Leader Cough

Description

Dextromethorphan Polistirex Extended-Release Oral Suspension is a cough suppressant formulated as a grape-flavored liquid. This preparation is alcohol-free and is packaged in a 3 FL OZ (89 mL) container. It contains sodium metabisulfite, which is a sulfite that may cause allergic-type reactions in sensitive individuals.

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation, which may occur with the common cold or as a result of inhaled irritants. Additionally, it is indicated for the temporary relief of the impulse to cough, facilitating sleep.

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

Dosage and Administration

The bottle should be shaken well before use. Dosing must be measured exclusively with the dosing cup provided; the use of this cup with other products is not recommended.

For adults and children aged 12 years and older, the recommended dose is 10 mL every 12 hours, with a maximum limit of 20 mL within a 24-hour period. For children aged 6 to under 12 years, the dosage is 5 mL every 12 hours, not to exceed 10 mL in a 24-hour period. For children aged 4 to under 6 years, the appropriate dose is 2.5 mL every 12 hours, with a maximum of 5 mL in 24 hours. This product is not indicated for use in children under 4 years of age.

Healthcare professionals should ensure that patients adhere to these dosing guidelines or any alternative instructions provided by a physician.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, and for a period of 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI.

Additionally, this product contains sodium metabisulfite, which may cause allergic-type reactions in individuals with sulfite sensitivity.

Warnings and Precautions

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

This product is contraindicated for individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. It is also advised not to use this product for at least two weeks following the discontinuation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional, such as a doctor or pharmacist, is recommended.

Patients should be aware of the Allergy Alert: this product contains sodium metabisulfite, a sulfite that may trigger allergic-type reactions in susceptible individuals.

Patients are advised to discontinue use and consult a healthcare provider if any side effects occur. Side effects can be reported to the FDA at 1-800-FDA-1088. Additionally, if a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or headache that lasts, these may indicate a serious underlying condition requiring medical evaluation.

General precautions include consulting a healthcare professional prior to use if the patient has a chronic cough associated with smoking, asthma, or emphysema. Furthermore, individuals should seek medical advice before using this product if their cough is accompanied by excessive phlegm (mucus).

No specific laboratory tests are recommended for the safe use of this product.

Side Effects

Patients may experience various adverse reactions associated with the use of this medication. It is important to note that side effects can occur, and patients are encouraged to report any adverse reactions to the FDA at 1-800-FDA-1088.

Serious adverse reactions may include a persistent cough that lasts more than 7 days, or a cough that recurs or is accompanied by fever, rash, or headache. These symptoms could indicate a serious underlying condition that requires medical attention.

Common adverse reactions reported include chronic cough, particularly in patients with a history of smoking, asthma, or emphysema. Additionally, some patients may experience a cough that is associated with excessive phlegm (mucus).

Patients should be vigilant for these symptoms and consult healthcare professionals if they arise, as they may necessitate further evaluation and management.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, psychiatric or emotional conditions, and Parkinson’s disease. Patients should not take this product while on MAOIs or for a period of two weeks following the discontinuation of an MAOI.

It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, if there is any uncertainty regarding the presence of an MAOI in their current prescription medications before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Leader Cough (dextromethorphan polistirex). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to under 12 years may be administered 5 mL every 12 hours, with a maximum dosage of 10 mL in a 24-hour period. For children aged 4 to under 6 years, the recommended dosage is 2.5 mL every 12 hours, not to exceed 5 mL in 24 hours. Use is not recommended for children under 4 years of age.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

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 associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

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

Patients with renal impairment may necessitate dosage adjustments based on their level of renal function. It is essential for healthcare professionals to monitor renal function regularly in these patients. Dosage adjustments should be guided by creatinine clearance levels. Additionally, it is recommended to perform renal function tests prior to initiating therapy and periodically thereafter in patients with renal impairment to ensure safe and effective treatment.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to altered drug metabolism and clearance. Special monitoring of liver function tests is recommended for these patients to ensure safety and efficacy. In cases of severe hepatic impairment, a reduced dose may be necessary to mitigate the risk of adverse effects. Caution is advised when administering the drug to patients with liver dysfunction, and careful consideration should be given to the potential for increased drug exposure and associated risks.

Overdosage

There is currently no specific information available regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL).

Healthcare professionals are advised to monitor patients closely for any signs or symptoms that may arise in the event of an overdose. In the absence of detailed guidance, it is recommended that standard supportive measures be employed. This may include symptomatic treatment and monitoring of vital signs, as well as providing appropriate interventions based on the clinical presentation of the patient.

In cases of suspected overdosage, it is essential to contact a poison control center or seek expert consultation for further management recommendations.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Side effects have been reported in the postmarketing experience. Healthcare professionals and patients are encouraged to report any adverse events to the FDA at 1-800-FDA-1088.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical help or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose. It is crucial to inform patients that this product should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are medications prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients should also be cautioned against using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult their doctor or pharmacist.

Providers should alert patients to the presence of sodium metabisulfite in the formulation, which may trigger allergic-type reactions in susceptible individuals. Patients should be instructed to discontinue use and consult a doctor if they experience any side effects. Additionally, they may report side effects to the FDA at 1-800-FDA-1088.

Patients should be advised to stop using the product and seek medical advice if their cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts, as these symptoms may indicate a serious condition. It is also important for healthcare providers to recommend that patients consult a doctor before using this product if they have a chronic cough associated with smoking, asthma, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied with a dosing cup included for accurate measurement. It should be stored at a temperature range of 20° to 25°C (68° to 77°F) to ensure optimal stability and efficacy. Proper storage conditions are essential for maintaining the integrity of the product.

Additional Clinical Information

Patients aged 12 years and older are advised to administer 10 mL every 12 hours, with a maximum of 20 mL in a 24-hour period. For children aged 6 to under 12 years, the recommended dosage is 5 mL every 12 hours, not exceeding 10 mL in 24 hours. Children aged 4 to under 6 years should receive 2.5 mL every 12 hours, with a maximum of 5 mL in 24 hours. The medication is not recommended for children under 4 years of age.

Clinicians should counsel patients to consult a doctor before use if they have a cough due to minor throat and bronchial irritation, such as that caused by the common cold or inhaled irritants. Patients should discontinue use and seek medical advice if the cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or headache, as these may indicate a serious condition. Pregnant or breastfeeding individuals should also consult a healthcare professional prior to use. It is important to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose.

Drug Information (PDF)

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

View product document (PDF)