Mucus Relief

Description

This product contains the following active ingredients: acetaminophen (650 mg), a pain reliever and fever reducer; dextromethorphan HBr (20 mg), a cough suppressant; guaifenesin (400 mg), an expectorant; and phenylephrine HCl (10 mg), a nasal decongestant. It is indicated for mucus relief and the alleviation of symptoms associated with cold, flu, and sore throat.

The formulation provides multi-symptom relief, addressing headache and fever, controlling cough, relieving nasal and chest congestion, and thinning and loosening mucus. It is intended for use in individuals aged 12 years and older.

The product is packaged in fluid ounces (FL OZ) and is distributed by Topco Associates LLC, located in Elk Grove Village, IL 60007. It is important to note that this product is not manufactured or distributed by Reckitt Benckiser, the distributor of Maximum Strength Mucinex® Fast-Max® Cold, Flu & Sore Throat. A tamper evident warning is included, stating: "DO NOT USE IF PRINTED SAFETY SEAL AROUND OR UNDER CAP IS BROKEN OR MISSING."

For further inquiries, contact can be made via email at topcare@topco.com or through the website www.topcarebrand.com.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including nasal congestion, headache, sinus congestion and pressure, sore throat, minor aches and pains, and cough due to minor throat and bronchial irritation. Additionally, it temporarily reduces fever and promotes nasal and/or sinus drainage. The formulation 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 and administration guidelines to ensure safety and efficacy. The maximum dosage should not exceed the specified limits, and caution is advised to prevent overdose.

For adults and children aged 12 years and older, the recommended dose is 20 mL, administered using the dosing cup provided, every 4 hours as needed. It is imperative that no more than 6 doses are taken within a 24-hour period.

For children under 12 years of age, the use of this medication is not recommended.

To ensure accurate dosing, it is essential to measure the medication only with the dosing cup provided; the use of any other dosing device is not advised.

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.

• 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. This includes certain medications used for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is uncertainty about whether a prescription drug contains an MAOI, a healthcare professional should be consulted prior to use.

Warnings and Precautions

This product contains acetaminophen, which carries significant warnings regarding liver health. Severe liver damage may occur if the maximum daily dosage of 6 doses within 24 hours is exceeded, if it is taken concurrently with other medications containing acetaminophen, or if the product is used while consuming three or more alcoholic drinks daily.

Healthcare professionals should be vigilant for potential allergic reactions associated with acetaminophen. Severe skin reactions may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

A sore throat warning is also applicable; if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt consultation with a physician is advised.

General precautions emphasize the importance of adhering strictly to the recommended dosage. Exceeding the directed use is not advised.

In cases of overdose, immediate medical attention is crucial. Healthcare providers should instruct patients to contact a Poison Control Center or seek emergency medical help without delay, as timely intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients should be advised to discontinue use and consult a physician if any of the following occur: redness or swelling, nervousness, dizziness, or sleeplessness; the emergence of new symptoms; worsening pain, nasal congestion, or cough lasting more than seven days; fever that worsens or persists beyond three days; or a cough that recurs or is accompanied by a rash or persistent headache. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe adverse reactions associated with this product include significant liver damage, which may occur if patients exceed six doses within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use and seek immediate medical assistance.

Additionally, if patients experience a sore throat that is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, they should consult a healthcare professional promptly.

Patients are advised to stop use and contact a doctor if they notice redness or swelling, experience nervousness, dizziness, or sleeplessness, or if new symptoms arise. Furthermore, if pain, nasal congestion, or cough worsens or lasts longer than seven days, or if fever worsens or persists beyond three days, medical advice should be sought. A return of cough, particularly if accompanied by a rash or persistent headache, may indicate a serious condition requiring evaluation.

Overdose of this product can lead to liver damage. Patients should seek medical help or contact a Poison Control Center immediately if they suspect an overdose, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Drug Interactions

Concurrent use of this medication with other products containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

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

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

Packaging & NDC

Below are the non-prescription pack sizes of 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 those 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 crucial 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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

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 drug insert 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 absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should be aware that this product contains acetaminophen, which carries a risk of severe liver damage. It is crucial for these patients to adhere to the following guidelines to minimize the risk of adverse effects.

The maximum recommended dosage is 6 doses within a 24-hour period. Patients must not exceed this limit, as doing so may lead to significant liver injury. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen, as this can further increase the risk of liver damage. Consumption of 3 or more alcoholic drinks daily while using this product is also contraindicated, as it may exacerbate liver toxicity.

Patients with a history of liver disease are advised to consult a healthcare professional prior to using this product. In the event of an overdose, which is defined as taking more than the recommended dose, immediate medical assistance should be sought. Quick intervention is essential for both adults and children, even if no signs or symptoms of overdose are apparent.

Monitoring of liver function may be warranted in patients with compromised liver health, and any signs of liver damage should be promptly evaluated by a healthcare provider.

Overdosage

Taking more than the recommended dose of this medication may lead to serious liver damage. In the event of an overdose, it is imperative to seek medical assistance immediately or contact a Poison Control Center. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be vigilant in monitoring for potential symptoms of overdose, which may not always be immediately apparent. The importance of rapid response cannot be overstated, as timely management can significantly impact patient outcomes.

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 these contexts.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Notable among these are severe skin reactions, which may present as skin reddening, blisters, and rash. In the event of a skin reaction, it is recommended that the product be discontinued immediately and medical assistance sought.

Additionally, new symptoms may arise during treatment, and if such symptoms occur, it is advised to stop use and consult a healthcare professional, as these may indicate a serious condition.

Reports also indicate that overdose of the product may lead to liver damage. In cases of overdose, it is crucial to obtain medical help or contact a Poison Control Center promptly, as swift medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patient Counseling

Healthcare providers should advise patients about the potential risks associated with overdose, emphasizing that taking more than the recommended dose may lead to liver damage. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately, as prompt medical attention is crucial 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 whether a drug contains acetaminophen, they should consult a doctor or pharmacist for clarification.

It is important to communicate that this product is not intended for use in children under 12 years of age. Additionally, patients should be cautioned against using 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 encouraged to ask their healthcare provider or pharmacist if they are unsure whether their prescription medication contains an MAOI.

Patients should be instructed to discontinue use and consult a doctor if they experience redness or swelling, nervousness, dizziness, or sleeplessness. They should also be advised to seek medical advice if new symptoms arise, or if pain, nasal congestion, or cough worsens or persists for more than 7 days. Furthermore, patients should be informed to stop use and contact a doctor if fever worsens or lasts more than 3 days, or if a cough recurs or is accompanied by a rash or persistent headache, as these may indicate a serious condition.

While using this product, patients should adhere strictly to the directed dosage and not exceed it. Healthcare providers should encourage patients to consult a doctor before use if they have any of the following conditions: diabetes, liver disease, heart disease, thyroid disease, high blood pressure, persistent or chronic cough (such as that associated with smoking, asthma, chronic bronchitis, or emphysema), cough with excessive phlegm, or difficulty urinating due to an enlarged prostate gland. Additionally, patients taking the blood-thinning medication warfarin should seek advice from their doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in a specific packaging configuration, with the NDC numbers available upon request. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF). Refrigeration is not permitted, as it may compromise the integrity of the product.

For accurate dosing, it is crucial to use only the dosing cup provided with the product. After opening, any remaining product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)