Quality Choice Mucus Relief Dm

Description

The drug is presented as a white to off-white, round, biconvex tablet, imprinted with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation, which may occur with a common cold. It assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the clearance of bothersome mucus from the bronchial passageways. Additionally, this medication helps to make coughs more productive.

Dosage and Administration

Adults and children aged 12 years and older are instructed to take 1 tablet every 4 hours as needed. For children aged 6 to 10 years, the recommended dosage is 1/2 tablet every 4 hours as needed. It is essential that children under 6 years of age consult a healthcare professional before administration.

Healthcare professionals should advise patients not to exceed 6 doses within a 24-hour period, unless otherwise directed by a physician.

Contraindications

Use of this product is contraindicated in patients who experience symptoms accompanied by fever, rash, or persistent headache. Additionally, discontinuation and consultation with a healthcare professional are advised if cough persists for more than one week or tends to recur.

Warnings and Precautions

It is imperative that this product not be used concurrently with prescription monoamine oxidase inhibitors (MAOIs), which are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, the product should not be used for a minimum of two weeks following the discontinuation of any MAOI. Healthcare professionals should advise patients to consult with their doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in their current prescription medications.

Patients are instructed to discontinue use and seek medical advice if they experience symptoms such as fever, rash, or a persistent headache. Furthermore, if a cough persists for more than one week or tends to recur, it is essential to consult a healthcare provider, as this may indicate a more serious underlying condition.

In the event of an overdose, immediate medical assistance should be sought, or the local Poison Center should be contacted without delay. Prompt action is crucial in managing potential overdose situations effectively.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious adverse reactions may occur, particularly in patients who are currently taking or have recently discontinued a prescription monoamine oxidase inhibitor (MAOI). It is crucial that patients do not use this product if they are taking an MAOI or for at least two weeks after stopping such medication. Patients are advised to consult their doctor or pharmacist if they are uncertain whether their prescription contains an MAOI.

In clinical practice, patients should be instructed to stop using the product and seek medical advice if they experience symptoms such as fever, rash, or a persistent headache. Additionally, if a cough persists for more than one week or tends to recur, it may indicate a serious underlying condition, warranting further evaluation by a healthcare professional.

Patients with a history of persistent or chronic cough, such as those with smoking-related conditions, asthma, bronchitis, or emphysema, should consult their doctor before using this product. Furthermore, if the cough is accompanied by excessive phlegm (mucus), medical advice should be sought prior to use.

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 use this product while taking an MAOI or for a minimum of two weeks following the discontinuation of an MAOI. It is essential for patients to consult with their healthcare provider 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 Quality Choice Mucus Relief Dm (dextromethorphan hydrobromide / guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 to 10 years may take 1/2 tablet every 4 hours as needed. For children under 6 years of age, it is advised to consult a doctor before administration. In contrast, adults and children aged 12 years and over are recommended to take 1 tablet every 4 hours as needed. Care should be taken to adhere to these dosing guidelines to ensure safety and efficacy in the pediatric population.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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 in these populations to ensure the safety of both the mother and the fetus or infant.

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 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 in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be prioritized.

Potential Symptoms While specific symptoms related to overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the variability in individual responses to medication.

Management Procedures Management of overdosage should include the following steps:

1. Conduct a thorough evaluation of the patient, including a review of the medication history and any concomitant medications.

2. Implement supportive measures as necessary, which may include intravenous fluids, electrolyte management, and other interventions based on the patient's clinical presentation.

3. Consider contacting a poison control center for additional guidance and recommendations tailored to the specific situation.

In summary, due to the lack of specific overdosage information, healthcare professionals are encouraged to apply standard overdosage management protocols and remain alert to the potential for adverse effects.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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 difficulty breathing.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Center immediately.

Patients should be informed to discontinue use and consult their doctor if symptoms are accompanied by fever, rash, or a persistent headache. Additionally, they should be advised to stop use and seek medical advice if a cough persists for more than one week or tends to recur, as a persistent cough may indicate a serious underlying condition.

It is important for healthcare providers to recommend that patients consult their doctor before using the medication if they have a persistent or chronic cough, particularly if it is associated with smoking, asthma, bronchitis, or emphysema. Furthermore, patients should be encouraged to ask their doctor before use if their cough is accompanied by excessive phlegm (mucus).

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 15° to 30°C (59° to 86°F) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)