Sinus Relief

Description

This product contains a combination of active ingredients including acetaminophen, guaifenesin, diphenhydramine HCl, and phenylephrine HCl, formulated for maximum strength relief. It serves multiple therapeutic purposes: acetaminophen acts as a pain reliever, guaifenesin functions as an expectorant, diphenhydramine HCl provides antihistamine and cough suppressant effects, and phenylephrine HCl serves as a nasal decongestant.

The product is designed for temporary relief of sinus pressure, headache, and congestion, and is indicated for use in individuals aged 12 years and older. It is available in a package containing 12 daytime caplets and 8 nighttime caplets, totaling 20 caplets. The caplets are tamper evident, and users are advised not to use the product if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering.

It is important to note that daytime and nighttime products should not be taken simultaneously. The product is distributed by Rite Aid, located at 200 Newberry Commons, Etters, PA 17319.

Uses and Indications

This drug is indicated for the temporary relief of common cold symptoms, including nasal congestion, headache, minor aches and pains, sinus congestion and pressure, cough (for nighttime use only), and runny nose and sneezing (for nighttime use only). Additionally, it temporarily promotes nasal and/or sinus drainage and assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the expulsion of bothersome mucus and making coughs more productive during the daytime.

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 ensure that patients understand the importance of not exceeding the directed dosage to avoid potential adverse effects.

Contraindications

The concurrent use of DAYTIME and NIGHTTIME products is contraindicated. Additionally, this product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription; consult a healthcare professional if uncertain about the presence of acetaminophen in other medications.

Use is contraindicated 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 an MAOI. If there is uncertainty regarding the presence of an MAOI in a prescription drug, a healthcare professional should be consulted prior to use.

Patients with a history of allergic reactions to this product or any of its ingredients should not use it. Furthermore, the use of this product is contraindicated with any other product containing diphenhydramine, including topical formulations (Nighttime only).

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 cause 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: heart disease, high blood pressure, liver disease, thyroid disease, diabetes, difficulty urinating due to prostate gland enlargement, persistent or chronic cough (such as that associated with smoking, asthma, chronic bronchitis, or emphysema), cough accompanied by excessive phlegm, or breathing problems like emphysema or chronic bronchitis (specifically at night). Additionally, patients with glaucoma should also seek medical advice before use, particularly for nighttime administration.

Patients should be cautioned to consult a doctor or pharmacist before using this product if they are currently taking the anticoagulant warfarin or sedatives/tranquilizers, especially for nighttime use.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Patients are advised to 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 new symptoms arise; if fever worsens or lasts more than three days; if redness or swelling occurs; or if a cough recurs or is accompanied by a rash or headache that persists. These symptoms may indicate a serious underlying condition that requires further evaluation.

Side Effects

Severe adverse reactions associated with this product include the potential for severe liver damage, particularly 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.

Patients should be aware of the risk of severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Common adverse reactions may include nervousness, dizziness, and sleeplessness. Patients are advised to stop use and consult a healthcare professional if pain, nasal congestion, or cough worsens or persists beyond seven days, if new symptoms arise, if fever worsens or lasts more than three days, or if redness or swelling is observed. Additionally, a cough that recurs or occurs alongside a rash or headache that lasts may indicate a serious condition requiring medical evaluation.

During the use of this product, patients should adhere 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 caution is advised when driving or operating machinery. Alcoholic beverages should be avoided during nighttime 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 prior to use. Additionally, those with persistent or chronic coughs, breathing problems such as emphysema or chronic bronchitis, or glaucoma should seek medical advice before using this product.

Patients taking the blood-thinning medication warfarin or those on sedatives or tranquilizers should also consult a doctor or pharmacist before use to mitigate potential interactions.

Drug Interactions

Concurrent use of this medication with any other product 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) for conditions such as depression, psychiatric disorders, or Parkinson’s disease, as well as for a period of two weeks following the discontinuation of an MAOI. This interaction may lead to serious and potentially life-threatening side effects.

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

Additionally, caution is advised for individuals using sedatives or tranquilizers, particularly at nighttime. The combination of this medication with alcohol, sedatives, or tranquilizers may enhance drowsiness, necessitating careful monitoring of sedation levels and potential impairment of motor skills.

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 aged 12 years and older may take 2 caplets every 4 hours. The use of this medication is not recommended for children under 12 years of age.

Caution is advised as excitability may occur, particularly in children, when used at nighttime. Additionally, marked drowsiness may also be experienced during nighttime use.

It is essential for both adults and pediatric patients to seek prompt medical attention, even in the absence of noticeable signs or symptoms.

Geriatric Use

Elderly patients may not require specific dosage adjustments or present notable safety concerns as per the available prescribing information. However, it is essential for healthcare providers to exercise caution and consider the following general recommendations when prescribing to geriatric patients.

Before initiating treatment, it is advisable to consult a physician if the elderly patient has any of the following conditions: heart disease, high blood pressure, liver disease, thyroid disease, diabetes, difficulty in urination due to prostate gland enlargement, persistent or chronic cough (such as that associated with smoking, asthma, chronic bronchitis, or emphysema), cough accompanied by excessive phlegm, or breathing problems like emphysema or chronic bronchitis, particularly at night. Additionally, patients with glaucoma should also be evaluated before use, especially for nighttime administration.

Marked drowsiness may occur with the use of this medication, and the concomitant use of alcohol, sedatives, or tranquilizers can exacerbate this effect, which is particularly pertinent for elderly patients. Therefore, caution is advised when engaging in activities that require alertness, such as driving a motor vehicle or operating machinery, especially during nighttime hours. Regular monitoring and assessment of the patient's response to treatment are recommended to ensure safety and efficacy.

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 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 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 patients 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 be advised of the potential risks associated with the use of this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the recommended dosage of 4,000 mg of acetaminophen in a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

It is essential for patients with liver disease to consult a healthcare professional prior to using this product. Monitoring of liver function may be warranted in these patients to prevent potential adverse effects.

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, even in the absence of observable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

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

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, emphasizing that prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to take DAYTIME and NIGHTTIME products concurrently, as this could lead to adverse effects. It is essential to stress the importance of adhering to the recommended dosage and not exceeding it.

Providers should discuss the potential for excitability, particularly in children, which may occur with the use of the NIGHTTIME product. Additionally, patients should be made aware that marked drowsiness is a possible side effect associated with the NIGHTTIME formulation.

Healthcare providers should caution patients that the consumption of alcohol, sedatives, and tranquilizers may enhance drowsiness when using the NIGHTTIME product. It is advisable to recommend that patients 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 advised to avoid alcoholic beverages while taking the NIGHTTIME formulation to minimize the risk of increased drowsiness.

Storage and Handling

The product is supplied in a tamper-evident package. It is essential to refrain from using the product 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 proper identification, the expiration date and lot number can be found on the end flap of the packaging.

Additional Clinical Information

Patients aged 12 years and older are advised to take 2 caplets every 4 hours, with a maximum limit of 12 caplets within a 24-hour period. 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 overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is recommended, as prompt attention is critical for both adults and children, even if no symptoms are apparent.

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)