Herbal Cough Drops

Description

The drug is a natural herb product identified by SPL Code 34089-3. It contains a proprietary blend of herbal ingredients, formulated in a capsule dosage form. Each capsule contains 500 mg of the herbal blend. Inactive ingredients include gelatin and magnesium stearate.

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 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 healthcare professional.

Contraindications

There are no specific contraindications identified for this product. However, it is advised to discontinue use and consult a healthcare professional under the following circumstances:

• If cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious underlying condition.

• If symptoms of a sore mouth do not improve within 7 days, or if irritation, pain, or redness persists or worsens.

Warnings and Precautions

Severe and persistent sore throat may indicate a serious condition, particularly when accompanied by fever, headache, nausea, and vomiting. In such cases, it is imperative to consult a healthcare professional promptly. Patients are advised not to use the medication for more than two consecutive days without medical guidance.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if any of the following occur: a cough that persists for more than seven days, a cough that tends to recur, or a cough accompanied by fever, rash, or a persistent headache. These symptoms may signify an underlying serious condition that requires further evaluation.

Additionally, if symptoms of a sore mouth do not show improvement within seven days, or if there is a persistence or worsening of irritation, pain, or redness, patients should stop taking the medication and consult their healthcare provider for further assessment and management.

Side Effects

Patients may experience a range of adverse reactions while using the medication. Serious adverse reactions include severe and persistent sore throat, which may be accompanied by fever, headache, nausea, and vomiting. Such symptoms should prompt immediate consultation with a healthcare provider. It is advised that the medication not be used for more than 2 days in the presence of a severe sore throat.

Additionally, patients should discontinue use and seek medical advice if they experience a cough that persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these may indicate a serious underlying condition. Symptoms related to a sore mouth that do not improve within 7 days, or if irritation, pain, or redness persists or worsens, also warrant consultation with a healthcare professional.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. 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 Herbal Cough Drops (herbal menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should use this medication only as directed by a healthcare professional. For children 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 healthcare provider. It is important to keep this medication out of the reach of children to ensure safety.

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 adverse effects or changes in therapeutic response, 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 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 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 event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the substance is known, specific antidotes or treatments may be indicated, and healthcare providers should refer to established guidelines for the management of the particular overdose scenario.

It is vital for healthcare professionals to remain vigilant and act swiftly in the event of an overdose to ensure the best possible outcomes for affected individuals.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

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 side effects associated with the use of the product. For inquiries or to report an adverse event, individuals may contact the designated helpline at 1-833-552-1767.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of the 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 7 days, tends to recur, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

Additionally, patients should be informed to seek medical advice if symptoms of a sore mouth do not improve within 7 days, or if they experience worsening irritation, pain, or redness. It is important for patients to be aware of these signs and to take appropriate action to ensure their health and safety.

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, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)