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Halls

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Active ingredient
Menthol 5.8 mg
Other brand names
Dosage form
Lozenge
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2019
Label revision date
June 16, 2025
Active ingredient
Menthol 5.8 mg
Other brand names
Dosage form
Lozenge
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2019
Label revision date
June 16, 2025
Manufacturer
Mondelez Global LLC
Registration number
M012
NDC root
12546-109

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Drug Overview

Halls is a product designed to temporarily relieve cough caused by a cold and to soothe occasional minor irritation or soreness in the throat. It is commonly used when you are experiencing discomfort from these symptoms, providing a soothing effect to help you feel more comfortable.

Uses

If you're dealing with a cold, this medication can help by temporarily relieving your cough. It also provides relief for occasional minor irritation or soreness in your throat, making it easier for you to feel comfortable while you recover.

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 5 years and older, you should dissolve one drop of the medication slowly in your mouth. You can repeat this every two hours if you need to.

For children under 5 years old, it’s important to consult a doctor before using this medication. Always follow their guidance to ensure safety and effectiveness.

What to Avoid

If you are using this medication, it's important to know when to stop and seek medical advice. You should stop using it and consult a doctor if your cough lasts more than a week, comes back frequently, or is accompanied by symptoms like fever, rash, or a persistent headache, as these could indicate a more serious issue. Additionally, if your sore mouth does not improve within 7 days, or if you experience ongoing irritation, pain, or redness, you should also reach out to your healthcare provider.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, always prioritize your health and safety by following these guidelines.

Side Effects

If you experience a sore throat that is severe, lasts more than two days, or is accompanied by fever, headache, rash, swelling, or vomiting, it’s important to consult a doctor right away, as these could indicate a serious issue. Additionally, if your cough persists for more than a week, keeps coming back, or is accompanied by fever, rash, or a persistent headache, seek medical advice, as these symptoms may also signal a serious condition.

You should stop using the medication and contact a doctor if your sore mouth does not improve within seven days, or if you notice any irritation, pain, or redness that persists or worsens. It's advisable to ask a doctor before using this medication if you have a chronic cough related to smoking, asthma, or emphysema, or if your cough comes with excessive mucus.

Warnings and Precautions

If you experience a severe sore throat that lasts more than two days or is accompanied by fever, headache, rash, swelling, or vomiting, it’s important to consult a doctor right away, as these could be signs of a serious issue.

You should also stop using the medication and contact your doctor if your cough lasts more than a week, keeps coming back, or is accompanied by fever, rash, or a persistent headache. Additionally, if a sore mouth does not improve within seven days, or if you notice ongoing irritation, pain, or redness that worsens, seek medical advice.

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 extreme 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

When it comes to using this medication during pregnancy, there is no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before starting or continuing this medication. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

If you have a child under 5 years old, it's important to consult with a doctor before using this medication. For children aged 5 years and older, you can give them one drop to dissolve slowly in their mouth, repeating this every two hours as needed. Always ensure you follow these guidelines to keep your child safe and healthy.

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 issues, 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 problems).

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall health.

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 or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and any tests you may be undergoing.

Storage and Handling

To ensure the best performance of your product, store it at room temperature in a cool, dry place. It's important to protect it from excessive heat and moisture, as these can affect its quality. Always keep the product out of reach of children to prevent any accidental use. If you open the product and do not use it, be sure to discard it to maintain safety and effectiveness.

Additional Information

You should take this medication orally. For adults and children aged 5 years and older, dissolve 1 drop slowly in your mouth and repeat every 2 hours as needed. If the patient is under 5 years old, it's important to consult a doctor before use.

FAQ

What is Halls used for?

Halls is used to temporarily relieve cough due to a cold and occasional minor irritation or sore throat.

How should I use Halls?

For adults and children 5 years and over, dissolve 1 drop slowly in the mouth and repeat every 2 hours as needed. For children under 5 years, ask a doctor.

Are there any warnings associated with Halls?

Yes, if you have a severe sore throat that persists for more than 2 days or is accompanied by fever, headache, rash, swelling, or vomiting, consult a doctor promptly.

When should I stop using Halls and consult a doctor?

Stop use and ask a doctor if your cough persists for more than 1 week, if sore mouth does not improve in 7 days, or if irritation, pain, or redness persists or worsens.

Is Halls safe for children?

