Goodsense Menthol Cough Drops

Description

Good Sense 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 30 drops per package. The cough drops are designed for oral administration and are intended for temporary relief of throat irritation and cough.

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

There are no contraindications listed for this product.

However, healthcare professionals should advise patients to discontinue use and consult a physician if any of the following conditions occur:

• Cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious condition.

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

• Sore mouth does not improve within 7 days.

Warnings and Precautions

Severe sore throat symptoms warrant immediate medical attention. Healthcare professionals should advise patients to consult a doctor promptly if a sore throat is severe, persists for more than 2 days, or is accompanied by additional symptoms such as fever, headache, rash, swelling, nausea, or vomiting. These accompanying symptoms may indicate a serious underlying condition. Furthermore, if symptoms of a sore mouth do not show improvement within 7 days, patients should be referred to a dentist or physician for further evaluation.

In addition, patients should be instructed to discontinue use and seek medical advice if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache. These signs may suggest a serious health issue. Healthcare providers should remain vigilant for patients reporting severe sore throat symptoms or prolonged irritation, pain, or redness, as these may necessitate further investigation and intervention.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. Serious adverse reactions include severe sore throat, which, if it is persistent for more than 2 days or accompanied by symptoms such as fever, headache, rash, swelling, nausea, or vomiting, necessitates prompt consultation with a healthcare provider. Additionally, if sore mouth symptoms do not improve within 7 days, patients are advised to seek medical attention from a dentist or doctor, as these symptoms may indicate a serious condition.

Common adverse reactions warranting attention include a persistent cough that lasts more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may also suggest a serious underlying condition. Patients should discontinue use and consult a healthcare professional if they experience severe sore throat, or if irritation, pain, or redness persists or worsens.

It is recommended that patients consult a doctor before using this medication if they have a persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Goodsense 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 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of specific guidance when treating patients with renal impairment.

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 clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data may necessitate careful monitoring and assessment of the patient's overall health status.

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 initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that particular substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

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

Patient Counseling

Patients should be advised to keep this medication out of reach of children to prevent accidental ingestion. Healthcare providers should instruct patients to discontinue use and seek medical advice if any of the following occur: if a cough persists for more than 7 days, tends to recur, or is accompanied by fever, rash, or a persistent headache, as these may indicate a serious condition; if a sore throat is severe, or if irritation, pain, or redness lasts or worsens; or if a sore mouth does not show improvement within 7 days.

Additionally, patients should be encouraged to consult with their healthcare provider before using this medication if they have a persistent or chronic cough, such as that associated 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. If the bag is found to be torn or open, the product should not be used.

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 storage conditions to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)