Daytime Nighttime Sinus Relief

Description

ACETAMINOPHEN is a combination medication that includes Guaifenesin and Phenylephrine HCl, serving as a pain reliever, expectorant, and nasal decongestant. Another formulation contains ACETAMINOPHEN, Diphenhydramine HCl, and Phenylephrine HCl, functioning as a pain reliever, antihistamine, cough suppressant, and nasal decongestant. The product is available in two sizes: 12 daytime caplets and 8 nighttime caplets. The packaging is tamper-evident; do not use if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering. The National Drug Code (NDC) for this product is 11673-794-09. It is distributed by Target Corporation, located in Minneapolis, MN 55403. TM & ©2024 Target Brands, Inc.

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 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; consult a healthcare professional if uncertain about acetaminophen content 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

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:

• Consumption of more than 4,000 mg of acetaminophen within a 24-hour period.

• Concurrent use with other medications containing acetaminophen.

• Daily intake of three or more alcoholic beverages while using this product.

In addition to the liver warning, there is an allergy alert associated with acetaminophen. Patients may experience severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, it is imperative that the patient discontinue use immediately and seek medical assistance.

Healthcare providers should also exercise caution and recommend that patients consult a physician prior to using this product if they have any of the following conditions:

• Heart disease

• Liver disease

• Diabetes

• Thyroid disease

• High blood pressure

• Difficulty urinating due to prostate enlargement

• Persistent or chronic cough, particularly associated with smoking, asthma, chronic bronchitis, or emphysema

• Cough accompanied by excessive phlegm

• Breathing problems such as emphysema or chronic bronchitis (specifically at night)

• Glaucoma (specifically at night)

Furthermore, patients should be advised to consult a doctor or pharmacist before use if they are currently taking blood thinners such as warfarin or sedatives and tranquilizers, particularly at night.

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

Patients should also be advised to discontinue use and contact their healthcare provider if they experience any of the following:

• Nervousness, dizziness, or sleeplessness

• Worsening pain, nasal congestion, or cough lasting more than 7 days

• Fever that worsens or persists beyond 3 days

• Presence of redness or swelling

• Onset of new symptoms

• Recurrence of cough, especially if accompanied by a rash or headache lasting for an extended period, as these may indicate a serious underlying condition.

Side Effects

Patients using this product should be aware of potential adverse reactions, which can range from serious to common.

Severe liver damage is a significant concern associated with the use of this product, particularly due to its acetaminophen content. Patients are advised that liver damage may occur if they exceed 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.

Allergic reactions may manifest as severe skin reactions, including symptoms such as skin reddening, blisters, and rash. If any of these symptoms occur, patients should discontinue use immediately and seek medical assistance.

Common adverse reactions may include nervousness, dizziness, and sleeplessness. Patients should stop using the product and consult a healthcare provider 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 new symptoms arise. Additionally, if cough recurs or is accompanied by a rash or headache that lasts, these may indicate a serious condition requiring medical evaluation.

During use, patients should adhere to the recommended dosage to avoid excitability, particularly in children, and marked drowsiness, which may occur at nighttime. The use of alcohol, sedatives, and tranquilizers can exacerbate drowsiness, and patients are advised to avoid alcoholic beverages while using this product. Caution is recommended when driving or operating machinery due to the potential for drowsiness.

Patients with pre-existing conditions such as heart disease, liver disease, diabetes, thyroid disease, high blood pressure, 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 like emphysema or chronic bronchitis, or glaucoma should seek medical advice prior to use.

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

Drug Interactions

Concurrent use of this medication with any other drug 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), which includes certain medications prescribed for depression, psychiatric conditions, or Parkinson’s disease. Additionally, it should not be administered for at least 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.

Furthermore, individuals who are using sedatives or tranquilizers, particularly at nighttime, should seek advice from a healthcare provider before use. The combination of alcohol, sedatives, and tranquilizers may enhance drowsiness, necessitating caution in activities requiring alertness.

Packaging & NDC

Below are the non-prescription pack sizes of Daytime Nighttime 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 overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay, as prompt medical attention is critical for both adults and children, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may exhibit increased sensitivity to the side effects of diphenhydramine, which can lead to pronounced drowsiness and a heightened risk of falls. While the product is indicated for adults and children aged 12 years and older, there are no specific dosage adjustments or safety concerns outlined for geriatric patients.

Healthcare providers should exercise caution when prescribing this medication to elderly patients, particularly regarding activities that require alertness, such as driving a motor vehicle or operating machinery. The potential for increased drowsiness in this population necessitates careful monitoring and consideration of the individual patient's health status and risk factors.

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 should consult a healthcare professional prior to use, particularly if they experience difficulty in urination due to prostate gland enlargement. Additionally, it is advisable for patients taking the anticoagulant warfarin to seek guidance from a doctor or pharmacist before using this product. Care should be taken to adhere to the recommended dosage, as exceeding this may pose risks, especially in individuals with reduced kidney function.

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, 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 care as needed.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 7 days, fever that worsens or persists beyond 3 days, presence of redness or swelling, emergence of new symptoms, or recurrence of cough accompanied by rash or headache lasting for an extended period, as these 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 can lead to adverse effects. It is important to communicate the necessity of adhering to the recommended dosage and to avoid exceeding it.

Healthcare providers should inform patients that excitability may occur, particularly in children when using the Nighttime product. Additionally, patients should be made aware that marked drowsiness is a potential side effect associated with the Nighttime formulation.

Patients should be cautioned that the consumption of alcohol, sedatives, and tranquilizers may enhance drowsiness when using the Nighttime product. Therefore, it is advisable to avoid alcoholic beverages while taking this medication.

Finally, healthcare providers should emphasize the importance of exercising caution when driving a motor vehicle or operating machinery after taking the Nighttime product, as drowsiness may impair the 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.

For optimal storage, the product must be kept at a temperature of 25°C (77°F), with permissible excursions between 15°C and 30°C (59°F to 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 should seek immediate medical assistance or contact a Poison Control Center, as prompt attention is crucial for both adults and children, even if no symptoms are apparent.

Drug Information (PDF)

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

View product document (PDF)