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Alka-Seltzer Plus Severe Sinus Cold and Cough

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Active ingredients
  • Acetaminophen 250 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 2015
Label revision date
December 4, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Acetaminophen 250 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 2015
Label revision date
December 4, 2025
Manufacturer
Bayer HealthCare LLC.
Registration number
M013
NDC root
0280-0507
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 temporarily relieve symptoms associated with a cold, such as nasal congestion, sinus pressure, headaches, minor aches and pains, cough, and sore throat. It works by restoring freer breathing through the nose and helps to loosen phlegm (mucus) and thin bronchial secretions, making coughs more productive. Additionally, it can temporarily reduce fever, providing you with some comfort while you recover.

Uses

This medication is designed to help you feel better when you're suffering from a cold. It temporarily relieves symptoms such as nasal congestion, sinus pressure, headaches, minor aches and pains, cough, and sore throat. By restoring freer breathing through your nose, it can make it easier for you to breathe comfortably.

Additionally, this medication helps to loosen phlegm (mucus) and thin bronchial secretions, which can clear out your bronchial passageways and make your coughs more productive. It also temporarily reduces fever, helping you feel more comfortable while you recover.

Dosage and Administration

It's important to follow the recommended dosage when taking this medication. For adults and children aged 12 years and older, you should take 2 capsules with a glass of water every 4 hours. However, make sure not to exceed 12 capsules in a 24-hour period unless directed by your doctor.

If you have children under 12 years old, this medication is not suitable for them, so please do not use it for that age group. Always remember to stick to the guidelines to ensure your safety and effectiveness of the treatment.

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 about a medication, it's best to consult with your doctor or pharmacist. Additionally, do not use this product if you are taking a prescription monoamine oxidase inhibitor (MAOI) for depression or other conditions, or if you have stopped taking an MAOI within the last two weeks. It's also important to avoid this product if you have had an allergic reaction to it or any of its ingredients, and it should not be given to children under 12 years of age.

While using this product, make sure to follow the recommended dosage and never exceed it. Be aware that misuse or abuse of this product can lead to dependence (a condition where your body becomes reliant on a substance) and other serious health issues. Always prioritize your safety and well-being by adhering to these guidelines.

Side Effects

You should be aware that this product contains acetaminophen, which can lead to severe liver damage if you exceed the maximum daily limit of 12 capsules, take it with other acetaminophen-containing medications, or consume three or more alcoholic drinks daily while using it. Additionally, acetaminophen may cause serious allergic reactions, including severe skin reactions. Symptoms to watch for include skin reddening, blisters, rash, hives, facial swelling, wheezing, or shock. If you experience any of these symptoms, stop using the product and seek medical help immediately.

It's important to consult a doctor if your sore throat is severe, lasts more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting. You should also stop using the product and seek medical advice if your pain, cough, or nasal congestion worsens or lasts more than seven days, if your fever worsens or lasts more than three days, or if you notice any new symptoms. Be cautious if you experience nervousness, dizziness, or sleeplessness, as these may indicate a need for medical attention.

Warnings and Precautions

This product contains acetaminophen, which can lead to severe liver damage if you take more than 12 capsules 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 or allergic reactions, such as skin reddening, blisters, rash, hives, facial swelling, wheezing, or shock. If you experience any of these symptoms, stop using the product and seek medical help immediately.

If you have a sore throat that is severe, lasts more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, consult your doctor promptly. Additionally, stop using the product and contact your doctor if your pain, cough, or nasal congestion worsens or lasts more than seven days, if your fever worsens or lasts more than three days, or if you notice any new symptoms. Nervousness, dizziness, or sleeplessness are also reasons to reach out to your healthcare provider.

In case of an overdose, it is crucial to get emergency medical help or contact a Poison Control Center right away, even if you do not notice any signs or symptoms. Quick medical attention is essential for both adults and children.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, you should contact your local emergency services or go to the nearest hospital right away. Always keep the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, it's better to be safe and get checked out if you have any concerns about an overdose.

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

It's important to know that this medication should not be given to children under 12 years of age. For those aged 12 and older, the recommended dosage is 2 capsules taken with water every 4 hours, but you should not exceed 12 capsules in a 24-hour period unless directed by a doctor.

Always keep this medication out of reach of children. In the event of an overdose, seek medical help immediately or contact a Poison Control Center. Quick medical attention is crucial for both adults and children, even if there are no noticeable signs or symptoms.

Geriatric Use

When it comes to using this medication in older adults, there are no specific guidelines about adjusting the dosage or any unique safety concerns. This means that, while the medication can be used, it’s important for you or your caregiver to monitor for any side effects or changes in your health. Always consult with your healthcare provider to ensure that this medication is appropriate for your individual needs, especially if you have other health conditions or are taking other medications.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to be cautious when using this product, as it contains acetaminophen. Taking more than 12 capsules in a 24-hour period can lead to severe liver damage, which is the maximum daily amount recommended. Additionally, avoid using other medications that also contain acetaminophen, as this can increase the risk of liver injury.

