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Sinus Pressure, Pain and Cough

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Active ingredients
  • Acetaminophen 325 mg
  • Guaifenesin 200 mg
  • Dextromethorphan Hydrobromide 10 mg
  • Phenylephrine Hydrochloride 5 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
Dosage form
Tablet, Film Coated
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2022
Label revision date
February 25, 2026
Active ingredients
  • Acetaminophen 325 mg
  • Guaifenesin 200 mg
  • Dextromethorphan Hydrobromide 10 mg
  • Phenylephrine Hydrochloride 5 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist, alpha-1 Adrenergic Agonist
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 2022
Label revision date
February 25, 2026
Manufacturer
Walgreen Company
Registration number
M012
NDC root
0363-6171

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Drug Overview

Sinus Pressure, Pain & Cough is a medication designed to provide temporary relief from symptoms associated with the common cold, including nasal congestion, headache, sinus pressure, minor aches and pains, and cough. It works by combining several active ingredients: acetaminophen (a pain reliever), dextromethorphan HBr (a cough suppressant), guaifenesin (an expectorant that helps loosen mucus), and phenylephrine HCl (a nasal decongestant). Together, these components help to promote sinus drainage, relieve discomfort, and make coughs more productive by thinning bronchial secretions.

This maximum strength formulation is recommended by Walgreens pharmacists and is intended to help you feel more comfortable when dealing with cold symptoms. Each package contains 20 caplets, making it easy to manage your symptoms effectively.

Uses

This medication is designed to help you feel better when you're dealing with common cold symptoms. It temporarily relieves nasal congestion, headaches, and sinus pressure, making it easier for you to breathe and feel comfortable. If you're experiencing minor aches and pains or a cough due to a cold, this medication can also provide relief.

Additionally, it works to loosen phlegm (mucus) and thin bronchial secretions, which helps clear out your bronchial passageways. This can make your coughs more productive, allowing you to expel bothersome mucus more effectively. If you're feeling congested, this medication can also promote drainage in your nasal passages and sinuses, helping you breathe easier.

Dosage and Administration

It's important to follow the dosage instructions carefully to ensure your safety and effectiveness of the medication. 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 remember to take only the directed amount to avoid any potential risks.

What to Avoid

You should avoid using this product if you are currently taking any other medication that contains acetaminophen, whether it's a prescription or over-the-counter drug. If you're unsure whether a medication includes acetaminophen, please consult your doctor or pharmacist. Additionally, do not use this product if you are 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. Again, if you're uncertain about your medications, it's best to ask a healthcare professional.

It's also important not to use this product if you have ever experienced an allergic reaction to it or any of its ingredients. Your safety is paramount, so please follow these guidelines closely.

Side Effects

You should be aware that this product contains acetaminophen, which can lead to severe liver damage if you exceed 4,000 mg in a 24-hour period, take it with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using it. Additionally, acetaminophen may cause serious skin reactions, such as blisters, rash, or skin reddening. If you notice any skin reactions, stop using the product and seek medical help immediately.

It's important to stop using this product and consult a doctor if you experience nervousness, dizziness, or sleeplessness. You should also reach out to a healthcare professional 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 redness or swelling. New symptoms or a cough that returns with a rash or headache could indicate a serious condition, so please take these signs seriously.

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 medications containing acetaminophen, or consume three or more alcoholic drinks daily while using it. Be aware that acetaminophen may also cause serious skin reactions, such as blisters, rash, or skin reddening. 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, diabetes, thyroid disease, chronic cough (like from smoking or asthma), liver disease, high blood pressure, or difficulty urinating due to an enlarged prostate. If you are taking the blood thinner warfarin, check with your doctor or pharmacist before use. If you suspect an overdose, seek emergency medical help or contact a Poison Control Center right away, even if you don’t notice any symptoms.

You should stop using this 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; if you notice redness or swelling; if new symptoms develop; or if your cough returns with a rash or headache that lasts. These could indicate a more serious condition.

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, but you should not exceed 12 caplets in a 24-hour period.

