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Acetaminophen/Phenylephrine hydrochloride/Guaifenesin
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- Active ingredients
- Acetaminophen 325 mg
- Guaifenesin 200 mg
- Phenylephrine Hydrochloride 5 mg
- Reference brand
- Sinus Relief
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Prescription status
- OTC (over the counter)
- Marketed in the U.S.
- Since 2017
- Label revision date
- December 17, 2025
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Active ingredients
- Acetaminophen 325 mg
- Guaifenesin 200 mg
- Phenylephrine Hydrochloride 5 mg
- Reference brand
- Sinus Relief
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Prescription status
- OTC (over the counter)
- CSA schedule
- Not a scheduled drug
- Marketed in the U.S.
- Since 2017
- Label revision date
- December 17, 2025
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
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Drug Overview
This medication is designed to temporarily relieve common cold symptoms such as nasal congestion, headache, minor aches and pains, sinus congestion and pressure, as well as cough, runny nose, and sneezing, particularly during nighttime. It comes in both daytime and nighttime formulations, which contain different active ingredients to address these symptoms effectively. The daytime version typically includes acetaminophen (a pain reliever), guaifenesin (an expectorant that helps loosen mucus), and phenylephrine HCl (a nasal decongestant). The nighttime formulation adds diphenhydramine HCl, which acts as an antihistamine and cough suppressant.
In addition to alleviating these symptoms, this medication promotes nasal and sinus drainage and helps thin bronchial secretions, making coughs more productive during the day. It is suitable for individuals aged 12 and older, and it is important to avoid taking the daytime and nighttime products simultaneously.
Uses
This medication is designed to temporarily relieve common cold symptoms, including nasal congestion, headaches, minor aches and pains, and sinus congestion and pressure. If you're experiencing a cough, runny nose, or sneezing, this product can help, especially at nighttime.
Additionally, it promotes nasal and sinus drainage, which can help clear your airways. During the daytime, it also works to loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive by helping to clear out bothersome mucus from your bronchial passages.
Dosage and Administration
You should take this medication as directed on the label. For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 4 hours. However, do not exceed 12 caplets in a 24-hour period. If you are under 12 years old, do not use this medication. Always follow the instructions carefully to ensure safe and effective use.
What to Avoid
You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric conditions, or Parkinson’s disease, or if you have stopped taking an MAOI within the last two weeks. Additionally, do not take the DAYTIME and NIGHTTIME products at the same time, and avoid using any other medications that contain acetaminophen (a common pain reliever) or diphenhydramine (an antihistamine), including topical forms. If you have ever had an allergic reaction to this product or any of its ingredients, do not use it. If you are unsure whether a medication contains acetaminophen or an MAOI, consult your doctor or pharmacist.
Side Effects
You should be aware of several potential side effects when using products containing acetaminophen for sinus relief. Severe liver damage can occur if you take more than 4,000 mg in 24 hours, use other medications with acetaminophen, or consume three or more alcoholic drinks daily while using these products. Additionally, acetaminophen may cause serious skin reactions, including redness, blisters, and rashes. If you experience any skin reactions, stop using the product and seek medical help immediately.
While using these medications, you may experience excitability, especially in children, and marked drowsiness, particularly with nighttime formulations. Alcohol, sedatives, and tranquilizers can increase drowsiness, so it's important to avoid these substances and use caution when driving or operating machinery. If you notice symptoms like nervousness, dizziness, worsening pain, or a cough that lasts more than seven days, or if you develop new symptoms, consult a doctor. Always check with a healthcare professional if you have pre-existing conditions such as heart disease, liver disease, or if you are taking blood thinners like warfarin.
Warnings and Precautions
This product contains acetaminophen, which can cause 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 lead to serious skin reactions, including skin reddening, blisters, or rash. If you experience any of these symptoms, 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, difficulty urinating due to prostate enlargement, or a persistent cough (especially if you have chronic bronchitis or emphysema). If you are taking blood thinners like warfarin or sedatives, check with your doctor or pharmacist before use.
