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Severe Congestion Relief

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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
Capsule, Liquid Filled
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
January 19, 2026
Drug Information (PDF)
Prescribing information, PDF file
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
Capsule, Liquid Filled
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 2021
Label revision date
January 19, 2026
Manufacturer
Walgreens
Registration number
M012
NDC root
0363-9018
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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 provide temporary relief from various symptoms associated with colds, allergies, or sinus issues. It helps relieve nasal congestion, headaches, minor aches and pains, sinus congestion and pressure, and cough. Additionally, it promotes nasal and sinus drainage and helps loosen phlegm (mucus), making coughs more productive by thinning bronchial secretions.

By addressing these symptoms, this medication can help you feel more comfortable and improve your ability to breathe and function throughout the day.

Uses

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

In addition, it helps alleviate sinus congestion and pressure, which can be uncomfortable. If you're dealing with a cough, this medication works to promote nasal and sinus drainage, helping to loosen phlegm (mucus) and thin bronchial secretions. This makes your cough more productive, allowing you to clear out bothersome mucus from your airways.

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 softgels every 4 hours as needed. However, make sure not to exceed 12 softgels in a 24-hour period.

If you are caring for children under 12 years of age, please do not use this medication for them. Always remember to stick to the recommended dosage to avoid any potential overdose, which can be serious. If you have any questions or concerns about how to take this medication, consult with a healthcare professional.

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 contains acetaminophen, please consult your doctor or pharmacist. Additionally, do not use this product if you are taking a prescription monoamine oxidase inhibitor (MAOI) for conditions like depression or Parkinson's disease, or for two weeks after stopping an MAOI. Again, if you're uncertain about your medications, it's best to ask a healthcare professional.

It's also important to follow the dosing instructions carefully and not exceed the recommended amount when using this product. Taking more than directed can lead to serious health risks. Always prioritize your safety by checking with a healthcare provider if you have any questions or concerns.

Side Effects

You should be aware that taking more than 12 softgels in 24 hours, using other medications with acetaminophen, or consuming three or more alcoholic drinks daily while using this product can lead to severe liver damage. Additionally, acetaminophen may cause serious skin reactions, which can include symptoms like skin reddening, blisters, or rash. If you experience any of these skin reactions, stop using the product and seek medical help immediately.

It's important to stop using the product and consult a doctor if you experience nervousness, dizziness, or sleeplessness, if your pain, nasal congestion, or cough worsens or lasts more than seven days, or if your fever worsens or lasts more than three days. Redness or swelling, new symptoms, or a cough that returns with a rash or headache that lasts are also reasons to seek medical advice, as these could indicate a serious condition. Remember, taking more than the recommended dose can lead to serious health issues, so if you suspect an overdose, seek medical help or contact a Poison Control Center right away.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you exceed 12 softgels in 24 hours, take 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 of these symptoms, stop using the product and seek medical help immediately. In case of overdose, it's crucial to get medical assistance or contact a Poison Control Center right away, even if you don't notice any symptoms.

Before using this product, consult your doctor if you have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to an enlarged prostate, or a persistent cough. If you are taking the blood thinner warfarin, check with your doctor or pharmacist before use. Always follow the recommended dosage and do not exceed it. If you experience nervousness, dizziness, sleeplessness, worsening pain, nasal congestion, or cough lasting more than seven days, or if your fever worsens or lasts more than three days, stop taking the product and contact your doctor. New symptoms or a cough that returns with a rash or headache should also prompt a call to your healthcare provider, as these may indicate a serious condition.

Overdose

Taking more of this medication than directed can lead to serious health issues. If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center. Quick medical attention is crucial for both adults and children, even if you don’t see any signs or symptoms of an overdose.

Be aware that signs of an overdose can vary, but it’s always better to err on the side of caution. If you or someone else has taken too much, don’t wait for symptoms to appear—get help right away.

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, please note that it is not recommended for children under 12 years of age. For those aged 12 and older, the typical dosage is 2 softgels every 4 hours.

It's important to be aware of the overdose warning: if you suspect an overdose, seek medical help immediately, even if your child does not show any signs or symptoms. Always prioritize safety and consult with a healthcare professional if you have any questions or concerns about using this medication.

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, it’s important to consult with a healthcare provider before starting the medication. 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 consult your doctor before using this medication, especially if you experience difficulty urinating due to an enlarged prostate gland. Your healthcare provider can help determine if this medication is safe for you and may suggest adjustments to your dosage or monitoring based on your kidney function. Always prioritize open communication with your doctor regarding your kidney health and any medications you are considering.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using this product, which contains acetaminophen. To avoid severe liver damage, do not exceed 12 softgels in a 24-hour period, and be careful not to take other medications that also contain acetaminophen. Additionally, limit your alcohol intake to fewer than three drinks per day while using this product, as drinking more can increase the risk of liver damage.

