Maximum Strength Mucus Relief

Description

NDC 83324-143-06. QC® QUALITY CHOICE Maximum Strength Mucus Relief Cold, Flu & Sore Throat is formulated for individuals aged 12 and older. This liquid dosage form contains the following active ingredients: Acetaminophen, a pain reliever and fever reducer; Dextromethorphan HBr, a cough suppressant; Guaifenesin, an expectorant; and Phenylephrine HCl, a nasal decongestant. The product is presented in a 6 FL OZ (177 mL) container. This formulation is comparable to the active ingredients found in Maximum Strength Mucinex® Fax Max™ Cold, Flu & Sore Throat.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including sore throat, nasal congestion, minor aches and pains, headache, cough due to minor throat and bronchial irritation, and sinus congestion and pressure. Additionally, it temporarily reduces fever and promotes nasal and/or sinus drainage. The formulation aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes and making coughs more productive.

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

Dosage and Administration

Patients should adhere strictly to the recommended dosage and administration guidelines. The maximum dosage should not exceed the specified limits, and caution is advised to prevent overdose (refer to the Overdose warning).

For adults and children aged 12 years and older, the recommended dose is 20 mL, to be measured using the dosing cup provided, administered every 4 hours as needed. It is imperative that the dosing cup is used exclusively for this product and not with any other medications.

Children under 12 years of age should not use this product.

In any case, if there are uncertainties regarding the appropriate dosage, healthcare professionals should be consulted for further guidance.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose.

• In children under 12 years of age, as safety and efficacy have not been established in this population.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing an MAOI, due to the potential for serious drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare professional is advised.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks that healthcare professionals must communicate to patients.

Liver Warning Severe liver damage may occur if the patient exceeds 6 doses within a 24-hour period, which is the maximum daily amount. Caution is advised when administering this product in conjunction with other medications containing acetaminophen. Additionally, patients should be informed that consuming 3 or more alcoholic drinks daily while using this product increases the risk of liver damage.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must be instructed to discontinue use immediately and seek medical assistance.

Sore Throat Warning In cases of severe sore throat that persists for more than 2 days, or if it is accompanied or followed by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a healthcare provider promptly.

General Precautions Healthcare professionals should emphasize the importance of adhering to the recommended dosage to avoid overdose, which can result in liver damage. In the event of an overdose, immediate medical attention is crucial. Patients should be directed to contact a Poison Control Center without delay, even if no signs or symptoms are apparent.

Emergency Medical Help Instructions Instruct patients to seek emergency medical help or contact a Poison Control Center immediately in the event of an overdose.

Stop Taking and Call Your Doctor Instructions Patients should be advised to discontinue use and consult a healthcare provider if they experience any of the following: nervousness, dizziness, or sleeplessness; worsening pain, nasal congestion, or cough lasting more than 7 days; fever that worsens or lasts more than 3 days; presence of redness or swelling; emergence of new symptoms; or if a cough recurs or occurs alongside a rash, fever, or persistent headache, as these may indicate a serious condition.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur with the use of this product, particularly if patients exceed 6 doses in a 24-hour period, take it in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Additionally, there is an allergy alert associated with acetaminophen, which may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious regarding sore throat symptoms. If a sore throat is severe, persists for more than 2 days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is recommended that they consult a doctor promptly.

Participants in clinical trials and postmarketing experiences have reported various adverse reactions that warrant attention. Patients should stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or lasts more than 7 days, or if fever worsens or lasts more than 3 days, medical advice should be sought. Redness or swelling, the emergence of new symptoms, or a cough that returns or occurs with rash, fever, or persistent headache may indicate a serious condition and should prompt immediate medical consultation.

Before using this product, patients with certain pre-existing conditions should seek medical advice. These conditions include liver disease, heart disease, diabetes, high blood pressure, thyroid disease, and difficulty urinating due to an enlarged prostate gland. Patients with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also consult a doctor. Furthermore, those taking the blood-thinning medication warfarin should ask a doctor or pharmacist before use.

