Freegells Cough Drops Menthol Cherry 80ct

Description

No specific information related to the Description section for SPL code 34089-3 is provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with a cold. Additionally, it provides temporary relief from occasional minor irritation and sore throat.

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

Dosage and Administration

For adults and children aged 5 years and older, the recommended dosage is to dissolve one lozenge slowly in the mouth. This may be repeated 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 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 are 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. 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 provider. Additionally, if symptoms of a sore mouth do not improve within 7 days, patients are advised to seek medical attention from a dentist or doctor, as these symptoms may indicate a serious condition.

Common adverse reactions warranting caution include persistent or chronic cough, particularly in patients with underlying conditions such as smoking, asthma, or emphysema. Patients should consult a healthcare professional before using the medication if they have a cough accompanied by excessive phlegm (mucus).

Patients are also advised 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 persistent headache, as these may be signs 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 7 days, patients should also seek medical attention.

For pregnant or breastfeeding patients, it is recommended to consult a healthcare professional before using this medication to ensure safety for both the patient and the child.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. 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 Cherry 80ct (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 5 years and older are instructed to dissolve 1 lozenge slowly in the mouth, with the option to repeat 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 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the available information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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 caution and consider the lack of data when prescribing this medication to patients with liver problems.

Overdosage

In the event of an overdose, it is imperative to seek medical attention immediately. Healthcare professionals should be aware that symptoms of overdose may manifest as severe drowsiness, confusion, and difficulty breathing.

Prompt recognition of these symptoms is crucial for effective management. Upon identification of an overdose, appropriate medical interventions should be initiated to ensure patient safety and mitigate potential complications.

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 the 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 children.

Storage and Handling

The product is supplied in a secure bag, and it is imperative that the bag remains intact. If the bag is found to be torn or open, the product should not be used.

For optimal storage, the product should be kept in a controlled environment, ensuring that it is protected from moisture and extreme temperatures. Specific temperature ranges and container requirements are not provided; however, general best practices for storage should be followed to maintain product integrity. Special handling needs include avoiding any damage to the packaging to ensure the product remains safe for use.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Freegells Cough Drops Menthol Cherry 80ct, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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