Throat Coat

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation due to the common cold and inhaled irritants. Additionally, it provides temporary relief from occasional minor irritations, pain, sore mouth, 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 should dissolve one lozenge slowly in the mouth. This process may be repeated every 2 hours as needed or as directed by a healthcare professional, with a maximum of 5 lozenges per day.

For children under 12 years of age, it is recommended to consult a healthcare professional for appropriate dosing guidance.

Contraindications

Use is contraindicated in individuals with a known allergy to any of the ingredients. Additionally, the product should not be used if it is manufactured in a facility that also processes coconut oil, due to the potential for cross-contamination and subsequent allergic reactions.

Warnings and Precautions

Severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition. Healthcare professionals should advise patients to consult a physician promptly in such cases. It is important to note that the product should not be used for more than 2 days or administered to children under 12 years of age unless directed by a physician.

Patients should be cautioned against using this product if they have a known allergy to any of its ingredients. Additionally, it is manufactured in a facility that also processes coconut oil, which may pose a risk for individuals with coconut allergies.

Healthcare providers should instruct patients to discontinue use and seek medical advice if the cough persists for more than one week, recurs, or is accompanied by fever, rash, or persistent headache, as these symptoms may signify a serious underlying condition. Similarly, if a sore throat is severe, lasts longer than 2 days, or is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, medical consultation is warranted. Patients should also be advised to seek medical attention if symptoms of a sore mouth do not improve within 7 days, or if irritation, pain, or redness persists or worsens.

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, or vomiting. Such symptoms may indicate a serious condition, and patients are advised to consult a physician promptly. It is important to note that the medication should not be used for more than 2 days or administered to children under 12 years of age unless directed by a physician.

Common adverse reactions warranting discontinuation of use and consultation with a healthcare provider include a cough that persists for more than one week, recurs, or is accompanied by fever, rash, or persistent headache. Additionally, patients should stop use and seek medical advice if a sore throat is severe, lasts more than 2 days, or is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting. Symptoms of a sore mouth that do not improve within 7 days, or if irritation, pain, or redness persists or worsens, also necessitate medical consultation.

Before using this medication, patients should ask a doctor if they have a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Throat Coat (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication unless directed by a physician. It is advised that caregivers consult a healthcare professional before administering this medication to children in this age group.

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

The available prescribing information does not provide specific data regarding the use of this product during pregnancy, including safety concerns, dosage modifications, or special precautions. Therefore, healthcare professionals are advised to exercise caution when prescribing this product to pregnant patients. The potential risks and benefits should be carefully considered, and alternative therapies may be explored in consultation with the patient. Women of childbearing potential should be informed of the lack of data and encouraged to discuss any concerns with their healthcare provider.

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 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 overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or toxicology expert may also be warranted to guide management decisions.

It is crucial to document all findings and interventions in the patient's medical record and to report any adverse events to the appropriate regulatory authorities as required.

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.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. Patients should be instructed not to use the product if they have a known allergy to any of its ingredients or if they are aware that it is manufactured in a facility that also handles coconut oil.

Patients should be informed to stop using the medication and consult a doctor 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 indicate a serious condition. Additionally, they should seek medical advice if they experience a severe sore throat that lasts more than two days or is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting. If symptoms of a sore mouth do not improve within seven days, or if irritation, pain, or redness persists or worsens, patients should also stop use and contact a healthcare professional.

Furthermore, patients should be encouraged to ask a doctor before using the medication if they have a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in a secure outer wrap to ensure integrity. It is essential to store the product in a cool, dry place to maintain its quality and efficacy. Healthcare professionals should be advised not to use the product if the outer wrap is opened or missing, as this may compromise the safety and effectiveness of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)