Menthol Cough Drops

Description

Family Wellness Menthol Cough Drops are formulated to provide symptomatic relief for coughs. Each package contains 30 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 dosage form suitable for adults and children. The appearance of the cough drops is consistent with standard menthol formulations, providing a soothing effect upon administration.

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.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 5 years and older are instructed to dissolve one lozenge slowly in the mouth. This process may be repeated every 2 hours as needed or as directed by a healthcare professional.

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

Contraindications

There are no specific contraindications listed for this product. However, healthcare professionals should advise patients to discontinue use and consult a physician under the following circumstances:

• If cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious condition.

• If sore throat is severe, or if irritation, pain, or redness lasts or worsens.

• If sore mouth does not improve within 7 days.

Warnings and Precautions

Patients should be closely monitored for the following symptoms and conditions, as they may indicate the need for medical intervention.

Sore Throat Warning Healthcare professionals should advise patients to seek prompt medical attention if they experience a severe sore throat that persists for more than two days, especially if it is accompanied or followed 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, patients should be instructed to consult their dentist or physician without delay.

Cough Monitoring Patients should be advised to discontinue use and consult a healthcare provider if a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache. These signs may suggest a serious health issue that requires further evaluation.

Sore Throat and Mouth Symptoms In cases where a sore throat is severe, or if irritation, pain, or redness persists or worsens, patients should be instructed to stop use and seek medical advice. Furthermore, if symptoms of a sore mouth do not show improvement within seven days, it is essential for patients to consult a healthcare professional promptly.

Side Effects

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

Severe adverse reactions warrant immediate medical attention. Patients should consult a doctor promptly if they experience a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting. 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 seek medical advice if it lasts for more than 7 days, tends to recur, or is accompanied by fever, rash, or a persistent headache. These symptoms may also suggest the presence of a serious underlying condition. Furthermore, patients should stop use and consult a doctor if they experience severe sore throat, or if irritation, pain, or redness lasts or worsens.

Drug Interactions

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

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.

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

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and consider general principles of management for suspected overdosage.

Recommended Actions

In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be prioritized.

Potential Symptoms

While specific symptoms of overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the lack of documented information.

Management Procedures

Healthcare professionals are encouraged to consult local poison control centers or relevant toxicology resources for guidance on the management of potential overdosage cases. It is critical to provide supportive care tailored to the patient's needs, which may include intravenous fluids, monitoring of electrolytes, and other interventions as clinically indicated.

In summary, due to the absence of specific overdosage information, a cautious and supportive approach is recommended for any suspected cases.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 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 seek medical advice if they experience a severe sore throat or if irritation, pain, or redness lasts or worsens. It is also important to inform patients that if their sore mouth does not improve within 7 days, they should contact their healthcare provider.

Before using the medication, patients should be encouraged to ask a doctor 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). This information is crucial for ensuring safe and effective use of the medication.

Storage and Handling

The product is supplied in a secure bag, and it is imperative that the bag remains intact. Healthcare professionals should not use the product if the bag is torn or open, as this may compromise the integrity and safety of the contents.

For optimal storage, the product should be kept in a controlled environment, away from direct sunlight and moisture. Specific temperature ranges for storage have not been provided; therefore, it is advisable to adhere to standard storage conditions for similar products. Proper handling is essential to maintain the quality and efficacy of the product.

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)