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Freegells Cough Drops Menthol 80ct

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Active ingredient
Menthol 5.4 mg
Other brand names
Dosage form
Lozenge
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
December 20, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Menthol 5.4 mg
Other brand names
Dosage form
Lozenge
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
December 20, 2024
Manufacturer
R. L. ALBERT & SON, INC
Registration number
M012
NDC root
83002-004
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 that this medication is designed to temporarily relieve coughs that can occur with a cold, as well as to soothe occasional minor throat irritation and soreness. It works by addressing the symptoms associated with these conditions, helping you feel more comfortable during your recovery. If you're experiencing a cough or throat discomfort, this medication could 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.

Dosage and Administration

If you are an adult or a child aged 5 years and older, you should dissolve one lozenge slowly in your mouth. You can repeat this every two hours as needed, or follow your doctor's instructions for use.

For children under 5 years old, it's important to consult a doctor before giving them this medication. Always make sure to follow the guidance provided by your healthcare professional to ensure safe and effective use.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no known reasons that would prevent you from using it safely. Always consult with your healthcare provider if you have any concerns or questions about your treatment.

Side Effects

You may experience some side effects while using this medication. If you have a sore throat that is severe, lasts more than two days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, it’s important to consult a doctor right away, as these could indicate a serious issue. Additionally, if your sore mouth symptoms do not improve within seven days, you should see a dentist or doctor.

Before using this medication, talk to your doctor if you have a persistent cough due to smoking, asthma, or emphysema, or if your cough comes with excessive mucus. You should also stop using the medication and seek medical advice if your cough lasts more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache. If your sore throat is severe or if irritation, pain, or redness worsens, contact your doctor.

Warnings and Precautions

If you experience a severe sore throat that lasts more than two days or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, it’s important to consult a doctor right away. Additionally, if symptoms in your mouth do not improve within seven days, please see your dentist or doctor, as these could indicate a more serious issue.

Before using this medication, talk to your doctor if you have a persistent cough due to smoking, asthma, or emphysema, or if your cough comes with excessive mucus. You should stop using the medication and contact your doctor if your cough lasts more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache. Also, seek medical advice if your sore throat is severe or if irritation, pain, or redness lasts or worsens.

If you are pregnant or breastfeeding, please consult a healthcare professional before using this medication.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

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 keep this medication out of reach of children to ensure their safety. For children aged 5 years and older, you can give them one lozenge to dissolve slowly in their mouth every two hours as needed, or as directed by a doctor. However, if your child is under 5 years old, you should consult a doctor before giving them this medication. Always follow the guidance of a healthcare professional to ensure the best care 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, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you, but it's always best to consult with your healthcare provider for personalized advice. They can help ensure that any treatment you receive is safe and effective based on your kidney health.

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 for the medication do not change based on liver function. However, it’s always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can help ensure that your treatment is safe and effective for you.

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 the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medication or health status with your healthcare provider to avoid any potential issues and to get the best care possible.

Storage and Handling

To ensure the best use of your product, store it at room temperature. This helps maintain its effectiveness and safety. Before using, always check the packaging; do not use the product if the bag is torn or open, as this could compromise its integrity and safety. Following these simple guidelines will help you handle the product safely and effectively.

Additional Information

You should take this medication orally. For adults and children aged 5 years and older, dissolve one lozenge slowly in your mouth and repeat every two hours as needed or as directed by your doctor. If the patient is under 5 years old, consult a doctor for guidance on use.

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.

How should adults and children over 5 years use this drug?

Adults and children 5 years and over should dissolve 1 lozenge slowly in the mouth and can repeat every 2 hours as needed or as directed by a doctor.

What should children under 5 years do?

Children under 5 years should ask a doctor before use.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What should I do if my sore throat is severe?

If your sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, consult a doctor promptly.

What should I do if my cough persists?

You should stop use and ask a doctor if your cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache.

Is this drug safe to use during pregnancy or breastfeeding?

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

How should this drug be stored?

Store this drug at room temperature and do not use if the bag is torn or open.

Packaging Info

Below are the non-prescription pack sizes of Freegells Cough Drops Menthol 80ct (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Freegells Cough Drops Menthol 80ct.
Details

Drug Information (PDF)

This file contains official product information for Freegells Cough Drops Menthol 80ct, 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 or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 5 years and older are instructed to dissolve one lozenge slowly in the mouth. This process may be repeated every 2 hours as needed or as directed by a healthcare professional.

For children under 5 years of age, it is recommended to consult a doctor before administration.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

Severe sore throat symptoms warrant immediate medical attention. If a patient experiences a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, they should consult a healthcare provider promptly. Additionally, if symptoms of a sore mouth do not improve within seven days, it is advisable for the patient to seek evaluation from a dentist or physician, as these symptoms may indicate a serious underlying condition.

Healthcare professionals should advise patients to consult a doctor prior to use if they have a persistent or chronic cough, particularly those associated with smoking, asthma, or emphysema. Furthermore, patients with a cough that is accompanied by excessive phlegm (mucus) should also seek medical advice before initiating treatment.

Patients are instructed to discontinue use and consult a healthcare provider if the cough persists for more than seven days, tends to recur, or is accompanied by fever, rash, or a persistent headache, as these may be indicative of a serious health issue. In cases where the sore throat is severe, or if irritation, pain, or redness lasts or worsens, medical consultation is also recommended. If symptoms of a sore mouth do not show improvement within seven days, patients should seek professional advice.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional before using this product to ensure safety for both the mother and child.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions include severe sore throat, which, if it persists for more than 2 days or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, necessitates prompt consultation with a healthcare provider. Additionally, if symptoms of a sore mouth do not improve within 7 days, patients are advised to seek medical attention from a dentist or doctor, as these symptoms may indicate a serious condition.

Common adverse reactions warranting caution include persistent or chronic cough, particularly in patients with underlying conditions such as smoking, asthma, or emphysema. Patients should also consult a healthcare professional before use if they experience a cough accompanied by excessive phlegm (mucus).

Patients are advised to discontinue use and seek medical advice if their cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or a persistent headache, as these may be signs of a serious condition. Furthermore, if sore throat symptoms are severe or if irritation, pain, or redness lasts or worsens, medical consultation is recommended.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Freegells Cough Drops Menthol 80ct (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Freegells Cough Drops Menthol 80ct.
Details

Pediatric Use

Pediatric patients should be kept out of reach of children. For those aged 5 years and older, the recommended dosage is to dissolve 1 lozenge slowly in the mouth every 2 hours as needed or as directed by a healthcare professional. For children under 5 years of age, it is advised to consult a doctor before use.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 medication 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 information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 caution and consider the lack of data when prescribing this medication to patients with liver problems.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for appropriate treatment and follow-up care.

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 insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young individuals.

Storage and Handling

The product is supplied in a secure packaging format. It is essential to store the product at room temperature to maintain its integrity and effectiveness. Healthcare professionals should ensure that the packaging remains intact; the product must not be used if the bag is torn or open, as this could compromise its safety and efficacy.

Additional Clinical Information

The medication is administered orally. For adults and children aged 5 years and older, the recommended dosage is to dissolve one lozenge slowly in the mouth, with the option to repeat every two hours as needed or as directed by a healthcare professional. For children under 5 years of age, it is advised to consult a doctor before administration.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Freegells Cough Drops Menthol 80ct, 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 Freegells Cough Drops Menthol 80ct, 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.