Mucus Relief Dm

Description

MUCUS RELIEF DM is an expectorant and cough suppressant formulated as extended-release tablets. Each tablet contains 600 mg of guaifenesin and 30 mg of dextromethorphan HBr. This combination is designed to control cough while thinning and loosening mucus. The product is packaged in a bottle containing 20 extended-release tablets. The National Drug Code (NDC) for this formulation is 60000-058-67.

Uses and Indications

This drug is indicated for the relief of cough associated with minor throat and bronchial irritation, which may occur due to the common cold or inhaled irritants. It aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the expulsion of bothersome mucus and enhancing the productivity of coughs.

Additionally, this drug temporarily alleviates the intensity of coughing and reduces 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 tablets with a full glass of water. It is important to note that the tablets must not be crushed, chewed, or broken prior to ingestion. This product can be administered without regard for the timing of meals.

For adults and children aged 12 years and older, the recommended dosage is 1 or 2 tablets every 12 hours, with a maximum of 4 tablets in a 24-hour period. The use of this product is not recommended for children under 12 years of age.

Contraindications

There are no contraindications listed for this product. However, it is essential to adhere to the recommended dosage guidelines, as exceeding the directed use may lead to adverse effects.

Warnings and Precautions

The use of this product is contraindicated in children under 12 years of age. Healthcare professionals should ensure that this medication is not prescribed to this demographic to avoid potential adverse effects.

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease, should not use this product. Additionally, it is essential to refrain from using this medication for at least two weeks after discontinuing an MAOI. If there is uncertainty regarding the presence of an MAOI in a patient's current medication regimen, it is advisable to consult a healthcare provider or pharmacist prior to administration.

In the event of an overdose, immediate medical assistance should be sought. Patients or caregivers are encouraged to contact a Poison Control Center at 1-800-222-1222 without delay.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may indicate a more serious underlying condition that requires further evaluation and intervention.

Side Effects

Patients should be aware of the potential adverse reactions associated with this medication. Serious adverse reactions may occur, and it is crucial to discontinue use and consult a healthcare professional if a cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms could indicate a serious underlying condition.

This medication is contraindicated in children under 12 years of age. Additionally, it should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing such medications, which are often prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients uncertain about whether their prescription includes an MAOI should seek guidance from a doctor or pharmacist prior to use.

Before initiating treatment, patients should consult a healthcare provider if they have a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

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, 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 Mucus Relief Dm (guaifenesin and dextromethorphan hbr). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. There is insufficient data to support its safety and efficacy in this age group. Therefore, healthcare professionals are advised to avoid prescribing this treatment to children younger than 12 years.

Geriatric Use

Elderly patients do not require specific dosage adjustments when receiving this medication, as no safety concerns have been identified in this population. However, healthcare providers should remain vigilant and monitor for any potential adverse effects, as individual responses may vary. It is essential to consider the overall health status and comorbidities of geriatric patients when prescribing this medication to ensure optimal therapeutic outcomes.

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, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 not been specifically addressed in the available data 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 information necessitates careful clinical judgment and monitoring.

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 in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Healthcare professionals should monitor patients closely for any potential symptoms that may arise from an overdose. Symptoms may vary depending on the substance involved and the individual patient's response. In the event of an overdose, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary.

Management procedures should include the following steps:

1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide supportive care tailored to the patient's needs, which may include intravenous fluids, oxygen supplementation, or other interventions as indicated.

3. Consultation: Consider consulting a poison control center or a medical toxicologist for guidance on specific management strategies based on the clinical scenario.

4. Documentation: Ensure that all findings, interventions, and patient responses are meticulously documented in the patient's medical record.

In summary, while specific overdosage information is not available, healthcare professionals should remain vigilant and prepared to implement standard overdosage management protocols in the event of an overdose.

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 have been received through voluntary submissions and surveillance programs. Patients and healthcare professionals are encouraged to report any adverse events associated with the use of the product to the designated contact number provided.

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. It is important for patients to be aware that they should discontinue use and consult a doctor if their cough persists for more than 7 days, returns after improvement, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

Patients should be instructed to adhere strictly to the recommended dosage and not exceed the directed amount while using this product. Additionally, healthcare providers should encourage patients to consult with a doctor prior to use if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients should be advised to seek medical advice if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in a tamper-evident container. It is essential to refrain from using the product if the seal over the bottle opening is broken or missing.

For optimal storage conditions, the product should be maintained at a temperature range of 20° to 25°C (68° to 77°F). Proper adherence to these storage guidelines is crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 1 or 2 tablets every 12 hours, with a maximum of 4 tablets within a 24-hour period. It is contraindicated for use in children under 12 years of age.

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

Drug Information (PDF)

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

View product document (PDF)