ADD CONDITION
Daytime Nighttime Sinus Relief
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- Active ingredients
- Acetaminophen 325 mg
- Guaifenesin 200 mg
- Phenylephrine Hydrochloride 5 mg
- Other brand names
- Day and Night Sinus (by Wal-Mart Stores Inc)
- Daytime Nighttime Sinus Relief (by Target Corporation)
- Daytime Sinus Nighttime Sinus (by Target Corporation)
- Sinus Pressure and Pain (by Walgreen Company)
- Sinus Pressure and Pain (by Walgreen Company)
- Sinus Relief (by Cvs Pharmacy)
- Sinus Relief (by Kroger Company)
- Sinus Relief (by Rite Aid Corporation)
- View full label-group details →
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Prescription status
- OTC (over the counter)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2025
- Label revision date
- June 14, 2025
- Drug Information (PDF)
- Prescribing information, PDF file
- Active ingredients
- Acetaminophen 325 mg
- Guaifenesin 200 mg
- Phenylephrine Hydrochloride 5 mg
- Other brand names
- Day and Night Sinus (by Wal-Mart Stores Inc)
- Daytime Nighttime Sinus Relief (by Target Corporation)
- Daytime Sinus Nighttime Sinus (by Target Corporation)
- Sinus Pressure and Pain (by Walgreen Company)
- Sinus Pressure and Pain (by Walgreen Company)
- Sinus Relief (by Cvs Pharmacy)
- Sinus Relief (by Kroger Company)
- Sinus Relief (by Rite Aid Corporation)
- View full label-group details →
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Prescription status
- OTC (over the counter)
- CSA schedule
- Not a scheduled drug
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2025
- Label revision date
- June 14, 2025
- Manufacturer
- Target Corporation
- Registration number
- M012
- NDC root
- 11673-530
- Drug Information (PDF)
- Prescribing information, PDF file
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
If you are a consumer or patient please visit this version.
Drug Overview
This medication is designed to temporarily relieve various symptoms associated with the common cold, including nasal congestion, headache, minor aches and pains, sinus congestion and pressure, as well as cough, runny nose, and sneezing, particularly at night. It also promotes nasal and sinus drainage, helping to alleviate discomfort.
Additionally, during the daytime, this drug helps to loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive by clearing the bronchial passageways of bothersome mucus. This can provide you with some relief from the discomfort of cold symptoms, allowing you to feel more at ease.
Uses
If you're dealing with a common cold, this medication can help you feel better by temporarily relieving several bothersome symptoms. It can ease nasal congestion, headaches, minor aches and pains, and sinus congestion and pressure. If you're struggling with a cough, runny nose, or sneezing at night, this medication can also provide relief for those symptoms.
Additionally, it promotes drainage from your nasal passages and sinuses, helping to clear out mucus. During the day, it works to loosen phlegm (a thick substance produced in your lungs) and thin bronchial secretions, making it easier to cough up bothersome mucus and helping you breathe more comfortably.
Dosage and Administration
It's important to follow the dosage instructions carefully to ensure your safety. For adults and children aged 12 years and older, you should take 2 caplets every 4 hours as needed. However, make sure not to exceed 12 caplets in a 24-hour period.
If you are caring for children under 12 years old, please do not use this medication for them. Always stick to the recommended dosage and never take more than directed to avoid any potential risks.
What to Avoid
You should be aware of several important guidelines when using this product. First, do not take the DAYTIME and NIGHTTIME versions at the same time, as this can lead to unwanted side effects. It's also crucial to avoid using this product with any other medications that contain acetaminophen, whether they are prescription or over-the-counter. If you're unsure whether a medication contains acetaminophen, please consult your doctor or pharmacist.
Additionally, do not use this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions like depression or Parkinson’s disease, or if you have stopped taking an MAOI within the last two weeks. If you have a history of allergic reactions to this product or any of its ingredients, you should also refrain from using it. Lastly, avoid using any other products that contain diphenhydramine, even topical ones, if you are using the Nighttime version. Always prioritize your safety and consult a healthcare professional if you have any questions.
