Equate Menthol Cough Drops

Description

Equate Menthol Cough Drops are formulated to provide symptomatic relief from coughs. Each drop contains menthol as the active ingredient, which acts as a cough suppressant. The product is presented in a convenient dosage form of lozenges, packaged in a count of 30 per container. The cough drops are designed for oral administration and are intended for temporary relief of cough associated with minor throat and bronchial irritation.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with a cold. Additionally, it provides temporary relief from 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 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, recurs, 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 development of severe symptoms associated with sore throat. If a patient experiences a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, it is imperative to consult a healthcare professional promptly. Additionally, if symptoms of a sore mouth do not show improvement within seven days, the patient should seek evaluation from a dentist or physician, as these symptoms may indicate a serious underlying condition.

Healthcare professionals should advise patients to discontinue use and seek medical advice if the following occurs: a cough that persists for more than seven days, a cough that tends to recur, or a cough accompanied by fever, rash, or persistent headache. These symptoms may signify a serious health issue that requires further investigation. Furthermore, if a sore throat is severe or if irritation, pain, or redness lasts or worsens, immediate medical consultation is warranted. Lastly, if symptoms of a sore mouth do not improve within seven days, patients should be instructed to contact their healthcare provider for further assessment.

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, patients are advised to see their dentist or doctor, as these symptoms may indicate a serious condition.

Common adverse reactions include persistent cough. Patients should stop use and seek medical advice if a cough lasts for more than 7 days, tends to recur, or is accompanied by fever, rash, or a persistent headache, as these may also be signs of a serious underlying condition. Furthermore, if sore throat symptoms are severe or if irritation, pain, or redness lasts or worsens, patients should consult a healthcare professional.

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 Equate 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

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. It is essential to evaluate the potential risks and benefits associated with the use of this medication during pregnancy and lactation. Healthcare providers are advised to consider the individual circumstances of each patient when making recommendations.

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

There is no specific information 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 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 in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Healthcare providers should monitor patients 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, it is recommended that healthcare professionals initiate supportive care and symptomatic treatment as necessary.

Management procedures should include the following steps:

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

2. Supportive Care: Provide supportive care tailored to the patient's needs, which may include intravenous fluids, oxygen supplementation, or other interventions as indicated.

3. Consultation: Consider consulting a poison control center or a medical toxicologist for guidance on specific management strategies based on the substance involved and the severity of the overdose.

Due to the lack of specific overdosage information, it is imperative for healthcare professionals to remain vigilant and utilize their clinical judgment in managing any suspected cases of overdosage.

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

Reports of adverse events have been received through voluntary submissions and surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events to the designated contact number, 1-800-245-2898, available Monday through Friday from 9 AM to 4 PM EST. This facilitates ongoing monitoring and assessment of the product's safety profile.

Patient Counseling

Patients should be advised to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients that they should discontinue use and consult a healthcare provider 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.

Patients should also be instructed to seek medical advice if they experience a severe sore throat, or if irritation, pain, or redness lasts or worsens. Additionally, if a sore mouth does not show improvement within 7 days, patients should be encouraged to contact their healthcare provider.

Before using this medication, patients should be advised to consult a healthcare professional 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). 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. It is essential to adhere to the recommended storage conditions to ensure the product's efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)