Mucus Relief All in One

Description

This product contains a combination of active ingredients designed to provide relief from multiple cold and flu symptoms. Each dosage unit includes 650 mg of acetaminophen, serving as a pain reliever and fever reducer; 20 mg of dextromethorphan HBr, acting as a cough suppressant; 400 mg of guaifenesin, functioning as an expectorant; and 10 mg of phenylephrine HCl, which serves as a nasal decongestant.

The formulation is classified as maximum strength and is indicated for individuals aged 12 years and older. It is designed to alleviate aches, fever, sore throat, nasal and chest congestion, as well as sinus congestion and pressure. Additionally, it controls cough and aids in thinning and loosening mucus.

The product is packaged in fluid ounces (FL OZ) and is distributed by Walgreens Co., located at 200 Wilmot Rd., Deerfield, IL 60015. It is important to note that this product is not manufactured or distributed by Reckitt Benckiser, the distributor of Maximum Strength Mucinex® Fast-Max® All-in-One Cold & Flu. The packaging includes a tamper-evident safety seal, and the product should not be used if this seal is broken or missing.

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, stuffy nose, and sinus congestion and pressure. Additionally, it is indicated for the temporary reduction of fever. This medication also 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 following dosing instructions are provided:

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 no more than 6 doses are taken within a 24-hour period.

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

To ensure accurate dosing, it is essential to use only the dosing cup included with the product; other dosing devices should not be utilized. The dosing cup should be kept with the product at all times to facilitate proper measurement.

Patients are advised not to exceed the directed dosage, and they should be aware of the overdose warning associated with this medication.

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, consultation with a healthcare professional is recommended.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks for liver damage. Healthcare professionals should advise patients that severe liver damage may occur if they 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.

Patients should be informed of the potential for severe skin reactions associated with acetaminophen. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, patients must discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be instructed to consult a physician promptly.

General precautions should be taken when considering the use of this product. Patients are advised to consult a healthcare provider prior to use if they have any of the following conditions: liver disease, heart disease, diabetes, thyroid disease, high blood pressure, 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.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help right away, even if no signs or symptoms are apparent.

Patients should also be advised to discontinue use and contact a healthcare provider 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 underlying condition that requires medical evaluation.

Side Effects

Severe liver damage may occur in patients who 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. Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may 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.

Patients experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly. Additionally, individuals should stop use and seek medical advice 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 is present; if new symptoms arise; or if a cough recurs with a rash or headache that persists.

Patients with pre-existing conditions such as liver disease, heart disease, diabetes, thyroid disease, high blood pressure, or those experiencing trouble urinating due to an enlarged prostate gland, as well as individuals with a persistent or chronic cough (e.g., due to smoking, asthma, chronic bronchitis, or emphysema) or cough accompanied by excessive phlegm, should consult a doctor before use. Furthermore, patients taking the blood-thinning medication warfarin should seek advice from a healthcare provider or pharmacist prior to using this product.

An overdose of acetaminophen may lead to liver damage. In cases of overdose, it is crucial to seek medical help or contact a Poison Control Center (1-800-222-1222) immediately, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

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 2 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 be administered this medication. Safety and efficacy have not been established in this population, and use in younger children is contraindicated.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 on 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 individuals 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 exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen 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. Due to the potential for overdose, which may lead to liver damage, it is critical that patients adhere to the recommended dosage. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay. Prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are apparent.

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 immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

Importance of Prompt Action

Quick medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are initially apparent. Healthcare professionals should be aware that early intervention can significantly impact the outcome in cases of overdose.

Recommended Management Procedures

Upon recognition of an overdose, healthcare providers should initiate appropriate management protocols, which may include monitoring liver function and providing supportive care as necessary. It is essential to follow established guidelines for the treatment of overdose to mitigate potential complications effectively.

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. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

Postmarketing experience has identified severe skin reactions associated with the use of acetaminophen. These reactions include symptoms such as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised that the use of the product be discontinued immediately and medical assistance be sought.

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 immediately or contact a Poison Control Center at 1-800-222-1222, 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 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 one 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 nervousness, dizziness, or sleeplessness. They should also 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 or a recurrence of cough, especially if accompanied by a rash or headache that lasts, should prompt immediate consultation with a healthcare provider, as these may indicate a serious condition.

While using this product, patients must adhere strictly to the directed dosage and should consult a doctor before use if they have any of the following conditions: liver disease, heart disease, diabetes, thyroid disease, high blood pressure, or 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 seek medical advice before use. Furthermore, patients should be advised 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 a dosing cup, which should be kept with the product at all times. It is essential to store the product at a temperature range of 20-25ºC (68-77ºF) and to avoid refrigeration. After opening, the product must be discarded to ensure safety and efficacy.

The packaging features a tamper-evident safety seal. Users should not utilize the product if the printed safety seal around or under the cap is broken or missing, as this indicates potential tampering.

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.

View product document (PDF)