Menthol Cough Drops Honey Vanilla Flavor

Description

This 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 package label includes a principal display panel, which is visually represented by an image in JPEG format, referenced as "HV Cough.jpg." The label is designed to provide essential information regarding the product's use and characteristics.

Uses and Indications

This drug is indicated for the temporary relief of cough due to a cold. It is also indicated for the alleviation of 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

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, nausea, or vomiting, it is imperative to consult a healthcare professional promptly. These symptoms may indicate a more serious underlying condition that requires immediate attention.

Healthcare providers should advise patients to discontinue use and seek medical advice if the following conditions arise: a cough that persists for more than one week, recurs frequently, or is accompanied by fever, rash, or a persistent headache. Such symptoms may suggest a serious health issue that necessitates further evaluation. Additionally, if symptoms of a sore mouth do not show improvement within seven days, or if there is ongoing irritation, pain, or redness that persists or worsens, patients should be instructed to contact their healthcare provider for further assessment and management.

Regular monitoring of these symptoms is essential 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 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 a 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 which occurs 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

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.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled on the absence of established safety data and the importance of discussing any potential pregnancy with their healthcare provider.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the safety of this product during lactation has not been established. Caution is advised when using this product while breastfeeding.

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 initiate supportive care, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Overall, vigilance and prompt intervention are critical in managing any suspected overdose effectively.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 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 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 associated with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus). This precaution is essential to ensure safe and effective use of the medication.

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)