Seek emergency medical help if you suspect an overdose, even if you do not notice any symptoms.
Stop using the product and call your doctor if you experience nervousness, dizziness, sleeplessness, worsening pain, nasal congestion, or cough lasting more than 7 days, fever lasting more than 3 days, redness or swelling, new symptoms, or if your cough returns with a rash or headache. These could indicate a serious condition.
Overdose
If you or someone else has taken too much of a sinus relief medication, it's important to get medical help immediately or contact a Poison Control Center at 1-800-222-1222. This is crucial for both adults and children, even if there are no noticeable signs or symptoms of an overdose.
Signs of an overdose can vary, but you should be aware that any unusual symptoms may indicate a problem. Always err on the side of caution and seek help right away if you suspect an overdose has occurred.
Pregnancy Use
If you are pregnant or breastfeeding, it is important to consult a healthcare professional before using any sinus relief medications, including tablets or film-coated forms. This precaution helps ensure the safety of both you and your baby, as some ingredients may not be suitable during pregnancy or lactation. Always prioritize your health and seek guidance from a qualified provider regarding any medications you consider taking.
Lactation Use
If you are pregnant or breastfeeding, it is important to consult a health professional before using any medication, including those for sinus pressure and pain relief. This ensures that you receive safe and appropriate care for your health and your baby's well-being. Always prioritize open communication with your healthcare provider regarding any treatments you may consider during this time.
Pediatric Use
You should not use this medication for children under 12 years old. For adults and children aged 12 years and older, the recommended dosage is 2 caplets every 4 hours. Be aware that excitability and marked drowsiness may occur, particularly at night. It's important to keep this medication out of reach of children. In case of an overdose, seek medical help or contact a Poison Control Center immediately, as prompt medical attention is crucial for both adults and children, even if no symptoms are noticeable.
Geriatric Use
You may not find specific information regarding the use of sinus medications in older adults, including dosage adjustments or safety concerns. This means that while these medications, such as those for sinus pressure and pain, are available in tablet or film-coated forms, there are no tailored guidelines for elderly patients.
As always, it's important to consult with your healthcare provider before starting any new medication, especially if you have underlying health conditions or are taking other medications. They can help ensure that the treatment is safe and appropriate for your individual health needs.
Renal Impairment
When considering sinus relief medications, it's important to be aware of certain precautions, especially if you have kidney issues. While most product labels do not provide specific information on dosage adjustments or monitoring for renal impairment, it is advised to consult with your doctor if you experience difficulty urinating, particularly if this is due to an enlarged prostate. Additionally, if you are taking the blood thinner warfarin, it's crucial to discuss this with your healthcare provider or pharmacist before using these medications.
Always remember to follow the recommended dosage and exercise caution when driving or operating machinery, especially if you have any kidney concerns. Your health and safety should always come first.
Hepatic Impairment
If you are considering using products that contain acetaminophen for sinus relief, it's important to be aware of potential liver risks. 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 these products can lead to severe liver damage.
If you have liver disease, please consult your doctor before using these medications. Your healthcare provider can help determine the safest options for you.
Drug Interactions
When using medications for sinus pressure and pain, it's crucial to be aware of potential interactions. Avoid taking any other products that contain acetaminophen, as this can lead to severe liver damage. If you're using diphenhydramine, be cautious about combining it with alcohol, sedatives, or tranquilizers, as this may increase drowsiness. Additionally, if you're on the blood thinner warfarin, consult your doctor before using these medications, as they may interact.
Always discuss your medications and any tests with your healthcare provider to ensure your safety and the effectiveness of your treatment. This is important because certain combinations can lead to serious health risks.
Storage and Handling
To ensure the effectiveness of your sinus relief tablets, store them at a temperature of 25°C (77°F). It's acceptable for the temperature to fluctuate between 15°C and 30°C (59°F to 86°F). Always check the packaging for the expiration date and lot number, which can be found on the end flap.
