Cough Drops Menthol

Description

The product, identified by SPL code 34089-3, contains menthol as the active ingredient. Menthol is a colorless or white crystalline substance characterized by its distinct odor and taste. The formulation includes several inactive ingredients: corn starch, dextrose, gelatin, glycerin, magnesium stearate, natural and artificial flavors, sugar, and water.

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 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 may be repeated every 2 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 specific contraindications identified for 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 administration to children under 12 years of age.

Healthcare professionals should advise patients to discontinue use and seek medical attention if symptoms of a sore mouth do not show improvement within 7 days. Additionally, if any irritation, pain, or redness persists or worsens during treatment, it is essential to stop taking the product and consult a doctor. Monitoring for these symptoms is crucial to ensure patient safety and effective management of potential complications.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, and vomiting. Such symptoms may indicate a more serious condition, and patients are advised to consult a doctor promptly. It is important to note that the product 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 medical consultation if symptoms do not improve within 7 days. Patients should stop use and seek medical advice if they experience sore mouth symptoms that persist or worsen, including irritation, pain, or redness.

Additionally, patients are encouraged to ask a doctor before use if they have a severe sore throat that is accompanied by difficulty in breathing or lasts more than 2 days. They should also consult a healthcare professional if their sore throat is associated with fever, headache, rash, swelling, nausea, or vomiting.

Drug Interactions

No drug interactions have been identified in the available data. Additionally, there are no reported interactions between drugs and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Cough Drops Menthol (menthol cough drops). 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 2 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 maternal health. 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 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 event of an accidental overdose, it is imperative to seek immediate medical assistance. Healthcare professionals should advise patients or caregivers to contact a Poison Control Center at 1-800-222-1222 without delay.

Prompt intervention is crucial in managing potential overdose situations, as timely medical help can significantly mitigate risks and complications associated with excessive intake. It is essential for healthcare providers to be aware of the signs and symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information.

Management of an overdose may involve supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and assessment are recommended to ensure patient safety and to address any complications that may develop.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication and all other drugs out of the reach of children to prevent accidental ingestion.

Patients should be instructed to stop using the medication and consult a doctor if symptoms of a sore mouth do not improve within 7 days, or if they experience any irritation, pain, or redness that persists or worsens.

It is important for patients to seek medical advice before using this medication if they have a severe throat condition that is accompanied by difficulty in breathing or lasts more than 2 days. Additionally, patients should be encouraged to consult a doctor if they have a sore throat that is accompanied by fever, headache, rash, swelling, nausea, or vomiting, as these may indicate a more serious condition.

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 quality parameters.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)