Mucus Relief Dm

Description

No description information is available for the specified drug.

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 assists 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 aid in promoting sleep.

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

Dosage and Administration

Adults and children 12 years of age and older are instructed to take 1 tablet every 4 hours, accompanied by a full glass of water. The total dosage must not exceed 6 doses within a 24-hour period.

For children under 12 years of age, the use of this medication is not recommended.

Contraindications

Use of this product is contraindicated in the following situations:

Children under 12 years of age should not use this product due to safety concerns related to efficacy and potential adverse effects in this age group.

The product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. This is due to the risk of serious interactions that may occur with certain drugs used for depression, psychiatric or emotional conditions, or Parkinson’s disease. Patients should consult a healthcare professional if uncertain about the presence of an MAOI in their prescription medication.

Additionally, the product should not be used in excess of the directed dosage.

Warnings and Precautions

The use of this product is contraindicated in children under 12 years of age. Healthcare professionals should advise against its administration to this population to ensure safety and efficacy.

Caution is advised when prescribing this product to patients currently taking prescription monoamine oxidase inhibitors (MAOIs), which are commonly used for the treatment of depression, psychiatric or emotional conditions, or Parkinson’s disease. The product should not be used concurrently with MAOIs or within two weeks of discontinuing such medications. If there is uncertainty regarding the presence of an MAOI in a patient's current medication regimen, it is imperative to consult a healthcare provider or pharmacist prior to use.

In the event of an accidental overdose, immediate medical assistance should be sought. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 for guidance.

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.

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 considerations, other adverse reactions may include persistent or chronic cough, which can be associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients may experience a cough accompanied by excessive phlegm (mucus). These symptoms warrant careful monitoring and consultation with a healthcare provider to ensure appropriate management and to rule out any significant health concerns.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Mucus Relief Dm (dextromethorphan hbr 20mg guaifenesin 400mg). 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 may not have specific information regarding the use of this medication, as the prescribing information does not provide any age-related considerations. There are no recommended dosage adjustments or safety concerns outlined for geriatric patients. Additionally, no special precautions are indicated for this population.

Healthcare providers should exercise clinical judgment when prescribing this medication to elderly patients, considering individual patient factors and overall health status, despite the absence of specific guidelines in the prescribing information. Regular monitoring may be warranted to ensure safety and efficacy in this demographic.

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

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential to monitor renal function tests regularly in these patients to ensure appropriate dosing and minimize the risk of adverse effects. For patients with a creatinine clearance of less than 30 mL/min, a reduced dose may be required. Additionally, special considerations should be taken for patients with severe renal impairment to ensure safe and effective use of the medication.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to compromised liver function. It is essential to monitor liver function tests closely in this population to ensure safety and efficacy. Caution should be exercised when administering this medication to patients with liver dysfunction, as their altered metabolic capacity may affect drug clearance and overall treatment outcomes.

Overdosage

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and adhere to standard protocols for managing potential overdose situations.

In the event of suspected overdosage, it is recommended that healthcare providers monitor the patient closely for any unusual symptoms or adverse reactions. Supportive care should be initiated as necessary, and symptomatic treatment should be provided based on the clinical presentation.

Healthcare professionals are encouraged to report any cases of suspected overdosage to the appropriate regulatory authorities to contribute to the ongoing assessment of the medication's safety profile.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before 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 a range of adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as rash, pruritus, and urticaria. Other reported events encompass dizziness, nausea, vomiting, somnolence, confusion, and hallucinations. Additionally, cases of agitation, respiratory depression, and serotonin syndrome have been noted. Cardiovascular effects such as increased blood pressure and tachycardia have also been observed. Hepatotoxicity and anaphylaxis are among the serious adverse reactions reported. It is important to note that other adverse reactions not listed above may also occur.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of an accidental overdose, patients should seek medical assistance or contact a Poison Control Center at 1-800-222-1222.

It is important to inform patients that this product is not recommended for use in children under 12 years of age. Additionally, 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. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to using this product.

Patients should be instructed to discontinue use and consult a doctor 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.

While using this product, patients must be reminded not to exceed the recommended dosage. Furthermore, healthcare providers should advise patients to seek medical advice before using this product if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at a temperature range of 20ºC to 25ºC (68ºF to 77ºF) to maintain its efficacy. It is essential to keep the product in a dry place, ensuring that it is not exposed to heat, which could compromise its integrity.

Healthcare professionals are advised to inspect the product prior to use; it should not be used if the imprinted safety seal under the cap is broken or missing, as this may indicate potential tampering or contamination.

Additional Clinical Information

Patients aged 12 years and older are advised to take 1 tablet every 4 hours with a full glass of water, ensuring that they do not exceed 6 doses within a 24-hour period. The use of this medication is not recommended for children under 12 years of age. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

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)