Please remember that these tablets are tamper evident. Do not use them if the outer package is opened or if the blister is torn or broken. For safe disposal, follow local guidelines for medication disposal, as improper disposal can harm the environment.
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).
What are the active ingredients in the daytime formulation?
The daytime formulation includes acetaminophen (pain reliever), guaifenesin (expectorant), and phenylephrine HCl (nasal decongestant).
What are the active ingredients in the nighttime formulation?
The nighttime formulation includes acetaminophen (pain reliever), diphenhydramine HCl (antihistamine/cough suppressant), and phenylephrine HCl (nasal decongestant).
How should I take this medication?
Adults and children 12 years and over should take 2 caplets every 4 hours, not exceeding 12 caplets in any 24-hour period.
Are there any contraindications for using this drug?
Do not take this drug with any other product containing acetaminophen or if you are taking a monoamine oxidase inhibitor (MAOI).
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 marked drowsiness, excitability, and severe skin reactions. If you experience nervousness, dizziness, or worsening symptoms, consult a doctor.
What should I avoid while using this product?
Do not take Daytime and Nighttime products at the same time, and avoid using with other drugs containing acetaminophen.
What are the storage instructions for this product?
Store at 25°C (77°F), with permitted excursions between 15°-30°C (59°-86°F).
Who should use this product?
This product is intended for adults and children aged 12 and over. Children under 12 years should not use it.
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).
It also temporarily promotes nasal and/or sinus drainage and helps loosen phlegm (mucus) and thin bronchial secretions, facilitating the clearance of bothersome mucus from the bronchial passageways and making coughs more productive (daytime only).
Limitations of Use
There are no teratogenic or nonteratogenic effects mentioned for this drug.
Dosage and Administration
Adults and children aged 12 years and over are instructed to take 2 caplets every 4 hours as needed. The maximum allowable dosage is 12 caplets within a 24-hour period. It is essential that patients do not exceed the recommended dosage.
Children under 12 years of age should not use this medication.
The product is available in film-coated tablet form.
Contraindications
Do not take DAYTIME and NIGHTTIME products at the same time. Use is contraindicated with any other drug containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a drug, consultation with a doctor or pharmacist is advised.
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 2 weeks after discontinuation of the MAOI. If there is uncertainty about whether a prescription drug contains an MAOI, a doctor or pharmacist should be consulted before taking this product.
Patients with a history of allergic reactions to this product or any of its ingredients should not use it. Additionally, use is contraindicated with any other product containing diphenhydramine, including topical formulations (Nighttime only).
Warnings and Precautions
Liver Warning This product contains acetaminophen. Severe liver damage may occur if the following conditions are met:
More than 4,000 mg of acetaminophen is taken in 24 hours.
Other drugs containing acetaminophen are used concurrently.
Three or more alcoholic drinks are consumed daily while using this product.
Allergy Alert Acetaminophen may cause severe skin reactions. Symptoms may include:
Skin reddening
Blisters
Rash If a skin reaction occurs, stop use and seek medical help right away.
General Precautions Consult a doctor before use if the individual has any of the following conditions:
Heart disease
Liver disease
Diabetes
Thyroid disease
High blood pressure
Difficulty in urination due to enlargement of the prostate gland
Persistent or chronic cough (e.g., smoking, asthma, chronic bronchitis, or emphysema)
Cough that occurs with excessive phlegm (mucus)
A breathing problem such as emphysema or chronic bronchitis (Nighttime only)
Glaucoma (Nighttime only)
Consult a doctor or pharmacist before use if the individual is:
Taking the blood-thinning drug warfarin
Taking sedatives or tranquilizers (Nighttime only)
Get Emergency Medical Help In case of overdose, get medical help or contact a Poison Control Center immediately. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are noticed.
