Freegells Cough Drops Menthol Honey Lemon 200ct

Description

This product is identified by the code 51945-4 and is associated with the effective date of July 10, 2023. The labeling includes two multimedia references, both in JPEG format, which provide visual representations of the product. The first image is labeled as IMAGE_200CT.jpg, and the second as IMAGE_200CT_2.jpg. The product label is designed for professional use, ensuring that all relevant details are clearly presented for healthcare professionals.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with a cold. It also provides temporary relief from occasional minor irritation 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 dissolve one lozenge slowly in the mouth. This process may be repeated every 2 hours as needed or as directed by a healthcare professional.

For children under 5 years of age, it is recommended to consult a doctor before administration.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

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 of a sore mouth do not improve within seven days, it is recommended that patients consult their dentist or healthcare provider.

Healthcare professionals should inquire about the patient's medical history before recommending this treatment, particularly if the patient has a persistent or chronic cough associated with smoking, asthma, or emphysema. Caution is also advised for patients experiencing a cough accompanied by excessive phlegm (mucus).

Patients should be instructed to discontinue use and consult a healthcare provider if their cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache, as these may be indicative of a serious condition. Furthermore, if a sore throat is severe or if irritation, pain, or redness lasts or worsens, medical advice should be sought. In cases where sore mouth symptoms do not improve within seven days, patients should also seek professional guidance.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional prior to use to ensure safety for both the mother and child.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. It is important to monitor for serious symptoms and seek medical advice when necessary.

Severe sore throat is a notable warning; if patients experience a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, they should consult a doctor promptly. Additionally, if symptoms of a sore mouth do not improve within 7 days, patients are advised to see their dentist or doctor, as these symptoms may indicate a serious condition.

Patients with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should consult a doctor before using this medication. Furthermore, if a cough is accompanied by excessive phlegm (mucus), medical advice should be sought prior to use.

Patients are instructed to discontinue use and consult a 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 may be signs of a serious condition. In cases where sore throat symptoms are severe, or if irritation, pain, or redness lasts or worsens, medical consultation is also recommended.

For patients who are pregnant or breastfeeding, it is essential to seek advice from a health professional before using this medication to ensure safety for both the patient and the child.

Drug Interactions

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Freegells Cough Drops Menthol Honey Lemon 200ct (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be kept out of reach of children. For those aged 5 years and older, the recommended dosage is to dissolve 1 lozenge slowly in the mouth every 2 hours as needed 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

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, given the lack of targeted data.

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 associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication 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 information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for effective management 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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

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 or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young individuals.

Storage and Handling

The product is supplied in a configuration that includes specific packaging details, which are essential for proper handling and storage. It is crucial to store the product at room temperature to maintain its integrity and effectiveness.

Healthcare professionals should ensure that the product is not used if the bag is found to be torn or open, as this may compromise the quality and safety of the contents. Proper adherence to these storage and handling guidelines is necessary to ensure optimal product performance.

Additional Clinical Information

The medication is administered orally. For adults and children aged 5 years and older, the recommended dosage is to dissolve one lozenge slowly in the mouth, with the option to repeat every two hours as needed or as directed by a healthcare professional. For children under 5 years of age, it is advised to consult a doctor before administration.

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

Drug Information (PDF)

This file contains official product information for Freegells Cough Drops Menthol Honey Lemon 200ct, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)