Equate Severe Menthol Throat Drop

Description

Equate Severe Menthol Throat Drops are formulated to provide symptomatic relief for sore throats. Each drop contains menthol as the active ingredient, which acts as a local anesthetic to soothe throat irritation. The product is presented in a convenient dosage form of throat drops, with a total count of 45 drops per package. The appearance of the drops is consistent with standard menthol throat lozenges, designed for ease of use and effective delivery of the active ingredient.

Uses and Indications

This drug is indicated for the temporary relief of occasional minor irritation and pain associated with sore throat and sore mouth.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 12 years and over, the recommended dosage is to dissolve 1 drop slowly in the mouth. This may be repeated every two hours as needed or as directed by a healthcare professional.

The use of this medication is not recommended for children under 12 years of age.

Contraindications

There are no specified contraindications for the use of this product. However, it is essential to adhere to the recommended dosage guidelines, as exceeding the recommended dosage may lead to adverse effects.

Warnings and Precautions

Severe sore throat may indicate a more serious condition. If a patient experiences a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, it is imperative to consult a healthcare professional promptly. The product should not be used for more than 2 days, and it is contraindicated for children under 12 years of age.

Healthcare professionals should advise patients to discontinue use and seek medical advice if symptoms do not improve within 7 days or if irritation, pain, or redness persists or worsens.

No specific emergency medical help instructions are provided; however, it is essential for healthcare providers to remain vigilant and assess the need for immediate intervention based on the patient's clinical presentation.

Currently, there are no laboratory tests recommended for monitoring the safe use of this product.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe sore throat, particularly if it is accompanied by difficulty in breathing, fever, headache, rash, swelling, nausea, or vomiting. In such cases, patients are advised to consult a doctor promptly.

Common adverse reactions may include sore throat, which should not be used for more than 2 days. If a sore throat persists for more than 2 days or is accompanied by any of the aforementioned symptoms, medical consultation is recommended. Additionally, if a sore mouth does not improve within 7 days, or if irritation, pain, or redness persists or worsens, patients should stop use and seek medical advice.

It is important for patients to be aware of these warnings and to seek medical attention as necessary to ensure their safety and well-being.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Equate Severe Menthol Throat Drop (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For patients aged 12 years and older, the recommended dosage is to dissolve 1 drop slowly in the mouth, with the option to repeat every two hours as needed or as directed by a healthcare professional. Caution is advised when considering the use of this medication in pediatric populations, particularly in those under the age of 12.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 mothers.

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 to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for 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 maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management 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 compound in these areas.

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 information contributes to the ongoing monitoring of the product's safety profile.

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 their doctor if their sore mouth does not improve within 7 days, or if they experience persistent or worsening irritation, pain, or redness.

It is important for healthcare providers to emphasize that patients should not exceed the recommended dosage of the medication. Additionally, patients should be encouraged to ask their doctor before using the medication if they have a severe sore throat that is accompanied by difficulty in breathing or lasts more than 2 days. They should also seek medical advice if their sore throat is accompanied by fever, headache, rash, swelling, nausea, or vomiting.

Storage and Handling

The product is supplied in a secure bag that must not be used if it is torn or open. It is essential to ensure the integrity of the packaging prior to use to maintain product safety and efficacy.

Storage conditions should be monitored to prevent any compromise of the product. Specific temperature ranges and container requirements are not provided; however, general best practices for storage should be followed to ensure optimal product stability. Special handling needs should be adhered to, particularly regarding the condition of the packaging, to avoid any potential contamination or degradation of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)