Natural Honey Lemon with Echinacea Cough Suppressant Throat Drops

Description

The product is represented by an image file named "Honey Lemon Echinacera 45 m_merged-2.jpg," which is in JPEG format. The effective date of the information is September 20, 2021.

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 resulting from sore throat or sore mouth.

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

Dosage and Administration

Adults and children aged 6 years and older are instructed to dissolve 2 drops (one at a time) slowly in the mouth. 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 specific contraindications listed for this product. However, healthcare professionals should advise patients to discontinue use and consult a physician under the following circumstances:

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

• If a sore mouth does not improve within 7 days.

• If irritation, pain, or redness persists or worsens.

Warnings and Precautions

Patients should be advised to seek medical attention promptly if they experience a severe sore throat that persists for more than 2 days, particularly if it is accompanied or followed by symptoms such as fever, headache, rash, swelling, nausea, or vomiting, as these may indicate a serious underlying condition.

This product is contraindicated in children under 6 years of age unless specifically directed by a healthcare professional.

Healthcare providers should instruct patients to discontinue use and consult a physician if any of the following occur: a cough that persists for more than 1 week, a cough that tends to recur, or a cough accompanied by fever, rash, or persistent headache, as these symptoms may suggest a serious health issue. Additionally, if a sore mouth does not show improvement within 7 days, or if irritation, pain, or redness persists or worsens, medical advice should be sought.

Monitoring for these symptoms is essential to ensure patient safety and to facilitate timely intervention if necessary.

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, warrants prompt consultation with a healthcare provider. Additionally, patients should be advised not to use this medication in children under 6 years of age unless specifically directed by a doctor.

Common adverse reactions necessitating discontinuation of use and consultation with a healthcare provider include a cough that persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious underlying condition. Patients should also seek medical advice if a sore mouth does not improve within 7 days or if there is persistent or worsening irritation, pain, or redness.

Before using this medication, patients should consult a healthcare provider if they have a persistent chronic cough, such as that associated with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. 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 Natural Honey Lemon with Echinacea Cough Suppressant Throat 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 aged 6 years and older, the recommended dosage is to dissolve 2 drops (one at a time) slowly in the mouth, with the option to repeat every 2 hours as needed or as directed by a doctor. Parents and caregivers are advised to consult a doctor for guidance regarding the use of this medication in children under 6 years.

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 potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of Natural Honey Lemon with Echinacea Cough Suppressant Throat Drops during pregnancy. As such, the safety of this product in pregnant patients has not been established. There are no known dosage modifications or special precautions indicated for use during pregnancy. Healthcare professionals should weigh the potential benefits against any unknown risks when considering this product for women of childbearing potential. It is advisable to exercise caution and consult with a healthcare provider before recommending this product to pregnant patients.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication. It is advisable to monitor breastfed infants for any potential effects, although no specific concerns have been noted in the available information.

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 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 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, the following management procedures should be considered:

1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide supportive care as needed, which may include airway management, oxygen supplementation, and intravenous fluids.

3. Consultation: Engage with a poison control center or a medical toxicologist for guidance on specific interventions and antidotes, if applicable.

4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement these general management strategies in the event of an overdose, even in the absence of specific overdosage data.

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 fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. Patients should be instructed to discontinue use and consult a doctor if their 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, if a sore mouth does not improve within seven days, or if irritation, pain, or redness persists or worsens, patients should seek medical advice.

It is also important for healthcare providers to encourage patients to consult with their doctor before using the medication if they have a persistent chronic cough, such as that associated with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus). This ensures that patients receive appropriate guidance tailored to their specific health conditions.

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 crucial to store the product in a dry place to maintain its integrity and effectiveness. Proper storage conditions are vital to ensure the product remains within its specified quality parameters throughout its shelf life.

Additional Clinical Information

The medication is administered orally. For adults and children aged 6 years and older, the recommended dosage is to dissolve 2 drops (one at a time) slowly in the mouth, 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 for appropriate guidance.

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

Drug Information (PDF)

This file contains official product information for Natural Honey Lemon with Echinacea Cough Suppressant Throat Drops, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)