Herbal Throat Drops

Description

The product is identified by SPL Code 34089-3 and is formulated as a lemon mint herb drop. It comprises several inactive ingredients, including sugar, citric acid, natural lemon flavor, and natural mint flavor.

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 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 healthcare professional.

Contraindications

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

• If a severe sore throat occurs, or if irritation, pain, or redness persists or worsens.

• If a sore mouth does not show improvement within 7 days.

These recommendations are made to ensure patient safety and to address potential underlying conditions that may require medical attention.

Warnings and Precautions

Patients should be aware of the following warnings and precautions regarding the use of this medication.

Sore Throat Warning Severe sore throat that persists for more than 2 days warrants immediate medical consultation. Additionally, if the sore throat is accompanied or followed by symptoms such as fever, headache, rash, swelling, nausea, or vomiting, it is imperative to seek medical attention promptly. These symptoms may indicate a serious underlying condition.

Consultation Guidelines Patients are advised to discontinue use and consult a healthcare professional if they experience any of the following:

• Severe sore throat or if irritation, pain, or redness lasts or worsens.

• Sore mouth symptoms that do not show improvement within 7 days.

In such cases, timely intervention is crucial to address potential complications. Regular monitoring of symptoms is recommended to ensure safe use of the medication.

Side Effects

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

Severe adverse reactions include symptoms associated with sore throat. Patients should be advised to consult a doctor promptly if they experience 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. These symptoms may indicate a serious condition that requires immediate medical attention. Additionally, if symptoms of a sore mouth do not improve within 7 days, patients should seek advice from a dentist or doctor.

Common adverse reactions warranting attention include sore throat irritation, pain, or redness that lasts or worsens. In such cases, patients are advised to stop use and consult a healthcare professional. It is crucial for patients to monitor their symptoms closely and seek medical advice if their condition does not improve as expected.

Drug Interactions

No specific drug interactions have been identified for the product. 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 Herbal Throat Drops (lemon mint herbal). 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

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 currently no available data on the excretion of this drug 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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to assess the patient for any signs of toxicity or distress.

Management of an overdose should be guided by the severity of the symptoms and the clinical judgment of the healthcare provider. Supportive care and symptomatic treatment may be necessary, and the involvement of poison control experts can provide additional guidance on the appropriate management strategies.

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

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

Patient Counseling

Healthcare providers should advise patients to keep the medication out of the reach of children to prevent accidental ingestion.

Patients should be instructed to stop using the medication and consult a doctor if they experience a severe sore throat, or if irritation, pain, or redness persists or worsens. Additionally, if a sore mouth does not show improvement within 7 days, patients should seek medical advice.

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 Herbal Throat Drops, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)