Before using this product, please consult your doctor if you have liver disease. They can provide guidance tailored to your specific health needs and help ensure your safety while using this medication.

Drug Interactions

It's important to be aware that certain medications can interact with each other, potentially affecting how they work in your body. For instance, if you take acetaminophen (a common pain reliever) along with warfarin (a blood thinner), it may enhance the effects of warfarin, which could increase your risk of bleeding. If you are using both, your healthcare provider may want to monitor your INR (a blood test that measures how long it takes your blood to clot) more closely to ensure your safety.

Always discuss any medications you are taking with your healthcare provider, including over-the-counter drugs like acetaminophen. This conversation is crucial to avoid any harmful interactions and to ensure that your treatment is as effective and safe as possible.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20-25°C (68-77°F). It's important to avoid exposing it to excessive heat, as this can affect its effectiveness and safety.

When handling the product, always do so with care to maintain its integrity. Following these simple storage and handling guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally, with the recommended dosage for adults and children aged 12 years and older being 2 softgels every 4 hours. It's important to follow this guideline to ensure safe and effective use. If you have any questions or concerns about your treatment, be sure to consult with your healthcare provider.

FAQ

What symptoms does this drug temporarily relieve?

This drug temporarily relieves nasal congestion, headache, minor aches and pains, sinus congestion and pressure, and cough.

How should adults and children 12 years and over take this drug?

Adults and children 12 years and over should take 2 softgels every 4 hours.

What is the maximum number of softgels I can take in 24 hours?

You should not take more than 12 softgels in any 24-hour period.

Are there any contraindications for using this drug?

Do not use this drug with any other drug containing acetaminophen or if you are taking a prescription monoamine oxidase inhibitor (MAOI).

What should I do in case of overdose?

In case of overdose, get medical help or contact a Poison Control Center right away.

What are the liver warnings associated with this drug?

Severe liver damage may occur if you take more than 12 softgels in 24 hours, with other drugs containing acetaminophen, or if you consume 3 or more alcoholic drinks daily while using this product.

What should I do if I experience a skin reaction?

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

Can I use this drug if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

What should I do if my symptoms worsen or new symptoms occur?

Stop use and ask a doctor if your pain, nasal congestion, or cough worsens or lasts more than 7 days, or if new symptoms occur.

What precautions should I take if I have certain health conditions?

Ask a doctor before use if you have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or trouble urinating due to an enlarged prostate gland.

Packaging Info

Below are the non-prescription pack sizes of Severe Congestion Relief (acetaminophen, guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Severe Congestion Relief.
Details

Drug Information (PDF)

This file contains official product information for Severe Congestion Relief, 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, minor aches and pains, sinus congestion and pressure, and cough. It promotes nasal and/or sinus drainage and helps to loosen phlegm (mucus) and thin bronchial secretions, facilitating the clearance of bothersome mucus and enhancing the productivity of coughs.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should adhere strictly to the recommended dosage to avoid the risk of overdose. The maximum allowable dosage is 12 softgels within a 24-hour period.

For adults and children aged 12 years and older, the recommended dosage is 2 softgels every 4 hours as needed. It is imperative that patients do not exceed the specified dosage within the 24-hour timeframe.

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

Contraindications

Use of this product is contraindicated in the following situations:

  • Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

  • Concurrent use with prescription monoamine oxidase inhibitors (MAOIs), which are utilized for the treatment of depression, psychiatric or emotional conditions, or Parkinson's disease, is contraindicated. This includes a prohibition on use for a period of 2 weeks following the discontinuation of an MAOI. If there is uncertainty about whether a prescription drug contains an MAOI, a healthcare professional should be consulted prior to use.

  • It is also advised to adhere strictly to the recommended dosage and not exceed the directed amount while using this product.

Warnings and Precautions

This product contains acetaminophen, which poses a risk of severe liver damage if the following conditions are met: exceeding 12 softgels within a 24-hour period, using concurrently with other medications containing acetaminophen, or consuming three or more alcoholic drinks daily while using this product.

Acetaminophen may also lead to severe skin reactions, which can manifest as skin reddening, blisters, or rash. Should any of these symptoms occur, it is imperative to discontinue use immediately and seek medical assistance.

