Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Alka-Seltzer Cool Action Heartburn Relief

Last content change checked dailysee data sync status

Active ingredient
Calcium Carbonate 750 mg
Other brand names
Drug classes
Blood Coagulation Factor, Phosphate Binder
Dosage form
Gum, Chewing
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2020
Label revision date
December 4, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Calcium Carbonate 750 mg
Other brand names
Drug classes
Blood Coagulation Factor, Phosphate Binder
Dosage form
Gum, Chewing
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 2020
Label revision date
December 4, 2025
Manufacturer
Bayer HealthCare LLC.
Registration number
M001
NDC root
0280-0001
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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® is an antacid that contains calcium carbonate, which helps to quickly relieve discomfort from acid indigestion, heartburn, sour stomach, and upset stomach associated with these symptoms. It is designed to work fast and provides extra strength relief, making it a popular choice for those seeking quick relief from digestive issues.

In addition to its effectiveness, Alka-Seltzer® has a cool mint flavor, which can make taking the medication more pleasant. If you're experiencing any of the discomforts mentioned, Alka-Seltzer® may be a helpful option for you.

Uses

You can use this medication to help relieve discomfort from several common digestive issues. It is effective for alleviating acid indigestion, heartburn, sour stomach, and upset stomach that may accompany these symptoms.

Rest assured, there are no known teratogenic effects (which means it does not cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can chew 1 to 2 pieces of the gum whenever you experience symptoms, or as your doctor advises. However, it's important not to exceed 5 pieces in a 24-hour period. If you are under 12 years old, please consult your doctor before using this product.

If you are pregnant, you should also limit your use to no more than 5 pieces in a 24-hour period. Remember, do not swallow the gum; it is meant to be chewed. Following these guidelines will help ensure you use the medication safely and effectively.

What to Avoid

You should avoid using this product if you have ever had an allergic reaction to it or any of its ingredients. Additionally, it’s important not to exceed 5 pieces in a 24-hour period, whether you are pregnant or not. If you find that you need to use the maximum dosage, do so only for a maximum of 2 weeks and under the guidance of a physician.

Be mindful that misuse or overuse of this product can lead to dependence (a condition where your body becomes reliant on a substance) and other health issues. Always prioritize your safety and consult with a healthcare professional if you have any concerns.

Side Effects

It's important to be aware of potential side effects when considering this medication. You should not use this product if you have ever experienced an allergic reaction to it or any of its ingredients. Allergic reactions can range from mild symptoms, like rashes, to severe reactions that may require immediate medical attention.

Always consult with your healthcare provider if you have any concerns about your medical history or how this medication may affect you. Your safety is a priority, and understanding these warnings can help you make informed decisions about your health.

Warnings and Precautions

You should not use this product if you have ever had an allergic reaction to it or any of its ingredients. Before using it, consult with your doctor or pharmacist, especially if you are currently taking any prescription medications, as antacids can interact with certain drugs.

When using this product, remember to limit yourself to no more than 5 pieces in a 24-hour period. If you are pregnant, do not exceed this limit, and avoid using the maximum dosage for more than 2 weeks unless directed by a physician. If you are pregnant or breastfeeding, make sure to inform your doctor that you are using this product. Always keep it out of reach of 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 an overdose, it is crucial to seek immediate medical help.

In case of an emergency, call your local emergency number 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 is important to let your doctor know that you are using this product. This information helps your healthcare provider assess any potential risks and make informed decisions about your care. Always prioritize open communication with your doctor regarding any medications or treatments you are using during this time.

Lactation Use

If you are pregnant or breastfeeding, it’s important to let your doctor know that you are using this product. This information helps ensure your safety and the well-being of your baby. Always consult with your healthcare provider about any medications or products you are using while nursing, as they can provide guidance tailored to your specific situation.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before using this medication. For those aged 12 and older, you can give them 1 to 2 pieces as needed for symptoms, but make sure they do not exceed 5 pieces in a 24-hour period.

Always keep this medication out of reach of children to ensure their safety. Additionally, pregnant women should also follow the same maximum dosage guidelines of no more than 5 pieces in a 24-hour period.

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.

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 you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help monitor your kidney function and make any necessary adjustments to your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver problems).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's important to be aware that some over-the-counter medications, such as antacids containing calcium carbonate, can interact with certain prescription drugs. This interaction may affect how well those medications work in your body. Because of this, it's crucial to discuss all the medications you are taking, including any antacids, with your healthcare provider. They can help ensure that your treatments are safe and effective.

Always keep your healthcare provider informed about any changes in your medication routine, as they can provide guidance tailored to your specific health needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, away from humidity and excessive heat. It's important to keep it in an environment where temperatures do not exceed 40ºC (104ºF), as high heat can affect its effectiveness.

