Menthol Cough Drops

Description

Menthol is a compound characterized by its suitability for topical application. The specific physical characteristics of the product facilitate its use in various formulations. The inactive ingredients have not been specified in the provided information.

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 irritations and sore throat.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

Adults and children aged 5 years and older are instructed to allow 1 drop to dissolve slowly in the mouth. This dosage may be repeated every two hours as necessary 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 is contraindicated in patients who experience a cough that persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious underlying condition. Additionally, patients should discontinue use and consult a healthcare professional if they have a severe sore throat or if irritation, pain, or redness lasts or worsens. If a sore mouth does 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 they experience severe sore throat symptoms or if irritation, pain, or redness lasts or worsens. It is crucial to monitor these symptoms closely to ensure timely intervention and management.

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 should consult a doctor promptly. Additionally, if symptoms of a sore mouth do not improve within 7 days, it is advised that patients see their dentist or doctor, as these symptoms may indicate a serious condition.

Common adverse reactions include persistent cough, which should prompt patients to stop use and consult a doctor if it lasts for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. Furthermore, if sore throat symptoms are severe or if irritation, pain, or redness lasts or worsens, patients should also seek medical advice. It is important for patients to be aware that these symptoms could signify a serious underlying condition.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. 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 aged 5 years and older may use the medication by allowing 1 drop to dissolve slowly in the mouth, with the option to repeat every two hours as necessary or as directed by a healthcare professional. For children under 5 years of age, it is advised to consult a doctor before use.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 available data on the excretion of this drug in human 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 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 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 event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt action is crucial to mitigate potential adverse effects associated with overdosage.

Healthcare professionals should be aware that the symptoms of overdose may vary depending on the specific substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should monitor the patient closely for any signs of toxicity and initiate interventions as necessary. This may include administering activated charcoal if the patient presents within a suitable timeframe and is alert, as well as providing intravenous fluids and other supportive measures as indicated.

It is vital for healthcare professionals to remain vigilant and prepared to implement emergency protocols in cases of suspected overdose, ensuring the safety and well-being of the patient.

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 medication and consult their doctor if they experience any of the following: a cough that persists for more than 7 days, a cough that tends to recur, or a cough accompanied by fever, rash, or a persistent headache, as these may indicate a serious condition. Additionally, patients should seek medical advice if they have a severe sore throat, or if irritation, pain, or redness lasts or worsens. If a sore mouth does not improve within 7 days, patients should also consult their healthcare provider.

It is important for patients to ask their doctor before using this medication 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. Currently, there are no specified storage or handling conditions provided. It is recommended that healthcare professionals refer to the product's labeling for any additional information regarding supply and storage requirements.

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)