Sinus Pressure and Pain and Cough

Description

up & up™ Maximum Strength Sinus Pressure, Pain and Cough is formulated as a combination of active ingredients including acetaminophen, dextromethorphan HBr, guaifenesin, and phenylephrine HCl. Acetaminophen serves as a pain reliever, while dextromethorphan HBr acts as a cough suppressant. Guaifenesin functions as an expectorant, aiding in the thinning and loosening of mucus, and phenylephrine HCl serves as a nasal decongestant.

This product is indicated for the relief of headache, sinus pressure, and congestion, as well as for cough control. The formulation is presented in the form of 20 caplets. The National Drug Code (NDC) for this product is 11673-961-09. It is distributed by Target Corporation, located in Minneapolis, MN 55403. This product is not manufactured or distributed by RB Health (US) LLC, the owner of the registered trademark Maximum Strength Mucinex® SINUS-MAX® Pressure, Pain & Cough.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion, headache, sinus congestion and pressure, minor aches and pains, and cough associated with the common cold. It aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the clearance of mucus from the bronchial passageways and making coughs more productive. Additionally, it temporarily promotes nasal and/or sinus drainage.

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.

The use of this medication is not recommended for children under 12 years of age. Healthcare professionals should ensure that patients are aware of these guidelines to prevent potential overdose and ensure safe administration.

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) or within 2 weeks of discontinuing such treatment. MAOIs are commonly prescribed for depression, psychiatric, or emotional conditions, as well as for Parkinson’s disease. If there is uncertainty about the presence of an MAOI in a prescription, a healthcare professional should be consulted prior to use.

• In individuals with a history of allergic reactions to this product or any of its ingredients, as this may lead to severe allergic responses.

Warnings and Precautions

This product contains acetaminophen, which carries a significant risk of severe liver damage if not used according to the guidelines. Healthcare professionals should advise patients that the risk of liver damage increases with the following conditions: 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 beverages daily while using this product.

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

General precautions should be taken for patients with specific health conditions. Prior to use, patients should consult a healthcare provider if they have a history of heart disease, diabetes, thyroid disease, persistent or chronic cough (such as that associated with smoking, asthma, chronic bronchitis, or emphysema), liver disease, high blood pressure, cough accompanied by excessive phlegm, or difficulty urinating due to prostate enlargement. Additionally, patients taking the anticoagulant warfarin should seek advice from a healthcare professional or pharmacist before using this product.

In cases of overdose, immediate medical attention is essential. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, even if no symptoms are apparent, as prompt intervention is critical for both adults and children.

Patients should be advised to 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 develop; or if a cough recurs or is accompanied by a rash or headache lasting longer than usual. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of potential adverse reactions, including serious warnings related to liver health and allergic reactions.

Severe liver damage may occur 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.

Additionally, acetaminophen may cause severe skin reactions, which can manifest as blisters, rash, or skin reddening. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be instructed to stop use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Other concerning symptoms include 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 lasting for an extended period. These symptoms may indicate a serious underlying condition that requires medical 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 and potential hepatotoxicity.

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 serious interactions.

Patients taking the anticoagulant warfarin should consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication. Monitoring of coagulation parameters may be warranted to ensure safety and efficacy.

Packaging & NDC

Below are the non-prescription pack sizes of Sinus Pressure and Pain and Cough (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 adolescents aged 12 years and older, the recommended dosage is 2 caplets every 4 hours, with a maximum of 12 caplets in a 24-hour period. It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised. Prompt medical attention is critical for both adults and children, 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 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, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical for patients to adhere to the following guidelines to minimize the risk of hepatotoxicity:

• Patients should not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period.

• Concurrent use with other medications containing acetaminophen is contraindicated, as this may lead to cumulative dosing and increase the risk of liver damage.

• Consumption of three or more alcoholic drinks per day while using this product is not recommended, as it may exacerbate the potential for liver injury.

Additionally, patients with a history of liver disease are advised to consult a healthcare professional prior to using this product to ensure safe and appropriate use. Regular monitoring of liver function may be warranted in patients with compromised liver function to detect any potential adverse effects promptly.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, regardless of whether any signs or symptoms are apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

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 the following adverse reactions associated with acetaminophen use: severe skin reactions, including blisters, rash, and skin reddening. These events have been reported voluntarily or through surveillance programs.

Patient Counseling

Healthcare providers should advise patients on the importance of adhering to the recommended dosage of the medication. Patients must be informed that exceeding the recommended dosage can lead to serious health risks.

In the event of an overdose, it is crucial for patients to seek medical help immediately or contact a Poison Control Center. Healthcare providers should emphasize that prompt medical attention is essential for both adults and children, even if no signs or symptoms of overdose are apparent. This proactive approach can significantly impact the outcome in cases of overdose.

Storage and Handling

The product is supplied in a tamper-evident package. It should not be used if the outer package is opened or if the blister is torn or broken.

Storage conditions require the product to be maintained at a temperature of 25°C (77°F), with permissible excursions between 15°-30°C (59°-86°F). For optimal integrity, it is essential to monitor storage conditions closely.

The expiration date and lot number can be found on the end flap of the packaging.

Additional Clinical Information

Patients should be informed that the medication is administered orally. Clinicians are advised to counsel patients regarding the importance of consulting a health professional if they are pregnant or breastfeeding before use. It is crucial to keep the medication out of reach of children. In the event of an overdose, patients must seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Additionally, clinicians should be aware of the potential for medicine abuse among teens and can refer to www.StopMedicineAbuse.org for further information.

Drug Information (PDF)

This file contains official product information for Sinus Pressure and Pain and Cough, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

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