Severe Throat Sore Drops

Description

The product, identified by SPL code 34089-3, is a cough drop formulated to provide temporary relief from cough and sore throat. It contains menthol as the active ingredient. Each bag contains 45 drops. The inactive ingredients include sugar, corn syrup, natural and artificial flavors, and color additives.

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 12 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.

The product is not recommended for use in children under 12 years of age.

Contraindications

There are no specific contraindications identified for this product. However, it is advised to discontinue use and consult a healthcare professional if symptoms of a sore mouth do not improve within 7 days, or if irritation, pain, or redness persists or worsens.

Warnings and Precautions

Severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, or vomiting, may indicate a serious condition. In such cases, it is imperative to consult a healthcare professional promptly. This product should not be used for more than 2 days consecutively, and it is contraindicated for children under 12 years of age.

Healthcare professionals should advise patients to discontinue use and seek medical attention if symptoms of a sore mouth do not show improvement within 7 days. Additionally, if any irritation, pain, or redness persists or worsens, it is essential to stop taking the product and consult a doctor for further evaluation and management.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, and vomiting. Such symptoms may indicate a serious condition, and patients are advised to consult a doctor promptly. It is important to note that the product should not be used for more than 2 days, and it is contraindicated for children under 12 years of age.

Common adverse reactions necessitate immediate cessation of use and consultation with a healthcare professional if sore mouth symptoms do not improve within 7 days, or if irritation, pain, or redness persists or worsens.

Patients should also seek medical advice prior to use if they have a severe sore throat that is accompanied by difficulty in breathing or lasts more than 2 days. Additionally, those experiencing a sore throat with fever, headache, rash, swelling, nausea, or vomiting should consult a doctor before using the product.

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 the current information.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is to dissolve 1 drop slowly in the mouth, which may be repeated every 2 hours as needed or as directed by a healthcare professional.

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, 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. It is important to assess the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

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 prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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 event of an accidental 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 overdosage.

Healthcare professionals should be vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain informed about the appropriate protocols for managing overdose situations, ensuring that patients receive timely and effective care.

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 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 designated support line at 1-617-848-4560, available Monday to Friday from 9 AM to 4 PM Eastern Time.

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 stop using the medication and consult a doctor if symptoms of a sore mouth do not improve within 7 days, or if they experience any irritation, pain, or redness that persists or worsens.

Additionally, healthcare providers should encourage patients to seek medical advice before using the medication if they have a severe throat condition that is accompanied by difficulty in breathing or lasts more than 2 days. Patients should also be advised to consult a doctor if they experience a sore throat along with fever, headache, rash, swelling, nausea, or vomiting.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is recommended to store the product in a cool and dry place to maintain its integrity and efficacy. Proper storage conditions are crucial to ensure the product remains effective throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)