Menthol Cough Drop

Description

Signature Care Menthol Cough Drops are formulated to provide symptomatic relief for coughs. Each package contains 30 cough drops. The active ingredient is menthol, which acts as a cough suppressant. The drops are designed for oral use and are presented in a convenient, individually wrapped format for ease of use.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with a cold, as well as for the alleviation of 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 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 prior to administration.

The route of administration is oral, with the method involving the slow dissolution of 1 drop in the mouth. The frequency of administration can be every two hours, contingent upon necessity or specific medical advice.

Contraindications

There are no specific contraindications identified for this product. However, it is advised to discontinue use and consult a healthcare professional if any of the following conditions occur:

• 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.

• Severe sore throat or if irritation, pain, or redness lasts or worsens.

• Sore mouth does not improve within 7 days.

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 related to a sore mouth do not show improvement within seven days, it is essential for patients to consult their dentist or healthcare provider.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache, as these may be indicative of a serious health issue. Furthermore, if a sore throat is severe or if irritation, pain, or redness lasts or worsens, patients should also be advised to consult a healthcare professional. 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 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 professional. 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 immediate medical consultation include a cough that persists for 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 doctor if they experience severe sore throat, or if irritation, pain, or redness lasts or worsens.

Furthermore, patients are advised to seek medical guidance before using this medication 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).

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Menthol Cough Drop (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 1 drop to be allowed to dissolve slowly in the mouth. This dosage may be repeated every two hours as necessary or as directed by a healthcare provider.

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.

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 regarding 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 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 these patients to ensure safety and efficacy.

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 excessive dosing. Symptoms of overdosage 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 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 further management and intervention strategies.

Documentation of the incident, including the amount ingested and the time of exposure, is crucial for effective treatment and follow-up care.

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 compound in these areas.

Postmarketing Experience

Adverse events have been reported voluntarily and through surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events by calling 1-800-245-2898, available Monday through Friday from 9 AM to 4 PM EST.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. Patients should be instructed to stop use and consult a doctor 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, patients should seek medical advice if they experience 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 healthcare providers to remind patients to ask a doctor before use if they have a persistent or chronic cough, such as that which occurs with smoking, asthma, or emphysema. Patients should also be encouraged to consult a healthcare professional if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in a secure bag, and it is imperative that the bag remains intact. If the bag is found to be torn or open, the product should not be used.

For optimal storage, the product should be kept in a cool, dry place, away from direct sunlight and moisture. It is essential to handle the product with care to maintain its integrity and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)