Children under 5 years should ask a doctor before use. For those 5 years and older, it is safe to use as directed.

How should I store Halls?

Store Halls at room temperature in a cool, dry place, away from excessive heat and moisture, and keep out of reach of children.

Are there any contraindications for using Halls?

No specific contraindications are listed for Halls.

Can I use Halls if I am pregnant or nursing?

There are no specific warnings or recommendations regarding the use of Halls during pregnancy or lactation.

Packaging Info

Below are the non-prescription pack sizes of Halls (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Halls.
Details

Drug Information (PDF)

This file contains official product information for Halls, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Halls Cherry is a product identified by the SPL code 34089-3. It is available in a count of 30 units per package.

Uses and Indications

This drug is indicated for the temporary relief of cough due to a cold. Additionally, it provides temporary relief from occasional minor irritation or sore throat.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 5 years and older, the recommended dosage is to dissolve 1 drop slowly in the mouth. This may be repeated every 2 hours as needed.

For children under 5 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

There are no specific contraindications listed for this product. However, healthcare professionals should advise patients to discontinue use and consult a physician under the following circumstances:

  • If cough persists for more than one week, recurs, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious condition.

  • If a sore mouth does not improve within 7 days.

  • If irritation, pain, or redness persists or worsens.

Warnings and Precautions

Severe sore throat may indicate a serious underlying condition. If a patient experiences a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, swelling, or vomiting, it is imperative to consult a healthcare professional promptly.

Healthcare providers should advise patients to discontinue use and seek medical attention if a cough persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may signify a serious condition. Additionally, if a sore mouth does not show improvement within seven days, or if irritation, pain, or redness persists or worsens, medical consultation is warranted.

While no specific emergency medical help instructions or general precautions are provided, it is essential for healthcare professionals to remain vigilant and assess patients for any signs of serious conditions that may require immediate intervention. Regular monitoring and patient education on recognizing concerning symptoms are crucial for ensuring safe use of the medication.

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, or vomiting, necessitates prompt consultation with a healthcare provider. Additionally, patients should discontinue use and seek medical advice if a cough persists for more than 1 week, recurs, or is accompanied by fever, rash, or persistent headache, as these symptoms may indicate a serious underlying condition.

Common adverse reactions may include sore mouth, which should be monitored closely; if there is no improvement within 7 days, patients are advised to consult a doctor. Furthermore, any irritation, pain, or redness that persists or worsens should also prompt a discussion with a healthcare professional.

Patients with a history of persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should seek medical advice before using this medication. Additionally, those experiencing a cough accompanied by excessive phlegm (mucus) are also encouraged to consult a healthcare provider prior to use.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Halls (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Halls.
Details

Pediatric Use

Pediatric patients under 5 years of age should consult a healthcare professional before use. For children aged 5 years and older, the recommended dosage is to dissolve 1 drop slowly in the mouth, with the option to repeat every 2 hours as needed.

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 therapeutic response, given the potential for altered pharmacokinetics and pharmacodynamics in this population.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in the absence of established safety profiles for use in pregnant individuals. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific contraindications. Further clinical judgment should be applied based on the individual circumstances of the lactating mother and her breastfed infant.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information 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 based on clinical judgment.

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, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols tailored to the substance involved. Continuous assessment and supportive measures should be prioritized to ensure patient safety and mitigate potential complications associated with overdose.

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 out of reach of children to prevent accidental ingestion.

Patients should be instructed to stop using the medication and consult a doctor if their cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious condition. Additionally, if a sore mouth does not improve within 7 days, or if irritation, pain, or redness persists or worsens, patients should seek medical advice.

It is also important for healthcare providers to remind patients to consult a doctor before using this medication if they have a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It should be stored at room temperature, specifically in a cool, dry place to maintain its integrity. It is essential to protect the product from excessive heat and moisture to prevent degradation.

To ensure safety, the product must be kept out of reach of children. Additionally, any unused portion should be discarded after opening to avoid potential contamination or loss of efficacy.

Additional Clinical Information

The medication is administered orally. For adults and children aged 5 years and older, the recommended dosage is to dissolve 1 drop slowly in the mouth, with the option to repeat every 2 hours as needed. For children under 5 years of age, it is advised to consult a doctor for appropriate guidance. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Halls, 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 Halls, 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.

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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.