Nice Assorted Cough Drops

Description

NICE Assorted Cough Drops are formulated to provide symptomatic relief for coughs. Each package contains 24 individually wrapped drops, featuring a variety of flavors. The product is designed for oral use and is intended to soothe throat irritation associated with coughs. The specific composition and active ingredients are not detailed in the provided information.

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, administered orally in the form of a lozenge. The lozenge should be dissolved slowly in the mouth. For the management 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 total daily intake should not exceed 10 lozenges. For children under 6 years of age, it is advised to consult a healthcare professional before administration.

Contraindications

Use is contraindicated in patients who experience a cough lasting more than 7 days, a cough that recurs, or a cough accompanied by fever, rash, or headache, as these may indicate a serious underlying condition.

Additionally, the product should not be used if a sore throat is severe, persists for more than 2 days, or is 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 last longer than 7 days, or if irritation, pain, or redness worsens.

Exceeding the recommended dosage may result in a laxative effect; therefore, adherence to dosing instructions is essential.

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.

If a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a headache that lasts, it is imperative to discontinue use and consult a healthcare provider, as these symptoms may indicate a serious underlying condition. Similarly, 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. Patients should also stop use and consult a doctor 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 general precautions have been provided. Furthermore, there are no laboratory tests recommended for monitoring in relation to the use of this product.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious adverse reactions may necessitate immediate medical attention. Patients are advised to consult a healthcare professional prior to use if they have a chronic cough that persists or occurs alongside smoking, asthma, chronic bronchitis, or emphysema. Additionally, individuals experiencing a cough accompanied by excessive phlegm (mucus) should seek medical advice.

Patients should discontinue use and consult a doctor if any of the following occur: a cough that lasts more than 7 days, recurs, or is accompanied by fever, rash, or headache lasting longer than a few days, as these symptoms may indicate a serious underlying condition. Furthermore, if a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, medical consultation is recommended. Patients should also seek medical advice if symptoms of a sore mouth last longer than 7 days, or if irritation, pain, or redness continues or worsens.

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 specific dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Nice Assorted Cough Drops (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 6 years of age should consult a healthcare professional before use. For children aged 6 years and older, the recommended dosage is 5 mg per lozenge.

Geriatric Use

There is no specific information available 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

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in consultation with the patient. Women of childbearing potential should be informed of the absence of established safety data during pregnancy.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert text 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 data 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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, 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 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 use of the compound in these contexts.

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 lasts more than 7 days, returns, or is accompanied by fever, rash, or headache, as these may indicate a serious condition. Additionally, if a patient experiences a severe sore throat that lasts more than 2 days or is accompanied by fever, headache, rash, swelling, nausea, or vomiting, they should seek medical advice. Patients should also be informed that if symptoms of a sore mouth persist for more than 7 days, or if irritation, pain, or redness continues or worsens, they should contact their healthcare provider.

When using this product, patients must be cautioned not to exceed the recommended dosage, as taking more than directed may result in a laxative effect. Furthermore, healthcare providers should encourage patients to consult a doctor before using this product if they have a chronic cough that lasts or occurs alongside smoking, asthma, chronic bronchitis, or emphysema, or if their cough is associated with excessive phlegm (mucus).

Storage and Handling

The product is supplied in a tightly closed container to ensure its integrity. It should be stored at room temperature, away from excessive heat and moisture to maintain its efficacy. Additionally, it is essential to keep the product 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 taken every 2 hours. It is important for patients to adhere to the maximum dosage limit of 10 lozenges per day.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)