Daytime Sinus Nighttime Sinus

Description

This product contains acetaminophen, guaifenesin, and phenylephrine HCl as active ingredients, functioning as a pain reliever, expectorant, and nasal decongestant. It is available in a dosage form of caplets, with a total of 12 caplets per package. The product is indicated for maximum strength daytime sinus relief and is suitable for individuals aged 12 years and older.

The National Drug Code (NDC) for this product is 11673-694-09. It is important to note that this product is comparable to the active ingredients found in Maximum Strength Mucinex® SINUS-MAX® Day. The packaging includes a tamper-evident feature, and it should not be used if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering.

This product is distributed by Target Corp., located in Minneapolis, MN 55403. It is not manufactured or distributed by Reckitt Benckiser LLC, the owner of the registered trademark Maximum Strength Mucinex® SINUS-MAX® Day & Night.

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 are advised to administer the medication as follows:

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 a total of 12 caplets within a 24-hour period.

The medication is not indicated for use in children under 12 years of age.

Healthcare providers should ensure that patients are informed not to exceed the recommended dosage to avoid 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 drug interactions. If there is uncertainty regarding the presence of an MAOI in a prescription medication, seek advice from a healthcare professional.

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

• Co-administration with any product containing diphenhydramine, including topical formulations, due to the potential for increased side effects.

Additionally, the product should not be taken in conjunction with DAY & NIGHT formulations, and the recommended dosage should not be exceeded. Alcoholic beverages should be avoided 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 taking 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.

Before initiating treatment, it is essential for healthcare providers to assess patients for the following conditions: heart disease, liver disease, diabetes, thyroid disease, high blood pressure, and urinary difficulties due to prostate enlargement. Additionally, patients with persistent or chronic coughs, particularly those associated with smoking, asthma, chronic bronchitis, or emphysema, should be evaluated. Coughs accompanied by excessive phlegm or those occurring at night, as well as patients with glaucoma, require careful consideration before use.

Patients taking anticoagulants such as warfarin or those on sedatives or tranquilizers should consult with a healthcare professional or pharmacist prior to using this product, particularly if they are using it at night.

In cases of accidental overdose, immediate medical attention is critical. Patients should be instructed to contact a Poison Control Center (1-800-222-1222) or seek emergency medical help without delay, regardless of the presence of symptoms.

Patients should be advised to discontinue use and consult a physician if they experience nervousness, dizziness, or sleeplessness. Additionally, worsening pain, nasal congestion, or cough lasting more than seven days, fever persisting beyond three days, or the emergence of new symptoms warrants immediate medical evaluation. A return of cough accompanied by a rash or headache that persists should also be considered a potential indicator of a serious condition, necessitating further investigation.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions.

Severe liver damage may occur if patients exceed a 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, acetaminophen may cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Common adverse reactions may include nervousness, dizziness, or sleeplessness. Patients should stop use and consult a doctor if pain, nasal congestion, or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, or if redness or swelling is observed. New symptoms or a recurrence of cough, particularly if accompanied by a rash or headache that lasts, should also prompt a consultation with a healthcare provider, as these may indicate a serious condition.

When using this product, patients should adhere to the recommended dosage to avoid adverse effects. Notably, excitability and marked drowsiness may occur, particularly in children, and the use of alcohol, sedatives, or tranquilizers may exacerbate drowsiness. Patients are cautioned to avoid alcoholic beverages and to exercise caution when driving or operating machinery.

Patients with certain pre-existing conditions should consult a doctor before use. These conditions include heart disease, liver disease, diabetes, 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 with excessive phlegm, and breathing problems like emphysema or chronic bronchitis. Additionally, patients with glaucoma should seek medical advice before use.

Patients taking blood-thinning medications such as warfarin or those using sedatives or tranquilizers should also consult a doctor or pharmacist prior to using this product.

Drug Interactions

Co-administration 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 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 two weeks following the discontinuation of the 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 concomitant use of these agents may enhance drowsiness and sedation. It is recommended to avoid alcoholic beverages during this time, as alcohol can further exacerbate these effects.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Sinus Nighttime 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 may occur, particularly in children, and marked drowsiness is also a potential effect, especially when used at nighttime.

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 without delay. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially apparent.

Geriatric Use

Elderly patients may use this product; however, caution is advised due to the potential for increased sensitivity to its effects. There are no specific dosage adjustments or safety concerns outlined for patients aged 65 and older. Nevertheless, it is important to consider that elderly patients may have comorbid conditions that are more prevalent in this population, such as heart disease, liver disease, diabetes, thyroid disease, high blood pressure, and urinary difficulties due to prostate enlargement.

Marked drowsiness may occur, particularly with the Nighttime formulation, which could pose a significant concern for elderly patients. Therefore, it is recommended that these patients exercise caution when engaging in activities that require alertness, such as driving or operating machinery.

Elderly patients should also be aware of potential medication interactions. It is advisable for them to consult a healthcare provider or pharmacist if they are concurrently taking blood thinners, such as warfarin, or sedatives/tranquilizers, as these may heighten the risk of adverse effects. Additionally, the consumption of alcohol, sedatives, and tranquilizers may further increase drowsiness, necessitating careful consideration of these substances in geriatric patients.

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 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 concurrent use with 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 liver disease are advised to consult a healthcare professional to assess the appropriateness of this product for their condition. Monitoring of liver function may be warranted in patients with compromised liver function to ensure safety and efficacy during treatment.

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 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 several adverse events reported voluntarily or through surveillance programs. Acetaminophen has been associated with severe skin reactions, which may 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, excitability has been noted, particularly in children, during nighttime use. Marked drowsiness is also a reported effect during nighttime administration. The concurrent use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness.

Healthcare professionals are advised to recommend discontinuation and consultation if patients experience nervousness, dizziness, or sleeplessness. Furthermore, 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. Patients should also be instructed to seek medical attention if redness or swelling occurs, new symptoms develop, or if a cough recurs alongside a rash or headache that lasts.

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 they are taking the correct dosage. It is important to inform patients that they should not take DAY & NIGHT products simultaneously and must not exceed the recommended dosage.

Providers should also discuss the potential for excitability, particularly in children, as well as the likelihood of marked drowsiness associated with the NIGHTTIME product. Patients should be made aware 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.

Finally, healthcare providers should caution patients about the risks of driving a motor vehicle or operating machinery after taking the NIGHTTIME product, as drowsiness may impair their ability to perform these activities safely.

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

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. 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 at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, regardless of the presence of symptoms.

Patients taking both nighttime and daytime products should carefully read the dosing instructions for each to avoid taking them simultaneously.

Drug Information (PDF)

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

View product document (PDF)