Sinus Pressure and Pain

Description

No description information is available.

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 (nighttime only), and runny nose and sneezing (nighttime 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 daytime coughs more productive.

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 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 informed about the importance of following these guidelines to avoid potential overdose.

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; if there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Use is also 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 about whether a prescription drug contains an MAOI, a healthcare professional should be consulted prior to use.

Furthermore, this product should not be used with any other product containing diphenhydramine, including topical formulations, particularly for nighttime use.

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.

Acetaminophen may also provoke 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.

Healthcare providers should exercise caution and recommend that patients consult a physician prior to using this product if they have any of the following conditions: heart disease, high blood pressure, liver disease, thyroid disease, diabetes, difficulty urinating due to prostate 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 seek medical advice before use, especially if symptoms occur at night.

Patients taking anticoagulants such as warfarin or those on sedatives or tranquilizers should consult a healthcare professional or pharmacist before using this product to avoid potential interactions.

In the event of an overdose, immediate medical attention is crucial. Patients should be advised to contact a Poison Control Center or seek emergency medical help without delay, regardless of whether symptoms are present, as prompt intervention is essential for both adults and children.

Patients should be instructed to discontinue use and contact their 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 lasting longer than expected. 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 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 should be aware of the risk of severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Common adverse reactions may include nervousness, dizziness, and sleeplessness. Patients experiencing worsening pain, nasal congestion, or cough lasting more than seven days, as well as those with new symptoms or a fever that worsens or persists beyond three days, should stop use and consult a healthcare professional. Redness or swelling, or a cough that recurs or is accompanied by a rash or headache lasting longer than usual, 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 night. The use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness, and patients are cautioned against driving or operating machinery during this time. Alcoholic beverages should be avoided while using this product at night.

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 use. Additionally, those with persistent or chronic coughs, breathing problems like emphysema or chronic bronchitis, or glaucoma should seek medical advice prior to use. Patients taking blood thinners such as warfarin or sedatives and tranquilizers should also consult a doctor or pharmacist before using this product.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen is contraindicated due to the risk of severe liver damage. It is essential to avoid such combinations to ensure patient safety.

When diphenhydramine is taken concurrently with sedatives or tranquilizers, there is an increased risk of enhanced drowsiness. Patients should be advised to exercise caution when engaging in activities that require alertness, such as driving or operating machinery.

Patients on warfarin, a blood-thinning medication, should consult a healthcare professional prior to using this drug, as potential interactions may affect anticoagulation control. Monitoring of INR levels may be warranted to ensure therapeutic efficacy and safety.

Packaging & NDC

Below are the non-prescription pack sizes of Sinus Pressure and Pain (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 and marked drowsiness may occur, particularly during nighttime use. 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 crucial 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 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 can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 mothers.

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 in 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 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 arising from an overdose. 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 identified that acetaminophen may be associated with severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance immediately.

Additionally, users are encouraged 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, the emergence of new symptoms, fever that worsens or persists beyond three days, or the presence of redness or swelling. A recurrence of cough, particularly when accompanied by rash or headache that lasts, may indicate a serious condition.

In cases of overdose, it is imperative to seek medical help or contact a Poison Control Center without delay, as prompt medical attention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

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 instructed not to take DAYTIME and NIGHTTIME products concurrently, as this could lead to adverse effects. It is important to communicate the necessity of adhering to the recommended dosage and to avoid exceeding it.

Providers should inform patients that excitability may occur, particularly in children when using the nighttime formulation. Additionally, marked drowsiness is a potential side effect associated with the nighttime product, and patients should be made aware of this.

Patients should be cautioned that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness when taking the nighttime formulation. Therefore, it is advisable to avoid alcoholic beverages while using this product. Furthermore, healthcare providers should emphasize the importance of exercising caution when driving a motor vehicle or operating machinery after taking the nighttime product, due to the risk of drowsiness.

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 proper inventory management, 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.

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, patients must seek medical assistance or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, regardless of the presence of symptoms. Additionally, patients should be advised not to take DAYTIME and NIGHTTIME products concurrently.

Drug Information (PDF)

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

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