Throat Coat

Description

No description information is available for the 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 for 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 over 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 is manufactured in a facility that also processes coconut oil, which may pose a risk for those with coconut allergies.

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 this 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 stop use 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 require medical attention.

Before using this medication, patients should consult 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 should not use this medication for more than 2 days or be administered to children under 12 years of age unless directed by a physician. For children under 12 years, 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 adverse effects or changes in therapeutic response, 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 warranted based on individual patient circumstances. Women of childbearing potential should be informed of the lack of data and encouraged to discuss any concerns with their healthcare provider.

Lactation

Nursing mothers should consult a physician before using this product. There is a potential for excretion in breast milk, and the safety of this product during lactation has not been established. Caution is advised when administering this product to nursing mothers.

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

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on clinical judgment.

For further guidance, healthcare professionals may refer to established protocols for managing drug overdosage or consult a poison control center.

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.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. Patients should be informed 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 instructed 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, if a sore throat is severe, lasts more than two days, or is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, patients should seek medical advice. They should also be informed that if symptoms of a sore mouth do not improve within seven days, or if irritation, pain, or redness persists or worsens, they should contact their healthcare provider.

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 efficacy. Healthcare professionals should be advised not to use the product if the outer wrap is opened or missing, as this may compromise the quality and safety 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)