If you consume three or more alcoholic drinks daily, you should also refrain from using this product, as combining alcohol with acetaminophen can further harm your liver. Always consult with your healthcare provider for personalized advice and to ensure your safety while using this medication.

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. This is crucial because combining certain medications can affect how well they work or increase the risk of side effects.

Since there are no specific drug interactions or laboratory test interactions listed, it’s still a good practice to keep your healthcare provider informed about all the medications and supplements you are taking. This way, they can help ensure your treatment is safe and effective.

Storage and Handling

To ensure the best performance and safety of your product, store it at a temperature between 15-25ºC (59-77ºF). This temperature range helps maintain the integrity of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

No further information is available.

FAQ

What symptoms does this drug relieve?

This drug temporarily relieves symptoms due to a cold, including nasal congestion, sinus congestion and pressure, headache, minor aches and pains, cough, and sore throat.

How does this drug help with breathing?

It temporarily restores freer breathing through the nose and helps loosen phlegm (mucus) to make coughs more productive.

What is the recommended dosage for adults and children over 12?

Adults and children 12 years and over should take 2 capsules with water every 4 hours, not exceeding 12 capsules in 24 hours.

Are there any contraindications for this drug?

Do not use 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 it or its ingredients.

What should I do if I experience severe allergic reactions?

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

What should I do if my symptoms worsen?

Stop use and consult a doctor if pain, cough, or nasal congestion worsens or lasts more than 7 days, or if fever lasts more than 3 days.

Is this drug safe for children under 12?

No, this drug should not be used in children under 12 years of age.

What should I do in case of overdose?

In case of overdose, get medical help or contact a Poison Control Center right away, as quick medical attention is critical.

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

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

What are the storage instructions for this drug?

Store the drug at 15-25ºC (59-77ºF).

Packaging Info

Below are the non-prescription pack sizes of Alka-Seltzer Plus Severe Sinus Cold and Cough (acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Alka-Seltzer Plus Severe Sinus Cold and Cough.
Details

Drug Information (PDF)

This file contains official product information for Alka-Seltzer Plus Severe Sinus Cold 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 symptoms associated with the common cold, including nasal congestion, sinus congestion and pressure, headache, minor aches and pains, cough, and sore throat. It temporarily restores freer breathing through the nose and assists in loosening phlegm (mucus) and thinning bronchial secretions, thereby facilitating the clearance of bothersome mucus and enhancing the productivity of coughs. Additionally, this drug temporarily reduces fever.

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

Dosage and Administration

Adults and children aged 12 years and over are advised to take 2 capsules with water every 4 hours as needed. The total daily dosage must not exceed 12 capsules within a 24-hour period, unless otherwise directed by a healthcare professional.

Use of this medication is not recommended for children under 12 years of age. It is imperative that patients adhere to the recommended dosage and not exceed the specified limits 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.

  • In patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication, as this may lead to serious drug interactions.

  • In individuals with a history of allergic reactions to this product or any of its ingredients, to prevent potential anaphylactic reactions.

  • In children under 12 years of age, due to safety concerns and lack of efficacy data in this population.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks for liver damage. Healthcare professionals should advise patients that severe liver injury may occur if they exceed 12 capsules within a 24-hour period, which is the maximum daily dosage. Additionally, the risk increases if the product is taken concurrently with other medications containing acetaminophen or if the patient consumes three or more alcoholic beverages daily while using this product.

Patients should be made aware of the potential for severe allergic reactions associated with acetaminophen. Symptoms indicative of such reactions may include skin reddening, blisters, rash, hives, facial swelling, wheezing, and shock. In the event of any skin or general allergic reaction, patients must discontinue use immediately and seek medical assistance.

A specific warning is warranted for patients experiencing a severe sore throat. If the sore throat persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, it is imperative that they consult a healthcare provider without delay.

Healthcare professionals should instruct patients to stop using the product and seek medical advice if any of the following occur:

  • Pain, cough, or nasal congestion worsens or lasts longer than seven days.

  • Fever worsens or persists for more than three days.

  • Redness or swelling develops.

  • New symptoms arise.

  • Cough recurs or is accompanied by fever, rash, or headache lasting longer than expected, as these may indicate a serious underlying condition.

  • Symptoms of nervousness, dizziness, or sleeplessness manifest.

In cases of overdose, immediate medical attention is crucial. Patients should be advised to contact a Poison Control Center or seek emergency medical help right away, as prompt intervention is essential for both adults and children, even in the absence of noticeable signs or symptoms.

