Menthol Cough Drops

Description

Harris Teeter Menthol Cough Drops are formulated to provide symptomatic relief for coughs. Each drop contains menthol as the active ingredient, which acts as a cough suppressant and throat soother. The product is presented in a convenient dosage form of lozenges, with a total count of 30 drops per package. The cough drops are designed for oral administration and are intended for temporary relief of cough associated with minor throat and bronchial irritation.

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 and 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 one lozenge slowly in the mouth. This process may be repeated every 2 hours as needed or as directed by a healthcare professional.

For children under 5 years of age, it is recommended to consult a doctor before administration.

Contraindications

Use of this product is contraindicated in the following situations:

Patients should discontinue use and consult a healthcare professional if cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious underlying condition.

Additionally, patients should stop use and seek medical advice if they experience severe sore throat, or if irritation, pain, or redness persists or worsens.

If sore mouth symptoms do not improve within 7 days, medical consultation is also advised.

Warnings and Precautions

Patients should be advised to seek medical attention promptly if they experience a severe sore throat that persists for more than two days, especially if accompanied by fever, headache, rash, swelling, nausea, or vomiting. These symptoms may indicate a serious underlying condition. Additionally, if symptoms of a sore mouth do not show improvement within seven days, it is recommended that patients consult their dentist or healthcare provider.

Healthcare professionals should instruct patients to discontinue use and contact their doctor if any of the following occur: a cough that persists for more than seven days, a cough that tends to recur, or a cough accompanied by fever, rash, or a persistent headache, as these may be indicative of a serious condition. Furthermore, patients should be advised to seek medical advice if a sore throat is severe or if irritation, pain, or redness lasts or worsens. It is also crucial to monitor for any sore mouth symptoms that do not improve within a week, as this may necessitate further evaluation by a healthcare professional.

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, if symptoms of a sore mouth do not improve within 7 days, patients are advised to seek medical attention from a dentist or doctor, as these symptoms may indicate a serious condition.

Common adverse reactions warranting attention include a persistent cough that lasts more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache. Such symptoms may also suggest the presence of a serious underlying condition. Patients should discontinue use and consult a healthcare professional if they experience severe sore throat, or if irritation, pain, or redness lasts or worsens.

Furthermore, patients with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should seek medical advice before using this medication. Cough accompanied by excessive phlegm (mucus) also requires consultation with a healthcare provider prior to use.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Menthol Cough Drops (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 lozenge slowly 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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 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 standard 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 also be beneficial in guiding management decisions.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Reports of adverse events have been received through voluntary reporting and surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events to the designated contact number, 1-800-245-2898, available Monday through Friday from 9 AM to 4 PM EST. This information contributes to the ongoing monitoring of the product's safety profile.

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 healthcare professional if their cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious condition. Additionally, if a patient experiences a severe sore throat, or if irritation, pain, or redness lasts or worsens, they should seek medical advice. Patients should also be informed that if a sore mouth does not improve within 7 days, they should contact their healthcare provider.

Before using this medication, patients should be encouraged to ask their doctor if they have a persistent or chronic cough, such as that which occurs with smoking, asthma, or emphysema. Furthermore, patients should be advised to consult a healthcare professional if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is available in various package configurations, with specific NDC numbers assigned for identification. Storage and handling instructions are not explicitly provided; therefore, standard practices for pharmaceutical products should be followed. It is advisable to store the product in a controlled environment, ensuring that it is kept at appropriate temperature ranges to maintain its integrity. Containers should be secure and suitable for the product type to prevent contamination or degradation. Special handling requirements are not specified, but general precautions should be taken to ensure the product's safety and efficacy during storage and transportation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)