Mucus Relief Dm

Description

Mucus Relief DM is a combination expectorant and cough suppressant formulated as tablets. Each tablet contains 20 mg of Dextromethorphan HBr and 400 mg of Guaifenesin. The product is dye-free and is packaged in a tamper-evident container, with a warning to not use if the printed safety seal under the cap is broken or missing. Users are advised to keep the outer carton for complete warnings and product information. Mucus Relief DM is distributed by Geiss, Destin & Dunn, Inc., a Perrigo Company, located in Peachtree City, GA 30269. Further information can be accessed at www.PerrigoDirect.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 alleviates the intensity of coughing and reduces the impulse to cough, which may assist patients in achieving restful sleep.

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

Adults and children 12 years of age and older are instructed to take 1 tablet every 4 hours while symptoms persist. It is essential that the total dosage does not exceed 6 tablets within a 24-hour period. Each tablet should be taken with a full glass of water to ensure proper administration and absorption.

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

Contraindications

Use is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI. This contraindication is due to the potential for serious interactions that may occur when combining these medications. If there is uncertainty regarding the presence of an MAOI in a prescription drug, consultation with a healthcare professional is advised prior to use.

Warnings and Precautions

Patients should not use 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 taken for at least two weeks following the discontinuation of an MAOI. Healthcare professionals are advised to confirm with patients whether their current prescriptions include an MAOI, and to consult a doctor or pharmacist if there is any uncertainty.

It is imperative to discontinue use and seek medical advice if a cough persists for more than seven days, recurs, or is accompanied by fever, rash, or a persistent headache. These symptoms may indicate a serious underlying condition that requires further evaluation.

In the event of an overdose, immediate medical assistance should be sought. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 without delay.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. Serious warnings include the contraindication of use in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such treatment. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease.

Patients are advised to stop use and consult a healthcare professional if their cough persists for more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition.

Additionally, individuals should seek medical advice before using this medication if they have a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, or if their cough is accompanied by excessive phlegm (mucus).

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

Drug Interactions

The concomitant use of this drug with 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 initiate therapy with this drug while currently taking an MAOI 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 prescription medication contains an MAOI before starting this drug.

Packaging & NDC

Below are the non-prescription pack sizes of Mucus Relief Dm (guaifenesin). 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 4 hours as needed while symptoms persist, with a maximum of 6 tablets in a 24-hour period. Caution is advised to ensure that the dosage does not exceed the recommended limits.

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 potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

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 considered, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider 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 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 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 medication. Consequently, there are no 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 vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose will depend on the substance involved and the severity of the symptoms presented.

It is essential to follow established protocols for overdose management, which may include supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient’s condition is recommended to ensure appropriate interventions are implemented in a timely manner.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before use. There are no specific non-teratogenic effects or detailed nonclinical toxicology information available. Additionally, no specific animal pharmacology and toxicology details have been provided.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 crucial to inform patients that this medication should not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are used for treating depression, psychiatric or emotional conditions, or Parkinson's disease. Patients should also be cautioned against using this medication for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription includes an MAOI, they should be encouraged to consult their doctor or pharmacist prior to taking this medication.

Patients should be instructed to discontinue use and consult a healthcare provider if their cough persists for more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, as these symptoms may indicate a serious underlying condition. It is important to emphasize that patients must adhere to the recommended dosage and not exceed the directed amount while using this product.

Additionally, healthcare providers should recommend that patients consult a doctor before using this medication 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 a tamper-evident seal. It is essential to inspect the safety seal under the cap; the product should not be used if this seal is broken or missing.

For optimal storage, the product must be kept at a temperature range of 20-25ºC (68-77ºF). It is recommended to retain the outer carton, as it contains important warnings and product information that may be necessary for reference.

Additional Clinical Information

The medication is administered orally and should be taken with a full glass of water. For adults and children aged 12 years and older, the recommended dosage is one tablet every four hours as needed, with a maximum of six tablets within 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.

View product document (PDF)