Mucus Relief Cold, Flu and Sore Throat

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including minor aches and pains, sinus congestion and pressure, stuffy nose, cough, headache, nasal congestion, and sore throat. Additionally, it temporarily promotes nasal and/or sinus drainage, reduces fever, and helps to loosen phlegm (mucus) and thin 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 and administration guidelines. The maximum allowable dosage is 6 doses within a 24-hour period. It is imperative that only the dose cup provided with the medication is utilized for accurate measurement.

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 medication is not recommended.

Healthcare professionals should ensure that patients understand the importance of not exceeding the directed dosage to avoid potential adverse effects.

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use 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.

• In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment, as this may lead to serious drug interactions. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted.

• In individuals with a known allergy to this product or any of its ingredients, as this may result in severe allergic reactions.

Additionally, it is important to adhere to the recommended dosage to avoid potential adverse effects.

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 4,000 mg of acetaminophen within a 24-hour period, uses other medications containing acetaminophen concurrently, or consumes three or more alcoholic drinks daily while using this product. It is essential to monitor patients for signs of liver dysfunction, particularly in those with pre-existing liver conditions.

Allergy Alert Acetaminophen may induce severe skin reactions, which can manifest as blisters, rash, or skin reddening. If any of these symptoms occur, patients should be advised to discontinue use immediately and seek medical assistance.

Sore Throat Warning Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should be instructed to consult a physician promptly.

General Precautions Healthcare professionals should advise patients to consult a doctor before using this product if they have any of the following conditions: cough with excessive phlegm, liver disease, thyroid disease, heart disease, difficulty urinating due to prostate enlargement, high blood pressure, diabetes, or a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients taking the anticoagulant warfarin should seek guidance from a doctor or pharmacist prior to use.

Emergency Medical Help In the event of an overdose, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center or seek emergency medical help, regardless of whether symptoms are present.

Discontinuation of Use Patients should stop taking this product and consult a healthcare provider if they experience any of the following: worsening pain, nasal congestion, or cough lasting more than seven days; the emergence of new symptoms; nervousness, dizziness, or sleeplessness; fever worsening or lasting more than three days; redness or swelling; or a cough that recurs or is accompanied by a rash or headache lasting longer than expected. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

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

Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as blisters, rash, or skin reddening. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be cautious if they experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, as these symptoms warrant prompt consultation with a healthcare provider.

Patients are instructed to stop use and consult a doctor if any of the following occur: worsening pain, nasal congestion, or cough lasting more than seven days; the emergence of new symptoms; nervousness, dizziness, or sleeplessness; fever worsening or lasting more than three days; presence of redness or swelling; or if a cough recurs or occurs with a rash or headache that persists, as these may indicate a serious condition.

Before using this product, patients should seek medical advice if they have a cough associated with excessive phlegm, liver disease, thyroid disease, heart disease, difficulty urinating due to prostate enlargement, high blood pressure, diabetes, or a persistent or chronic cough related to smoking, asthma, chronic bronchitis, or emphysema.

Furthermore, patients taking the blood-thinning medication warfarin should consult a doctor or pharmacist prior to use.

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated. Patients should be advised to consult a healthcare professional if there is uncertainty regarding the presence of acetaminophen in other medications.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric disorders, or Parkinson’s disease. Patients should seek guidance from a healthcare provider if they are unsure whether their prescription includes an MAOI.

Additionally, caution is advised when using this medication in conjunction with warfarin, a blood-thinning agent. Patients should consult a healthcare professional prior to use to ensure safe co-administration and to discuss potential monitoring requirements.

Packaging & NDC

Below are the non-prescription pack sizes of Mucus Relief Cold, Flu and Sore Throat (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 patients aged 12 years and older, the recommended dosage is 20 mL administered every 4 hours using the dosing cup provided.

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may use this product; however, there are no specific dosage adjustments or safety concerns outlined for this population in the available information. The product is indicated for adults and children aged 12 years and older, suggesting that it may not be appropriate for individuals under 12 years of age.

While there are general warnings regarding potential liver damage and other health conditions, no additional risks or considerations specific to elderly patients have been detailed. It is important for healthcare providers to be vigilant and consider the overall health status of geriatric patients. Consultation with a physician is recommended if patients have pre-existing health conditions such as liver disease, heart disease, or urinary difficulties due to prostate enlargement, as these conditions may be more prevalent in the elderly population.

Monitoring and assessment of the patient's health status are advised to ensure safe and effective use of the product in geriatric patients.

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 no specific data available regarding the excretion of this medication in 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 should consult a healthcare professional prior to use, particularly if they experience difficulty in urination due to enlargement of the prostate gland. Additionally, it is advisable for patients with liver disease to seek medical advice before initiating treatment, as liver function may influence renal clearance and overall drug metabolism. Monitoring and appropriate dosing adjustments may be necessary for individuals with reduced kidney function to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical that patients do not exceed 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Before initiating treatment, patients with known liver disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during the course of therapy.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate interventions as necessary.

Nonclinical Toxicology

No teratogenic effects were reported in the studies conducted. Additionally, there was no increase in fetal malformations observed, indicating a lack of non-teratogenic effects.

Information regarding nonclinical toxicology and animal pharmacology and toxicology was not provided in the insert.

Postmarketing Experience

No specific postmarketing experience details are available in the extracted data. As such, there are no additional adverse events or rare case reports to summarize.

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 critical for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should be encouraged to consult a doctor or pharmacist.

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

Patients with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use. Healthcare providers should also inform patients to discontinue use and consult a doctor if pain, nasal congestion, or cough worsens or persists for more than seven days. Additionally, patients should be advised to seek medical advice if new symptoms arise, or if they experience nervousness, dizziness, or sleeplessness.

If patients develop a fever that worsens or lasts more than three days, or if they notice redness or swelling, they should be instructed to stop using the product and consult a healthcare professional. Patients should also be made aware that a returning cough, especially if accompanied by a rash or persistent headache, may indicate a serious condition, warranting immediate medical attention.

While 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 a cough associated with excessive phlegm (mucus), liver disease, thyroid disease, heart disease, difficulty urinating due to prostate enlargement, high blood pressure, diabetes, or a persistent or chronic cough related to smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients taking the blood-thinning medication warfarin should be advised to seek guidance from a doctor or pharmacist prior to using this product.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a controlled room temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 86°F). It is essential to adhere to the expiration date indicated on the package to ensure product efficacy and safety.

Additional Clinical Information

No additional information is available regarding laboratory tests, route, method, and frequency of administration, or postmarketing experience.

Clinicians should be aware of the potential for medicine abuse among teens and can refer to resources such as www.StopMedicineAbuse.orgwww.StopMedicineAbuse.org for further information. In the event of an overdose, it is crucial for patients to seek immediate medical assistance or contact a Poison Control Center, as prompt intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

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)