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Sugar Free 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
January 19, 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
January 19, 2024
Manufacturer
Cardinal Health 110, Inc.
Registration number
M012
NDC root
70000-0641
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.

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 symptoms of a sore mouth, 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 taking 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 any concerns.

Overdose

If you suspect an accidental overdose, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1212 for guidance. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Don’t wait to see if symptoms improve; getting prompt assistance can be crucial. Always prioritize your health and safety by reaching out for help if you think an overdose has occurred.

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 who are 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.

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 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 information provided does not include any specific guidelines about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no established recommendations 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 health. They can help you understand how to manage your condition while considering any medications you may need.

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, tailored specifically to your 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 and monitor for any potential issues that may arise. Your health and safety are the top priority, so don't hesitate to ask questions or express concerns.

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. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of the product when it is no longer needed.

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 adults and children 12 years and over 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.

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 in the provided text.

What should I do if I experience severe side effects?

Consult a doctor immediately if you experience severe or persistent symptoms.

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

Packaging configurations for Sugar Free Cough Drops.
Details

Drug Information (PDF)

This file contains official product information for Sugar Free 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, contains menthol as the active ingredient. It is formulated for oral administration and includes the following inactive ingredients: acacia, corn syrup, dextrose, glycerin, natural and artificial flavors, propylene glycol, sodium benzoate, 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 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.

The use of this medication 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 administration to children under 12 years of age.

Healthcare professionals should advise patients to discontinue use and seek medical attention if symptoms of a sore mouth do not show improvement within 7 days. Additionally, if any irritation, pain, or redness persists or worsens during treatment, it is essential to stop taking the product and consult a doctor. Monitoring for these symptoms is crucial to ensure patient safety and effective management of potential complications.

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

Packaging configurations for Sugar Free 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 when administering this medication to ensure adherence to the specified age restrictions.

Geriatric Use

There is no specific information 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and maternal health. 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 no specific data available regarding the excretion of this medication in 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 renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for 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. Regular monitoring of liver function may be warranted in these patients, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1212 for guidance on managing the situation effectively.

Prompt intervention is crucial to mitigate potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may arise during the course of treatment.

Nonclinical Toxicology

No relevant information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no pertinent data concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Adverse events have been reported voluntarily and through surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events to the designated contact number, 1-833-552-1767. This information contributes to the ongoing monitoring of the product's safety profile.

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 any irritation, pain, or redness persists or worsens.

Additionally, healthcare providers should encourage patients to seek medical advice before using the medication if they experience 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 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 quality parameters.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Sugar Free 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 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.