Leader Cough Dm

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation, which may occur due to the common cold or inhaled irritants. It also serves to alleviate the impulse to cough, thereby 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 their 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

The use of this product is contraindicated in 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 to refrain from using this product for at least two weeks following the discontinuation of an MAOI. Healthcare professionals should counsel patients to verify with their doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Allergy Alert This product contains sodium metabisulfite, a sulfite that may provoke allergic-type reactions in susceptible individuals. Patients with a known sulfite allergy should be advised to avoid this product.

General Precautions Prior to use, patients should consult a healthcare provider if they have a chronic cough associated with smoking, asthma, or emphysema. Additionally, individuals experiencing a cough that produces excessive phlegm (mucus) should seek medical advice before using this product.

Stop Taking and Call Your Doctor Instructions Patients are instructed to discontinue use and consult a healthcare professional if any side effects occur. Side effects can be reported to the FDA at 1-800-FDA-1088. Furthermore, if a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a headache that lasts, patients should seek medical attention, as these symptoms may indicate a serious underlying condition.

Get Emergency Medical Help Instructions 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.

Side Effects

Patients may experience adverse reactions associated with the use of this medication. Notably, there is an Allergy Alert due to the presence of sodium metabisulfite, a sulfite that may provoke allergic-type reactions in susceptible individuals.

Patients are advised to discontinue use and consult a healthcare professional if any side effects occur. It is also recommended that patients seek medical attention if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or headache lasting longer than expected, as these symptoms may indicate a serious underlying condition.

For any adverse reactions, patients are encouraged to report their experiences to the FDA at 1-800-FDA-1088.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this medication while on MAOIs or for a period of two weeks following the discontinuation of MAOI therapy. The combination may result in serious interactions that could pose significant health risks. It is essential to ensure that the patient has completed the appropriate washout period before initiating treatment with this medication.

Packaging & NDC

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

Pediatric Use

Pediatric patients aged 12 years and older may be administered 10 mL every 12 hours, with a maximum dosage 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 to exceed 10 mL in 24 hours. In children aged 4 to under 6 years, the dosage is 2.5 mL every 12 hours, with a maximum of 5 mL in 24 hours. The use of this medication is not recommended in children under 4 years of age.

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, given the lack of targeted data for 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 the safety of both the mother 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 on the excretion of this drug 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 have not been specifically addressed in the drug insert 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 absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Healthcare professionals are advised to call the Poison Control Center at 1-800-222-1222 for guidance on managing the situation effectively.

Prompt intervention is crucial in mitigating potential adverse effects associated with overdose. Symptoms may vary depending on the substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the specific clinical presentation of the patient. Continuous monitoring and evaluation are essential to ensure patient safety and to address any complications that may arise during the course of treatment.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to 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

Reports of side effects associated with the use of the product have been received through voluntary reporting and surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events to the FDA at 1-800-FDA-1088. This information contributes to the ongoing monitoring of the product's safety profile.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose.

Patients should be informed of the Allergy Alert regarding the presence of sodium metabisulfite, which is a sulfite that may lead to allergic-type reactions in susceptible individuals.

It is important for healthcare providers to instruct patients to discontinue use and consult a doctor if any side effects occur. Patients may also report side effects to the FDA at 1-800-FDA-1088.

Patients should be cautioned to stop use and seek medical advice if their cough persists for more than 7 days, returns after improvement, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a serious underlying condition.

Healthcare providers should encourage patients to consult a doctor prior to use if they have a chronic cough associated with smoking, asthma, or emphysema. Additionally, patients should be advised to seek medical guidance if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in a bottle that requires careful handling and storage to maintain its integrity. It should be stored at a temperature range of 20° to 25°C (68° to 77°F). Prior to use, the bottle must be shaken well to ensure proper mixing of the contents.

For accurate dosing, it is essential to use only the dosing cup provided with the product. The dosing cup should not be used with any other products to prevent cross-contamination. Additionally, if the carton is opened or if the printed foil under the cap is broken or missing, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is important to keep the medication out of reach of children. In the event of an overdose, patients are advised to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)