Sugar Free Menthol Cough Drops

Description

CareOne SF Menthol Cough Drops are formulated to provide symptomatic relief for coughs. Each package contains 25 drops. The active ingredient, menthol, is known for its soothing properties. These cough drops are designed for oral administration and are presented in a convenient, individually wrapped format. The product is intended for use in managing 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 or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 5 years and older are instructed to allow 1 drop to dissolve slowly in the mouth. This dosage may be repeated every 2 hours as necessary 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 is contraindicated in patients who experience a cough that persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious underlying condition. Additionally, discontinue use and consult a healthcare professional if severe sore throat occurs, or if irritation, pain, or redness lasts or worsens. Patients should also seek medical advice if a sore mouth does not improve within 7 days.

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 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 the following occurs:

• 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 condition.

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

• Symptoms of a sore mouth do not improve within seven days.

Monitoring for these symptoms is crucial to ensure timely intervention and management of potential complications.

Side Effects

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

Severe adverse reactions warrant immediate medical attention. Patients should consult a doctor promptly if they experience a sore throat that is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting. 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.

Common adverse reactions include persistent cough. Patients should stop use and seek medical advice if a cough lasts for more than 7 days, tends to recur, or is accompanied by fever, rash, or a persistent headache, as these may also be signs of a serious underlying condition. Furthermore, if sore throat symptoms are severe or if irritation, pain, or redness lasts or worsens, patients should consult a healthcare professional.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. 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 1 drop to be allowed to dissolve slowly in the mouth. This dosage may be repeated every 2 hours as necessary or as directed by a healthcare provider.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in 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 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

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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 1-800-245-2898, available Monday through Friday from 9 AM to 4 PM EST.

Patient Counseling

Healthcare providers should advise patients to keep this 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, if a patient experiences a severe sore throat, or if irritation, pain, or redness lasts or worsens, they should seek medical advice. Patients should also be informed that if a sore mouth does not improve within 7 days, they should contact their healthcare provider.

Before using this medication, patients should be encouraged to ask a doctor if they have a persistent or chronic cough, such as that which occurs with smoking, asthma, or emphysema. Furthermore, patients should be advised to consult a healthcare professional if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in various package configurations, though specific NDC numbers or packaging details were not provided. Currently, there are no specified storage or handling conditions available for this product. Healthcare professionals are advised to refer to the manufacturer's guidelines for any updates or additional information regarding supply and storage 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)