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Alka Seltzer Plus Maximum Strength Cough Chest Congestion Powerfast Fizz

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Active ingredients
  • Guaifenesin 200 mg
  • Dextromethorphan Hydrobromide 10 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Tablet, Effervescent
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
December 4, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Guaifenesin 200 mg
  • Dextromethorphan Hydrobromide 10 mg
Other brand names
Drug classes
Expectorant, Sigma-1 Agonist, Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Dosage form
Tablet, Effervescent
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 2022
Label revision date
December 4, 2025
Manufacturer
Bayer Healthcare LLC.
Registration number
M012
NDC root
0280-0089
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Alka Seltzer Plus Maximum Strength Cough & Chest Congestion is a medication designed to help relieve cough and chest congestion. It contains two active ingredients: Dextromethorphan HBr, which acts as a cough suppressant to temporarily relieve coughing caused by minor throat and bronchial irritation, and Guaifenesin, an expectorant that helps loosen phlegm (mucus) and thin bronchial secretions. This combination makes coughs more productive by clearing out bothersome mucus from the bronchial passageways.

Available in a convenient effervescent tablet form, Alka Seltzer Plus is formulated to provide effective relief for symptoms associated with colds, helping you feel more comfortable during your recovery.

Uses

If you're dealing with a cough caused by minor throat and bronchial irritation, such as what you might experience with a cold, this medication can help. It temporarily relieves your cough and reduces its intensity, making it easier for you to manage.

Additionally, this medication works to loosen phlegm (mucus) and thin out bronchial secretions. This action helps clear your bronchial passageways of bothersome mucus, allowing your coughs to be more productive and effective in clearing your airways.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should take 2 tablets of the medication, making sure they are fully dissolved in 4 ounces of water. You can repeat this every 4 hours, but be careful not to exceed 12 tablets in a 24-hour period unless your doctor advises otherwise.

For children under 12 years of age, this medication is not recommended, so please avoid using it for that age group. Always follow the instructions provided by your healthcare provider to ensure safe and effective use.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

You should avoid using this product if you are currently taking a prescription monoamine oxidase inhibitor (MAOI) for conditions like depression or Parkinson's disease, or if you have had an allergic reaction to it or any of its ingredients. It is also not recommended for children under 12 years of age.

Before using this product, consult your doctor if you have a cough with excessive mucus, a persistent cough due to smoking or chronic lung conditions, or if you are on a sodium-restricted diet. If your cough lasts more than 7 days, returns, or is accompanied by a fever, rash, or persistent headache, stop using the product and seek medical advice, as these may indicate a more serious health issue.

Warnings and Precautions

You should not use 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, avoid this product if you have ever had an allergic reaction to it or any of its ingredients, and do not give it to children under 12 years of age.

Before using this product, consult your doctor if you have a cough with excessive mucus, a persistent cough due to smoking, asthma, chronic bronchitis, or emphysema, or if you are on a sodium-restricted diet. If your cough lasts more than 7 days, returns, or is accompanied by a fever, rash, or persistent headache, stop using the product and contact your doctor, as these may indicate a more serious condition.

In the event of an overdose, seek emergency medical help or contact a Poison Control Center immediately.

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 an overdose, it’s crucial to seek immediate medical help.

In case of an emergency, call your local emergency services or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

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 is important to note that this medication should not be used in children under 12 years of age. If you are a parent or caregiver, please ensure that your child is at least 12 years old before considering this treatment. Always consult with a healthcare professional if you have any questions or concerns about the appropriate use of this medication for your child.

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 wise to discuss any potential risks or benefits with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness. If you notice any unusual side effects or changes in health, be sure to report these to your healthcare team promptly.

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.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and effective for you.

Hepatic Impairment

If you have liver 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 standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. It's important to keep it away from excessive heat, as high temperatures can affect its effectiveness.

When handling the product, always do so with care to maintain its integrity. Following these simple storage and handling guidelines will help ensure your product remains safe and effective for use.

Additional Information

No further information is available.

FAQ

What is Alka Seltzer Plus Maximum Strength Cough & Chest Congestion used for?

It is used to temporarily relieve cough due to minor throat and bronchial irritation, as well as to help loosen phlegm (mucus) and thin bronchial secretions.

What are the active ingredients in this medication?

It contains Dextromethorphan HBr, a cough suppressant, and Guaifenesin, an expectorant.

How should adults and children over 12 take this medication?

You should take 2 tablets fully dissolved in 4 oz of water every 4 hours, not exceeding 12 tablets in 24 hours unless directed by a doctor.

