Mucus Relief Dm

Description

MUCUS RELIEF DM is an extended-release tablet formulation containing 600 mg of guaifenesin and 30 mg of dextromethorphan HBr. This combination serves as an expectorant and cough suppressant, providing temporary control of cough while thinning and loosening mucus. The product is designed for a 12-hour duration of action. It is important to note that this product is not manufactured or distributed by Reckitt Benckiser LLC, the distributor of Mucinex® DM.

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 clearance of mucus from the bronchial passageways and making coughs more productive.

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 associated with this drug.

Dosage and Administration

Patients should take the tablets with a full glass of water. It is important to note that the tablets must not be crushed, chewed, or broken prior to ingestion. 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 or 2 tablets every 12 hours, with a maximum of 4 tablets in a 24-hour period.

This medication is not recommended for use in 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.

Warnings and Precautions

The use of this product is contraindicated in children under 12 years of age. Additionally, it must not be administered to individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised prior to use.

Healthcare professionals should exercise caution and recommend that patients consult a physician before using this product if they have a persistent or chronic cough, particularly those associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients experiencing a cough accompanied by excessive phlegm (mucus) should also seek medical advice prior to use.

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.

Patients are advised 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.

Side Effects

Patients should be aware of the following adverse reactions associated with the use of this product.

Serious adverse reactions may occur, and patients are advised to stop use and consult a healthcare professional if the cough persists for more than 7 days, returns, or is accompanied by fever, rash, or a persistent headache, as these symptoms could indicate a serious illness.

This 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 stopping such medications. Patients uncertain about whether their prescription contains an MAOI should seek guidance from a doctor or pharmacist prior to use.

Patients with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should consult a healthcare professional before using this product. Additionally, those experiencing a cough accompanied by excessive phlegm (mucus) should also seek medical advice.

During the use of this product, it is crucial that patients adhere strictly to the recommended dosage and do not exceed the directed amount.

For pregnant or breastfeeding individuals, it is recommended to consult a health professional before use.

This product should be kept 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.

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, to verify whether their current prescription medication contains an MAOI 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. There are no established safety or efficacy profiles for this age group, and its use is contraindicated in children younger than 12 years. Healthcare professionals are advised to consider alternative treatments for pediatric patients within this age range.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, as the prescribing information does not provide any 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 is advised, as individual responses may vary.

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 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 prescribing information 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 drug. 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. Healthcare professionals should advise patients or caregivers to call the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is crucial in managing overdose situations, as timely medical help can significantly influence outcomes. Symptoms of overdose may vary depending on the substance involved and the individual’s health status. Therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Healthcare providers are encouraged to follow established protocols for overdose management, which may involve decontamination, administration of antidotes if applicable, and continuous monitoring of vital signs and clinical status.

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 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 stopped taking an MAOI drug 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 illness.

When using this product, patients should be reminded not to exceed the recommended dosage. Additionally, healthcare providers should advise patients to consult a doctor prior to use 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. Once opened, the product should be discarded.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 1 or 2 tablets every 12 hours, with a maximum of 4 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.

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