Natural Herbal Cough Drops

Description

No specific description details related to SPL code 34089-3 were found in the provided text.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with a cold. It also provides temporary relief from 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 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

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 serious underlying conditions.

• If sore throat is severe or if irritation, pain, or redness lasts or worsens.

• If sore mouth does not improve within 7 days.

Warnings and Precautions

If a patient experiences a severe sore throat that persists for more than two days, or if it is accompanied or followed by symptoms such as fever, headache, rash, swelling, nausea, or vomiting, it may indicate a serious condition. In such cases, it is imperative to consult a healthcare professional promptly. Additionally, if symptoms of a sore mouth do not show improvement within seven days, the patient should seek evaluation from a dentist or physician, as these symptoms may also be indicative of a serious underlying issue.

Healthcare professionals should advise patients to discontinue use and seek medical attention if the following occurs: a cough that persists for more than seven days, a cough that recurs, or a cough accompanied by fever, rash, or a persistent headache, as these may signal a serious health concern. Furthermore, if a sore throat is severe or if irritation, pain, or redness lasts or worsens, immediate consultation with a healthcare provider is warranted. It is essential to monitor these symptoms closely to ensure timely intervention and management.

Side Effects

Patients may experience a range of adverse reactions, which can vary in seriousness and frequency.

Severe adverse reactions warrant immediate medical attention. Patients should consult a doctor promptly if they experience a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, as these symptoms may indicate a serious condition. 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 this may also signify a serious issue.

Common adverse reactions include persistent cough, which should prompt patients to stop use and consult a doctor if it lasts for more than 7 days, tends to recur, or is accompanied by fever, rash, or a persistent headache. Furthermore, if sore throat symptoms are severe or if irritation, pain, or redness lasts or worsens, patients should discontinue use and seek medical advice.

Drug Interactions

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

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. 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

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 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 aware that the specific symptoms of 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 specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the safety and well-being of the patient.

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

Postmarketing experience has included the collection of adverse event reports received voluntarily and through surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events or inquiries regarding the product. Reports can be made by calling 1 617-848-4560, available Monday to Friday from 9:00 am to 4:00 pm ET.

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 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 condition. Additionally, if a patient experiences a severe sore throat or if irritation, pain, or redness lasts or worsens, they should seek medical advice. Patients should also be informed that if a sore mouth does not improve within 7 days, they should contact their healthcare provider.

It is important for patients to ask their doctor before using this medication if they have a persistent or chronic cough, such as that which occurs with smoking, asthma, or emphysema. Furthermore, patients should be advised to consult their healthcare provider if their cough is accompanied by excessive phlegm (mucus).

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

View product document (PDF)