Mountain Herb Sugar Free with Stevia Cough Suppressant Oral Anesthetic

Description

The product is identified by the SPL Code 34089-3. It is represented visually by the image file named SFMountainHerbwStevia19ct.jpg, which is in JPEG format. The media type associated with this image is image/jpeg.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with a cold or inhaled irritants. It is also indicated for the alleviation of occasional minor irritation and pain resulting from sore throat or sore mouth.

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

Dosage and Administration

Adults and children aged 6 years and older should dissolve 2 drops of the medication, one at a time, slowly in the mouth. It is important that the drops are not bitten or chewed. This process may be repeated every 2 hours as needed or as directed by a healthcare professional.

For children under 6 years of age, it is advised to consult a doctor before administration.

Contraindications

There are no specific contraindications identified for this product. However, healthcare professionals should advise patients to discontinue use and consult a physician under the following circumstances:

• If cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious condition.

• If sore mouth symptoms do not improve within 7 days.

• If irritation, pain, or redness persists or worsens.

Warnings and Precautions

If a patient experiences a severe sore throat that persists for more than 2 days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, it is imperative to consult a healthcare professional promptly, as these symptoms may indicate a serious underlying condition.

This product is contraindicated for use in children under 6 years of age unless specifically directed by a healthcare provider.

Healthcare professionals should advise patients to discontinue use and seek medical advice if the following occur:

• Cough persists for more than 1 week, recurs, or is accompanied by fever, rash, or a persistent headache, as these may be indicative of a serious condition.

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

• Any irritation, pain, or redness persists or worsens.

Monitoring for these symptoms is essential to ensure patient safety and to facilitate timely medical intervention when necessary.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions include severe sore throat, which, if it persists for more than 2 days or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, necessitates prompt consultation with a healthcare provider. Additionally, patients should be advised against using this medication in children under 6 years of age unless specifically directed by a doctor.

Common adverse reactions warranting attention include a persistent cough that lasts more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, as these symptoms may indicate a serious underlying condition. Patients should also seek medical advice if a sore mouth does not improve within 7 days or if there is ongoing irritation, pain, or redness that persists or worsens.

Before using this medication, patients should consult a healthcare professional if they have a persistent 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 no specific drug interactions identified for the product, nor are there any noted interactions with laboratory tests. As such, no dosage adjustments or monitoring recommendations are necessary based on the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Mountain Herb Sugar Free with Stevia Cough Suppressant Oral Anesthetic (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should not use this medication unless directed by a healthcare professional. For children in this age group, it is advised to consult a doctor before administration.

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

There are no specific warnings, precautions, or dosage modifications regarding the use of MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETIC (menthol lozenge) in pregnant patients. The prescribing information does not indicate whether the product is contraindicated during pregnancy or if there are any associated risks to the fetus. Additionally, no safety concerns related to the use of this product during pregnancy have been provided. Healthcare professionals should consider the absence of data when advising women of childbearing potential regarding the use of this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney function.

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 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Furthermore, specific antidotes or treatments may be indicated depending on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide management decisions and ensure optimal patient care.

Overall, vigilance and prompt intervention are critical in managing cases of suspected overdose, even in the absence of detailed information regarding specific overdosage effects.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

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

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 mouth does not improve within 7 days, or if irritation, pain, or redness persists or worsens, patients should seek medical advice.

It is also important for healthcare providers to remind patients to consult their doctor before using this medication if they have a persistent 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 configurations that include specific NDC numbers. It is essential to protect the product from heat and moisture to maintain its integrity. Proper storage conditions should be observed to ensure optimal efficacy and safety.

Additional Clinical Information

The product is administered orally. Clinicians should counsel patients that excessive use may lead to a laxative effect. Additionally, the product may be beneficial for diabetic patients, but this should be undertaken only under the guidance of a healthcare professional. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Mountain Herb Sugar Free with Stevia Cough Suppressant Oral Anesthetic, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)