Herbal Cough Drops Original Herb

Description

The product is a natural herb drop, formulated for oral use. It is packaged in a bottle containing 45 drops. The active ingredients comprise various herbal extracts, while the inactive ingredients include water, glycerin, and natural flavors. This formulation is free from artificial colors and preservatives. The SPL Code for this product is 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with a cold, as well as for the alleviation of occasional minor irritation and sore throat.

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, dosing should be determined and directed by a physician.

Contraindications

There are no contraindications listed for this product. However, it is essential to adhere to the recommended dosage guidelines, as exceeding the recommended dosage may lead to adverse effects.

Warnings and Precautions

Severe or persistent sore throat accompanied by high fever, headache, nausea, and vomiting may indicate a serious condition. Healthcare professionals are advised to recommend that patients consult a doctor promptly if these symptoms occur. It is important to note that the product should not be used for more than 2 days without medical supervision.

General precautions must be observed, particularly regarding dosage. Patients should be instructed not to exceed the recommended dosage to avoid potential adverse effects.

In the event of an overdose, immediate medical assistance should be sought. Patients or caregivers should be advised to contact a Poison Control Center or seek emergency medical help without delay.

Healthcare professionals should also instruct patients to discontinue use and contact their doctor if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these may be indicative of a more serious underlying condition. Additionally, if symptoms of a sore mouth do not improve within 7 days, or if irritation, pain, or redness persists or worsens, patients should be advised to seek medical attention.

Side Effects

Patients may experience a range of adverse reactions, some of which may require immediate medical attention. Severe or persistent sore throat, particularly when accompanied by high fever, headache, nausea, and vomiting, may indicate a serious condition. In such cases, it is advised that patients consult a healthcare professional promptly. Additionally, it is recommended that the product not be used for more than 2 days in the presence of a sore throat.

Cough that persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache may also signal a serious underlying condition and should be evaluated by a healthcare provider. Furthermore, symptoms related to a sore mouth that do not improve within 7 days, or if irritation, pain, or redness persists or worsens, warrant medical consultation to rule out more serious issues.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Herbal Cough Drops Original Herb (cough drops). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 years and older are instructed to dissolve 1 drop 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, dosing should be determined by a doctor.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential 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. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

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 and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, healthcare professionals should consider contacting a poison control center for guidance on specific management protocols tailored to the substance involved in the overdose.

Documentation of the incident, including the amount and timing of the substance taken, 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

Postmarketing experience has included the collection of voluntary reports and data from surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events or concerns related to the use of the product. For inquiries or to report an adverse event, individuals may contact 1-888-423-0139.

Patient Counseling

Healthcare providers should advise patients to keep this product out of the reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be reminded not to exceed the recommended dosage while using this product. It is important for healthcare providers to inform patients that if a cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or a persistent headache, they should stop using the product and consult a doctor, as these symptoms may indicate a serious condition.

Additionally, patients should be counseled to stop using the product and seek medical advice if symptoms of a sore mouth do not improve within 7 days, or if they experience worsening irritation, pain, or redness.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product in a cool and dry place to maintain its integrity and effectiveness. Proper storage conditions are crucial to ensure the product remains within its specified quality parameters.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)