Side Effects
This product contains acetaminophen, which can lead to severe liver damage if you take more than 4,000 mg in 24 hours, use it with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using it. Be aware that acetaminophen may also cause serious skin reactions, including redness, blisters, or rashes. If you notice any skin reactions, stop using the product and seek medical help immediately.
While using this product, you may experience excitability or marked drowsiness, especially at night. Alcohol, sedatives, and tranquilizers can increase drowsiness, so it's best to avoid them. If you experience nervousness, dizziness, or sleeplessness, or if your symptoms worsen or new symptoms appear, stop use and consult a doctor. Additionally, if you have certain health conditions like heart or liver disease, diabetes, or breathing problems, consult your doctor before using this product.
Warnings and Precautions
This product contains acetaminophen, which can lead to severe liver damage if you take more than 4,000 mg in 24 hours, use it with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using it. Be aware that acetaminophen may also cause serious skin reactions, such as skin reddening, blisters, or rash. If you experience any skin reactions, stop using the product and seek medical help immediately.
Before using this product, consult your doctor if you have any of the following conditions: heart disease, liver disease, diabetes, thyroid disease, high blood pressure, or difficulty urinating due to prostate enlargement. It's also important to talk to your doctor or pharmacist if you are taking blood thinners like warfarin or sedatives. If you suspect an overdose, seek emergency medical assistance or contact a Poison Control Center right away, even if you don't notice any symptoms.
You should stop using the product and call your doctor if you experience nervousness, dizziness, or sleeplessness, if your pain, nasal congestion, or cough worsens or lasts more than seven days, if your fever worsens or lasts more than three days, or if you notice any redness or swelling. New symptoms or a cough that returns with a rash or headache that lasts could indicate a serious condition, so it's important to get medical advice.
Overdose
If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center. This is crucial for both adults and children, even if you don’t see any signs or symptoms of an overdose.
Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. Remember, acting quickly can make a significant difference, so don’t hesitate to get help.
Pregnancy Use
If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.
Lactation Use
If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.
Pediatric Use
If you are considering this medication for your child, it's important to know that it should not be used in children under 12 years old. For those aged 12 and older, the recommended dosage is 2 caplets every 4 hours. Be aware that this medication may cause excitability or marked drowsiness, particularly when taken at night.
Always keep an eye on your child after administering the medication, and seek prompt medical attention for both adults and children, even if there are no noticeable signs or symptoms. Your vigilance is key to ensuring their safety.
Geriatric Use
When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.
Renal Impairment
If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have renal impairment (kidney issues).
Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help monitor your kidney function and make any necessary adjustments to your treatment plan.
Hepatic Impairment
If you have liver problems, it's important to be cautious when using products that contain acetaminophen. Taking more than 4,000 mg of acetaminophen in a 24-hour period, using other medications that also contain acetaminophen, or consuming three or more alcoholic drinks daily while using this product can lead to severe liver damage.
Before using this product, you should consult with your doctor if you have liver disease. They can provide guidance on safe usage and any necessary adjustments to your dosage. Your health and safety are the top priority, so don’t hesitate to seek professional advice.
Drug Interactions
It's important to be cautious when taking this medication, especially regarding potential interactions with other drugs. You should not use it alongside any other products that contain acetaminophen, whether they are prescription or over-the-counter. Additionally, if you are currently taking a monoamine oxidase inhibitor (MAOI)—a type of medication often used for depression or Parkinson’s disease—or have taken one in the last two weeks, you should avoid this medication.
Before using this medication, consult with your doctor or pharmacist if you are taking blood thinners like warfarin, or if you are using sedatives or tranquilizers, particularly at night. Combining alcohol with this medication can increase drowsiness, so it's best to avoid alcoholic beverages while using it. Always discuss your current medications and any concerns with your healthcare provider to ensure your safety.
