Menthol

Description

Cough Drops Assorted, Honey Lemon flavor, are manufactured by McKesson. Each jar contains 250 cough drops. The product is identified by the National Drug Code (NDC) 68599-0465-9 and is associated with the manufacturer number 27996L.

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.

For children under 12 years of age, the product is not recommended and should not be administered.

It is essential to adhere to the recommended dosage and not exceed the directed amount. The route of administration is oral, and the method involves allowing the drop to dissolve slowly in the mouth.

Contraindications

Use is contraindicated in patients with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema. Additionally, the product should not be used in individuals experiencing a cough accompanied by excessive phlegm (mucus). These conditions may indicate underlying issues that require medical evaluation and intervention.

Warnings and Precautions

If a patient experiences a severe sore throat that persists for more than two days, or if it is accompanied or followed by symptoms such as fever, headache, rash, nausea, or vomiting, it is imperative to consult a healthcare professional promptly. These accompanying symptoms may indicate a serious underlying condition that requires immediate medical attention.

Healthcare professionals should advise patients to discontinue use and seek medical advice if they develop a persistent or chronic cough, particularly in cases associated with smoking, asthma, or emphysema. Additionally, if the cough is accompanied by excessive phlegm (mucus), it is essential to consult a doctor to evaluate the need for further investigation or treatment. Monitoring these symptoms is crucial to ensure patient safety and to address any potential complications that may arise.

Side Effects

Patients may experience a range of adverse reactions, which can vary in seriousness and frequency.

In the event of a severe sore throat that persists for more than two days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, patients are advised to consult a doctor promptly, as these symptoms may indicate a serious condition.

Additionally, patients should seek medical advice if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, or emphysema. A cough that is accompanied by excessive phlegm (mucus) also warrants consultation with a healthcare professional.

Drug Interactions

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

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

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 therapeutic response, 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, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider 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 available data on the excretion of this medication in human 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 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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide the management of the patient and to determine the most appropriate interventions.

Overall, vigilance and prompt action are critical in managing cases of suspected overdose to mitigate potential complications and ensure patient safety.

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 encouraged to consult with their healthcare provider if they experience a persistent or chronic cough, particularly if it is associated with conditions such as smoking, asthma, or emphysema. Additionally, patients should be informed to seek medical advice if their cough is accompanied by excessive phlegm (mucus), as this may indicate a need for further evaluation.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 59ºF to 86ºF (15ºC to 30ºC). Care must be taken to protect the product from moisture and heat to ensure its integrity and efficacy. Proper storage conditions are essential 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)