Menthol Cough Drops

Description

Meijer Menthol Cough Drops are formulated to provide symptomatic relief for coughs. Each drop contains menthol as the active ingredient, which acts as a cough suppressant. The product is presented in a dosage form of lozenges, with a total count of 30 drops per package. The cough drops are designed for oral administration and are intended for temporary relief of throat irritation and 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, as well as for the alleviation of occasional minor irritation and sore throat.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

Adults and children aged 5 years and older are instructed to dissolve one lozenge slowly in the mouth. This process may be repeated every 2 hours as needed or as directed by a healthcare professional.

For children under 5 years of age, it is recommended to consult a doctor before administration.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional if any of the following conditions occur:

• 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.

• Severe sore throat or if irritation, pain, or redness lasts or worsens.

• Sore mouth does not improve within 7 days.

Warnings and Precautions

If a patient experiences a severe sore throat that persists for more than two days, or if it 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.

Patients should discontinue use and contact their healthcare provider if any of the following occur: a cough that persists for more than seven days, a cough that tends to recur, or a cough accompanied by fever, rash, or a persistent headache. These symptoms may signify a serious health issue. Furthermore, if the sore throat is severe or if irritation, pain, or redness lasts or worsens, immediate medical consultation is advised. It is also essential to seek medical attention if sore mouth symptoms do not improve within seven days.

While no specific emergency medical instructions or general precautions are provided, healthcare professionals should remain vigilant for any signs of serious conditions in patients presenting with the aforementioned symptoms. Regular monitoring and appropriate laboratory tests may be warranted based on the clinical judgment of the healthcare provider.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious reactions warrant immediate medical attention, particularly in the case of severe sore throat, which may be accompanied by symptoms such as fever, headache, rash, swelling, nausea, or vomiting. If a sore throat persists for more than two days or if sore mouth symptoms do not improve within seven days, patients are advised to consult a healthcare professional promptly, as these symptoms may indicate a serious condition.

Common adverse reactions include persistent cough, which should be evaluated if it lasts longer than seven days, recurs, or is accompanied by fever, rash, or persistent headache. These signs may suggest an underlying serious condition that requires medical assessment. Additionally, patients should seek medical advice if they experience severe sore throat or if irritation, pain, or redness lasts or worsens.

Patients with a history of persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should consult a doctor before using this medication. Furthermore, those experiencing a cough accompanied by excessive phlegm (mucus) should also seek medical guidance prior to use.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

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 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

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.

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 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 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 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 these patients to ensure safety and efficacy.

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, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with 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

Adverse events have been reported voluntarily and through surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events by calling 1-800-245-2898, available Monday through Friday from 9 AM to 4 PM EST. This reporting helps to enhance the understanding of the safety profile of the product.

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 a doctor 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. Additionally, patients should seek medical advice if they experience a severe sore throat, or if irritation, pain, or redness lasts or worsens. If a sore mouth does not improve within 7 days, patients should also consult their healthcare provider.

It is important for healthcare providers to remind patients to ask a doctor before using the medication if they have a persistent or chronic cough, such as that which occurs with smoking, asthma, or emphysema. Patients should also be advised to consult a healthcare professional if their cough is accompanied by excessive phlegm (mucus).

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. Specific temperature ranges for storage have not been provided; therefore, it is advisable to adhere to standard storage conditions for similar products. Proper handling is essential to maintain the quality and efficacy of the product.

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)