Menthol

Description

The product is identified by NDC 68599-0464-9 and is manufactured by McKesson. It is formulated as cough drops with a menthol eucalyptus flavor. Each jar contains 250 cough drops, and the manufacturer reference number is 27996M.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with colds or inhaled irritants. 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 12 years and older are instructed to allow 1 drop to dissolve slowly in the mouth. This dosage may be repeated every 2 hours as necessary or as directed by a healthcare professional.

It is important to note that this product is not recommended for use in children under 12 years of age.

The route of administration is oral, and the method involves allowing the drop to dissolve slowly in the mouth. Care should be taken to adhere to the recommended dosage and frequency to ensure safe and effective use.

Contraindications

Use is contraindicated in the following situations:

Patients should discontinue use and consult a healthcare professional if cough persists for more than one week, recurs, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious underlying condition. Additionally, if a sore mouth does not improve within 7 days, or if irritation, pain, or redness persists or worsens, medical advice should be sought. Pregnant or breastfeeding individuals are advised to consult a healthcare professional prior to use.

Warnings and Precautions

Severe sore throat may indicate a serious condition. If a patient experiences a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a healthcare professional promptly.

Prior to use, patients should be advised to seek medical guidance if they have a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema. Additionally, a consultation is recommended for those whose cough is accompanied by excessive phlegm (mucus).

Patients should discontinue use and contact their healthcare provider if the cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache, as these symptoms may indicate a serious underlying condition. Furthermore, if a sore mouth does not show improvement within seven days, or if irritation, pain, or redness persists or worsens, medical advice should be sought. Pregnant or breastfeeding individuals should also consult a healthcare professional before use.

No specific emergency medical instructions or general precautions have been provided. Additionally, there are no laboratory tests recommended for monitoring in relation to the use of this product.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions warrant immediate medical attention. A notable warning includes the occurrence of a severe sore throat that persists for more than 2 days, especially if accompanied or followed by symptoms such as fever, headache, rash, nausea, or vomiting. These symptoms may indicate a serious underlying condition.

Additionally, patients should discontinue use and consult a healthcare professional if a cough persists for more than 1 week, recurs, or is accompanied by fever, rash, or a persistent headache, as these may also signify a serious condition. Furthermore, if a sore mouth does not show improvement within 7 days, or if irritation, pain, or redness persists or worsens, it is advised to seek medical advice promptly.

Monitoring for these adverse reactions is essential to ensure patient safety and effective management of symptoms.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Menthol (cough suppressant). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. Safety and efficacy have not been established in this age group, and therefore, it is contraindicated for use in children under 12.

Geriatric Use

There is no specific information available 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

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently 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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 per established protocols. Additionally, contacting a poison control center for guidance on management strategies is recommended.

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

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 medication and consult a doctor if any of the following occur: if a 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 show improvement within 7 days, or if irritation, pain, or redness persists or worsens, patients should seek medical advice.

For patients who are pregnant or breastfeeding, it is essential to recommend that they consult a healthcare professional before using this medication to ensure safety for both themselves and their child.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at temperatures ranging from 59ºF to 86ºF (15ºC to 30ºC). Care should be taken to protect the product from moisture and heat to ensure its integrity and efficacy. Proper storage conditions are crucial for maintaining 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, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)