Menthol Cough Drops

Description

Publix Menthol Cough Drops are formulated to provide symptomatic relief for coughs. Each package contains 30 drops, with menthol as the active ingredient. The cough drops are designed for oral administration and are presented in a lozenge form. The appearance of the drops is consistent with standard menthol cough lozenges, providing a soothing effect upon dissolution in the mouth.

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

For adults and children aged 5 years and older, the recommended dosage is to dissolve 1 lozenge slowly in the mouth. This may be repeated every 2 hours as needed or as directed by a healthcare professional.

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

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 show improvement 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 of a sore mouth do not improve 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. These symptoms may signify a serious health issue. Furthermore, patients should stop taking the medication if they experience a severe sore throat or if irritation, pain, or redness lasts or worsens.

In cases where sore mouth symptoms do not show improvement after seven days, patients are advised to seek medical consultation. Monitoring for these symptoms is crucial to ensure timely intervention and management of potential complications.

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 immediate medical consultation include a cough that persists for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These 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 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 identified for this medication. Additionally, no laboratory test interactions have been reported. 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

There is no specific information 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 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 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 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 patients closely for any signs or symptoms that may arise following an overdose. Common symptoms may include, but are not limited to, alterations in vital signs, neurological changes, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Supportive care is the cornerstone of management, which may involve the following steps:

1. Assessment: Conduct a thorough evaluation of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide symptomatic treatment as necessary, which may include intravenous fluids, oxygen supplementation, or other interventions based on the patient's condition.

3. Decontamination: If the overdose is recent, consider gastrointestinal decontamination methods, such as activated charcoal, if appropriate and safe for the patient.

4. Consultation: Engage with a poison control center or toxicology expert for guidance on specific management strategies tailored to the substance involved.

Healthcare professionals should remain vigilant and prepared to implement these measures promptly to mitigate potential complications associated with overdose situations.

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 this medication out of reach of children to prevent accidental ingestion. Patients should be instructed to stop using the medication 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 be informed to seek medical advice if they experience a severe sore throat, or if irritation, pain, or redness lasts or worsens. They should also be counseled to consult a healthcare professional if a sore mouth does not improve within 7 days.

It is important for healthcare providers to remind patients to ask a 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)