used for?

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

How should I use this drug?

Adults and children 12 years and over should dissolve 1 drop slowly in the mouth, repeating every 2 hours as needed or as directed by a doctor.

Can children use this drug?

No, do not use this drug in children under 12 years of age.

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 I should be aware of?

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

Is it safe to use this drug if I am pregnant or breastfeeding?

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

Packaging Info

Below are the non-prescription pack sizes of Cough Drops (sugar free honey lemon). 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

No description information is available for the specified 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

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.

Use is not recommended for 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 discontinue 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. 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 children under 12 years of age.

Patients are advised to discontinue use and seek medical attention 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 using this product, individuals should consult a healthcare provider if they experience a severe sore throat that is accompanied by difficulty breathing or lasts longer than 2 days. Additionally, a sore throat that occurs with fever, headache, rash, swelling, nausea, or vomiting warrants medical consultation prior to use.

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 medical consultation if symptoms do not improve within 7 days. Patients should stop use and seek medical advice if they experience sore mouth symptoms that persist or worsen, including irritation, pain, or redness.

Additionally, patients are advised to ask a doctor before using the product if they have a severe sore throat that is accompanied by difficulty in breathing or lasts more than 2 days. They should also consult a healthcare professional if their sore throat is accompanied by fever, headache, rash, swelling, nausea, or vomiting.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding 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 Cough Drops (sugar free honey lemon). 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 patients 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.

Caution is advised, as the medication should not be used for more than 2 days.

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 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

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there is no information available regarding dosage adjustments, special monitoring requirements, or precautions 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.

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

No postmarketing experience details are available in the provided 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 persistent or worsening irritation, pain, or redness.

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.