Menthol Cough Drops

Description

Family Wellness Menthol Cough Drops are formulated to provide symptomatic relief for coughs. Each package contains 80 drops. The active ingredient is menthol, which is known for its soothing properties. The cough drops are designed for oral use and are presented in a convenient, easy-to-carry format.

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 mentioned in the available data.

Dosage and Administration

Adults and children aged 5 years and older should dissolve one lozenge slowly in the mouth. This process may be repeated every two 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

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, discontinue use and consult a healthcare professional if severe sore throat occurs, or if irritation, pain, or redness lasts or worsens. Patients should also stop use and seek medical advice if a sore mouth does not improve within 7 days.

Warnings and Precautions

Severe sore throat symptoms warrant immediate medical attention. Healthcare professionals should advise patients to consult a doctor promptly if a sore throat is severe, persists for more than 2 days, or is accompanied by additional symptoms such as fever, headache, rash, swelling, nausea, or vomiting. These accompanying symptoms may indicate a serious underlying condition. Furthermore, if symptoms related to a sore mouth do not show improvement within 7 days, patients should be referred to a dentist or physician for further evaluation.

In addition, patients should be instructed to discontinue use and seek medical advice if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache. These signs may also suggest a serious health issue. It is crucial for healthcare providers to monitor these symptoms closely and ensure appropriate follow-up care is provided.

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 attention include a persistent cough that lasts 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 healthcare professional if they experience severe sore throat, or if irritation, pain, or redness persists or worsens.

It is recommended that patients with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, consult a doctor prior to use. Furthermore, individuals experiencing a cough accompanied by excessive phlegm (mucus) should also seek medical advice before using this medication.

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 two 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 considering the use of this medication during lactation.

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, 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 an overdose. Symptoms 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 the management of the overdose effectively.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for appropriate 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 use of the compound in these contexts.

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, if a patient experiences a severe sore throat or if irritation, pain, or redness lasts or worsens, they should seek medical advice. Patients should also be informed that if a sore mouth does not improve within 7 days, they should contact their healthcare provider.

Before using this 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. Furthermore, patients should be advised 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 to ensure safety and efficacy.

Storage conditions require that the product 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 Drops, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)