Mucus Relief Dm Max

Description

Mucus Relief DM Max is a pharmaceutical formulation containing Dextromethorphan HBr, indicated for the relief of cough, and Guaifenesin, which aids in alleviating chest congestion and mucus. This product is intended for use by individuals aged 12 years and older. It features a tamper-evident design, and users are advised not to use the product if the printed safety seal around or under the cap is broken or missing. Mucus Relief DM Max is distributed by C.D.M.A., Inc., located at 43157 W. Nine Mile, Novi, MI 48376-0995. For further inquiries, contact 248-449-9300 or visit www.qualitychoice.com.

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 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 maximum recommended dosage is 6 doses within a 24-hour period. Dosing should be measured exclusively with the dosing cup provided with the product; the use of any other dosing device is not advised. It is essential to keep the dosing cup with the product at all times to ensure accurate measurement.

For adults and children aged 12 years and older, the recommended dose is 20 mL every 4 hours, as needed. For children under 12 years of age, the product is not indicated and should not be used. Healthcare professionals should advise patients to adhere strictly to these dosing guidelines or to follow the directions provided by their physician.

Contraindications

Use is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use is contraindicated for a period of 2 weeks following the cessation of an MAOI. Patients should consult a healthcare professional if uncertain whether their prescription includes an MAOI.

Exceeding the recommended dosage is also contraindicated.

Warnings and Precautions

The use of this product is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it should not be used for at least two weeks following the discontinuation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

General precautions should be observed prior to use. Patients should be advised to seek medical advice if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, individuals experiencing a cough that produces excessive phlegm (mucus) should also consult a healthcare provider before using this product.

In the event of an overdose, it is imperative to seek emergency medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Patients should be instructed to discontinue use and consult a healthcare professional if their cough persists for more than seven days, recurs, or is accompanied by fever, rash, or headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in individuals taking prescription monoamine oxidase inhibitors (MAOIs). It is contraindicated to use this product if a patient is currently taking an MAOI or has stopped taking one within the past two weeks. Patients are advised to consult a healthcare professional if they are uncertain whether their prescription includes an MAOI.

Common adverse reactions may include a persistent cough that lasts more than seven days, recurs, or is accompanied by fever, rash, or headache. These symptoms could indicate a serious underlying condition, and patients should discontinue use and seek medical advice if they experience such symptoms.

Additionally, patients with a history of persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should consult a healthcare provider before using this product. Coughs that produce excessive phlegm (mucus) also warrant a discussion with a healthcare professional prior to use.

In the event of an overdose, it is critical to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

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, to verify whether their current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Mucus Relief Dm Max (dextromethorphan hbr, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children under 12 years of age should not use this medication. For adults and pediatric patients aged 12 years and older, the recommended dosage is 20 mL every 4 hours.

It is essential 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 not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. It is important to assess the potential risks and benefits associated with the use of this medication during pregnancy and lactation. Healthcare providers should evaluate the individual circumstances of each patient to ensure the safety of both the mother and the fetus.

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 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 individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients, although specific recommendations are not provided.

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 at 1-800-222-1222. Prompt action is crucial to mitigate potential adverse effects associated with overdosage.

Healthcare professionals should be aware that symptoms of overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential. Management of an overdose typically involves supportive care and symptomatic treatment, tailored to the specific clinical presentation.

It is recommended that healthcare providers remain vigilant and prepared to implement appropriate interventions based on the severity of symptoms and the patient's medical history. Continuous monitoring and evaluation of the patient's response to treatment are critical components of effective overdose management.

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, itching, and swelling.

Patient Counseling

Patients should be advised 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 emphasize that patients should not exceed the recommended dosage.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their cough persists for more than 7 days, recurs, or is accompanied by fever, rash, or a headache that lasts. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Additionally, patients should be encouraged to consult with their healthcare provider prior to use if they have a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema. They should also seek advice if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in a configuration that includes a dosing cup. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF) and to avoid refrigeration.

To ensure safety and integrity, the product features a tamper-evident seal. Users should not use the product if the printed safety seal around or under the cap is broken or missing. Additionally, it is recommended to discard the product after opening to maintain safety and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)