Stop Taking and Call Your Doctor Stop use and consult a doctor if any of the following occur:
Nervousness, dizziness, or sleeplessness
Pain, nasal congestion, or cough worsens or lasts more than 7 days
Fever worsens or lasts more than 3 days
Redness or swelling is present
New symptoms occur
Cough returns or occurs with rash or headache that lasts These could be signs of a serious condition.
Side Effects
Severe liver damage may occur if patients exceed 4,000 mg of acetaminophen in 24 hours, use other drugs containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.
Acetaminophen may also cause severe skin reactions, which can manifest as skin reddening, blisters, or rash. If any skin reaction occurs, patients should stop use and seek medical help immediately.
Serious Adverse Reactions
Liver Damage: Risk increases with excessive dosage, concurrent use of other acetaminophen-containing products, or alcohol consumption.
Severe Skin Reactions: Symptoms include skin reddening, blisters, and rash.
Common Adverse Reactions
Drowsiness: Marked drowsiness may occur, particularly with nighttime formulations. Alcohol, sedatives, and tranquilizers may exacerbate this effect.
Excitability: This may occur, especially in children when using nighttime formulations.
Other Adverse Reactions
Patients should stop use and consult a doctor if they experience:
Nervousness, dizziness, or sleeplessness.
Worsening pain, nasal congestion, or cough lasting more than 7 days.
Fever that worsens or lasts more than 3 days.
Redness or swelling.
New symptoms or a cough that returns with a rash or headache lasting longer than usual, as these may indicate a serious condition.
Precautions
Patients should consult a doctor before use if they have:
Heart disease
Liver disease
Diabetes
Thyroid disease
High blood pressure
Difficulty urinating due to prostate enlargement
Chronic cough (e.g., from smoking, asthma, chronic bronchitis, or emphysema)
Cough with excessive phlegm
Breathing problems (e.g., emphysema or chronic bronchitis, particularly with nighttime formulations)
Glaucoma (particularly with nighttime formulations)
Additionally, patients should inform their doctor or pharmacist if they are taking:
Warfarin (a blood-thinning medication)
Sedatives or tranquilizers (especially with nighttime formulations)
Patients are advised to avoid exceeding the recommended dosage and to exercise caution when driving or operating machinery, particularly with nighttime formulations.
Drug Interactions
Taking into consideration the available data on drug interactions for products indicated for sinus pressure and pain, the following interactions have been identified:
Acetaminophen Interactions
Acetaminophen should not be used in conjunction with any other medications containing acetaminophen, as this may lead to severe liver damage. Additionally, the risk of liver damage is heightened when acetaminophen is consumed alongside three or more alcoholic drinks daily.
Diphenhydramine Interactions
Diphenhydramine may enhance drowsiness when taken with alcohol, sedatives, or tranquilizers. Caution is advised when combining diphenhydramine with these substances due to the potential for increased sedation.
Warfarin Interaction
Patients taking warfarin, a blood-thinning medication, should consult a healthcare provider before using products containing diphenhydramine, as there may be a risk of interaction.
No other drug interactions or laboratory test interactions have been reported for the products reviewed.
Pediatric Use
Children under 12 years should not use this medication. For adults and children aged 12 years and over, 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 at night. It is important 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. Prompt medical attention is critical for both adults and children, even if no signs or symptoms are observed.
Geriatric Use
No specific information regarding geriatric use, dosage adjustments, safety concerns, or special precautions for elderly patients is provided in the available labeling for the products reviewed. Therefore, healthcare professionals should exercise caution when prescribing these medications to geriatric patients, considering the potential for altered pharmacokinetics and increased sensitivity to medications in this population. Regular monitoring and assessment of therapeutic response and adverse effects are recommended for elderly patients receiving these treatments.
Pregnancy
Pregnant patients should consult a healthcare professional before using any sinus relief medications, including those in tablet or film-coated forms. This recommendation applies to all products listed, as there is insufficient data regarding the safety of these medications during pregnancy and breastfeeding. The potential risks to fetal outcomes have not been established, and therefore, caution is advised. Healthcare providers should evaluate the benefits and risks on a case-by-case basis when considering treatment options for pregnant patients experiencing sinus pressure and pain.