Storage and Handling
To ensure the best performance of your product, store it at a temperature of 25°C (77°F). It’s acceptable for the temperature to vary between 15-30°C (59-86°F) occasionally, but try to keep it as close to the recommended temperature as possible.
When handling the product, make sure to do so in a clean environment to maintain its integrity and safety. Always follow any specific instructions provided for use to ensure you are using it correctly and safely.
Additional Information
You should take this medication orally. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using it. Always keep this medication out of reach of children. In the event of an overdose, seek medical help or contact a Poison Control Center immediately, as prompt attention is crucial for both adults and children, even if there are no noticeable symptoms.
FAQ
What symptoms does this drug temporarily relieve?
This drug temporarily relieves nasal congestion, headache, minor aches and pains, sinus congestion and pressure, cough (nighttime only), and runny nose and sneezing (nighttime only).
How does this drug help with coughs?
During the daytime, it helps loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive.
What is the recommended dosage for adults and children over 12?
Adults and children 12 years and over should take 2 caplets every 4 hours, without exceeding 12 caplets in a 24-hour period.
Are there any contraindications for using this drug?
Do not take this drug with any other product containing acetaminophen, if you are taking a monoamine oxidase inhibitor (MAOI), or if you have had an allergic reaction to this product.
What should I do if I experience severe skin reactions?
If you notice symptoms like skin reddening, blisters, or rash, stop using the product and seek medical help immediately.
Can I use this drug if I am pregnant or breastfeeding?
If you are pregnant or breastfeeding, you should ask a health professional before using this drug.
What precautions should I take while using this drug?
Avoid alcoholic beverages, as they may increase drowsiness. Use caution when driving or operating machinery, especially at night.
What should I do in case of overdose?
In case of overdose, get medical help or contact a Poison Control Center right away, as prompt medical attention is critical.
What are the potential side effects of this drug?
Possible side effects include excitability, marked drowsiness, and severe skin reactions. If you experience nervousness, dizziness, or worsening symptoms, consult a doctor.
Packaging Info
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.
Details | ||||
|---|---|---|---|---|
| Tablet, Film Coated |
| ||
Kit Contents Each carton contains 2 components packaged together. Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Part 1 — Tablet
Part 2 — Tablet
| ||||
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.
Description
The provided data does not specify the chemical name, physical characteristics, or inactive ingredients of the drug. Therefore, a detailed description cannot be formulated based on the available information. Further details are required to create a comprehensive description.
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 and not exceed the maximum daily limit. For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 4 hours, with a maximum of 12 caplets within a 24-hour period.
It is important to note that this medication is not indicated for use in children under 12 years of age. Healthcare professionals should ensure that patients are aware of these guidelines to prevent potential overdose and ensure safe administration.
Contraindications
The concurrent use of DAYTIME and NIGHTTIME products is contraindicated. Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is also contraindicated; consult a healthcare professional if uncertain about acetaminophen content in other medications.
This product should not be used in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment, as these medications are used for depression, psychiatric, or emotional conditions, or Parkinson’s disease. If there is uncertainty regarding the presence of an MAOI in a prescription drug, a healthcare professional should be consulted prior to use.
Additionally, use is contraindicated in individuals with a history of allergic reactions to this product or any of its ingredients. For NIGHTTIME use, do not combine with any other product containing diphenhydramine, including topical formulations.
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 maximum recommended dosage is 4,000 mg of acetaminophen within a 24-hour period. Caution is also warranted when this product is used in conjunction with other medications containing acetaminophen or when patients consume three or more alcoholic drinks daily while using this product.
Acetaminophen may induce severe skin reactions, which can manifest as skin reddening, blisters, or rash. In the event of any skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.
