The Original Natural Herb Cough Drops

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. It is also indicated for the alleviation of 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 1 drop 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 show improvement 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 if it is accompanied or followed by symptoms such as fever, headache, rash, swelling, nausea, or vomiting, it is imperative to consult a healthcare professional promptly, as these 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 conditions occur:

• Cough that 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 health issue.

• A sore mouth that does not show improvement within 7 days.

• Any irritation, pain, or redness that 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 immediate medical attention include a cough that persists for more than 1 week, recurs, 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 irritation, pain, or redness persists or worsens.

Before using this medication, patients should consult a healthcare provider 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 specific drug interactions have been identified for this medication. 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 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 pediatric patients aged 6 years and older, the recommended dosage is to dissolve 1 drop slowly in the mouth, with the option to repeat every 2 hours as needed or as directed by a doctor. For children under 6 years, it is advised to consult a doctor before use.

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

There is no specific information regarding the use of THE ORIGINAL NATURAL HERB COUGH DROPS during pregnancy. As such, the safety of this product in pregnant patients has not been established. Healthcare professionals should exercise caution when recommending this product to women of childbearing potential, as the absence of data does not preclude potential risks. It is advisable to consider the benefits and risks of using this product during pregnancy, and to discuss alternative options with patients if necessary.

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 on the use of this medication.

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 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 standard protocols for managing potential cases of drug overdose.

It is essential to monitor patients closely for any signs or symptoms that may arise following an overdose. Common symptoms may include, but are not limited to, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, the administration of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

For further management, consultation with a poison control center or a medical toxicologist is advised to ensure the implementation of the most effective treatment strategies tailored to the specific circumstances of the overdose.

Documentation of the incident, including the substance involved, estimated dose, and time of ingestion, is crucial for guiding treatment and ensuring patient safety.

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

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 seven 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 a 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 a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity. The container must be kept tightly closed to prevent contamination and degradation. Additionally, the product should be protected from light exposure to ensure optimal stability. Once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

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)