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. Additionally, it provides temporary relief from 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

There are no specified contraindications for the use of this product. No conditions or situations have been identified that would warrant avoidance of use.

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 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, such as that associated with smoking, asthma, or emphysema. Additionally, patients with a cough 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 signs 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.

Regular monitoring of symptoms and prompt communication with healthcare providers is essential to ensure safe and effective use of this product.

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 symptoms such as 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 administration.

Geriatric Use

There is no specific information regarding the use of ORIGINAL HERB COUGH DROPS in geriatric patients. Healthcare providers should exercise caution when prescribing this product to elderly patients, as they may have altered pharmacokinetics and pharmacodynamics. It is advisable to monitor this population closely for any adverse effects or changes in efficacy. Additionally, healthcare providers should consider individual patient factors, such as comorbidities and concurrent medications, when determining the appropriateness of this product for geriatric patients.

Pregnancy

There is no specific information regarding the use of Original Herb Cough Drops during pregnancy. As such, the potential risks and benefits of using this product in pregnant patients have not been established. Healthcare professionals should exercise caution when recommending this product to women of childbearing potential and consider alternative therapies that have been studied for safety in pregnancy. It is advisable to discuss any concerns with patients regarding the use of this product during pregnancy and to monitor for any adverse effects should it be used.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this medication.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to 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 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 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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment 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 limits the assessment of potential risks associated with the use of the compound in these contexts.

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. It is important for patients to consult with their 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).

Patients should be instructed to discontinue use and seek medical advice if their cough persists for more than one week, tends to recur, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition. Additionally, patients should be informed to stop using the medication if a sore mouth does not show improvement within 7 days, or if they experience ongoing irritation, pain, or redness that 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

The medication is administered orally. For adults and children aged 6 years and older, the recommended method is to dissolve 1 drop slowly in the mouth without biting or chewing, with the option to repeat every 2 hours as needed or as directed by a healthcare professional. For children under 6 years of age, it is advised to consult a doctor before administration.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

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)