The Original Natural Herb Cough Drops

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

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. 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 before administration.

Contraindications

There are no specific contraindications listed 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, recurs, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious condition.

• If a sore mouth does 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 two 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 in children under 6 years of age unless specifically directed by a physician.

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

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

• A sore mouth that does not show improvement within seven days.

• Any irritation, pain, or redness that persists or worsens, necessitating further evaluation.

Monitoring for these symptoms is essential to ensure patient safety and effective management of potential complications.

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, warrants prompt consultation with a healthcare provider. Additionally, patients should be advised not to use this medication in children under 6 years of age unless directed by a doctor.

Common adverse reactions necessitating a stop in use and consultation with a healthcare provider include a cough that persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious underlying condition. Patients should also seek medical advice if a sore mouth does not improve within 7 days or if irritation, pain, or redness persists or worsens.

Before using this medication, patients should consult a doctor 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

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of The Original Natural Herb Cough Drops (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, with the option to repeat 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The available data does not indicate any specific warnings, precautions, or dosage modifications for the use of this product during pregnancy. Healthcare professionals should consider the absence of documented risks when prescribing this product to pregnant patients. However, as with any medication, the potential benefits must be weighed against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled regarding the importance of informing their healthcare provider if they become pregnant or plan to become pregnant while using this product.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any effects on breastfed infants.

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 of these patients.

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 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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for effective management and follow-up 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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 discontinue use 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 underlying condition. Additionally, if a sore mouth does not show improvement 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 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 guidance tailored to their specific health conditions.

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 imperative to store the product in a 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

The medication is administered orally. For adults and children aged 6 years and older, the recommended dosage is to dissolve 2 drops (one at a time) 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, it is advised to consult a doctor for appropriate guidance.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for The Original Natural Herb Cough Drops, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)