In the event of an overdose, it is crucial to seek medical help immediately or contact a Poison Control Center. Quick medical attention is essential for both adults and children, even if there are no noticeable signs or symptoms. Always prioritize safety and follow these guidelines closely.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially considering potential changes in how the body processes drugs as we age.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your doctor 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 your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition 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 it alongside 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 talk to your doctor or pharmacist before using this medication, especially if you are taking warfarin, a blood-thinning drug. Combining these medications can increase the risk of bleeding, so your healthcare provider can help ensure your safety by managing your medications appropriately. Always keep an open line of communication about any other medications or supplements you are taking to avoid potential interactions.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature, ideally around 25°C (77°F). It can safely be kept within a range of 15°-30°C (59°-86°F). Always check the end flap for the expiration date and lot number to confirm its validity.

When handling the product, be cautious: do not use it if the outer package is opened or if the blister (the sealed compartment holding the product) is torn or broken. This tamper-evident feature is crucial for your safety, so always inspect the packaging before use.

Additional Information

If you are considering using this medication, it is important to take it orally as directed. If you are pregnant or breastfeeding, be sure to consult a healthcare professional before using it. In the event of an overdose, seek medical help immediately or contact a Poison Control Center, as quick action is crucial for both adults and children, even if there are no noticeable symptoms.

Additionally, if you want to learn more about the potential for medicine abuse among teens, you can visit www.StopMedicineAbuse.org for more information.

FAQ

What is Sinus Pressure, Pain & Cough used for?

Sinus Pressure, Pain & Cough temporarily relieves nasal congestion, headache, sinus congestion and pressure, minor aches and pains, and cough due to the common cold.

What are the active ingredients in Sinus Pressure, Pain & Cough?

The active ingredients include acetaminophen (pain reliever), dextromethorphan HBr (cough suppressant), guaifenesin (expectorant), and phenylephrine HCl (nasal decongestant).

How should I take Sinus Pressure, Pain & Cough?

Adults and children 12 years and over should take 2 caplets every 4 hours, not exceeding 12 caplets in a 24-hour period. Do not use if you are under 12 years old.

Are there any warnings associated with this medication?

Yes, this product contains acetaminophen, which can cause severe liver damage if taken in excess of 4,000 mg in 24 hours or with other acetaminophen-containing drugs.

What should I do if I experience an allergic reaction?

If you experience symptoms like blisters, rash, or skin reddening, stop use immediately and seek medical help.

Can I use Sinus Pressure, Pain & Cough if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using this product.

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.

Are there any contraindications for using this medication?

Do not use this product if you are taking a prescription monoamine oxidase inhibitor (MAOI) or if you have had an allergic reaction to it or any of its ingredients.

What are the storage instructions for Sinus Pressure, Pain & Cough?

Store at 25°C (77°F), with permitted excursions between 15°-30°C (59°-86°F).

Packaging Info

Below are the non-prescription pack sizes of Sinus Pressure, Pain and Cough (acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sinus Pressure, Pain and Cough.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of nasal congestion, headache, sinus congestion and pressure, minor aches and pains, and cough associated with the common cold. It also aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating the clearance of mucus from the bronchial passageways and making coughs more productive. Additionally, this drug temporarily promotes nasal and/or sinus drainage.

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 understand the importance of not exceeding the directed dosage to avoid potential adverse effects.

Contraindications

Use of this product is contraindicated in the following situations:

  • Concurrent use 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.

  • In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such treatment. MAOIs are used for certain psychiatric or emotional conditions and Parkinson’s disease, and their interaction with this product may lead to serious adverse effects. Verify with a healthcare professional if there is uncertainty regarding MAOI status.

  • In individuals with a history of allergic reactions to this product or any of its components, as this may result in severe allergic responses.

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:

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

  • Concurrent use with other medications that contain acetaminophen.

  • Consumption of three or more alcoholic beverages daily while using this product.