Taking more than the recommended dosage can result in serious health complications. In the event of an overdose, it is crucial to obtain medical help or contact a Poison Control Center without delay, as prompt medical attention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

General precautions should be observed prior to use. Individuals with the following conditions should consult a healthcare professional: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a cough associated with excessive phlegm. Additionally, those with a persistent or chronic cough, such as that caused by smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice. It is also advisable to consult a doctor or pharmacist if taking the anticoagulant warfarin. Users must adhere strictly to the recommended dosage and avoid exceeding it.

Patients should discontinue use and contact a healthcare provider if they experience nervousness, dizziness, or sleeplessness; if pain, nasal congestion, or cough worsens or persists beyond seven days; if fever intensifies or lasts more than three days; if redness or swelling occurs; if new symptoms arise; or if a cough recurs alongside a rash or headache that persists. These symptoms may indicate a serious underlying condition.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 12 softgels within a 24-hour period, take the product in conjunction with other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Participants are advised to stop use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. Additionally, worsening pain, nasal congestion, or cough lasting more than seven days, fever that worsens or persists beyond three days, 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 longer than expected may indicate a serious condition requiring medical evaluation.

Patients should also be cautioned about the risks associated with overdose. Taking more than the directed amount can lead to serious health complications. In the event of an overdose, it is crucial to seek medical help or contact a Poison Control Center immediately, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Acetaminophen has been observed to enhance the anticoagulant effects of warfarin, which may result in an elevated risk of bleeding complications. It is recommended that the International Normalized Ratio (INR) be monitored closely in patients receiving both acetaminophen and warfarin to ensure safe therapeutic levels and to mitigate the risk of adverse effects.

No additional drug interactions or interactions with laboratory tests have been reported.

Packaging & NDC

Below are the non-prescription pack sizes of Severe Congestion Relief (acetaminophen, guaifenesin, dextromethorphan hydrobromide, and phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Severe Congestion Relief.
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 softgels every 4 hours.

Healthcare professionals should be aware of the critical need for quick medical attention in cases of overdose, as this is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data regarding the excretion of this drug 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 should consult a healthcare professional prior to use, particularly if they experience difficulties with urination due to an enlarged prostate gland. It is essential to assess renal function and consider any necessary dosing adjustments or monitoring to ensure safe and effective use of the medication in this population.

Hepatic Impairment

Patients with hepatic impairment should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 12 softgels within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this may further increase the risk of liver injury.

It is also advised that patients with compromised liver function refrain from consuming three or more alcoholic drinks daily while using this product, as alcohol can exacerbate the potential for liver damage.

Before initiating treatment, patients with a history of liver disease should consult a healthcare professional to assess the appropriateness of this product for their condition. Regular monitoring of liver function may be warranted in these patients to ensure safety and efficacy during treatment.

Overdosage

In cases of overdosage, the ingestion of amounts exceeding the recommended dosage can lead to significant health complications. It is imperative that individuals 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 observable signs or symptoms of overdose.

Healthcare professionals should be aware that the severity of symptoms may vary, and vigilance is necessary to monitor for any potential adverse effects. The importance of rapid response cannot be overstated, as timely treatment can mitigate serious health risks associated with overdosage.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: severe skin reactions, which may present as skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use and seek medical assistance promptly.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. Patients should be instructed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

It is important to inform patients that they should not use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. Patients should be advised to check with their healthcare provider if they are unsure whether their prescription medication contains an MAOI.

Patients should be instructed to discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Additionally, they should stop using the product and consult a doctor if pain, nasal congestion, or cough worsens or persists for more than seven days, if fever worsens or lasts more than three days, or if they notice any redness or swelling. Patients should also be advised to seek medical attention if new symptoms arise or if a cough returns or occurs alongside a rash or persistent headache, as these may indicate a serious condition.

When using this product, patients must be reminded not to exceed the recommended dosage. It is essential for patients to consult a doctor before using this medication if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Patients should also be advised to seek medical advice if they have a cough that produces excessive phlegm or if they have a persistent or chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema. Furthermore, patients taking the blood-thinning medication warfarin should be encouraged to consult a doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a temperature range of 20-25°C (68-77°F) to maintain its efficacy. Care should be taken to avoid exposure to excessive heat, as this may compromise the integrity of the product. Proper storage conditions are crucial for ensuring the quality and safety of the product throughout its shelf life.

Additional Clinical Information

The medication is administered orally, with the recommended dosage for adults and children aged 12 years and older being two softgels every four hours. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Severe Congestion Relief, 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 Severe Congestion Relief, 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.

Learn more in our Editorial Policy

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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.