Mucus Dm Extended Release

Description

Guaifenesin and Dextromethorphan Hydrobromide Extended-Release Tablets are formulated to deliver a combination of 1200 mg of guaifenesin and 60 mg of dextromethorphan hydrobromide. This medication serves as both an expectorant and a cough suppressant. Guaifenesin functions by thinning and loosening mucus in the airways, facilitating easier expectoration. Dextromethorphan hydrobromide acts to control cough, providing symptomatic relief. The extended-release formulation allows for prolonged therapeutic effects.

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 relieves the intensity of coughing and the impulse to cough, which may aid in promoting sleep.

Limitations of use include the absence of teratogenic or nonteratogenic effects as per 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. 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.

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.

This product is contraindicated for use in children under 12 years of age.

Healthcare professionals should advise patients against using this medication concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, this medication should not be used for a period of 2 weeks following the discontinuation of an MAOI. If there is uncertainty regarding the presence of an MAOI in a patient's current prescription regimen, it is imperative to consult a healthcare provider or pharmacist prior to administration.

Patients should be instructed 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, as these symptoms may indicate a serious underlying condition.

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 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 encouraged 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 within 2 weeks of discontinuing an MAOI. It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to confirm whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Mucus Dm Extended Release (guaifenesin, dextromethorphan hbr). 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.

Geriatric Use

Elderly patients may not require specific dosage adjustments or special precautions when using Mucus DM Extended Release, as the prescribing information does not indicate any unique geriatric use recommendations or safety concerns for this population. However, healthcare providers should remain vigilant in monitoring the overall health status of geriatric patients, as individual responses to medication can vary. It is advisable to consider the general health and comorbidities of elderly patients when prescribing this medication, even in the absence of specific guidelines.

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 currently no available data on the excretion of this drug 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 require dosage adjustments based on their renal function. It is essential for healthcare professionals to monitor renal function regularly in these patients. Dosage adjustments should be guided by creatinine clearance levels, with a reduced dose recommended for those with moderate to severe renal impairment. Additionally, renal function tests should be performed prior to initiating therapy and periodically during treatment to ensure appropriate dosing and safety.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to altered drug metabolism and clearance. It is recommended that liver function tests be monitored closely in this population to assess the extent of impairment and guide treatment decisions.

For patients with severe hepatic impairment, a reduced dose may be necessary to minimize the risk of adverse effects and ensure therapeutic efficacy. Careful consideration of liver function is essential when determining the appropriate dosage for these patients.

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 and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the substance involved in the overdose.

Overall, vigilance and prompt intervention are critical in managing any suspected overdose situation effectively.

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 several adverse reactions reported voluntarily or through surveillance programs. These include dizziness, nausea, vomiting, rash, and allergic reactions, which may encompass anaphylaxis. Additionally, cases of hallucinations, confusion, agitation, respiratory depression, and serotonin syndrome have been documented.

Further safety updates from postmarketing experience indicate reports of misuse and abuse of the product, particularly among individuals with a history of substance use disorders.

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), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. They should also refrain from using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to use.

Healthcare providers should instruct patients 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.

When using this product, patients must be reminded not to exceed the recommended dosage. 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 should be referenced for accurate identification. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy.

Care should be taken to ensure that the printed foil under the cap remains intact; the product should not be used if this foil is broken or missing, as this may compromise the safety and effectiveness of the product. Proper handling and storage conditions are crucial for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

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

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before using the medication. In the event of an overdose, patients are advised to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)