Are there any age restrictions for using this product?

Yes, it should not be used in children under 12 years of age.

What should I do if my cough lasts more than 7 days?

You should stop using the product and ask a doctor if your cough lasts more than 7 days, comes back, or is accompanied by a fever, rash, or persistent headache.

Are there any warnings associated with this medication?

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

What should I do if I am pregnant or breastfeeding?

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

How should I store this medication?

Store it at room temperature and avoid excessive heat.

Packaging Info

Below are the non-prescription pack sizes of Alka Seltzer Plus Maximum Strength Cough Chest Congestion Powerfast Fizz (dextromethorphan hydrobromide, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Alka Seltzer Plus Maximum Strength Cough Chest Congestion Powerfast Fizz.
Details

Drug Information (PDF)

This file contains official product information for Alka Seltzer Plus Maximum Strength Cough Chest Congestion Powerfast Fizz, 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 drug.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation, which may occur due to a cold. It is effective in reducing the intensity of coughing and assists in loosening phlegm (mucus) and thinning bronchial secretions. This action facilitates the clearance of bothersome mucus from the bronchial passageways, thereby making coughs more productive.

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

Dosage and Administration

Adults and children aged 12 years and over are instructed to take 2 tablets fully dissolved in 4 ounces of water every 4 hours as needed. The maximum dosage should not exceed 12 tablets within a 24-hour period unless otherwise directed by a healthcare professional.

The use of this medication is not recommended for children under 12 years of age.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

The use of this product is contraindicated in several specific circumstances. It should not be administered to individuals currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric disorders, or Parkinson's disease. Additionally, the product should not be used for a period of two weeks following the cessation of an MAOI. Healthcare professionals should advise patients to consult with a doctor or pharmacist if there is uncertainty regarding the presence of an MAOI in their current medications.

This product is also contraindicated in individuals with a known history of allergic reactions to it or any of its components. Furthermore, it is not recommended for use in children under 12 years of age.

General precautions should be observed prior to use. Patients should be advised to seek medical consultation if they experience a cough accompanied by excessive phlegm (mucus), or if they have a persistent or chronic cough associated with conditions such as smoking, asthma, chronic bronchitis, or emphysema. Additionally, individuals on a sodium-restricted diet should consult a healthcare provider before using this product.

Patients are instructed to discontinue use and contact a healthcare professional if their cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, as these may indicate a serious underlying condition.

In the event of an overdose, immediate medical assistance should be sought, or the individual should contact a Poison Control Center without delay.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in individuals with specific contraindications. The use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. Additionally, individuals with a history of allergic reactions to this product or any of its ingredients should not use it. This product is not recommended for children under 12 years of age.

Patients are advised to consult a healthcare professional prior to use if they have a cough that occurs with excessive phlegm, a persistent or chronic cough related to smoking, asthma, chronic bronchitis, or emphysema, or if they are on a sodium-restricted diet.

If a patient's cough persists for more than 7 days, recurs, or is accompanied by symptoms such as fever, rash, or a persistent headache, they should discontinue use and seek medical advice, as these symptoms may indicate a serious underlying condition.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Alka Seltzer Plus Maximum Strength Cough Chest Congestion Powerfast Fizz (dextromethorphan hydrobromide, guaifenesin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Alka Seltzer Plus Maximum Strength Cough Chest Congestion Powerfast Fizz.
Details

Pediatric Use

Pediatric patients under 12 years of age should not be administered this medication. Safety and efficacy have not been established in this age group, and use is contraindicated.

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 potential for altered 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 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 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 have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

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. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory distress, or any other unusual clinical manifestations.

Management of an overdose should be tailored to the individual patient and may involve supportive care, symptomatic treatment, and, if applicable, the use of specific antidotes. It is crucial to consult local poison control guidelines and the product's prescribing information for detailed management protocols.

In all instances of suspected overdose, healthcare professionals should ensure that appropriate measures are taken to ensure patient safety and to mitigate any potential adverse effects.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, including anaphylaxis, and serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center. Patients should be made aware of the signs of overdose and the urgency of obtaining assistance to ensure their safety and well-being.

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 room temperature, ensuring that it is kept away from excessive heat to maintain its integrity and efficacy. Proper storage conditions are crucial for preserving the quality of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Alka Seltzer Plus Maximum Strength Cough Chest Congestion Powerfast Fizz, 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 Maximum Strength Cough Chest Congestion Powerfast Fizz, 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.