Freegells Cough Drops Menthol Honey Lemon

Description

The drug is identified by SPL Code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "A" on one side and "123" on the other. Each tablet contains 500 mg of Acetaminophen. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, stearic acid, povidone, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, iron oxide red, and iron oxide yellow.

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 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

Use of this product is contraindicated in the following situations:

Patients should discontinue use and consult a healthcare professional if cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious underlying condition.

Additionally, patients should seek medical advice if they experience a severe sore throat or if irritation, pain, or redness persists or worsens.

If a sore mouth does not show improvement within 7 days, medical consultation is also advised.

Warnings and Precautions

If a patient experiences a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, it is imperative to consult a healthcare professional promptly. Additionally, if symptoms of a sore mouth do not improve 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 advise patients to discontinue use and seek medical advice if a 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. Furthermore, patients should be cautioned to seek medical attention if a sore throat is severe, or if irritation, pain, or redness lasts or worsens. In cases where sore mouth symptoms do not show improvement within seven days, a consultation with a healthcare provider is recommended.

General precautions should be taken into account before use. Patients should be advised to consult a healthcare professional if they have a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema. Additionally, if the cough is accompanied by excessive phlegm (mucus), medical advice should be sought prior to use.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions may include severe sore throat, particularly if it persists for more than 2 days or is accompanied by additional symptoms such as 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.

Common adverse reactions include sore throat that is severe or characterized by irritation, pain, or redness that lasts or worsens. Patients should also be aware that if sore mouth symptoms do not improve within 7 days, they should seek advice from a dentist or doctor.

Additionally, patients are advised to stop use and consult a doctor if a cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache, as these could also be signs of a serious condition. It is recommended that patients ask a doctor before use 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).

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 Honey Lemon (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 regarding the use of Freegells Cough Drops Menthol Honey Lemon in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when recommending this product to geriatric patients, as the absence of specific data necessitates careful clinical judgment. Monitoring for any adverse effects or unusual responses in this population is advisable.

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 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

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of detailed information necessitates careful clinical judgment. 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 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 relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

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

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to keep the medication out of reach of children to prevent accidental ingestion. Healthcare providers should instruct patients to discontinue use and consult a doctor if the 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. If a sore mouth does not show improvement within 7 days, patients should also be encouraged to contact their healthcare provider.

Before using the medication, patients should be advised to consult a doctor if they have a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema. Furthermore, patients should be cautioned to seek medical advice if their cough is accompanied by excessive phlegm (mucus).

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. 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.

There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)