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

General precautions should be taken for patients with specific health conditions. Healthcare providers should recommend that patients consult a physician prior to use if they have:

  • Heart disease

  • Diabetes

  • Thyroid disease

  • A persistent or chronic cough, particularly in cases of smoking, asthma, chronic bronchitis, or emphysema

  • Liver disease

  • High blood pressure

  • A cough accompanied by excessive phlegm (mucus)

  • Difficulty urinating due to prostate gland enlargement

Furthermore, patients taking the anticoagulant warfarin should consult with a healthcare professional or pharmacist before using this product.

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 persistent headache, as these may indicate a serious underlying condition.

Side Effects

Patients using this product should be aware of potential adverse reactions, particularly those related to liver health and allergic responses.

Severe liver damage may occur if patients exceed 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, there is an allergy alert associated with acetaminophen, which may lead to severe skin reactions. Symptoms of such reactions can include blisters, rash, and skin reddening. If any of these symptoms occur, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be instructed to stop using the product 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 seven days, fever that worsens or persists beyond three days, 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. These symptoms may indicate a serious underlying condition that requires medical evaluation.

Drug Interactions

Patients taking warfarin, a blood-thinning medication, should consult with a healthcare professional prior to using this drug. The interaction between this drug and warfarin may necessitate careful monitoring of coagulation parameters to ensure therapeutic efficacy and minimize the risk of bleeding complications. Adjustments to the dosage of either medication may be required based on clinical judgment and patient response.

Packaging & NDC

Below are the non-prescription pack sizes of Sinus Pressure, Pain and Cough (acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sinus Pressure, Pain and Cough.
Details

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, with a maximum dosage not exceeding 12 caplets in a 24-hour period. In the event of an overdose, it is essential to seek medical assistance or contact a Poison Control Center immediately, as prompt medical 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, 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 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 the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

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 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 patients 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 for patients to adhere to the following guidelines to minimize the risk of hepatotoxicity:

  • Patients should not exceed a maximum dosage of 4,000 mg of acetaminophen within a 24-hour period.

  • Concurrent use with other medications containing acetaminophen is contraindicated, as this may lead to unintentional overdose and increased risk of liver injury.

  • Consumption of three or more alcoholic drinks daily while using this product is not recommended, as it may exacerbate the potential for liver damage.

Additionally, patients with a known history of liver disease are advised to consult a healthcare professional prior to using this product to ensure safe and appropriate use. Regular monitoring of liver function may be warranted in patients with compromised liver function to detect any potential adverse effects promptly.

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 should be aware that the absence of symptoms does not preclude the possibility of serious complications. 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 data. Additionally, there is no information regarding nonclinical toxicology or animal pharmacology and toxicology provided in the insert.

Postmarketing Experience

Postmarketing experience has indicated that acetaminophen may be associated with severe skin reactions. These reactions can manifest as symptoms including blisters, rash, and skin reddening. In the event of a skin reaction, it is recommended that the use of acetaminophen be discontinued immediately and medical assistance be sought.

Patient Counseling

Healthcare providers should advise patients on the importance of seeking immediate medical assistance in the event of an overdose. Patients should be informed to contact a Poison Control Center or seek medical help right away, regardless of whether they observe any signs or symptoms. It is crucial for both adults and children to receive prompt medical attention in such situations to ensure their safety and well-being.

Storage and Handling

The product is supplied in a tamper-evident package. It is essential to refrain from using the product 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°-30°C (59°-86°F). For optimal integrity, it is advised to check the end flap for the expiration date and lot number prior to use.

Additional Clinical Information

Patients should be informed that the medication is administered orally. Clinicians are advised to counsel patients regarding the importance of consulting a health professional if they are pregnant or breastfeeding before using the medication. In the event of an overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center, as prompt attention is essential for both adults and children, even if no symptoms are apparent.

Additionally, clinicians should be aware of the potential for medicine abuse among teens and can refer to www.StopMedicineAbuse.org for further information. No further details are available regarding laboratory tests or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Sinus Pressure, Pain and Cough, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.