Original 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 without biting or chewing. 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

Use is contraindicated in patients who experience a cough that persists for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious underlying condition. Additionally, discontinue use and consult a healthcare professional if a sore mouth does not improve within 7 days. Patients should also stop use and seek medical advice if irritation, pain, or redness persists or worsens.

Warnings and Precautions

If a patient experiences a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, it is imperative to consult a healthcare professional promptly, as these symptoms may indicate a serious condition.

This product is contraindicated for use in children under 6 years of age unless specifically directed by a physician.

Healthcare professionals should advise patients to seek medical advice prior to use if they have a persistent or chronic cough, particularly those associated with smoking, asthma, or emphysema. Additionally, patients with a cough that is accompanied by excessive phlegm (mucus) should also consult a doctor before using this product.

Patients should be instructed to discontinue use and contact their healthcare provider if the cough persists for more than one week, tends to recur, or is accompanied by fever, rash, or a persistent headache, as these may be indicative of a serious underlying condition. Furthermore, if a sore mouth does not show improvement within seven days, or if irritation, pain, or redness persists or worsens, patients should seek medical attention.

No specific instructions for obtaining emergency medical help are provided; however, it is always advisable for patients to seek immediate care if they experience severe or concerning symptoms.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions include severe sore throat, particularly if it persists for more than 2 days or is accompanied by fever, headache, rash, swelling, nausea, or vomiting. In such cases, patients are advised to consult a doctor promptly, as these symptoms may indicate a serious condition.

Additionally, the medication is not recommended for use in children under 6 years of age unless directed by a healthcare professional. Patients should seek medical advice before using this product if they have a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

Patients are also instructed to discontinue use and consult a doctor if their cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, as these may be signs of a serious underlying condition. Furthermore, if a sore mouth does not improve within 7 days, or if irritation, pain, or redness persists or worsens, medical advice should be sought.

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 Original 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 children in this age group, it is advised to consult a doctor before use.

For pediatric patients aged 6 years and older, the recommended dosage is to dissolve 1 drop slowly in the mouth without biting or chewing. This can be repeated every 2 hours as needed or as directed by a healthcare provider.

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 Original Herb Cough Drops during pregnancy. As such, healthcare professionals should exercise caution when recommending this product to pregnant patients. The absence of data necessitates a careful consideration of the potential risks versus benefits in this population. Women of childbearing potential should be advised to consult their healthcare provider before using this product during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific considerations or precautions mentioned related to lactation. Therefore, healthcare professionals may consider the absence of contraindications when advising lactating mothers.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic 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 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 overdosage, there is currently no specific information available regarding the effects or management of such an occurrence. Healthcare professionals are advised to monitor the patient closely for any unusual symptoms and to provide supportive care as necessary.

Given the absence of detailed guidance, it is recommended that healthcare providers consult local poison control centers or relevant medical authorities for further assistance in managing potential overdosage situations. Continuous assessment and symptomatic treatment should be prioritized to ensure patient safety and well-being.

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 this medication out of reach of children to prevent accidental ingestion.

Patients should be instructed to consult a doctor before using this medication if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, or emphysema, or if the cough is accompanied by excessive phlegm (mucus).

Providers should inform patients to discontinue use and seek medical advice if the 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, patients should be advised to stop use and consult a doctor if a sore mouth does not improve within 7 days, or if irritation, pain, or redness persists or worsens.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It is essential to protect the product from heat and moisture to maintain its integrity. Proper storage conditions should be observed to ensure optimal efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)