Qch Maximum Strength Mucus Relief 617

Description

NDC 83324-144-06, QC® QUALITY CHOICE, is a maximum strength formulation designed for the relief of severe congestion and cough. Each 6 FL OZ (177 mL) dose contains the following active ingredients: Dextromethorphan HBr 20 mg, serving as a cough suppressant; Guaifenesin 400 mg, functioning as an expectorant; and Phenylephrine HCl 10 mg, acting as a nasal decongestant. This product is formulated to help control cough, relieve nasal and chest congestion, and thin and loosen mucus. It is comparable to the active ingredients found in Maximum Strength Mucinex® Fax Max™ Severe Congestion & Cough.

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, facilitating drainage of the bronchial tubes 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. It also alleviates nasal congestion associated with colds.

There are no teratogenic or nonteratogenic effects reported for this drug.

Dosage and Administration

The maximum recommended dosage is 6 doses within a 24-hour period. It is imperative to measure the dosage exclusively with the dosing cup provided, and this cup should not be used for measuring other products to ensure accuracy.

For adults and children aged 12 years and older, the recommended dose is 20 ml, administered every 4 hours as needed. For children under 12 years of age, the use of this product is not recommended.

Healthcare professionals should ensure that patients are aware of these guidelines to promote safe and effective use of the medication.

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 MAOIs, which are commonly prescribed for depression, psychiatric, or emotional conditions, as well as Parkinson's disease. Patients should consult a healthcare professional if uncertain about the presence of an MAOI in their current medications.

Additionally, the product should not be used in excess of the directed dosage.

Warnings and Precautions

Healthcare professionals should exercise caution when prescribing this medication, particularly in patients with specific underlying health conditions. Prior to initiating treatment, it is essential to consult a physician if the patient has a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Additionally, patients with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should be evaluated before use. It is also important to consider patients who present with a cough accompanied by excessive phlegm (mucus).

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients should be advised to discontinue use and consult their healthcare provider if they experience nervousness, dizziness, or sleeplessness. Furthermore, if symptoms do not improve within 7 days or are accompanied by fever, or if the cough recurs or is associated with a rash or persistent headache, these may indicate a serious condition requiring further evaluation.

Side Effects

Patients may experience a range of adverse reactions while using this medication. Notably, there are no specific side effects listed in the warnings section. However, patients are advised to stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days, or if they occur alongside fever, it is recommended to seek medical advice. A return of cough, particularly if accompanied by a rash or persistent headache, may indicate a serious condition that requires further evaluation.

Before using this medication, patients should consult a healthcare professional if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Furthermore, individuals with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use. Coughs that produce excessive phlegm (mucus) warrant consultation with a healthcare provider as well.

No additional adverse reactions have been reported in clinical trials or postmarketing experiences.

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, certain psychiatric conditions, or Parkinson's disease. Patients should not take this product while on MAOIs 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 current prescription includes an MAOI before initiating treatment with this product.

Packaging & NDC

Below are the non-prescription pack sizes of Qch Maximum Strength Mucus Relief 617 (dextromethorphan hbr, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For patients aged 12 years and older, the recommended dosage is 20 ml, administered every 4 hours using the dosing cup provided. Caution is advised when considering the use of this medication in pediatric populations, as safety and efficacy have not been established in children under 12 years.

Geriatric Use

There is no specific information available 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. 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 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. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to weigh the benefits and risks associated with the use of this medication during pregnancy.

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 drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

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 available sections of the drug insert, healthcare professionals are advised to exercise caution when administering the medication.

Should an overdosage occur, it is essential to monitor the patient closely for any adverse effects or symptoms that may arise. The lack of documented overdosage data necessitates a conservative approach to management.

Healthcare providers should implement supportive care measures as needed, which may include symptomatic treatment and monitoring of vital signs. In cases of suspected overdosage, it is recommended to contact a poison control center or seek expert consultation for further guidance on management strategies.

Documentation of the incident and any interventions taken is crucial for ongoing patient safety and for informing future clinical decisions.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in question.

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 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 taken one 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 should be instructed to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be advised to stop using the product and seek medical advice if their symptoms do not improve within 7 days or if they experience symptoms accompanied by fever. Patients should also be informed that they should stop use and consult a doctor if their cough returns or is associated with a rash or persistent headache, as these may indicate a serious condition.

When using this product, patients must be reminded not to exceed the recommended dosage. Healthcare providers should encourage patients to consult a doctor before use if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Furthermore, patients with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use. Lastly, patients should be advised to consult a healthcare professional if they have a cough that produces 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 15-30ºC (59-86ºF). Refrigeration is not recommended, as the product should not be exposed to temperatures outside this specified range. Proper handling and storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Qch Maximum Strength Mucus Relief 617, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)