Natural Herbal 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. Additionally, it provides temporary relief from occasional minor irritation and sore throat.

There are no teratogenic effects associated with this drug. Furthermore, no nonteratogenic effects have been reported.

Dosage and Administration

Adults and children aged 6 years and older are instructed to allow 2 drops to dissolve slowly in the mouth, one at a time. This dosing may be repeated every two 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

Use of this product is contraindicated in patients who experience a cough that persists for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious underlying condition. Additionally, patients should discontinue use and consult a healthcare professional if they have a severe sore throat or if irritation, pain, or redness lasts or worsens. Furthermore, if a sore mouth does not improve within 7 days, medical advice should be sought.

Warnings and Precautions

Patients should be advised to monitor for specific symptoms that may indicate a serious condition.

Sore Throat Warning In cases of severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, it is imperative to consult a healthcare professional promptly. Additionally, if symptoms related to a sore mouth do not show improvement within 7 days, patients should seek evaluation from a dentist or physician, as these symptoms may indicate a serious underlying issue.

Consultation Recommendations Patients are advised to discontinue use and contact their healthcare provider if any of the following occur:

• 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 serious condition.

• Severe sore throat or any irritation, pain, or redness that lasts or worsens.

• Sore mouth symptoms that do not improve within 7 days.

Prompt medical attention is essential in these scenarios to ensure appropriate management and care.

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, may indicate a serious condition requiring prompt medical consultation. Additionally, if symptoms of a sore mouth do not improve within 7 days, patients are advised to seek evaluation from a dentist or doctor, as these symptoms may also be serious.

Common adverse reactions warranting attention include a persistent cough that lasts more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These symptoms could signify a serious underlying condition, and patients should stop use and consult a doctor if they occur. Furthermore, if sore throat symptoms are severe or if irritation, pain, or redness lasts or worsens, medical advice should be sought.

Patients with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should consult a doctor before using this medication. Additionally, those experiencing a cough accompanied by excessive phlegm (mucus) are also advised to seek medical guidance prior to use.

In the event of an accidental overdose, it is crucial for patients to obtain medical help or contact a Poison Control Center immediately.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 6 years of age should consult a healthcare professional before use. For children aged 6 years and older, the recommended dosage is 2 drops to be allowed to dissolve slowly in the mouth, one at a time. This dosage may be repeated every two hours as needed or as directed by a healthcare provider.

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. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 drug 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 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 warranted based on clinical judgment.

Overdosage

In the event of an accidental 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 overdosage.

Healthcare professionals should be vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain informed about the appropriate protocols for managing overdose situations, ensuring that patients receive timely and effective 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

Reports of adverse events have been received through voluntary reporting and 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 1 800 632 6800.

Patient Counseling

Healthcare providers should advise patients to keep this medication and all other drugs out of the reach of children to prevent accidental ingestion.

Patients should be instructed to stop using the medication and consult their doctor if any of the following occur: if a cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or a persistent headache, as these may indicate a serious condition; if a sore throat is severe or if irritation, pain, or redness lasts or worsens; or if a sore mouth does not improve within 7 days.

Additionally, healthcare providers should recommend that patients ask a doctor before using this medication if they have a persistent or chronic cough, such as that which occurs with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

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 recommended to store the product in a cool and 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

No further data are available.

Drug Information (PDF)

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

View product document (PDF)