Mucus Relief Cold Flu and Sore Throat

Description

QUALITY CHOICE® is a combination medication identified by NSC 83324-104-20, formulated to provide relief from symptoms associated with cold, flu, and sore throat. Each dosage form contains active ingredients including acetaminophen, dextromethorphan HBr, guaifenesin, and phenylephrine HCl, which serve multiple therapeutic purposes: acetaminophen acts as a pain reliever and fever reducer; dextromethorphan HBr functions as a cough suppressant; guaifenesin serves as an expectorant; and phenylephrine HCl acts as a nasal decongestant.

This product is indicated for the relief of headache, fever, sore throat, cough, and nasal and chest congestion, while also thinning and loosening mucus. It is intended for use by individuals aged 12 years and older. The product is available in a package containing 20 caplets.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including nasal congestion, headache, cough, minor aches and pains, and sore throat. Additionally, it temporarily reduces fever and aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the clearance of mucus from the bronchial passageways 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. For adults and children aged 12 years and older, the prescribed dosage is 2 caplets every 4 hours, with a maximum limit of 12 caplets within a 24-hour period. It is imperative that patients do not exceed this maximum dosage.

The use of this medication is not recommended for children under 12 years of age. Healthcare professionals should ensure that patients are informed about the importance of following these guidelines to avoid potential adverse effects.

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. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs), which are utilized for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease, is contraindicated. This includes a prohibition on use for a period of 2 weeks following the discontinuation of an MAOI. If there is uncertainty about whether a prescription medication contains an MAOI, a healthcare professional should be consulted prior to using this product.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 12 caplets within a 24-hour period, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise patients to consult a doctor promptly if they experience a severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting.

Overdosing on acetaminophen can result in liver damage. In cases of suspected overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222, regardless of whether signs or symptoms are present.

General precautions should be taken prior to use. Patients should be advised to consult a healthcare provider if they have any of the following conditions: liver disease, heart disease, diabetes, high blood pressure, thyroid disease, difficulty urinating due to an enlarged prostate gland, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients should seek guidance from a doctor or pharmacist if they are currently taking the anticoagulant warfarin. It is essential that patients adhere strictly to the recommended dosage and not exceed the directed amount.

Patients should be instructed to stop taking the product and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond seven days; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms arise; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 12 caplets within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware that acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients are advised to consult a healthcare professional promptly.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients should inquire with a doctor or pharmacist if they are uncertain whether a drug contains acetaminophen. Additionally, this product is contraindicated for individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping such medication.

Patients with liver disease, heart disease, diabetes, high blood pressure, thyroid disease, or those experiencing trouble urinating due to an enlarged prostate gland should consult a doctor before use. Furthermore, individuals with persistent or chronic coughs, such as those associated with smoking, asthma, chronic bronchitis, or emphysema, as well as those with coughs that produce excessive phlegm, should also seek medical advice prior to use.

Patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist before using this product.

Patients are advised to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond seven days; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms develop; or if a cough recurs or is accompanied by a rash or headache that lasts. These symptoms may indicate a serious condition.

In the event of an overdose, which may result in liver damage, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Concurrent 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.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, it should not be used for at least 2 weeks following the discontinuation of an MAOI to avoid serious interactions.

Patients taking the anticoagulant warfarin should consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be warranted to ensure safe use and to mitigate the risk of altered anticoagulant effects.

Packaging & NDC

Below are the non-prescription pack sizes of Mucus Relief Cold Flu and Sore Throat (acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride). 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 2 caplets every 4 hours.

In cases of overdose, it is crucial to seek immediate medical attention for both adults and pediatric patients, even if no signs or symptoms are apparent.

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 efficacy, 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 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 mothers.

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 individuals with reduced kidney function, as there is no available data to guide appropriate dosing or monitoring in this population.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 12 caplets within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

It is advised that patients with a history of liver disease consult a healthcare professional prior to use. Monitoring for signs of liver damage is essential, particularly in those with compromised liver function. In the event of an overdose, which may lead to liver damage, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. Prompt medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent.

Overdosage

Taking more than the recommended dose of the medication may lead to liver damage. It is essential for healthcare professionals to recognize the seriousness of an overdose and the potential for significant health consequences.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to contact a Poison Control Center at 1-800-222-1222 for guidance. Prompt intervention is crucial, as quick medical attention is necessary for both adults and children, even in the absence of noticeable signs or symptoms.

Monitoring and management of the patient should be initiated as soon as possible to mitigate the risk of severe complications associated with overdose.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the substance. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology. As such, a comprehensive assessment of these aspects cannot be made at this time.

Postmarketing Experience

No specific postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be instructed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is important to inform patients that they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the last two weeks. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription medication contains an MAOI.

Patients should be instructed to discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be advised to stop using the product and consult a doctor if pain, nasal congestion, or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, or if any redness or swelling occurs. Patients should also be informed to seek medical attention if new symptoms arise or if a cough returns or occurs alongside a rash or headache that lasts.

Healthcare providers should emphasize the importance of adhering to the recommended dosage and not exceeding the directed amount. Patients with 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 this product. 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. Patients should be reminded to consult a doctor or pharmacist if they are taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers. It should be stored in a dry place at a temperature range of 20-25°C (68-77°F). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 2 caplets every 4 hours. It is advised that children under 12 years of age should not use this medication. Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding and to ensure the product is kept out of reach of children.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)