Drug Interactions

The concomitant use of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose and potential hepatotoxicity.

This medication should not be administered to patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing an MAOI. The combination may lead to serious adverse effects, including hypertensive crises.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication. Monitoring of coagulation parameters may be warranted to ensure safe and effective use, as interactions could potentially alter the anticoagulant effect of warfarin.

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 (acetaminophen, 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 adolescents and adults aged 12 years and older, the recommended dosage is 20 mL administered in the dosing cup provided every 4 hours. 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

Elderly patients may not require specific dosage adjustments or face unique safety concerns when using this product, as no explicit age-related considerations or special precautions are outlined in the available information. While the product is not recommended for children under 12 years of age, there are no additional warnings or risks specifically associated with geriatric patients.

Healthcare providers should remain vigilant and consider general health factors when prescribing this product to elderly patients. It is advisable to consult a physician if the patient has underlying conditions such as liver disease, heart disease, diabetes, high blood pressure, thyroid disease, or urinary difficulties due to an enlarged prostate gland. However, these considerations are not exclusive to the geriatric population and should be assessed for all patients as appropriate.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to 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 to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a healthcare 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 available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing 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 this patient population.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, as it contains acetaminophen, which poses a risk of severe liver damage. It is critical that patients do not exceed the maximum daily dosage of 6 doses within a 24-hour period. Additionally, patients must avoid concomitant use of other medications containing acetaminophen to prevent cumulative dosing that could lead to hepatotoxicity.

Furthermore, patients with compromised liver function should be advised against the consumption of 3 or more alcoholic drinks daily while using this product, as alcohol can exacerbate the risk of liver damage. Regular assessment of liver function may be warranted in these patients to ensure safety and efficacy during treatment.

Overdosage

In cases of overdosage, significant health risks are associated with the consumption of this product beyond the recommended limits.

Risk of Severe Liver Damage Healthcare professionals should be aware that severe liver damage may occur if a patient exceeds six doses within a 24-hour period, which is the maximum daily amount recommended. Additionally, the concomitant use of this product with other medications containing acetaminophen can also lead to severe liver damage.

Furthermore, patients who consume three or more alcoholic drinks daily while using this product are at an increased risk for severe liver damage.

Recommended Actions In the event of suspected overdosage, it is imperative to assess the patient's liver function and consider immediate medical intervention. Monitoring of liver enzymes and supportive care may be necessary, depending on the severity of the symptoms and the extent of the overdosage. Prompt recognition and management are crucial to mitigate potential complications associated with liver injury.

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

Postmarketing experience has identified several adverse reactions associated with the use of acetaminophen. Notably, severe skin reactions have been reported, which include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of acetaminophen be discontinued immediately, and medical assistance should be sought without delay.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed to verify whether a medication contains acetaminophen by consulting with a doctor or pharmacist if they are uncertain. It is important to instruct patients to discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness.

Additionally, patients should be counseled to stop using the medication and seek medical advice if pain, nasal congestion, or cough worsens or persists for more than 7 days. They should also be advised to stop use and consult a doctor if fever worsens or lasts longer than 3 days, or if they notice any redness or swelling. Patients should be made aware that new symptoms warrant a discussion with their healthcare provider.

If a cough recurs or is accompanied by a rash, fever, or persistent headache, patients should be instructed to seek medical attention, as these may indicate a serious condition. It is essential to emphasize that patients should not exceed the recommended dosage.

Patients with specific health conditions, such as liver disease, heart disease, diabetes, high blood pressure, thyroid disease, or those experiencing trouble urinating due to an enlarged prostate gland, should be advised to consult a doctor before using the medication. 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 taking the blood-thinning medication warfarin should be encouraged to consult a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied with a dosing cup included for accurate measurement. It should be stored at a temperature range of 15-30ºC (59-86ºF). Refrigeration is not recommended, as the product must not be exposed to temperatures outside this specified range to maintain its integrity and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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