Day and Night Sinus

Description

No description information is available for the specified drug.

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 helps to loosen phlegm (mucus) and thin bronchial secretions, 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 are aware of these guidelines to prevent any potential overdose or misuse.

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 other medications, consultation with a healthcare professional is advised.

This product 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 about whether a prescription drug contains an MAOI, a healthcare professional should be consulted prior to use.

Furthermore, the use of this product is contraindicated with any other product containing diphenhydramine, including topical formulations, specifically 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, diabetes, liver disease, thyroid disease, high blood pressure, 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 be advised to consult 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, regardless of the presence of symptoms.

Patients should be advised 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 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

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, use other medications containing acetaminophen concurrently, 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, patients are advised to discontinue use and seek medical assistance immediately.

During the use of this product, excitability may occur, particularly in children, and marked drowsiness is also a possibility, especially when taken at nighttime. The concomitant use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness. Patients are cautioned to avoid alcoholic beverages and to exercise caution when driving or operating machinery during nighttime use.

Patients should discontinue 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 worsens or lasts more than 3 days, medical advice should be sought. Signs such as 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 may indicate a serious condition, warranting immediate medical evaluation.

Drug Interactions

Acetaminophen co-administration with other products containing acetaminophen or the consumption of three or more alcoholic beverages daily may elevate the risk of severe liver damage. It is advisable to monitor liver function and consider dosage adjustments for patients using multiple acetaminophen-containing products or those with significant alcohol intake.

Diphenhydramine may enhance drowsiness when used concurrently with alcohol, sedatives, or tranquilizers. Caution is recommended when prescribing diphenhydramine to patients who consume alcohol or are on sedative therapy, and monitoring for increased sedation is warranted.

Packaging & NDC

Below are the non-prescription pack sizes of Day and Night Sinus (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 when used at nighttime. 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 recommended, as prompt attention is critical for both adults and children, even in the absence of noticeable signs or symptoms.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments or safety concerns. 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 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 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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 concurrent use with other medications that contain acetaminophen, as this may further increase the risk of liver injury.

Patients with compromised liver function are advised to consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. Furthermore, consumption of three or more alcoholic drinks per day while using this product is strongly discouraged, as it may exacerbate the risk of liver damage. Regular monitoring of liver function may be warranted in patients with existing liver conditions to ensure safety and efficacy during treatment.

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 attention is crucial for both adults and children, even in the absence of noticeable 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 interventions as necessary.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before 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

Severe skin reactions, including symptoms such as skin reddening, blisters, and rash, have been reported in association with the use of DAY AND NIGHT SINUS, potentially linked to acetaminophen. In cases of skin reactions, it is advised to discontinue use and seek medical assistance immediately.

Additional postmarketing experience includes reports of nervousness, dizziness, or sleeplessness. There have been instances where pain, nasal congestion, or cough may worsen or persist beyond 7 days, and fever may also worsen or last more than 3 days. Redness or swelling has been noted, along with the occurrence of new symptoms. Furthermore, cough may return or present alongside rash or headache that persists, which could indicate a serious condition.

Patient Counseling

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

Patients should be informed not to take DAYTIME and NIGHTTIME products simultaneously and to adhere strictly to the recommended dosage to avoid potential complications.

It is important to discuss the possibility of excitability, particularly in children, which may occur with nighttime use. Patients should also be made aware that marked drowsiness may result from nighttime use, and that the consumption of alcohol, sedatives, and tranquilizers can exacerbate this drowsiness. Therefore, patients should be advised to avoid alcoholic beverages while using the nighttime product.

Healthcare providers should caution patients about the risks associated with driving a motor vehicle or operating machinery after taking the nighttime product due to the potential for drowsiness.

Patients should be encouraged to consult with their healthcare provider before use if they have any of the following conditions: heart disease, diabetes, liver disease, thyroid disease, high blood pressure, or difficulty urinating due to an enlarged prostate gland. Additionally, patients 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.

Those experiencing a cough with excessive phlegm (mucus) or who have breathing problems, such as emphysema or chronic bronchitis, should be advised to consult a healthcare provider before using the nighttime product. Furthermore, patients with glaucoma should be informed to seek medical advice before use of the nighttime formulation.

Lastly, patients taking the blood-thinning medication warfarin, as well as those on sedatives or tranquilizers, should be encouraged to discuss their current medications with their healthcare provider or pharmacist prior to using the product.

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. The recommended storage temperature is 25°C (77°F), with permissible excursions between 15°-30°C (59°-86°F). Healthcare professionals are advised to check the end flap of the package for the expiration date and lot number to ensure product integrity and safety.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. 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, even in the absence of noticeable signs or symptoms.

Drug Information (PDF)

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

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