Sugar Free Menthol Cough Drops

Description

TopCare SF Menthol Cough Drops are formulated to provide symptomatic relief for coughs. Each drop contains menthol as the active ingredient, which acts as a cough suppressant. The product is presented in a convenient dosage form of lozenges, with a total count of 25 drops per package. The cough drops are designed for oral administration and are intended for temporary relief of cough associated with minor throat and bronchial irritation.

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 effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

Adults and children aged 5 years and older should dissolve 1 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

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 stop use and seek medical advice if they experience severe sore throat, or if irritation, pain, or redness persists or worsens.

If sore mouth symptoms do not improve within 7 days, medical consultation is also advised.

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, particularly if it is 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 show improvement within seven days, it is recommended that patients consult their dentist or healthcare provider.

Healthcare professionals should instruct patients to discontinue use and contact their doctor if a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache. These signs may suggest a more serious health issue. Furthermore, patients should be monitored for severe sore throat symptoms or if irritation, pain, or redness lasts or worsens. In such cases, immediate medical consultation is warranted.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions warrant immediate medical attention, particularly in the case of severe sore throat. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, patients should consult a doctor promptly, as these symptoms may indicate a serious condition.

Common adverse reactions include persistent cough, which should prompt patients to stop use and seek medical advice if it lasts for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache. These symptoms could also signify a serious underlying condition. Additionally, if a sore throat is severe or if irritation, pain, or redness lasts or worsens, patients are advised to discontinue use and consult a healthcare professional.

Patients should also be aware that if a sore mouth does not improve within 7 days, they should seek medical advice. It is recommended that individuals with a persistent or chronic cough, such as those associated with smoking, asthma, or emphysema, consult a doctor before using this product. Furthermore, patients experiencing a cough accompanied by excessive phlegm (mucus) should also seek medical guidance prior to use.

Drug Interactions

There are no known drug interactions associated with the use of this medication. Additionally, there are no reported interactions between this drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Sugar Free Menthol Cough Drops (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.

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 the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 available 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 this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established 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 prudent in these cases, although specific parameters are not defined in the available information.

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 patients closely for any signs or symptoms that may arise following an overdose. Common symptoms may include, but are not limited to, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Supportive care is the cornerstone of management, which may involve the following steps:

1. Assessment: Conduct a thorough evaluation of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide symptomatic treatment as necessary, which may include intravenous fluids, oxygen supplementation, or medications to stabilize the patient's condition.

3. Decontamination: If the overdose is recent and the patient is alert, activated charcoal may be administered to limit further absorption of the substance. However, this should be avoided in cases of altered mental status or risk of aspiration.

4. Consultation: Engage with a poison control center or toxicology specialist for guidance on specific antidotes or advanced interventions, if applicable.

Healthcare professionals should remain vigilant and prepared to implement these management strategies in the event of an overdose, despite the lack of specific information regarding the substance in question.

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 compound in these areas.

Postmarketing Experience

Adverse events have been reported voluntarily and through surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events by calling 1-888-423-0139. This information contributes to the ongoing monitoring of the product's safety profile.

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 stop using the medication 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 symptoms may indicate a serious condition.

Additionally, patients should be informed to discontinue use and seek medical advice if they experience a severe sore throat, or if irritation, pain, or redness lasts or worsens. It is important to remind patients that if a sore mouth does not improve within 7 days, they should also consult a doctor.

Healthcare providers should encourage patients to ask a doctor before using the medication if they have a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema. Furthermore, patients should be advised to consult a healthcare professional if their cough is accompanied by excessive phlegm (mucus) before using the medication.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. Currently, there are no specified storage or handling conditions outlined in the provided information. Therefore, healthcare professionals are advised to refer to the product's official labeling or consult with the manufacturer for any additional details regarding storage and handling requirements.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)