Freegells Cough Drops Menthol Strawberry

Description

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

Uses and Indications

This drug is indicated for the temporary relief of cough associated with a cold, as well as for the alleviation of 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 1 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 specific contraindications listed for this product. However, healthcare professionals should advise patients to discontinue use and consult a doctor under the following circumstances:

• If cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious condition.

• If sore throat is severe, or if irritation, pain, or redness lasts or worsens.

• If sore mouth does not improve within 7 days.

Warnings and Precautions

If a patient experiences a severe sore throat that persists for more than two days, or if it is accompanied or followed by symptoms such as fever, headache, rash, swelling, nausea, or vomiting, it is imperative to consult a healthcare professional promptly. Additionally, if symptoms related to a sore mouth do not show improvement within seven days, the patient should seek evaluation from a dentist or physician, as these symptoms may indicate a serious underlying condition.

Healthcare professionals should exercise caution and advise patients to consult a doctor prior to use if they have a persistent or chronic cough, particularly in cases associated with smoking, asthma, or emphysema. Furthermore, patients with a cough that is accompanied by excessive phlegm (mucus) should also seek medical advice before initiating treatment.

Patients should be instructed to discontinue use and contact their healthcare provider if the 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 health issue. In cases where a sore throat is severe, or if irritation, pain, or redness lasts or worsens, immediate medical consultation is warranted. Lastly, if symptoms related to a sore mouth do not improve within seven days, patients should seek medical attention.

Side Effects

Patients may experience a range of adverse reactions, which can vary in seriousness and frequency.

Serious adverse reactions may include severe sore throat that persists for more than 2 days, especially if accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting. In such cases, it is advised that patients consult a doctor promptly, as these symptoms may indicate a serious condition. Additionally, if sore mouth symptoms do not improve within 7 days, patients should seek medical attention from a dentist or doctor.

Common adverse reactions warranting medical consultation include a cough that persists for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache. These symptoms may also suggest a serious underlying condition. Furthermore, patients should be vigilant for severe sore throat symptoms or if irritation, pain, or redness lasts or worsens, as these may require medical evaluation.

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 Freegells Cough Drops Menthol Strawberry (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 5 years of age should consult a healthcare professional before use. For children aged 5 years and older, the recommended dosage is to dissolve 1 lozenge slowly in the mouth, with the option to repeat every 2 hours as needed or as directed by a healthcare provider.

Geriatric Use

There is no specific information available 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, 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. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

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 drug 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 have not been specifically addressed in the drug insert text 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 data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no information available regarding dosage adjustments, special monitoring, 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, as the lack of data may impact the safety and efficacy of treatment in this population. Regular monitoring of liver function may be warranted based on clinical judgment.

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 initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that particular substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

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 provided in the insert for Freegells Cough Drops Menthol Strawberry (SPL code 90375-7).

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 healthcare professional 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 be informed to seek medical advice if they experience a severe sore throat, or if irritation, pain, or redness lasts or worsens. They should also be counseled to contact a healthcare provider if a sore mouth does not show improvement within 7 days.

Before using the medication, patients should be encouraged to consult a healthcare professional if they have a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus). This information is crucial for ensuring safe and effective use of the medication.

Storage and Handling

The product is supplied in a secure packaging format, ensuring integrity during storage and handling. It is essential to store the product at room temperature to maintain its efficacy. Healthcare professionals should inspect the packaging prior to use; the product must not be utilized if the bag is torn or open, as this may compromise its safety and effectiveness.

Additional Clinical Information

The medication is administered orally, with specific instructions for different age groups. Adults and children aged 5 years and older should dissolve one lozenge slowly in the mouth, repeating every two hours as needed or as directed by a healthcare provider. For children under 5 years, it is advised to consult a doctor before use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Additionally, it is important to keep the medication out of reach of children. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)