Dual Action Honey Lemon Cough Suppressant Oral Anesthetic

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

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. 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 prior to administration. It is important to note that the drops should not be bitten or chewed to ensure proper efficacy and safety.

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, tends to recur, 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, especially if it is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting, as these symptoms may indicate a serious underlying condition.

The use of this medication 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 a cough persists for more than 1 week, recurs, or is accompanied by fever, rash, or a persistent headache, as these may be indicative of 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, patients should seek medical advice.

While no specific emergency medical help instructions or general precautions are provided, it is essential for healthcare professionals to remain vigilant and ensure that patients are aware of the signs and symptoms that warrant immediate medical evaluation. Regular monitoring and patient education are crucial for the safe use of this medication.

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 directed by a doctor.

Common adverse reactions may include a persistent cough that lasts more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, as these symptoms could 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 ongoing irritation, pain, or redness that persists or worsens.

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

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

Packaging & NDC

Below are the non-prescription pack sizes of Dual Action Honey Lemon Cough Suppressant Oral Anesthetic (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 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

There is no specific information regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while on this medication.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised when considering the use of this product during lactation.

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.

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 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 toxicology experts for guidance on specific management protocols and interventions that may be appropriate based on the clinical scenario.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and treatment planning.

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 the medication out of reach of children to prevent accidental ingestion. Patients should be instructed to stop using the medication 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 remind patients to consult 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 care and management for their symptoms.

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 dosage is to dissolve 1 drop 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 before use. Patients should be instructed not to bite or chew the drops.

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

Drug Information (PDF)

This file contains official product information for Dual Action Honey Lemon Cough Suppressant Oral Anesthetic, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)