Original Menthol and Eucalyptus Sugar Free

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor sore throat and cough due to minor throat and bronchial irritation, which may occur with a cold or as a result of inhaled irritants.

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 2 drops (one at a time) slowly in the mouth. This process may be repeated every 2 hours as needed for symptom relief.

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, 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 sore mouth symptoms do not improve within 2 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 2 days, especially if accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, it is imperative to consult a healthcare professional promptly. These symptoms may indicate a serious underlying condition that requires immediate attention.

Healthcare professionals should advise patients to discontinue use and seek medical advice if the following occurs:

• A cough persists for more than 1 week, recurs, or is accompanied by fever, rash, or a persistent headache, as these may be indicative of a serious health issue.

• A sore mouth does not show improvement within 2 days.

• Any irritation, pain, or redness persists or worsens, necessitating further evaluation.

Monitoring for these symptoms is crucial to ensure patient safety and to facilitate timely intervention when necessary.

Side Effects

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

Common adverse reactions include persistent cough that lasts more than 1 week, 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 2 days, or if irritation, pain, or redness persists or worsens, patients are advised to seek medical advice.

Patients with a history of persistent 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

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Original Menthol and Eucalyptus Sugar Free (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 5 years and older are instructed 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 recommended to consult a doctor before use.

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 lack of targeted data for this population.

Pregnancy

Pregnant patients should be aware that the safety of this medication during pregnancy has not been established. There are no available data regarding the potential risks or fetal outcomes associated with the use of this medication in pregnant individuals. Healthcare professionals are advised to consider the lack of information when prescribing this medication to women of childbearing potential and to discuss the potential risks and benefits with their patients. It is recommended that healthcare providers remain vigilant and informed about any emerging data related to the use of this medication in pregnant patients.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or its effects during lactation. Healthcare professionals should consider the lack of data when advising lactating mothers about the use of this medication. It is recommended to monitor breastfed infants for any potential adverse effects if the medication is administered to a nursing mother.

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 of these patients.

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 clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate assessment of the patient’s condition is critical. Recommended actions include:

1. Assessment and Monitoring: Conduct a thorough evaluation of the patient's vital signs, level of consciousness, and any presenting symptoms. Continuous monitoring may be necessary to detect any deterioration in the patient's condition.

2. Supportive Care: Initiate supportive measures as required, which may include airway management, oxygen supplementation, intravenous fluids, and other interventions tailored to the patient's needs.

3. Toxicology Consultation: Consider consulting a poison control center or a toxicologist for guidance on specific management strategies, including the use of antidotes if applicable.

4. Reporting: Document the incident and report any adverse effects or overdose cases to the appropriate regulatory authorities as per local guidelines.

Healthcare professionals are encouraged to familiarize themselves with the specific management protocols for the substances involved and to maintain an updated knowledge of potential antidotes and treatment options.

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

Adverse events have been reported voluntarily through various channels, including surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events associated with the use of the product. For reporting purposes, individuals can contact the designated hotline at 1-877-349-9443.

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 two 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 their doctor before using this medication if they have a persistent 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 various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature to maintain its integrity and effectiveness. Additionally, it should be kept out of reach of children to ensure safety. Special handling requirements are not specified; however, standard precautions should be observed during storage and handling.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Original Menthol and Eucalyptus Sugar Free, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)