Mucus Relief Sinus Pressure, Pain and Cough

Description

NDC 41250-979-02. This product is manufactured by Meijer® and is formulated to provide maximum strength relief for sinus pressure, congestion, headache, cough, and to thin and loosen mucus. The active ingredients include Acetaminophen, Dextromethorphan HBr, Guaifenesin, and Phenylephrine HCl, which function as a pain reliever, cough suppressant, expectorant, and nasal decongestant, respectively. The dosage form consists of 20 caplets, designed for adult use.

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. For adults and children aged 12 years and older, the prescribed dosage is 2 caplets every 4 hours, with a maximum limit of 12 caplets within a 24-hour period. It is imperative that patients do not exceed this maximum dosage.

The use of this medication is not recommended for children under 12 years of age. Healthcare professionals should ensure that patients are informed about the importance of following these guidelines to avoid potential adverse effects.

Contraindications

Use of this product is contraindicated in the following situations:

• Concurrent use 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 patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric, or emotional conditions, or Parkinson's disease, and for a period of 2 weeks following the discontinuation of the MAOI. This is due to the potential for serious drug interactions. 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, concurrent use with other medications containing acetaminophen, or consumption of three or more alcoholic beverages 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 any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

General precautions should be observed when using this product. It is contraindicated to use this medication in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in another medication, consultation with a healthcare professional is advised.

Additionally, this product should not be used by individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. MAOIs are typically prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. If there is any doubt regarding the presence of an MAOI in a prescription, a healthcare provider should be consulted prior to use.

Healthcare professionals should advise patients to seek medical guidance before using this product 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. Patients with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also consult a healthcare provider. Furthermore, individuals taking the anticoagulant warfarin should seek advice from a doctor or pharmacist before use.

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 crucial. Patients should contact a Poison Control Center or seek emergency medical help without delay, even if no symptoms are apparent. The contact number for the Poison Control Center is 1-800-222-1222.

Patients should discontinue use and consult 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 arise; 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 the maximum daily 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.

Patients are advised to stop use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond 7 days, or if fever intensifies or lasts more than 3 days, medical advice should be sought. Redness or swelling, the emergence of new symptoms, or a cough that recurs or is accompanied by a rash or headache that lasts are also indicators of a potential serious condition requiring medical evaluation.

In cases of overdose, which may result from exceeding the recommended dosage, patients are at risk for liver damage. Immediate medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent. In such instances, contacting a Poison Control Center at 1-800-222-1222 is strongly recommended.

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 disorders, 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 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 and effective use, as interactions could potentially alter the anticoagulant effect of warfarin.

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. Care should be taken to adhere to the specified age restrictions and dosing guidelines to ensure safety and efficacy in this population.

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. It is important to evaluate the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 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 the maximum daily dosage of 12 caplets 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. In the event of an overdose, which may lead to liver damage, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222. 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 the medication may lead to liver damage. It is essential for healthcare professionals to recognize the seriousness of an overdose and the potential for significant 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 for guidance. Prompt intervention is crucial, as quick medical attention is necessary for both adults and children, even in the absence of noticeable signs or symptoms.

Monitoring and management of the patient should be initiated as soon as possible to mitigate the risks associated with overdose 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 question.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reported symptoms of these reactions include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use of the medication and seek medical assistance immediately.

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 drug 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 stopped taking an MAOI within the last two weeks. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription medication contains an MAOI.

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

When using this product, patients should be reminded to adhere strictly to the recommended dosage and not exceed the directed amount. Healthcare providers should encourage patients to consult a doctor before use if they have any of the following conditions: diabetes, liver disease, heart disease, high blood pressure, thyroid disease, or difficulty urinating due to an enlarged prostate gland. Patients with a cough that produces excessive phlegm or those with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use. Lastly, 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, which are essential for identification and inventory management. It is crucial to store the product in a controlled environment, maintaining a temperature range of 20-25°C (68-77°F). The storage area should be dry to ensure the integrity of the product. Proper handling practices should be observed to maintain the quality and efficacy of the product throughout its shelf life.

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 experience.

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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