Mucus Relief Sinus Pressure Pain and Cough

Description

CVS Health® Mucus Relief Sinus Pressure, Pain & Cough is a maximum strength formulation designed to alleviate symptoms associated with sinus pressure, pain, and cough. Each caplet contains the following active ingredients: acetaminophen, a pain reliever; dextromethorphan HBr, a cough suppressant; guaifenesin, an expectorant that thins and loosens mucus; and phenylephrine HCl, a nasal decongestant. This product is indicated for individuals aged 12 years and over and is available in a package containing 20 caplets. The National Drug Code (NDC) for this product is 69842-796-02.

Uses and Indications

This drug is indicated for the temporary relief of headache, nasal congestion, minor aches and pains, sinus congestion and pressure, and cough. It promotes nasal and/or sinus drainage and assists in loosening phlegm (mucus) while thinning bronchial secretions, thereby 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 guidelines. For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 4 hours as needed. It is imperative that patients do not exceed 12 caplets within a 24-hour period.

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

Healthcare professionals should counsel patients to avoid exceeding the directed dosage to prevent the risk of overdose.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether 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.

• The product should not be used 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 or emotional conditions, and Parkinson's disease. If there is uncertainty about the presence of an MAOI in a prescription medication, a healthcare professional should be consulted prior to use.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 12 caplets within a 24-hour period, using it concurrently with other medications containing acetaminophen, or consuming 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 prior to use if they have any of the following conditions: diabetes, liver disease, heart disease, high blood pressure, thyroid disease, difficulty urinating due to an enlarged prostate gland, or a cough associated with excessive phlegm. Additionally, patients with a persistent or chronic cough, such as that caused by smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice before use. It is crucial to inform patients to consult a doctor or pharmacist if they are taking the anticoagulant warfarin. Patients must adhere strictly to the recommended dosage and should not exceed the directed amount.

In the event of an overdose, immediate medical attention is necessary. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 without delay, as prompt medical intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and consult a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond 7 days; if fever worsens or lasts more than 3 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 further evaluation.

Side Effects

Severe liver damage may occur in patients who exceed the maximum recommended dosage of 12 caplets within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, 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.

Participants are advised to stop use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, worsening pain, nasal congestion, or cough lasting more than seven days, fever that worsens or persists beyond three days, the presence of redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache should prompt medical evaluation, as these may indicate a serious condition.

An overdose warning is also pertinent; taking more than the recommended dose can lead to liver damage. In cases of suspected overdose, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Co-administration 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 for depression, psychiatric disorders, 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 or other serious adverse effects.

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 necessary to ensure safe use and to avoid potential alterations in the anticoagulant effect.

Packaging & NDC

Below are the non-prescription pack sizes of Mucus Relief Sinus Pressure Pain and Cough (acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 2 caplets every 4 hours.

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, 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 should consider individual circumstances and the specific health needs of the patient when making recommendations.

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. It is critical to adhere to the maximum daily dosage of 12 caplets within a 24-hour period, as exceeding this limit may lead to severe liver damage. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of hepatotoxicity.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product. The consumption of three or more alcoholic drinks daily while using this product is also contraindicated, as it may exacerbate the risk of liver damage.

In the event of an overdose, which may occur if the recommended dosage is exceeded, immediate medical assistance should be sought. Patients are encouraged to contact a Poison Control Center at 1-800-222-1222 for guidance. Prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms of overdose.

Overdosage

In the event of an overdose, defined as the ingestion of more than the recommended dose, there is a significant risk of liver damage. It is imperative that healthcare professionals recognize the seriousness of this condition and act swiftly.

Immediate medical assistance is crucial. In cases of suspected overdose, healthcare providers should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

It is important to note that prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms. Early intervention can be critical in mitigating potential harm and ensuring appropriate management of the overdose.

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 to keep this medication out of reach of children to prevent accidental ingestion. Patients should be instructed 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 be encouraged to consult a doctor or pharmacist.

It is important to inform patients that they should not use 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 advised to check with their healthcare provider if they are unsure whether their prescription includes an MAOI.

Patients should be instructed to discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, they should be informed to stop using the product and consult a doctor if pain, nasal congestion, or cough worsens or persists for more than seven days, or if fever worsens or lasts more than three days. Patients should also be advised to seek medical attention if they notice any redness or swelling, if new symptoms arise, or if a cough returns or occurs alongside a rash or headache that lasts.

Healthcare providers should emphasize the importance of adhering to the recommended dosage and not exceeding the directed amount. Patients with specific health conditions should be encouraged to consult their healthcare provider before using this product. These conditions include diabetes, liver disease, heart disease, high blood pressure, thyroid disease, difficulty urinating due to an enlarged prostate gland, or a cough associated with excessive phlegm. Patients with a persistent or chronic cough, such as those caused by smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use. Furthermore, patients taking the blood-thinning medication warfarin should be advised to consult a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers. It should be stored in a dry place at a temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions are essential to ensure the product remains effective throughout its shelf life.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being 2 caplets every 4 hours. It is advised that this medication not be used in children under 12 years of age.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before using the medication. Additionally, it is important to keep the product out of reach of children. 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 Sinus Pressure Pain and Cough, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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