Sugar Free Menthol Cough Drops

Description

Winco SF Menthol is a formulation designed for cough relief, presented in a dosage form of cough drops. Each package contains 25 individual drops. The active ingredient, menthol, provides a soothing effect for throat irritation. The product is intended for use in symptomatic relief of coughs associated with minor throat and bronchial irritation.

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

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 two 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, the product should not be used if the patient has a severe sore throat or if irritation, pain, or redness lasts or worsens. Patients should also discontinue use and consult a healthcare professional 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, particularly if it is accompanied or followed by fever, headache, rash, swelling, nausea, or vomiting. These symptoms may indicate a serious underlying condition. Additionally, if symptoms related to a sore mouth do not show improvement within seven days, it is essential for patients to 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, as well as any irritation, pain, or redness that lasts or worsens. If sore mouth symptoms do not improve within a week, a consultation with a healthcare provider 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 two 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. Patients are advised to stop use and seek medical advice if a cough persists for more than seven days, tends to recur, or is accompanied by fever, rash, or persistent headache, as these could also be signs of a serious condition. Additionally, if a sore throat is severe or if irritation, pain, or redness lasts or worsens, patients should discontinue use and consult a healthcare professional.

Patients should also be cautious if they have a sore mouth that does not improve within seven days. Before using this product, individuals with a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, should consult a doctor. Furthermore, if a cough is accompanied by excessive phlegm (mucus), it is advisable to seek medical advice prior to use.

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 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 two hours as necessary or as directed by a healthcare provider.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. It is essential to evaluate the potential risks and benefits associated with the use of this medication during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised. Healthcare providers should consider the individual circumstances of each patient when making recommendations regarding the use of this medication in these populations.

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 data 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 information necessitates careful clinical judgment and monitoring.

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 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 context of overdosage, it is important to note that no specific information regarding overdosage has been provided in the available documentation. Healthcare professionals are advised to exercise caution and consider the potential implications of an overdose based on the pharmacological profile of the medication in question.

In the absence of detailed overdosage data, it is recommended that healthcare providers monitor patients closely for any unusual symptoms or adverse effects that may arise. Should an overdose be suspected, standard emergency protocols should be initiated, including supportive care and symptomatic treatment as necessary.

Healthcare professionals are encouraged to consult relevant clinical guidelines and toxicology resources for further management strategies in cases of suspected overdosage.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Postmarketing experience includes information gathered from voluntary reports and surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events or concerns related to the use of the product. For inquiries or to report an adverse event, individuals may contact the designated support line at 800-824-1706, available Monday through Friday from 9 AM to 4 PM MST.

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 use 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 advise patients to stop use and consult a doctor if a sore mouth does not improve within 7 days.

Healthcare providers should also recommend that patients 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 encouraged to consult a doctor if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in a configuration that ensures optimal usability. It should be stored at room temperature, specifically in a cool, dry place to maintain its integrity. It is essential to protect the product from light exposure to prevent degradation. Freezing the product is strictly prohibited, as it may compromise its effectiveness. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally, with specific instructions for different age groups. For adults and children aged 5 years and older, one drop should be allowed to dissolve slowly in the mouth, with the option to repeat every two hours as necessary 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 Sugar Free Menthol Cough Drops, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)