Lactation
Lactating mothers are advised to consult a healthcare professional before using any medications for sinus pressure and pain, including those in tablet or film-coated forms. There is no specific data provided regarding the excretion of these medications in breast milk or their effects on breastfed infants. Therefore, caution is recommended to ensure the safety and well-being of both the mother and the infant during lactation.
Renal Impairment
Patients with renal impairment should exercise caution when using the medications listed, as specific information regarding dosage adjustments, monitoring, or safety considerations for this population is not provided in the drug inserts.
It is advised that patients consult a healthcare professional before use, particularly if they experience difficulty in urination due to prostate gland enlargement. Additionally, patients taking anticoagulants such as warfarin should seek guidance from a doctor or pharmacist prior to using these products.
While no explicit dosing modifications are outlined for patients with reduced kidney function, it is prudent for these individuals to be cautious, especially when engaging in activities that require alertness, such as driving or operating machinery. Adhering to the recommended dosage is essential to minimize potential risks.
Hepatic Impairment
Patients with hepatic impairment should be aware of the following important considerations when using products containing acetaminophen. Severe liver damage may occur if the total daily dosage exceeds 4,000 mg, if used concurrently with other medications containing acetaminophen, or if three or more alcoholic drinks are consumed daily while using these products.
It is essential for patients with liver disease to consult a healthcare professional before using these medications. Monitoring of liver function may be warranted, although specific lab values or monitoring parameters are not detailed in the available information. Caution is advised to prevent potential hepatotoxicity.
Overdosage
In the event of an overdose, it is imperative to seek medical assistance immediately or contact a Poison Control Center. The national hotline for Poison Control is 1-800-222-1222. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are initially observed.
Symptoms of overdose may vary, but it is essential to monitor for any unusual reactions or changes in condition. Due to the potential severity of an overdose, healthcare professionals should be notified without delay to ensure appropriate management and intervention.
Nonclinical Toxicology
Teratogenic Effects
If pregnant or breast-feeding, it is advised to consult a health professional before use.
Non-Teratogenic Effects
No specific non-teratogenic effects are mentioned in the available data.
Nonclinical Toxicology
No specific nonclinical toxicology details are provided in the available data.
Animal Pharmacology and Toxicology
No specific animal pharmacology and toxicology details are mentioned in the available data.
Storage and Handling
The product is supplied in tablet form, specifically as film-coated tablets. It is available under various labels, including Daytime Nighttime Sinus Relief, Sinus Relief, Sinus Pressure and Pain, and Day and Night Sinus.
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).
Each package is tamper evident; therefore, it should not be used if the outer package is opened or if the blister is torn or broken. Users are advised to check the end flap of the packaging for the expiration date and lot number to ensure product integrity and safety.
Product Labels
The table below lists all over-the-counter labels containing acetaminophen, phenylephrine hydrochloride, and guaifenesin. Use it to compare dosage forms, strengths, and uses across products.
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Wal-Mart Stores Inc | Tablet, Film Coated | Oral |
| 2020 | |
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Target Corporation | Tablet, Film Coated | Oral |
| 2025 | |
Indications
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Target Corporation | Tablet, Film Coated | Oral |
| 2024 | |
Indications
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Target Corporation | Tablet, Film Coated | Oral |
| 2017 | |
Indications
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Walgreen Company | Tablet, Film Coated | Oral |
| 2018 | |
Indications
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Walgreen Company | Tablet, Film Coated | Oral |
| 2018 | |
Indications
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CVS PHARMACY | Tablet, Film Coated | Oral |
| 2017 | |
Indications
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Kroger Company | Tablet, Film Coated | Oral |
| 2021 | |
Indications
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Rite Aid Corporation | Tablet, Film Coated | Oral |
| 2017 | |
Indications
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