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Cough Drops

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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 2023
Label revision date
October 8, 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 2023
Label revision date
October 8, 2024
Manufacturer
United Natural Foods, Inc.
Registration number
M012
NDC root
83455-205
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 may occur with a cold. It also helps ease occasional minor irritation and soreness in your throat. This can be particularly helpful when you're feeling under the weather and need some comfort.

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 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

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 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 may 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 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, 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’re unsure whether an overdose has occurred, 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 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, it’s always wise to discuss any medications with a healthcare provider, especially considering factors like kidney function and changes in cognition (thinking and memory) that can occur with age.

Make sure to inform your doctor about any other medications being taken, as well as any health conditions, to ensure the safest and most effective treatment plan. Always prioritize open communication with your healthcare team to address any concerns or questions you may have.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective, especially if you have any concerns about your kidney health. They can provide the necessary guidance based on your individual situation.

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 ensure that any medications you take are safe for you. Regular liver function tests (which check how well your liver is working) may be necessary to keep track of your health. Always communicate openly with your doctor about your liver condition and any concerns you may have.

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 way, you can work together to ensure your treatment is safe and effective.

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 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 should not be used in children under 12 years of age.

How should adults and children 12 years and over 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, pains, or redness persists or worsens.

Are there any warnings associated with this drug?

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

What should I do if I am pregnant 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.

Are there any known drug interactions?

No specific drug interactions are mentioned in the provided text.

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 is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

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 effects associated with this drug. Furthermore, no nonteratogenic effects have been reported.

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

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 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 in 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 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, those experiencing a sore throat with fever, headache, rash, swelling, nausea, or vomiting should consult a doctor 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, which may be repeated every 2 hours as needed or as directed by a healthcare professional.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. 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 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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

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 action is crucial to mitigate potential adverse effects associated with overdosage.

Healthcare professionals should be aware that 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. Healthcare providers should monitor the patient closely for any signs of toxicity and initiate interventions as necessary. This may include administering activated charcoal if the patient presents within a suitable timeframe and is alert, or other specific antidotes as indicated by the substance involved.

In summary, immediate medical intervention is critical in cases of overdose, and healthcare professionals should be prepared to provide comprehensive care based on the clinical presentation and the substance involved.

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

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 experience a sore throat along with 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 the recommended 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.