Nice Menthol Cough Drops

Description

Nice Menthol 24ct Cough Drops are formulated to provide symptomatic relief from coughs. Each cough drop contains menthol as the active ingredient, which acts as a cough suppressant. The product is presented in a convenient 24-count packaging, suitable for easy access and use. The cough drops are designed for oral administration and are intended for temporary relief of cough due to minor throat and bronchial irritation.

Uses and Indications

This drug is indicated for the temporary suppression and relief of coughs associated with minor throat and bronchial irritation due to colds or inhaled irritants. Additionally, it is indicated for the relief of occasional minor sore throat pain.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

The recommended dosage for adults and children aged 6 years and older is 5 mg per lozenge. The lozenge should be dissolved slowly in the mouth to ensure optimal effectiveness. For the relief of coughs, the lozenge may be repeated every hour as needed or as directed by a healthcare professional. In the case of sore throat, the lozenge may be repeated every 2 hours.

It is important to note that the maximum allowable dosage is 10 lozenges per day. For children under 6 years of age, it is advised to consult a doctor before administration.

Contraindications

Use is contraindicated in patients who experience a cough lasting more than 7 days, who have a cough that returns, or who present with fever, rash, or headache lasting longer than 7 days, as these may indicate a serious underlying condition.

Additionally, use is contraindicated in cases of severe sore throat lasting more than 2 days, or if accompanied by fever, headache, rash, swelling, nausea, or vomiting.

Patients should also discontinue use and consult a healthcare professional if symptoms of a sore mouth persist for more than 7 days, or if irritation, pain, or redness worsens.

Exceeding the recommended dosage is not advised, as it may result in a laxative effect.

Warnings and Precautions

Patients should consult a healthcare professional prior to use if they have a chronic cough that persists or is associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, individuals experiencing a cough accompanied by excessive phlegm (mucus) should seek medical advice before proceeding with treatment.

It is imperative to discontinue use and consult a healthcare provider if the cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a serious underlying condition. Furthermore, if a sore throat is severe, lasts longer than 2 days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, medical attention should be sought immediately. Patients should also stop use if symptoms of a sore mouth persist for more than 7 days, or if irritation, pain, or redness continues or worsens.

No specific emergency medical help instructions or laboratory tests are provided in this context.

Side Effects

Patients should be aware of several important warnings and recommendations regarding the use of this product. It is advised to consult a doctor prior to use if there is a history of chronic cough that persists or occurs alongside smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients experiencing a cough accompanied by excessive phlegm (mucus) should seek medical advice.

Patients are instructed to discontinue use and consult a doctor if the cough lasts more than 7 days, recurs, or is associated with fever, rash, or headache that persists, as these symptoms may indicate a serious underlying condition. Furthermore, if a sore throat is severe, lasts longer than 2 days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, medical attention should be sought. Symptoms of a sore mouth that persist beyond 7 days, or any irritation, pain, or redness that continues or worsens, also warrant consultation with a healthcare professional.

While using this product, it is crucial not to exceed the recommended dosage, as taking more than directed may result in a laxative effect.

Lastly, this product should be kept out of reach of children to prevent accidental ingestion or misuse.

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 Nice Menthol Cough Drops (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 years and older may be administered a dosage of 5 mg. For children under 6 years of age, it is advised to consult a healthcare professional for appropriate dosing recommendations.

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, given the lack of targeted data for this population.

Pregnancy

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. There are no contraindications noted for pregnant patients, nor are there any associated risks to the fetus identified in the available literature. Additionally, no dosage modifications or special precautions for use during pregnancy have been specified. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding nursing mothers or lactation in the provided text. Therefore, healthcare professionals may consider the use of this medication in lactating mothers on a case-by-case basis, taking into account the clinical context and the needs of the mother and infant.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney function.

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 consider general principles of management for potential overdose situations.

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 suspected overdosage, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, contacting a poison control center or a medical toxicologist for guidance on specific management strategies is advisable. Additionally, healthcare professionals should be prepared to provide detailed information regarding the substance involved, including dosage and timing of administration, to facilitate appropriate care.

Overall, vigilance and prompt action are critical in managing potential overdosage scenarios effectively.

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 in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Patients should be instructed to stop using the product and consult a doctor if their cough persists for more than 7 days, returns, or is accompanied by fever, rash, or headache lasting longer than a few days, 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 that lasts more than 2 days or is accompanied by fever, headache, rash, swelling, nausea, or vomiting. If symptoms of a sore mouth persist for more than 7 days, or if irritation, pain, or redness continues or worsens, patients should also stop using the product and consult a healthcare professional.

It is important to remind patients not to exceed the recommended dosage, as taking more than directed may result in a laxative effect. Furthermore, patients should be encouraged to consult a doctor before using this product if they have a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in its original packaging to ensure stability and integrity. It should be stored at room temperature, away from moisture, to maintain its efficacy. It is essential to keep the product in its original packaging until it is ready for use. Additionally, the product must be kept out of reach of children to ensure safety.

Additional Clinical Information

The medication is administered orally in the form of lozenges, which should be dissolved slowly in the mouth. For cough relief, patients may repeat the dosage every hour as needed or as directed by a healthcare professional. For sore throat relief, the lozenges may be repeated every two hours. It is important for patients to adhere to the maximum dosage limit of 10 lozenges per day to avoid potential adverse effects.

Drug Information (PDF)

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

View product document (PDF)