Mucus Relief Dm

Description

Guaifenesin, at a dosage of 1200 mg, is an expectorant that aids in thinning and loosening mucus in the airways. Dextromethorphan HBr, present at 60 mg, functions as a cough suppressant, effectively controlling cough reflexes. This formulation is designed for extended release, providing 12-hour relief from symptoms associated with respiratory conditions. The product is available in tablet form, ensuring convenient administration.

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 cough.

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

The tablet should be taken whole; it must not be crushed, chewed, or broken. It is recommended to administer the tablet with a full glass of water. This product can be taken 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:

• In children under 12 years of age.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised.

Additionally, it is important to adhere to the recommended dosage and not exceed the directed use of this product.

Warnings and Precautions

The use of this product is contraindicated in children under 12 years of age. Additionally, it should not be administered to individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Furthermore, it is essential to refrain from using this product for at least two weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in their prescription medications.

General precautions should be observed prior to use. Patients are advised to seek medical consultation if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, individuals experiencing a cough accompanied by excessive phlegm (mucus) should also consult a healthcare provider.

Patients must be instructed to discontinue use and contact a healthcare professional if their cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

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 should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in specific populations. The product is contraindicated for use in children under 12 years of age and should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing such medications. Patients are advised to consult a healthcare professional if they are currently taking any MAOI medications, which are often prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease.

Common adverse reactions may include persistent or chronic cough, particularly in individuals with underlying conditions such as smoking, asthma, chronic bronchitis, or emphysema. Patients experiencing a cough accompanied by excessive phlegm (mucus) should seek medical advice prior to using the product.

Patients are also instructed to discontinue use and consult a healthcare provider if their cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

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, 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. Safety and efficacy have not been established in this population, and use is contraindicated for children in this age group.

Geriatric Use

Elderly patients do not have specific recommendations for geriatric use, dosage adjustments, safety concerns, or special precautions associated with Mucus Relief DM Maximum Strength as outlined in the prescribing information. Therefore, healthcare providers should consider the absence of tailored guidance when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects, given the general considerations for medication use in 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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a healthcare 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 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. 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 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. The national Poison Control Center can be reached at 1-800-222-1222.

Healthcare professionals should be aware that timely intervention is crucial in managing overdose situations. Symptoms of overdose may vary depending on the substance involved, and it is essential to monitor the patient closely for any signs of adverse reactions.

Management of an overdose typically involves supportive care and symptomatic treatment. Healthcare providers should assess the patient's condition, including vital signs and level of consciousness, and initiate appropriate interventions based on the clinical presentation.

In summary, prompt action and professional medical guidance are essential in the event of an overdose to ensure the best possible outcome for the patient.

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

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: dizziness, nausea, vomiting, and allergic reactions, which include rash, pruritus, and urticaria.

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 past 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 must 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 condition.

It is essential to remind patients to adhere strictly to the recommended dosage and not exceed the directed amount while using this product. 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 tamper-evident blister unit. It is essential to inspect the blister unit prior to use; do not use if the unit is torn, broken, or shows any signs of tampering.

For optimal storage, the product should be maintained at a temperature range of 20º to 25ºC (68º to 77ºF). It is recommended to keep the outer carton to ensure access to complete warnings and product information.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is one tablet every 12 hours, with a maximum of two tablets in 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)