Menthol Cough Drops

Description

The product is a menthol formulation containing menthol as the active ingredient. Inactive ingredients include pectin, sugar, water, natural and artificial flavors, citric acid, sodium citrate, sodium benzoate, potassium sorbate, and color additives as applicable. It is presented in a liquid dosage form and packaged in a 30-unit container. The SPL Code for this product is 34089-3.

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

Adults and children aged 12 years and older are instructed to dissolve 1 drop slowly in the mouth. This process may be repeated every two hours as needed or as directed by a healthcare professional.

The use of this product 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 advised to discontinue use and consult a healthcare professional if symptoms of a sore mouth do not improve within 7 days, or if irritation, pain, or redness persists or worsens.

Warnings and Precautions

Severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, and vomiting, may indicate a serious condition. In such cases, it is imperative to consult a healthcare professional promptly. This 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 attention if sore mouth symptoms do not show improvement within 7 days, or if there is a persistence or worsening of irritation, pain, or redness.

Before recommending this product, it is essential to inquire whether the patient has a severe sore throat that is accompanied by difficulty in breathing or lasts longer than 2 days. Additionally, caution should be exercised if the sore throat is associated with fever, headache, rash, swelling, nausea, or vomiting, as these symptoms may warrant further evaluation.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions include severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, and vomiting. Such symptoms may indicate a serious condition, and patients are advised to consult a doctor promptly. It is important to note that the medication should not be used for more than 2 days, and it is contraindicated for children under 12 years of age.

Common adverse reactions necessitate immediate cessation of use and consultation with a healthcare provider if sore mouth symptoms do not improve within 7 days, or if irritation, pain, or redness persists or worsens.

Before using this medication, patients should seek medical advice if they have a severe sore throat that is accompanied by difficulty in breathing or lasts more than 2 days. Additionally, patients with a sore throat that is associated with fever, headache, rash, swelling, nausea, or vomiting should also consult a doctor prior to use.

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 12 years of age should not use this medication. For adolescents 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.

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, given the lack of targeted data for this population.

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 administering this medication to lactating individuals.

Renal Impairment

There is no specific information available 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 is no information available regarding dosage adjustments, special monitoring requirements, or precautions 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.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to assess the patient for any signs of toxicity or adverse reactions.

Management of an overdose should be guided by the severity of symptoms and the clinical judgment of the healthcare provider. Supportive care and symptomatic treatment may be necessary, depending on the patient's condition. Continuous monitoring and evaluation are recommended to ensure patient safety and effective management of the overdose situation.

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

Postmarketing experience has been gathered through voluntary reports and surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events or inquiries related to the product by calling 1 833 552 1737. This information contributes to the ongoing assessment of the product's safety profile.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of the reach of children to prevent accidental ingestion. Patients should be instructed to stop using the medication and consult a doctor if sore mouth symptoms do not improve within 7 days, or if irritation, pain, or redness persists or worsens.

Additionally, healthcare providers should encourage patients to seek medical advice before using the medication if they experience a severe throat condition that is accompanied by difficulty in breathing or lasts more than 2 days. Patients should also be informed to consult a doctor if they have a sore throat that is accompanied by fever, headache, rash, swelling, nausea, or vomiting.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product in a cool and dry place to maintain its integrity and effectiveness. Proper storage conditions are crucial to ensure the product remains within its specified temperature range and is protected from moisture.

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)