Side Effects

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

Severe liver damage is a significant concern associated with the use of this product, particularly in patients who exceed the maximum daily dosage of 12 capsules within a 24-hour period, use other medications containing acetaminophen, or consume three or more alcoholic drinks daily while using this product.

Allergic reactions may also occur, with acetaminophen potentially causing severe skin or allergic responses. Symptoms of such reactions can include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and in extreme cases, shock. Patients experiencing any signs of a skin or general allergic reaction are advised to discontinue use immediately and seek medical assistance.

Additionally, a sore throat warning is in place for patients whose sore throat is severe, persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting. In these instances, it is crucial to consult a healthcare provider promptly.

Patients should also be instructed to stop use and consult a doctor if pain, cough, or nasal congestion worsens or lasts longer than seven days, if fever worsens or persists for more than three days, if redness or swelling is observed, if new symptoms arise, or if a cough returns or occurs with fever, rash, or headache that lasts. These symptoms may indicate a serious underlying condition. Furthermore, if patients experience nervousness, dizziness, or sleeplessness, they should seek medical advice.

Drug Interactions

Patients taking the anticoagulant warfarin should consult with a healthcare professional prior to using this medication. This precaution is essential to ensure safe and effective use, as potential interactions may affect the efficacy of warfarin and increase the risk of bleeding.

Currently, there are no additional drug interactions or laboratory test interactions reported for this medication. Therefore, no specific dosage adjustments or monitoring recommendations are available beyond the advice regarding warfarin.

Packaging & NDC

Below are the non-prescription pack sizes of Alka-Seltzer Plus Severe Sinus Cold and Cough (acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Alka-Seltzer Plus Severe Sinus Cold and Cough.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For patients aged 12 years and older, the recommended dosage is 2 capsules taken with water every 4 hours, with a maximum of 12 capsules in a 24-hour period, unless otherwise directed by a healthcare professional.

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, and contacting a Poison Control Center is advised. Quick medical attention is crucial for both adults and pediatric patients, even if no signs or symptoms are apparent.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the prescribing information. 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 general considerations for pharmacokinetics and pharmacodynamics 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 safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 have not been specifically addressed in the available data 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 lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 12 capsules within a 24-hour period. Additionally, patients must avoid concomitant use with other medications containing acetaminophen, as this can 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. Regular assessment of liver function may be warranted in these patients to ensure safety and mitigate risks associated with acetaminophen use.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. These may include, but are not limited to, increased severity of known side effects, altered mental status, or any unusual physiological responses.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. Healthcare professionals should also consider contacting a poison control center for additional guidance on the management of overdose cases.

In summary, while specific overdosage information is not available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate supportive care in the event of an overdose.

Nonclinical Toxicology

No information is available regarding teratogenic effects. Additionally, there is no information provided concerning non-teratogenic effects. The insert does not contain any details related to nonclinical toxicology. Furthermore, there is no information available regarding animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs.

Severe skin reactions have been noted, including skin reddening, blisters, rash, hives, and facial swelling. Additionally, severe allergic reactions have been reported, which include symptoms such as asthma (wheezing) and shock.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, it is crucial for patients 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.

Patients should be informed not to use this medication in conjunction with any other products containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a medication contains acetaminophen, they should be encouraged to consult with a doctor or pharmacist.

It is important to instruct patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions such as depression, psychiatric disorders, or Parkinson's disease, or for two weeks after discontinuing an MAOI. Patients should be advised to check with a healthcare professional if they are unsure whether their prescription includes an MAOI.

Patients with a history of allergic reactions to this product or any of its ingredients should be cautioned against its use. Additionally, this medication is not recommended for children under 12 years of age.

Patients should be instructed to stop using the product and consult a doctor if their pain, cough, or nasal congestion worsens or persists for more than seven days. They should also seek medical advice if a fever worsens or lasts longer than three days, if there is any redness or swelling, or if new symptoms develop. Patients should be particularly vigilant if a cough returns or occurs alongside fever, rash, or a headache that lasts, as these may indicate a serious condition.

Furthermore, patients should be advised to discontinue use and consult a healthcare professional if they experience nervousness, dizziness, or sleeplessness. It is essential to emphasize that patients should not exceed the recommended dosage while using this product.

Lastly, patients taking the blood-thinning medication warfarin should be encouraged to consult with a doctor or pharmacist before using this product to ensure safety and avoid potential interactions.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 15-25ºC (59-77ºF) to maintain its efficacy and stability. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits to prevent degradation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Alka-Seltzer Plus Severe Sinus Cold 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 Alka-Seltzer Plus Severe Sinus Cold 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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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.