Halls

Description

Halls Mentholyptus is presented in a package containing 30 units. Each unit is formulated to provide menthol and eucalyptus flavoring, designed for oral use. The product is characterized by its distinct mentholated taste, which is intended to soothe the throat and provide a cooling sensation. The specific composition and formulation details are proprietary.

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 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 before administration.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional 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 sore mouth symptoms do not improve within 7 days.

• 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 if it is accompanied by fever, headache, rash, swelling, 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 associated with 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 any irritation, pain, or redness persists or worsens, medical consultation is advised.

Currently, there are no specific laboratory tests recommended for monitoring parameters associated with the use of this medication. However, healthcare professionals should remain vigilant for the aforementioned symptoms and advise patients accordingly.

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 be advised to stop use and seek medical attention if a cough persists for more than 1 week, tends to recur, 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 it does not improve within 7 days, medical advice should be sought. Patients may also experience irritation, pain, or redness that persists or worsens, warranting consultation with a healthcare professional.

Before using this medication, patients should consult a doctor 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). These considerations are important to ensure the safe and effective use of the medication.

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.

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 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 product in pregnant patients. The prescribing information does not indicate whether the product is contraindicated during pregnancy or outline any associated risks to the fetus. Additionally, there are no dosage modifications or special precautions recommended for use in this population. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific information is available.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 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 and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

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 and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized until the patient stabilizes or further treatment is determined.

Documentation of the incident, including the substance involved, estimated dose, and time of ingestion, is vital for ongoing management and potential reporting requirements.

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 usability. 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 moisture to prevent degradation. Additionally, the product must be kept out of reach of children to ensure safety. Any unused portion should be discarded after opening to avoid potential risks associated with prolonged exposure to air or contaminants.

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 further 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)