Mucus Relief Dm

Description

Guaifenesin 1200 mg and Dextromethorphan Hydrobromide 60 mg are formulated as extended-release tablets, designed for the management of cough and mucus associated with respiratory conditions. Each tablet serves a dual purpose as an expectorant and cough suppressant, effectively controlling cough while thinning and loosening mucus to facilitate easier expectoration. The extended-release formulation provides therapeutic effects for up to 12 hours. This product is supplied in a package containing 14 extended-release tablets.

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 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 mentioned in the available data.

Dosage and Administration

The tablet should be taken whole; it must not be crushed, chewed, or broken. It is recommended that the tablet be ingested with a full glass of water. This medication can be administered without regard to the timing of meals.

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

Contraindications

Use of this product is contraindicated in the following situations:

• Children under 12 years of age.

• Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past 2 weeks. Due to the potential for serious interactions, it is essential to consult a healthcare professional if there is uncertainty regarding the presence of an MAOI in any prescription medication.

Additionally, it is advised not to exceed the recommended dosage while using this product.

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.

It is imperative to adhere to the following precautions to ensure safe use of this product. This medication is not recommended for children under 12 years of age. Additionally, it 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. Furthermore, this product should not be taken for at least two weeks after discontinuing 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 advised.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a more serious underlying condition.

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

Side Effects

Patients should be aware that a cough lasting more than 7 days, returning after resolution, or occurring alongside fever, rash, or persistent headache may indicate a serious underlying illness and should prompt immediate medical evaluation.

In addition to the aforementioned serious warnings, participants may experience persistent or chronic cough, which can be associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema. Furthermore, a cough that is accompanied by excessive phlegm (mucus) may also occur. These adverse reactions should be monitored closely, and patients are advised to seek medical advice if they experience any concerning symptoms.

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 Mucus Relief Dm (dextromethorphan hbr, 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 12 hours, with a maximum of 2 tablets in a 24-hour period.

It is important to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Geriatric Use

Elderly patients may exhibit increased sensitivity to the side effects of this medication. Due to the potential for reduced kidney function in this population, dosage adjustments may be necessary to ensure safety and efficacy.

Healthcare providers are advised to monitor elderly patients closely for any adverse effects when administering this product. This vigilance is essential to mitigate risks and optimize therapeutic outcomes in geriatric patients.

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 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 to ensure safety and efficacy. It is essential for healthcare professionals to monitor renal function regularly in these patients. Dosage adjustments should be based on creatinine clearance levels to account for the reduced kidney function. Special consideration is required for patients with severe renal impairment, as they may require more stringent management to avoid potential adverse effects.

Hepatic Impairment

Hepatic impairment may affect the pharmacokinetics of the drug, necessitating dosage adjustments for patients with compromised liver function. It is recommended that liver function tests be monitored periodically in these patients to assess their hepatic status and ensure safe administration of the drug. Caution should be exercised when administering the drug to patients with liver problems, as their altered metabolic capacity may influence therapeutic outcomes and the risk of adverse effects.

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 available, the use of specific antidotes or treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the substance, amount ingested, and time of ingestion, is crucial for effective management and treatment planning.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. There are no specific non-teratogenic effects reported. Additionally, there is no available information regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include dizziness, nausea, vomiting, and rash. Additionally, allergic reactions, including anaphylaxis, have been noted. Neuropsychiatric effects such as hallucinations, confusion, and agitation were also reported. Cardiovascular effects, including increased heart rate, and respiratory depression have been observed. Furthermore, cases of serotonin syndrome and hepatotoxicity were documented. Other unspecified reactions have also been reported.

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 to inform patients that this product is not recommended for use in children under 12 years of age.

Patients should be cautioned against using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. Healthcare providers should encourage patients to consult with a doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Patients should be instructed to discontinue use and consult a healthcare professional if their cough persists for more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious illness.

When using this product, patients must be reminded to adhere strictly to the recommended dosage and not exceed the directed amount. Additionally, healthcare providers should advise patients to consult a doctor before using this product if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Patients should also be encouraged to seek medical advice if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product at a temperature range of 20-25°C (68-77°F) to maintain its efficacy and safety.

Healthcare professionals should ensure that the product is not used if the printed foil under the cap is broken or missing, as this may indicate compromised integrity. Proper handling and storage conditions are vital to ensure the product remains effective and safe for use.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of one tablet every 12 hours for adults and children aged 12 years and older, not exceeding two tablets within a 24-hour period. It is contraindicated for children under 12 years of age.

Clinicians should counsel patients to avoid using the product if the printed foil under the cap is broken or missing. Patients are advised to take the tablet with a full glass of water and may do so without regard to meal timing. It is important to instruct patients not to crush, chew, or break the tablet to ensure proper administration.

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)