Equate Menthol Chewable Gels

Description

Equate Menthol Soft Lozenge is presented in a package containing 30 lozenges. Each lozenge is formulated to provide menthol as the active ingredient, which is utilized for its soothing properties. The dosage form is a soft lozenge, designed for oral administration. The product is intended for temporary relief of throat irritation and cough.

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 one soft lozenge 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

Use of this product is contraindicated in the following situations:

Patients should discontinue use and consult a healthcare professional if 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.

Additionally, patients should stop use and seek medical advice if they experience severe sore throat, or if irritation, pain, or redness lasts or worsens.

If sore mouth does not improve within 7 days, medical consultation is also advised.

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, 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, immediate consultation with a healthcare provider is warranted. Lastly, if symptoms of a sore mouth do not improve within seven days, patients should be instructed to seek medical attention.

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 severe sore throat that persists for more than 2 days, or if it is accompanied or followed 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 that require attention include a cough that persists 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.

It is important for patients to monitor their symptoms closely and seek medical advice if any of the aforementioned conditions arise.

Drug Interactions

There are no documented 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 Chewable Gels (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 5 years and older are instructed to dissolve one soft lozenge in the mouth and may repeat this every 2 hours as needed or as directed by a healthcare professional. For children under 5 years of age, consultation with a doctor is recommended prior to use.

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 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

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial, as the symptoms of an overdose can vary significantly depending on the substance involved. Therefore, a thorough assessment and appropriate management strategies should be implemented as soon as possible to mitigate potential risks and complications associated with the overdose.

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

No postmarketing experience details are available in the insert text.

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 symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying 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 various package configurations, with specific NDC numbers available for identification. Currently, there are no specific 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 Equate Menthol Chewable Gels, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)