Mountain Herb Sugar Free with Stevia Cough Suppressant Oral Anesthetic

Description

The product is identified by the SPL Code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with a cold or inhaled irritants. Additionally, it provides temporary relief from occasional minor irritation and pain due to 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 are instructed to dissolve 2 drops (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 recommended to consult a doctor for appropriate dosing and administration guidance.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no identified risks of abuse, misuse, or dependence.

Warnings and Precautions

Patients should be advised to seek medical attention promptly if they experience a severe sore throat that persists for more than 2 days, particularly if it is accompanied or followed by symptoms such as fever, headache, rash, swelling, nausea, or vomiting, as these may indicate a serious underlying condition.

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

Healthcare providers should instruct patients to discontinue use and consult a physician if any of the following occur: a cough that persists for more than 1 week, a cough that tends to recur, or a cough accompanied by fever, rash, or persistent headache, as these symptoms may suggest a serious condition. Additionally, if a sore mouth does not show improvement within 7 days, or if irritation, pain, or redness persists or worsens, medical advice should be sought.

Monitoring for these symptoms is essential to ensure patient safety and to facilitate timely intervention if 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 or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

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 use.

For pediatric patients aged 6 years and older, the recommended dosage is to dissolve 2 drops (one at a time) slowly in the mouth without biting or chewing. This can be repeated every 2 hours as needed or as directed by a healthcare provider.

Geriatric Use

There is no specific information 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

The product has not been evaluated for safety during pregnancy. Currently, there are no specific warnings or contraindications associated with the use of this product in pregnant patients. Additionally, the prescribing information does not provide any dosage modifications for individuals who are pregnant. Furthermore, no special precautions regarding the use of this product during pregnancy are indicated. Healthcare professionals should consider the lack of safety data when prescribing this product to women of childbearing potential and weigh the potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific concerns have been identified in the available information.

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 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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

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.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the 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.

Providers should also encourage patients to consult with their doctor before using the 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). This ensures that patients receive appropriate care and management for their symptoms.

Storage and Handling

The product is supplied in configurations that ensure optimal preservation of its integrity. It is essential to protect the product from heat and moisture to maintain its efficacy.

Storage conditions should be carefully monitored, ensuring that the product is kept in a controlled environment that mitigates exposure to these elements. Proper handling practices must be adhered to in order to preserve the quality and effectiveness of the product throughout its shelf life.

Additional Clinical Information

The product is administered orally, with specific instructions for different age groups. Adults and children aged 6 years and older should dissolve 2 drops (one at a time) slowly in the mouth without biting or chewing, repeating every 2 hours as needed or as directed by a healthcare professional. For children under 6 years, consultation with a doctor is advised prior to use.

Clinicians should counsel patients on the potential for excessive use to result in a laxative effect. Additionally, the product may be beneficial for diabetic patients when used under medical guidance. 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)