Menthol Cough Drops Honey Vanilla Flavor

Description

The product is identified by the code 51945-4 and is associated with the root ID 2efc46c9-a420-1998-e063-6394a90aeb64. The effective date for this labeling is set for February 25, 2025. The principal display panel includes a multimedia component, specifically an image in JPEG format, referenced as "HV Cough.jpg." The image serves to visually represent the product, although a detailed description of the image is not provided.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with a cold. Additionally, it provides temporary relief from occasional minor irritation, pain, sore mouth, and sore throat.

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

Dosage and Administration

Adults and children aged 2 years and older are instructed to slowly dissolve 2 drops in the mouth, one at a time. This process may be repeated every 2 hours as needed, or as directed by a healthcare professional.

For children under 2 years of age, it is recommended to consult a doctor before administration.

Contraindications

There are no specific contraindications identified for this product. However, it is essential to adhere to the recommended dosage guidelines, as exceeding the recommended dosage may lead to adverse effects.

Warnings and Precautions

Severe sore throat should be taken seriously. 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.

In addition, patients should discontinue use and seek medical advice if any of the following occur: a cough that persists for more than one week, a cough that tends to recur, or a cough accompanied by fever, rash, or a persistent headache, as these may indicate a serious underlying condition. Furthermore, if symptoms of a sore mouth do not improve within seven days, or if there is ongoing irritation, pain, or redness that persists or worsens, medical consultation is advised.

While no specific emergency medical help instructions or general precautions are provided, it is essential for healthcare professionals to remain vigilant and responsive to any concerning symptoms presented by patients. Regular monitoring and assessment of symptoms are crucial for ensuring patient safety and effective management of their condition.

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 the case of severe sore throat. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, patients are advised to consult a doctor promptly.

Common adverse reactions include symptoms related to cough and sore throat. Patients should stop use and seek medical advice if a cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious underlying condition. Additionally, if symptoms of a sore mouth do not improve within 7 days, or if irritation, pain, or redness persists or worsens, patients should also consult a healthcare professional.

Before using this medication, patients should ask 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 safe and effective use of the medication.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Menthol Cough Drops Honey Vanilla Flavor (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children aged 2 years and older, the recommended dosage is to slowly dissolve 2 drops (one at a time) in the mouth, with the option to repeat every 2 hours as needed or as directed by a healthcare provider.

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 efficacy, given the lack of targeted data for this population.

Pregnancy

There is currently no information available regarding the use of Menthol Cough Drops Honey Vanilla Flavor during pregnancy. This includes any safety concerns, dosage modifications, or special precautions that may be necessary for pregnant patients. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in lactating mothers. Additionally, no information is available concerning the excretion of the drug in breast milk or its effects on breastfed infants. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this medication.

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

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may be beneficial for guidance on management strategies tailored to the specific situation.

Documentation of the incident, including the substance involved, estimated dose, time of exposure, and any symptoms observed, 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 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 and all other drugs out of the reach of children to prevent accidental ingestion.

Patients should be instructed to stop using the product 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 symptoms of a sore mouth do not improve within 7 days, or if irritation, pain, or redness persists or worsens, patients should seek medical advice.

It is important to emphasize to patients the necessity of adhering to the recommended dosage and not exceeding it while using this product.

Healthcare providers should also encourage patients to consult a doctor prior to use 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).

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, ensuring that it is kept away from excessive heat and direct sunlight to maintain its integrity and efficacy. Proper storage conditions are essential for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Menthol Cough Drops Honey Vanilla Flavor, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)