Maximum Strength Mucus Relief Dm Max

Description

Dextromethorphan HBr, at a concentration of 20 mg per 6 fluid ounces (177 mL), serves as a cough suppressant. Guaifenesin, present at 400 mg, functions as an expectorant. The formulation is flavored with cherry and is intended for use in individuals aged 12 years and older.

Uses and Indications

This drug is indicated for the relief of cough associated with minor throat and bronchial irritation, which may occur due to colds or inhaled irritants. It helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating drainage of the bronchial tubes and making coughs more productive. Additionally, this drug temporarily alleviates the intensity of coughing and reduces the impulse to cough, thereby aiding in sleep.

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

Dosage and Administration

The maximum recommended dosage is 6 doses within a 24-hour period. Healthcare professionals should instruct patients to measure the medication using only the dosing cup provided with the product. It is important to emphasize that the dosing cup should not be used with any other products to ensure accurate dosing.

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 use of this medication is not recommended. It is advisable to follow the dosing instructions or any specific directions provided by a healthcare provider.

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 its 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 potential for serious interactions that may occur with the use of MAOIs, which are commonly prescribed for depression, psychiatric, or emotional conditions, as well as for 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, the product should not be used in excess of the directed dosage.

Warnings and Precautions

In the event of an overdose, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately. Prompt action is crucial to mitigate potential adverse effects associated with overdose.

Healthcare professionals should advise patients to discontinue use and consult a physician 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 serious underlying condition that requires further evaluation and intervention.

Side Effects

Patients should be aware that there are no specific side effects listed for this medication. However, it is important to monitor for certain symptoms that may indicate a more serious condition. Patients are advised to stop use and consult a doctor if a cough persists for more than 7 days, returns after resolution, or is accompanied by fever, rash, or a persistent headache.

Additionally, patients should seek medical advice before using this medication if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema, or if the cough is accompanied by excessive phlegm (mucus). There are no additional adverse reactions reported in clinical trials or postmarketing experiences.

Drug Interactions

The concomitant use of this product with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not take this product while on MAOIs or within two weeks of discontinuing an MAOI. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. It is advisable for patients to consult with a healthcare professional, such as a doctor or pharmacist, to confirm whether their prescription medication contains an MAOI before initiating treatment with this product.

No specific laboratory test interactions have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Maximum Strength Mucus Relief Dm Max (dextromethorphan hbr, guaifenesin). 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 are no established safety or efficacy profiles for this age group, and its use is contraindicated.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any recommended age considerations, dosage adjustments, safety concerns, or special precautions for this population.

Healthcare providers should exercise clinical judgment when prescribing this medication to geriatric patients, considering the absence of data specific to this demographic. Monitoring for efficacy and safety may be warranted, given the general variability in drug response among elderly individuals.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice prior to use to ensure appropriate management and consideration of any potential risks.

Lactation

Lactating mothers are advised to consult a healthcare 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 have not been specifically addressed in the available data 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 lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to standard protocols for managing suspected cases of drug overdosage.

It is essential to monitor patients closely for any signs or symptoms that may arise following an overdose. Common symptoms may include, but are not limited to, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, the administration of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

For further management, consultation with a poison control center or a medical toxicologist is advisable to ensure the implementation of the most effective treatment strategies tailored to the specific circumstances of the overdose.

Documentation of the incident, including the amount and timing of the substance ingested, is crucial for ongoing management and potential reporting requirements.

Nonclinical Toxicology

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

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is essential for patients to understand the importance of prompt action in such situations to ensure their safety and well-being.

Storage and Handling

The product is supplied with a dosing cup included for accurate measurement. It should be stored at a temperature range of 15-30°C (59-86°F). It is important to note that refrigeration is not permitted, as the product must not be exposed to temperatures outside the specified range. Proper handling and storage conditions are essential to maintain the integrity of the product.

Additional Clinical Information

The medication is administered orally, with a recommended dosage of 20 mL every 4 hours for adults and children aged 12 years and older. It is contraindicated for use in children under 12 years of age. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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

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