Cough Drops

Description

The drug is a white to off-white, crystalline powder. Its chemical name is insert chemical name here. The molecular formula is insert molecular formula here, and it has a molecular weight of insert molecular weight here. Inactive ingredients include insert inactive ingredients here.

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.

Limitations of Use: There are no known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 5 years and older are instructed to dissolve 1 drop slowly in the mouth. This process may be repeated every 2 hours as needed. For children under 5 years of age, it is recommended to consult a physician prior to administration. The route of administration is oral, and the method involves allowing the drop to dissolve slowly in the mouth.

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).

Discontinue use if the cough persists for more than one week, recurs, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious underlying condition. Additionally, if a sore mouth does not improve within 7 days, or if irritation, pain, or redness persists or worsens, the product should be stopped.

Warnings and Precautions

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

Healthcare professionals 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 should be instructed to discontinue use and contact their healthcare provider if the cough persists for more than one week, recurs, or is accompanied by fever, rash, or a persistent headache, as these may be indicative of a serious underlying condition. Furthermore, if a sore mouth does not show improvement within seven days, or if any irritation, pain, or redness persists or worsens, it is essential to seek medical advice.

Side Effects

Patients may experience a range of adverse reactions, some of which may require prompt medical attention.

Severe adverse reactions include a sore throat that is severe, persists for more than 2 days, or is accompanied by headache, rash, swelling, nausea, or vomiting. Such symptoms should prompt immediate consultation with a healthcare provider, as they may indicate a serious condition. Additionally, a cough that persists for more than 1 week, recurs, or is accompanied by fever, rash, or persistent headache may also signal a serious underlying issue and should be evaluated by a physician.

Other notable adverse reactions include a sore mouth that does not improve within 7 days, as well as irritation, pain, or redness that persists or worsens. These symptoms should be monitored closely, and if they do not resolve, patients are advised to seek medical advice.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations 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 should be kept out of reach of children. For adults and 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. For children under 5 years of age, it is advised to consult a doctor before use.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of Cough Drops (menthol tablet, orally disintegrating) during pregnancy. As such, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

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

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 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, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, respiratory depression, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include airway management, oxygen supplementation, and intravenous fluids as necessary. The use of specific antidotes should be considered based on the clinical scenario and the substances involved.

Furthermore, it is advisable to contact a poison control center or a medical toxicologist for guidance on the management of overdose cases. Continuous monitoring and reassessment of the patient’s condition are crucial to ensure appropriate therapeutic interventions are implemented promptly.

Documentation of the incident, including the substance involved, estimated dose, time of exposure, and any symptoms observed, is critical for ongoing management and future reference.

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

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, or if the cough is accompanied by excessive phlegm (mucus).

Patients should be informed that 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, they should seek medical attention, as these may indicate a serious underlying condition. Additionally, if a sore mouth does not improve within 7 days, patients should contact their healthcare provider for further evaluation.

It is important to advise patients to report any irritation, pain, or redness that persists or worsens, as this may require medical assessment.

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 place to maintain its integrity and efficacy. Proper storage conditions are crucial for ensuring the product remains effective throughout its shelf life.

Additional Clinical Information

The medication is administered sublingually. For adults and 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. For children under 5 years of age, it is advised to consult a doctor for appropriate guidance.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

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)