Lemon Mint Herb Throat Drops

Description

The product is identified by the SPL code 34089-3 and is formulated as a cough drop with a lemon mint flavor. Each cough drop contains 10 mg of menthol as the active ingredient. This formulation is sugar-free and includes the following inactive ingredients: citric acid, flavor, glycerin, maltodextrin, and sodium bicarbonate.

Uses and Indications

This drug is indicated for the temporary relief of occasional minor irritation and pain associated with sore mouth and sore throat.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 6 years and older are instructed to dissolve 2 drops slowly in the mouth, one at a time. This dosage may be repeated every 2 hours as needed or as directed by a healthcare professional.

For children under 6 years of age, the dosage should be determined and directed by a healthcare professional.

Contraindications

There are no specific contraindications identified for this product. However, it is advised to discontinue use and consult a healthcare professional under the following circumstances:

• If symptoms of a sore mouth do not improve within 7 days, or if irritation, pain, or redness persists or worsens.

• If a sore throat is severe, or if irritation, pain, or redness lasts or worsens.

Warnings and Precautions

Severe or persistent sore throat accompanied by high fever, headache, nausea, and vomiting may indicate a serious condition. Healthcare professionals are advised to instruct patients to seek medical attention promptly under these circumstances. Additionally, if symptoms of a sore mouth do not show improvement within 7 days, patients should be encouraged to consult their dentist or physician, as these symptoms may signify a more serious underlying issue.

Patients should be advised to discontinue use and contact their healthcare provider if they experience any of the following: sore mouth symptoms that do not improve within 7 days, or if they notice any irritation, pain, or redness that persists or worsens. It is crucial for healthcare professionals to monitor these symptoms closely and provide appropriate guidance to ensure patient safety and effective management of their condition.

Side Effects

Patients may experience a range of adverse reactions, which can vary in seriousness and frequency.

Severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, and vomiting, may indicate a serious condition. Patients are advised to consult a doctor promptly if they experience these symptoms. Additionally, if sore mouth symptoms do not improve within 7 days, it is recommended that patients see their dentist or doctor, as these symptoms may also be serious.

In the context of over-the-counter (OTC) use, patients should discontinue use and seek medical advice if sore mouth symptoms do not improve in 7 days, or if they experience persistent or worsening irritation, pain, or redness. Similarly, patients should consult a doctor if they encounter a severe sore throat or if irritation, pain, or redness lasts or worsens.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. 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 Lemon Mint Herb Throat Drops (sugar free lemon mint herb). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should consult a healthcare professional before use. For children aged 6 years and older, the recommended dosage is to dissolve 2 drops slowly in the mouth, one at a time. This dosage may be repeated every 2 hours as needed or as directed by a healthcare provider.

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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt action is crucial to mitigate potential adverse effects associated with overdosage.

Healthcare professionals should be aware that the symptoms of overdose may vary depending on the specific substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should monitor the patient closely for any signs of toxicity and initiate interventions as necessary. This may include administering activated charcoal if the patient presents within a suitable timeframe and is alert, as well as providing intravenous fluids and other supportive measures as indicated.

It is vital for healthcare professionals to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the safety and well-being of the patient.

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 use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has been gathered through voluntary reports and surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events or concerns regarding the product. For inquiries or to report an adverse event, individuals may contact the dedicated helpline at 1-833-552-1767.

Patient Counseling

Healthcare providers should advise patients to keep this medication and all other drugs out of the reach of children to prevent accidental ingestion.

Patients should be instructed to discontinue use and consult a doctor if symptoms of a sore mouth do not improve within 7 days. Additionally, they should seek medical advice if they experience any irritation, pain, or redness that persists or worsens during treatment.

It is also important for healthcare providers to inform patients to stop using the medication and consult a doctor if they experience a severe sore throat or if irritation, pain, or redness lasts or worsens. Emphasizing these points will help ensure patients are aware of when to seek further medical evaluation.

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 and dry place to maintain its integrity and effectiveness. Proper storage conditions are crucial to ensure the product remains within its specified temperature range and is protected from moisture.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)