Sinus Relief

Description

Maximum Strength Mucinex® SINUSMAX® Day & Night is a registered trademark of Reckitt Benckiser LLC, located in Slough, United Kingdom. This product is distributed by The Kroger Co., based in Cincinnati, Ohio 45202.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion, headache, minor aches and pains, sinus congestion and pressure, cough (nighttime only), and runny nose and sneezing (nighttime only). It also temporarily promotes nasal and/or sinus drainage and helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the expulsion of bothersome mucus to make coughs more productive during the daytime.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals should advise patients to 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. Patients should be instructed to avoid taking more than the directed amount to prevent potential adverse effects.

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 uncertain about the presence of acetaminophen in other medications, consult a healthcare professional.

• Concurrent use with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing an MAOI, as this may lead to serious interactions. Verify with a healthcare professional if there is uncertainty regarding MAOI content in current medications.

• History of allergic reactions to this product or any of its ingredients, as this may result in severe hypersensitivity reactions.

• Co-use with any product containing diphenhydramine, including topical formulations, to avoid potential overdose and adverse effects.

Additionally, do not take DAY & NIGHT formulations simultaneously, exceed the recommended dosage, or consume alcoholic beverages while using the Nighttime formulation.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly 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 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, patients must be instructed to discontinue use immediately and seek medical assistance.

Before recommending this product, healthcare providers should inquire about the patient's medical history. It is particularly important to ask if the patient has any of the following conditions: heart disease, high blood pressure, liver disease, thyroid disease, diabetes, difficulty urinating due to prostate enlargement, or persistent cough associated with smoking, asthma, chronic bronchitis, or emphysema. Additionally, caution is advised for patients experiencing cough with excessive phlegm, breathing problems such as emphysema or chronic bronchitis (particularly at night), or glaucoma (also primarily at night).

Healthcare professionals should also consult with patients regarding the use of blood thinners, such as warfarin, and the concurrent use of sedatives or tranquilizers, especially at night, as these may interact with the product.

In cases of accidental 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 without delay, even if no symptoms are apparent.

Patients should be advised to discontinue use and consult a healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond seven days, or if new symptoms arise, medical advice should be sought. A worsening fever lasting more than three days, the presence of redness or swelling, or a cough that recurs or is accompanied by a rash or headache warrants immediate medical evaluation, as these may indicate a serious underlying condition.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly in patients who exceed the recommended dosage of 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, patients may experience severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative that patients discontinue use and seek immediate medical attention.

Common adverse reactions may include nervousness, dizziness, and sleeplessness. Patients are advised to stop use and consult a healthcare professional if these symptoms occur, or if pain, nasal congestion, or cough worsens or persists beyond seven days. New symptoms, worsening fever lasting more than three days, or the presence of redness or swelling should also prompt a consultation with a healthcare provider, as these may indicate a serious condition.

While using this product, patients should adhere strictly to the recommended dosage to avoid adverse effects. Notably, excitability and marked drowsiness may occur, particularly in children, when used at nighttime. The use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness, and patients should exercise caution when driving or operating machinery. It is also advised to avoid alcoholic beverages during use.

Patients with pre-existing conditions such as heart disease, high blood pressure, liver disease, thyroid disease, diabetes, or difficulty urinating due to prostate enlargement should consult a healthcare provider before using this product. Additionally, those with persistent or chronic coughs, breathing problems such as emphysema or chronic bronchitis, or glaucoma should seek medical advice prior to use, especially at nighttime.

Furthermore, patients taking the blood-thinning medication warfarin or those on sedatives or tranquilizers should consult a doctor or pharmacist before using this product to avoid potential interactions.

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.

The use of this medication is also contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson’s disease, as well as for a period of two weeks following the discontinuation of an MAOI.

Patients taking the anticoagulant warfarin should consult a healthcare professional prior to using this medication, as there may be an increased risk of bleeding.

Additionally, caution is advised for patients who are using sedatives or tranquilizers, particularly at nighttime, as these substances may enhance drowsiness when taken in conjunction with this medication. It is recommended that patients seek guidance from a healthcare provider before combining these agents.

Packaging & NDC

Below are the non-prescription pack sizes of Sinus Relief (acetaminophen, diphenhydramine hcl, 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. Caution is advised as excitability may occur, particularly in children, during nighttime use. Additionally, marked drowsiness may also be experienced in this population when used at night.

It is essential to keep this medication out of reach of children. In the event of an accidental overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may use this product as it is indicated for adults and children aged 12 years and older. There are no specific dosage adjustments or safety concerns outlined for this population in the available data. However, healthcare providers should remain vigilant regarding the general health conditions that are more prevalent in geriatric patients, such as heart disease, high blood pressure, and liver disease, as these may influence the overall safety and efficacy of the product.

It is advisable for elderly patients to consult with their healthcare provider prior to use, especially if they have any underlying health conditions. This precaution is particularly important given the potential for increased sensitivity or adverse effects in this age group. Regular monitoring and assessment of the patient's health status may be warranted to ensure safe and effective use of the product in elderly patients.

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 the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 that patients do not exceed 4,000 mg of acetaminophen within a 24-hour period. Additionally, patients should avoid the concurrent use of other medications containing acetaminophen and limit alcohol consumption to fewer than three alcoholic drinks per day while using this product.

Before initiating treatment, patients with known liver disease are advised to consult a healthcare professional. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy during the course of therapy.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the management of overdose cases may vary depending on the specific substance involved and the clinical presentation of the patient. Therefore, it is essential to conduct a thorough assessment and provide appropriate interventions based on the patient's condition and the guidance of poison control experts.

Nonclinical Toxicology

No relevant information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no pertinent data concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details have been reported for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) in the event of an accidental overdose. It is essential to emphasize that prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Patients should be instructed to carefully read the dosing instructions for both NIGHTTIME and DAYTIME products to ensure proper usage. It is important to inform them not to take DAY & NIGHT products simultaneously, as this could lead to dosing errors.

Providers should stress the importance of adhering to the recommended dosage and not exceeding it. Patients should be made aware that excitability may occur, particularly in children when using the NIGHTTIME product. Additionally, marked drowsiness is a potential side effect associated with the NIGHTTIME formulation.

Healthcare providers should caution patients that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness when taking the NIGHTTIME product. They should also advise patients to exercise caution when driving or operating machinery while using this product, as drowsiness may impair their ability to do so safely. Furthermore, patients should be encouraged to avoid alcoholic beverages while taking the NIGHTTIME formulation to prevent increased sedation.

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°C and 30°C (59°F to 86°F). For reference, 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. For adults and children 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. The medication is not recommended for children under 12 years of age.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding. It is essential to keep the medication out of reach of children. In the event of an accidental overdose, patients should seek medical assistance or contact a Poison Control Center immediately, as prompt attention is crucial for both adults and children, regardless of the presence of symptoms. Additionally, patients taking both nighttime and daytime products should carefully read the dosing instructions to avoid taking them simultaneously.

Drug Information (PDF)

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

View product document (PDF)