Mucus Relief All in One

Description

This product is formulated for individuals aged 12 and over and is designed to provide maximum strength relief from multiple cold and flu symptoms. It contains acetaminophen, a pain reliever and fever reducer; dextromethorphan HBr, a cough suppressant; guaifenesin, an expectorant; and phenylephrine HCl, a nasal decongestant. The formulation temporarily alleviates symptoms including headache, sore throat, nasal congestion, body pain, chest congestion, sinus congestion, fever, cough, and sinus pressure. It is suitable for use both day and night and is available in fluid ounces (FL OZ) and milliliters (mL). The product is not manufactured or distributed by Reckitt Benckiser, the distributor of Mucinex® Fast-Max® Maximum Strength All-in-One Cold & Flu. The packaging includes a tamper-evident safety seal; do not use if the seal is broken or missing. This product is distributed by Old East Main Co., located at 100 Mission Ridge, Goodlettsville, TN 37072.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including cough, nasal congestion, minor aches and pains, sore throat, headache, and stuffy nose. Additionally, it temporarily reduces fever and aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the expulsion of bothersome mucus and enhancing the productivity of coughs.

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 6 doses within a 24-hour period.

For adults and children aged 12 years and older, the recommended dose is 20 mL, to be measured using the dosing cup provided, every 4 hours as needed. It is imperative that the dosing cup remains with the product to ensure accurate measurement.

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

Healthcare professionals are advised to remind patients not to exceed the directed dosage and to refer to the overdose warning 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. 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 such treatment. MAOIs are used for certain psychiatric or emotional conditions and Parkinson's disease, and their interaction with this product may lead to serious adverse effects. If there is uncertainty regarding the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, if the following conditions are met: exceeding 4,000 mg of acetaminophen 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 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 immediately and seek medical assistance.

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

General precautions should be taken prior to use. Patients should be advised to seek medical advice if they have any of the following conditions: liver disease, heart disease, diabetes, thyroid disease, high blood pressure, persistent or chronic cough (such as that associated with smoking, asthma, chronic bronchitis, or emphysema), cough accompanied by excessive phlegm, or difficulty urinating due to an enlarged prostate gland. Additionally, patients taking the anticoagulant warfarin should consult a doctor or pharmacist before use.

In cases of overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help right away, regardless of the presence of symptoms.

Patients should also be advised to stop taking the product and consult a doctor 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 requiring medical evaluation.

Side Effects

Patients using this product should be aware of potential adverse reactions, which can range from serious to common.

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

Allergic reactions may manifest as severe skin reactions, including symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be vigilant for symptoms indicating a need for medical consultation. If a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, prompt medical attention is recommended.

Additionally, patients should stop use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or lasts longer than 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 occurs with a rash or headache that persists. These symptoms may indicate a serious condition requiring further evaluation.

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, 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 used 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 use and to mitigate the risk of increased bleeding.

Packaging & NDC

Below are the non-prescription pack sizes of Mucus Relief All in One (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 therapeutic response, 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 on 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

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in 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. Due to the risk of overdose and potential liver damage, patients must adhere strictly to the recommended dosage. In the event of an overdose, it is imperative to seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms. Regular monitoring of liver function may be warranted in patients with compromised liver function to mitigate the risk of adverse effects.

Overdosage

Taking more than the recommended dose of the 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 influence patient outcomes.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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 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 present.

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 be encouraged to consult a doctor or pharmacist.

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 advised to check with a healthcare professional 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 nervousness, dizziness, or sleeplessness. They should also be advised to stop using the product and seek medical advice if pain, nasal congestion, or cough worsens or persists for more than 7 days, if fever worsens or lasts more than 3 days, or if any redness or swelling occurs. New symptoms that arise should prompt a discussion with a healthcare provider, as should a cough that returns or occurs alongside a rash or headache that lasts, as these may indicate a serious condition.

When using this product, patients must be reminded to adhere strictly to the directed dosage. It is also essential for patients to consult a doctor before use if they have any of the following conditions: liver disease, heart disease, diabetes, thyroid disease, high blood pressure, a persistent or chronic cough (such as that associated with smoking, asthma, chronic bronchitis, or emphysema), cough accompanied by excessive phlegm, or difficulty urinating due to an enlarged prostate gland. Furthermore, patients should be advised to seek guidance from 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 a dosing cup. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF) and to avoid refrigeration.

To ensure safety and integrity, the product features a tamper-evident seal; it should not be used if the printed safety seal around or under the cap is broken or missing. After opening, the product must be discarded to maintain safety and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health 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 All in One, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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