Sugar Free Menthol Cough Drops

Description

Dollar General SF Menthol Cough Drops are formulated to provide symptomatic relief for coughs. Each package contains 70 drops, designed for oral administration. The active ingredient, menthol, is known for its soothing properties. The cough drops are presented in a convenient dosage form, suitable for use as needed to alleviate throat irritation and suppress cough reflexes.

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 mentioned in the available data.

Dosage and Administration

Adults and children aged 5 years and older are instructed to dissolve one 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 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 under specific circumstances related to sore throat and cough symptoms.

Sore Throat Warning In cases of severe sore throat that persists for more than 2 days, or if it is accompanied by additional 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 7 days, patients should seek evaluation from a dentist or physician, as these symptoms may indicate a serious underlying condition.

Cough and Sore Throat Management Patients are instructed to discontinue use and contact their healthcare provider if the following occurs:

• Cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these may be indicative of a serious health issue.

• Severe sore throat or any irritation, pain, or redness that lasts or worsens.

• Sore mouth symptoms that do not improve within 7 days.

Monitoring for these symptoms is essential 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, it is advised to seek dental or medical advice, as these symptoms may indicate a serious condition.

Common adverse reactions include persistent cough, which should prompt patients to stop use and consult a doctor if it lasts for more than 7 days, tends to recur, or is accompanied by fever, rash, or a persistent headache. Furthermore, if sore throat symptoms worsen or if irritation, pain, or redness lasts, patients are advised to seek medical consultation.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 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 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 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 regarding the excretion of this medication in human 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 these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding 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 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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the substance involved. Consultation with a poison control center or toxicology expert is recommended for guidance on the appropriate management of overdose cases.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available for 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 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 seek medical advice if they experience a severe sore throat or if irritation, pain, or redness lasts or worsens. It is also important to inform patients that if their sore mouth does not improve within 7 days, they should contact their healthcare provider.

Before using the 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, 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 bag, and it is imperative that the bag remains intact. Healthcare professionals should not use the product if the bag is torn or open, as this may compromise the integrity and safety of the contents.

For optimal storage, the product should be kept in a controlled environment, away from direct sunlight and moisture. It is essential to adhere to the recommended temperature ranges to ensure the product's efficacy and stability. Special handling precautions should be taken to maintain the product's quality throughout its storage and usage.

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)