Herbal Throat Drops Lemon Mint Herb

Description

The product is a liquid herbal supplement identified by SPL Code 34089-3. It contains a proprietary blend of herbal extracts, with active ingredients including Lemon Balm Extract, Peppermint Extract, and various other herbal components. Inactive ingredients consist of Glycerin, Purified Water, and Natural Flavor. The supplement is packaged in a bottle containing 45 units. The liquid formulation is characterized as clear to slightly cloudy and possesses a distinct herbal aroma.

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 1 drop slowly in the mouth. This process may be repeated every 2 hours as needed or as directed by a healthcare professional.

For children under 6 years of age, dosing should be determined and directed by a physician.

Contraindications

There are no contraindications listed for this product. However, it is essential to adhere to the recommended dosage guidelines to avoid potential adverse effects. Exceeding the recommended dosage may lead to complications, and therefore, should be strictly avoided.

Warnings and Precautions

Severe sore throat symptoms warrant immediate medical attention. If a patient experiences a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, it is imperative to consult a healthcare professional promptly. Additionally, if symptoms related to a sore mouth do not show improvement within seven days, the patient should seek evaluation from a dentist or physician, as these symptoms may indicate a serious underlying condition.

It is crucial to adhere to the recommended dosage guidelines. Exceeding the prescribed dosage can lead to adverse effects and complications.

Patients should be advised to discontinue use and consult a healthcare provider if they experience a severe sore throat, or if irritation, pain, or redness persists or worsens. Furthermore, if sore mouth symptoms do not improve within a week, medical consultation is necessary.

In the event of an overdose, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay. Prompt action is essential to mitigate potential health risks associated with overdose situations.

Side Effects

Patients may experience a range of adverse reactions, some of which may require prompt medical attention. A notable warning pertains to sore throat symptoms. If a patient experiences a severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, it is advised that they consult a doctor promptly. Additionally, if symptoms of a sore mouth do not improve within 7 days, patients should seek evaluation from a dentist or doctor, as these symptoms may indicate a serious condition.

It is crucial for patients to be aware of these signs and to take appropriate action if they occur, as they may signify underlying health issues that require further investigation and management.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been noted in the available data. 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 Herbal Throat Drops Lemon Mint Herb (throat drops). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 years and older are instructed to dissolve 1 drop slowly in the mouth, with the option to repeat every 2 hours as needed or as directed by a healthcare professional. For children under 6 years of age, dosing should be determined by a doctor.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers should consider individual circumstances and the specific needs of the patient when making recommendations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 event of an overdosage, there is currently no specific information available regarding the effects or management of such an occurrence. Healthcare professionals are advised to monitor the patient closely for any unusual symptoms and to provide supportive care as necessary.

Given the absence of detailed guidance, it is recommended that healthcare providers consult local poison control centers or relevant medical authorities for further assistance in managing potential overdosage situations. Continuous assessment of the patient's condition is essential to ensure appropriate interventions are implemented promptly.

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

Postmarketing experience has included the collection of voluntary reports and data from surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events associated with the use of the product. For inquiries or to report an adverse event, individuals may contact 1-888-423-0139.

Patient Counseling

Healthcare providers should advise patients to keep this product out of the reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients must be reminded not to exceed the recommended dosage while using this product. It is important for healthcare providers to inform patients to stop using the product and consult a doctor if they experience a severe sore throat, or if irritation, pain, or redness persists or worsens. Additionally, patients should be advised to seek medical attention if a sore mouth does not improve within 7 days.

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 quality parameters.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)