Mucus Relief Dm Cough

Description

LEADER Mucus Relief DM Cough is formulated as immediate-release tablets containing active ingredients dextromethorphan HBr at a dosage of 20 mg and guaifenesin at 400 mg. This product functions as both a cough suppressant and an expectorant. Each package contains 24 tablets, with the actual size of the tablets illustrated on the packaging. The product is distributed by Cardinal Health, located in Dublin, Ohio 43017. For further information, visit www.myleader.comwww.myleader.com. The packaging includes a tamper-evident statement, advising against use if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering.

Uses and Indications

This drug is indicated for the relief of cough associated with minor throat and bronchial irritation due to the common cold. It helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the clearance of mucus from the bronchial passageways and making coughs more productive.

Additionally, this drug temporarily relieves the intensity of coughing and the impulse to cough, which may assist patients in achieving restful sleep.

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

Dosage and Administration

Patients should take the medication with a full glass of water to ensure proper absorption.

For adults and children aged 12 years and older, the recommended dosage is 1 tablet every 4 hours as needed. It is important not to exceed a total of 6 tablets within a 24-hour period to avoid potential overdose.

This medication is not recommended for use in children under 12 years of age.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, use is contraindicated 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.

Exceeding the recommended dosage while using this product is also contraindicated.

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. Additionally, it should not be used for a period of two weeks following the discontinuation of an MAOI. Healthcare professionals are advised to confirm with patients whether their prescription medications contain an MAOI prior to recommending this product.

Healthcare providers should exercise caution and advise patients to consult a physician before using this product if they experience a cough that is accompanied by excessive phlegm (mucus) or if they have a persistent or chronic cough, particularly in cases related to smoking, asthma, chronic bronchitis, or emphysema.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should be instructed to discontinue use and consult a healthcare professional if their cough persists for more than seven days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a more serious underlying condition.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. It is important to note that the use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment, as this may lead to serious interactions.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if a cough persists for more than 7 days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. These symptoms may indicate a serious underlying condition that requires medical attention.

Additionally, patients should seek medical advice prior to using this medication if they have a cough that is accompanied by excessive phlegm (mucus) or if they suffer from a persistent or chronic cough, which may be associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema.

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 minimum 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, to verify whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 1 tablet every 4 hours, with a maximum of 6 tablets in a 24-hour period. Caution is advised to ensure adherence to the dosing guidelines to prevent potential overdose.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, 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 safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals 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 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 event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the substance is known, specific antidotes or treatments may be indicated, and healthcare providers should refer to established guidelines for the management of the particular overdose scenario.

It is critical to document all relevant information regarding the overdose, including the substance involved, the amount ingested, and the time of ingestion, to facilitate effective treatment and follow-up care.

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 for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center 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 be cautioned against using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription includes an MAOI, they should be encouraged to consult their doctor or pharmacist prior to use.

Patients should be instructed to discontinue use and consult a healthcare professional if their cough persists for more than seven days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition. It is important to emphasize that patients must not exceed the recommended dosage while using this product.

Additionally, healthcare providers should recommend that patients consult a doctor before using this product if they have a cough that is accompanied by excessive phlegm (mucus) or if they experience a persistent or chronic cough, which may be associated with smoking, asthma, chronic bronchitis, or emphysema.

Storage and Handling

The product is supplied in tamper-evident packaging. It should not be used if the outer package is opened or if the blister is torn or broken. The expiration date and lot number can be found on the end flap of the packaging.

For optimal storage, the product should be maintained at a temperature of 25°C (77°F). Temporary excursions are permissible between 15°C and 30°C (59°F to 86°F).

Additional Clinical Information

Patients should be counseled to consult a health professional if they are pregnant or breastfeeding before using the medication. It is important to keep the product out of reach of children. In the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately.

Clinicians are encouraged to be aware of resources regarding medicine abuse, particularly among teenagers, which can be found at www.StopMedicineAbuse.org.

Drug Information (PDF)

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

View product document (PDF)