General precautions should be taken for patients with specific health conditions. Prior to use, patients should consult a healthcare provider if they have a history of heart disease, liver disease, diabetes, thyroid disease, high blood pressure, or difficulty urinating due to prostate enlargement. Additionally, patients with persistent or chronic coughs, particularly those associated with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice. Nighttime use is particularly cautioned for individuals with breathing problems, glaucoma, or those taking sedatives or tranquilizers. Furthermore, patients on the anticoagulant warfarin should also consult a healthcare professional before use.
In cases of overdose, immediate medical attention is essential. Patients should be advised to contact a Poison Control Center or seek emergency medical help without delay, regardless of the presence of symptoms.
Patients should discontinue use and consult a healthcare provider 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 prompt medical attention.
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 drugs containing acetaminophen, 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 skin reaction occurs, patients should discontinue use and seek medical assistance immediately.
During the use of this product, patients should not exceed the recommended dosage. Notably, excitability and marked drowsiness may occur, particularly in children when used at nighttime. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness, and patients are advised to avoid alcoholic beverages. Caution is recommended when driving a motor vehicle or operating machinery during nighttime use.
Patients should stop using the product and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, if pain, nasal congestion, or cough worsens or persists beyond seven days, or if fever worsens or lasts more than three days, medical advice should be sought. Signs of serious conditions may also include the presence of 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.
Patients with certain medical conditions should consult a doctor before using this product. These conditions include heart disease, liver disease, diabetes, thyroid disease, high blood pressure, difficulty urinating due to prostate gland 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, particularly when used at nighttime. Furthermore, patients should seek advice from a doctor or pharmacist if they are taking the blood-thinning medication warfarin or using sedatives or tranquilizers, especially during nighttime use.
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, and 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.
Additionally, caution is advised for individuals using sedatives or tranquilizers, particularly at nighttime. The combination of this medication with these agents may enhance drowsiness. Therefore, it is recommended to avoid the consumption of alcoholic beverages during this time, as alcohol can further exacerbate sedation and impair cognitive and motor functions.
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.
Details | ||||
|---|---|---|---|---|
| Tablet, Film Coated |
| ||
Kit Contents Each carton contains 2 components packaged together. Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Part 1 — Tablet
Part 2 — Tablet
| ||||
Pediatric Use
Pediatric patients under 12 years of age should not use this medication. For those aged 12 years and older, the recommended dosage is 2 caplets every 4 hours.
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 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 potential adverse effects or changes in therapeutic response, 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 evaluate the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.
Lactation
Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding 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 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 individuals 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 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 a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period. Additionally, the concurrent use of other medications containing acetaminophen or the consumption of three or more alcoholic drinks daily while using this product may further increase the risk of liver damage.
Patients with known liver disease are advised to consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss potential risks. Monitoring of liver function may be warranted in these patients 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 intervention is crucial for both adults and children, regardless of whether any signs or symptoms are apparent.
Healthcare professionals are advised to remain vigilant, as the absence of symptoms does not preclude the possibility of serious complications. Early recognition and management of an overdose can significantly influence patient outcomes. Therefore, it is essential to ensure that patients and caregivers are aware of the importance of timely medical evaluation in cases of suspected overdose.
Nonclinical Toxicology
No relevant information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no pertinent data concerning nonclinical toxicology, animal pharmacology, or toxicology.
Postmarketing Experience
Postmarketing experience has revealed that acetaminophen may be associated with severe skin reactions. Reported symptoms include skin reddening, blisters, and rash. In the event of a skin reaction, users are 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.
For those using the NIGHTTIME product, healthcare providers should discuss the potential for excitability, particularly in children, as well as the likelihood of marked drowsiness. Patients should be cautioned that the use of alcohol, sedatives, and tranquilizers may exacerbate drowsiness associated with the NIGHTTIME product. Therefore, it is advisable to avoid alcoholic beverages while using this product.
Finally, healthcare providers should remind patients to exercise caution when driving 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 various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 25°C (77°F). Temporary excursions are permissible within the range of 15-30°C (59-86°F). Proper storage conditions are essential to maintain the integrity and efficacy of the product.
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 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 if no signs or 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.