Mucus Relief

Description

Acetaminophen, a pain reliever and fever reducer, is included in the formulation alongside dextromethorphan hydrobromide, which serves as a cough suppressant. Guaifenesin is incorporated as an expectorant to aid in the clearance of mucus, while phenylephrine hydrochloride functions as a nasal decongestant. This product is indicated for use in individuals aged 12 years and older.

Uses and Indications

This drug is indicated for the temporary relief of common cold and flu symptoms, including sinus congestion and pressure, minor aches and pains, nasal congestion, cough due to minor throat and bronchial irritation, sore throat, and headache. Additionally, it temporarily reduces fever and promotes nasal and/or sinus drainage. The formulation 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. The maximum dosage should not exceed 6 doses within a 24-hour period. It is imperative to measure the dose using only the dosing cup provided with the product; the use of any other dosing device is not advised. The dosing cup should be kept with the product for convenience.

For adults and children aged 12 years and older, the recommended dose is 20 mL every 4 hours, as needed, while symptoms persist. For children under 12 years of age, the use of this product is not recommended.

Healthcare professionals should ensure that patients are aware of the overdose warning and the importance of not exceeding the specified dosage.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen (prescription or nonprescription) is prohibited 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.

• This product is not indicated for use in children under 12 years of age.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, use is contraindicated for 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 use.

• Use of this product should not exceed the recommended dosage.

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 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 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 for patients with 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. Patients should be encouraged to seek medical advice before using this product if they have any of these conditions.

In the case 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, regardless of whether signs or symptoms are present.

Patients should 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 condition requiring further 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. In cases of overdose, which may result from taking more than the recommended dose, immediate medical assistance is essential. Patients are advised to contact a Poison Control Center (1-800-222-1222) without delay, as prompt intervention is critical for both adults and children, even in the absence of noticeable symptoms.

Acetaminophen may also lead to severe skin reactions, characterized by symptoms such as skin reddening, blisters, and rash. Should any skin reaction occur, patients must discontinue use and seek medical help immediately. Additionally, if a sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative to consult a healthcare professional promptly.

Patients should stop using the product 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 persists beyond three days; if redness or swelling is observed; if new symptoms arise; or if a cough recurs, particularly if accompanied by a rash or headache that lasts. These symptoms may indicate a serious underlying condition.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the potential for increased risk of hepatotoxicity.

Additionally, the use of this medication is 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. This contraindication extends for a period of two weeks following the discontinuation of the MAOI. Monitoring for adverse effects is advised in patients transitioning from MAOIs to this medication, as the interaction may lead to serious clinical consequences.

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 patients aged 12 years and older, the recommended dosage is 20 mL every 4 hours as needed while symptoms persist. Caution is advised when considering treatment for pediatric patients, and healthcare professionals should ensure that the medication is not administered to those younger than the specified age limit.

Geriatric Use

Elderly patients may not have specific information available 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 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. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing 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 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 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 liver disease consult a healthcare professional prior to use. Due to the risk of overdose, which may lead to liver damage, it is crucial for patients to adhere strictly 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 significant liver damage. It is crucial for healthcare professionals to recognize the seriousness of an overdose and the potential for severe 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 without delay. Prompt intervention is essential, as quick medical attention can be critical for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Monitoring and management of the patient should be initiated as soon as possible to mitigate the risks associated with liver damage and to ensure appropriate care is provided.

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 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 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 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 medication 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 taken one within the past two weeks. Patients should be encouraged to ask their healthcare provider or pharmacist if they are unsure whether their prescription includes 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 beyond 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 persistent headache, 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, 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.

Storage and Handling

The product is supplied in a container 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. Users should not use the product if the printed safety seal around or under the cap is broken or missing. Additionally, it is recommended to discard the product after opening to maintain quality and safety.

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, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)