Honey Lemon Cough Drops

Description

The product is identified by SPL code 34089-3 and is formulated as a sugar-free cough drop. Each cough drop is designed to provide relief from cough and features a honey and lemon flavor. The product is packaged in a bag containing 36 drops, ensuring convenient access to the active ingredients intended for cough relief.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with colds or inhaled irritants. Additionally, it provides temporary relief from occasional minor irritations and sore throat.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 5 years and older are instructed to allow 1 drop to dissolve slowly in the mouth. This dosage may be repeated every two hours as necessary or as directed by a healthcare professional. For children under 5 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 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious underlying condition. Additionally, patients should discontinue use and consult a healthcare professional if they have a severe sore throat or if irritation, pain, or redness lasts or worsens. Use is also contraindicated if a sore mouth does not improve within 7 days.

Warnings and Precautions

Patients should be advised to seek medical attention promptly if they experience a severe sore throat that persists for more than two days, especially if accompanied by fever, headache, rash, swelling, nausea, or vomiting. These symptoms may indicate a serious underlying condition. Additionally, if symptoms related to a sore mouth do not show improvement within seven days, it is essential to consult a dentist or physician.

Healthcare professionals should instruct patients to discontinue use and contact their doctor if any of the following occur: a cough that persists for more than seven days, a cough that tends to recur, or a cough accompanied by fever, rash, or a persistent headache, as these may be indicative of a serious health issue. Furthermore, patients should be advised to seek medical advice if a sore throat is severe or if irritation, pain, or redness lasts or worsens. It is also critical to monitor any sore mouth symptoms that do not improve within a week, as this may necessitate further evaluation.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. 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, necessitates prompt consultation with a healthcare professional. 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 these symptoms may indicate a serious underlying condition.

Common adverse reactions warranting attention 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 persistent headache. Furthermore, patients should discontinue use and seek medical advice if they experience severe sore throat or if irritation, pain, or redness lasts or worsens. It is also recommended that patients stop use if sore mouth symptoms do not show improvement within 7 days.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Honey Lemon Cough Drops (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 5 years and older may use the medication by allowing 1 drop to dissolve slowly in the mouth, with the option to repeat every two hours as necessary or as directed by a healthcare professional. For children under 5 years of age, it is advised to consult a doctor before use.

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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and maternal health. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 considered as part of standard clinical practice.

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 action is crucial to mitigate potential adverse effects associated with overdosage.

Healthcare professionals should be aware that symptoms of overdose may vary depending on the specific 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 specific antidotes are available, their administration should be considered based on the clinical scenario and the substance involved.

It is essential for healthcare providers to remain vigilant and prepared to implement emergency protocols in the event of an overdose, ensuring the best possible outcomes for affected individuals.

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 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, patients should seek medical advice if they experience a severe sore throat, or if irritation, pain, or redness lasts or worsens. If a sore mouth does not improve within 7 days, patients should also contact their healthcare provider.

It is important for healthcare providers to remind patients to ask a doctor before using this medication if they have a persistent or chronic cough, such as that which occurs with smoking, asthma, or emphysema, or 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. Currently, there are no specific storage or handling requirements outlined in the provided information. Therefore, it is recommended that healthcare professionals refer to standard storage practices for similar products unless otherwise specified.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)