Halls

Description

Halls Minis Sugar Free Mentho-Lyptus are formulated as a sugar-free lozenge designed to provide soothing relief for throat irritation. Each package contains 24 lozenges, which are characterized by their menthol and eucalyptus flavor profile. The product is intended for individuals seeking a sugar-free option for throat comfort. The lozenges are compact in size, facilitating ease of use and portability.

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

Adults and children aged 5 years and older should dissolve 2 drops (one at a time) 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 before administration.

Contraindications

There are no specific contraindications identified 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 show improvement within 7 days.

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

Warnings and Precautions

Severe sore throat may indicate a serious 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, nausea, or vomiting, it is imperative to consult a healthcare professional promptly.

Coughing that persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache should also prompt immediate medical evaluation, as these symptoms may signify a serious underlying condition. Additionally, if a sore mouth does not show improvement within seven days, or if irritation, pain, or redness persists or worsens, the patient should discontinue use and seek medical advice.

In the event of an overdose, it is crucial to obtain emergency medical assistance or contact a Poison Control Center without delay.

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, patients should be advised to stop use and seek medical attention if their 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) should consult a healthcare provider prior to use.

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 Halls (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

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 2 drops (one at a time) 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. 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

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. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in the absence of established safety profiles. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this medication.

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 relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined 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 prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

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 seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is essential for patients to understand the importance of prompt action in such situations to ensure their safety and well-being.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from excessive heat and moisture. Freezing the product is not recommended, as it may compromise its quality. After opening, the product should be discarded 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 2 drops (one at a time) 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 dosing guidance.

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 Halls, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)