Cough Drops

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available information.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with the common cold. Additionally, it provides temporary relief from occasional minor irritation or soreness of the 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 1 drop slowly in the mouth. This may be repeated every 2 hours as needed, based on symptomatology.

For children under 5 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

Use is contraindicated in patients with a persistent or chronic cough, including those associated with smoking, asthma, or emphysema, as well as in individuals experiencing a cough accompanied by excessive phlegm (mucus).

Additionally, if a cough persists for more than one week, recurs, or is accompanied by fever, rash, or persistent headache, the use of this product should be discontinued, and a healthcare professional should be consulted, as these symptoms may indicate a serious underlying condition.

Patients should also stop use and seek medical advice if a sore mouth does not improve within seven days, or if irritation, pain, or redness persists or worsens.

Warnings and Precautions

If a patient experiences a severe sore throat that persists for more than two days, or if it is accompanied by symptoms such as headache, rash, swelling, nausea, or vomiting, it is imperative to consult a healthcare professional promptly, as these may indicate a serious underlying condition.

Healthcare providers should advise patients to seek medical guidance prior to use if they have a persistent or chronic cough, particularly in cases associated with smoking, asthma, or emphysema. Additionally, patients with a cough that is accompanied by excessive phlegm (mucus) should also consult a doctor before initiating treatment.

Patients are instructed to discontinue use and contact their healthcare provider if their cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or a persistent headache, as these symptoms may signify a serious health issue. Furthermore, if a sore mouth does not show improvement within seven days, or if irritation, pain, or redness persists or worsens, medical advice should be sought.

No specific emergency medical help instructions or laboratory tests are provided in the current guidelines.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions warrant immediate medical attention and include severe sore throat, particularly if it persists for more than 2 days or is accompanied by symptoms such as headache, rash, swelling, nausea, or vomiting. These symptoms may indicate a serious underlying condition.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if they experience a cough that persists for more than 1 week, recurs, or is accompanied by fever, rash, or a persistent headache, as these may also be indicative of a serious condition. Additionally, if a sore mouth does not show improvement within 7 days, or if irritation, pain, or redness persists or worsens, patients should seek medical advice.

Monitoring for these adverse reactions is essential to ensure patient safety and effective management of symptoms.

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 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 drop slowly in the mouth, with the option to repeat every 2 hours as needed.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in consultation with the patient. Women of childbearing potential should be advised to discuss their pregnancy status and any plans for pregnancy with their healthcare provider prior to initiating treatment.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. The effects on breastfed infants have not been established.

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 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 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 excessive dosing. Symptoms of overdosage 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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and intervention strategies.

Documentation of the incident, including the amount ingested and the time of ingestion, is crucial for effective treatment 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 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 the medication out of reach of children to prevent accidental ingestion. Patients should be instructed to consult a doctor before using the medication if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, or emphysema. Additionally, patients should be made aware that if their cough is accompanied by excessive phlegm (mucus), they should seek medical advice.

Patients must be informed to discontinue use and consult a doctor if their cough persists for more than one week, tends to recur, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious condition. They should also be advised to seek medical attention if a sore mouth does not improve within 7 days or if irritation, pain, or redness persists or worsens.

For adults and children aged 5 years and older, it is recommended to dissolve 1 drop slowly in the mouth and repeat every 2 hours as needed. For children under 5 years of age, patients should be instructed to consult a doctor before use.

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 dry place, ensuring that it is protected from direct sunlight to maintain its integrity and efficacy. Proper handling and storage conditions are crucial for preserving the quality of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)