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Halls

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Active ingredient
Menthol 7.5 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 7.5 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
12546-110

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Drug Overview

Halls Honey Lemon is a soothing throat lozenge designed to temporarily relieve coughs caused by colds and minor throat irritations or soreness. The honey lemon flavor not only provides a pleasant taste but also helps to ease discomfort in your throat, making it easier for you to feel more comfortable during a cold.

Uses

If you're dealing with a cough caused by a cold, this medication can help provide temporary relief. It’s also effective for easing occasional minor irritation or soreness in your throat. This means you can find some comfort when you're feeling under the weather, allowing you to go about your day with less discomfort.

Rest assured, this medication does not have any known harmful effects on developing babies (teratogenic effects), making it a safer option for those who may be pregnant.

Dosage and Administration

For adults and children aged 5 years and older, you should dissolve one drop of the medication slowly in your mouth. If you need more relief, you can repeat this every two hours as necessary.

If your child is under 5 years old, it’s important to consult a doctor before giving them this medication. Always follow your healthcare provider's advice to ensure safe and effective use.

What to Avoid

If you are using this medication, it's important to know when to stop and seek medical advice. You should discontinue use and consult a doctor if your cough lasts more than a week, keeps coming back, or is accompanied by fever, rash, or a persistent headache, as these may indicate a serious condition. 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 a healthcare professional.

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

Side Effects

If you experience a sore throat that is severe, lasts more than two days, or is accompanied by symptoms like fever, headache, rash, swelling, nausea, or vomiting, it’s important to consult a doctor, as these could indicate a serious issue. Additionally, if your cough persists for more than a week, recurs frequently, or comes with fever, rash, or a persistent headache, seek medical advice, as these 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. If you have a chronic cough due to smoking, asthma, or emphysema, or if your cough is accompanied by excessive mucus, it’s advisable to consult a doctor before using this medication.

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, as these could be signs of a serious condition.

You should also stop taking the medication and call 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.

While there are no specific emergency instructions or lab tests mentioned, always prioritize your health and reach out to a healthcare professional if you have any concerns.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general 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 always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available about its safety, recommended 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 or planning to breastfeed, it's important to know that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk and your baby are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding. They can help you weigh the potential risks and benefits to ensure the safety of both you and your baby.

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. This can be repeated every two hours as needed. Always ensure you follow these guidelines to keep your child safe and healthy.

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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 monitor your liver function and make any necessary adjustments to your care.

Drug Interactions

It's great to know that there are no known interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you may start. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature in a cool, dry place. It's important to protect it from moisture, so make sure to keep the bag tightly closed when you're not using it. Additionally, remember to discard any unused lozenges after the expiration date to avoid any potential risks. Following these simple guidelines will help you maintain the product's effectiveness and safety.

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 Honey Lemon used for?

Halls Honey Lemon temporarily relieves cough due to a cold and occasional minor irritation or sore throat.

How should I use Halls Honey Lemon?

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

Are there any contraindications for Halls Honey Lemon?

No specific contraindications are mentioned for Halls Honey Lemon.

What should I do if my cough persists?

Stop use and ask a doctor if your cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache.

What warnings should I be aware of?

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

Is Halls Honey Lemon safe to use during pregnancy?

No specific information regarding the use of Halls Honey Lemon during pregnancy is provided.

How should I store Halls Honey Lemon?

Store Halls Honey Lemon at room temperature in a cool, dry place, and keep the bag tightly closed when not in use.

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 Honey Lemon is a cough suppressant and oral anesthetic, formulated to provide relief from cough symptoms. Each drop contains 7.5 mg of menthol, which contributes to its therapeutic effects. The product's inactive ingredients include glucose syrup, sucrose, citric acid, natural and artificial flavors, and added color.

Uses and Indications

This drug is indicated for the temporary relief of cough due to a cold. Additionally, it provides temporary relief for occasional minor irritation or 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 5 years and older are instructed to dissolve 1 drop slowly in the mouth. This process may be repeated every 2 hours as needed. For children under 5 years of age, it is recommended to consult a physician for appropriate dosing guidance.

Contraindications

Use is contraindicated in patients who experience a cough that persists for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious underlying condition. Additionally, discontinue use and consult a healthcare professional if a sore mouth does not improve within 7 days. Patients should also stop use and seek medical advice if irritation, pain, or redness persists or worsens.

Warnings and Precautions

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

Patients should discontinue use and seek medical advice if a cough persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache, as these may also be indicative of a serious health issue. Additionally, if a sore mouth does not show improvement within seven days, or if irritation, pain, or redness persists or worsens, medical consultation is advised.

While no specific emergency medical instructions are provided, it is essential for healthcare professionals to remain vigilant and responsive to any signs of serious conditions in their patients. Regular monitoring and assessment of symptoms are crucial for ensuring patient safety and effective management of any potential complications.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions warrant immediate medical attention and include severe sore throat, particularly if it persists for more than 2 days or is accompanied by symptoms such as fever, headache, rash, swelling, nausea, or vomiting. These symptoms may indicate a serious underlying condition.

Common adverse reactions include cough that persists for more than 1 week, especially if it tends to recur or is accompanied by fever, rash, or persistent headache. Such symptoms should prompt patients to consult a healthcare professional, as they may signify a serious condition. Additionally, if a sore mouth does not improve within 7 days, or if irritation, pain, or redness persists or worsens, patients are advised to seek medical advice.

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

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. 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

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. The effects on breastfed infants have not been established.

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 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 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 initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management 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 use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the 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 encourage patients to ask a doctor before using the medication if they have a persistent or chronic cough, such as that which occurs with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus). This ensures that patients receive appropriate guidance based on their individual health circumstances.

Storage and Handling

The product is supplied in a package that should be stored at room temperature. It is essential to keep the product in a cool, dry place, ensuring protection from moisture. To maintain product integrity, the bag must be kept tightly closed when not in use. Any unused lozenges should be discarded after the expiration date to ensure 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 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 experience.

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.