When handling the product, make sure to do so in a clean area to maintain its integrity. Always follow any specific disposal instructions provided to ensure safety and compliance. By taking these precautions, you can help ensure that the product remains safe and effective for use.

Additional Information

No further information is available.

FAQ

What is Alka-Seltzer® used for?

Alka-Seltzer® is used for the relief of acid indigestion, heartburn, sour stomach, and upset stomach associated with these symptoms.

How should I take Alka-Seltzer®?

Adults and children 12 years and over should chew 1-2 pieces as symptoms occur or as directed by a doctor. Do not exceed 5 pieces in a 24-hour period.

Can children use Alka-Seltzer®?

Children under 12 years should consult a doctor before use.

Is Alka-Seltzer® safe during pregnancy?

If pregnant, do not use more than 5 pieces in a 24-hour period and inform your doctor that you are using this product.

What should I do if I have an allergic reaction?

Do not use Alka-Seltzer® if you have ever had an allergic reaction to this product or any of its ingredients.

What are the storage instructions for Alka-Seltzer®?

Store Alka-Seltzer® at room temperature, avoiding humidity and excessive heat above 40ºC (104ºF).

What flavor does Alka-Seltzer® come in?

Alka-Seltzer® is available in a cool mint flavor.

How long can I use Alka-Seltzer®?

Do not use the maximum dosage of this product for more than 2 weeks except under the advice and supervision of a physician.

Packaging Info

Below are the non-prescription pack sizes of Alka-Seltzer Cool Action Heartburn Relief (calcium carbonate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Alka-Seltzer Cool Action Heartburn Relief.
Details

Drug Information (PDF)

This file contains official product information for Alka-Seltzer Cool Action Heartburn 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 relief of acid indigestion, heartburn, sour stomach, and upset stomach associated with these symptoms.

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to chew 1 to 2 pieces of the gum as symptoms occur or as directed by a healthcare professional. For children under 12 years of age, it is recommended to consult a doctor prior to use.

The maximum allowable dosage is 5 pieces within a 24-hour period for all users, including pregnant individuals. It is important to note that the gum should not be swallowed.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to the product or any of its ingredients.

Additionally, the following conditions warrant avoidance of use:

  • Administration of more than 5 pieces within a 24-hour period is contraindicated.

  • Pregnant individuals should not exceed 5 pieces in a 24-hour period.

  • The maximum dosage should not be used for more than 2 weeks unless under the guidance and supervision of a physician.

Warnings and Precautions

It is imperative that this product is not used by individuals who have a history of allergic reactions to it or any of its components.

Healthcare professionals should advise patients to consult with a doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with certain drugs.

When administering this product, it is crucial to adhere to the following guidelines:

  • The maximum recommended dosage is limited to 5 pieces within a 24-hour period. This limit applies equally to pregnant individuals.

  • The maximum dosage should not be utilized for more than 2 weeks unless under the guidance and supervision of a physician.

  • Pregnant or breastfeeding patients must inform their healthcare provider of their use of this product.

Additionally, it is essential to keep this product out of reach of children to prevent accidental ingestion.

No specific laboratory tests are required for monitoring the use of this product. However, healthcare professionals should remain vigilant for any adverse reactions or interactions, particularly in patients taking concurrent medications.

Side Effects

Patients should be aware that the use of this product is contraindicated in individuals who have a history of allergic reactions to the product or any of its ingredients. This warning is critical to prevent serious allergic responses that may occur upon administration.

In clinical trials and postmarketing experiences, no additional adverse reactions have been reported beyond those associated with allergic reactions. Therefore, healthcare providers should carefully evaluate the patient's medical history for any previous allergic responses before prescribing this product.

Drug Interactions

Antacids, particularly those containing calcium carbonate, may interact with certain prescription medications, potentially impacting their absorption and overall efficacy. It is advisable for healthcare professionals to monitor patients for any changes in therapeutic effects when these antacids are co-administered with other drugs. Adjustments to the timing of administration or dosage of the affected medications may be necessary to mitigate these interactions.

No additional drug interactions or laboratory test interactions have been identified.

Packaging & NDC

Below are the non-prescription pack sizes of Alka-Seltzer Cool Action Heartburn Relief (calcium carbonate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Alka-Seltzer Cool Action Heartburn Relief.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a doctor before use. For adolescents and adults aged 12 years and older, the recommended dosage is to chew 1 to 2 pieces as symptoms occur or as directed by a healthcare professional. The maximum dosage for this population is 5 pieces within a 24-hour period. It is important to note that this maximum dosage also applies to pregnant women. Additionally, safety precautions should be observed by keeping the product out of reach of children.

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 potential 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 inform their healthcare provider about their use of this product. The potential risks associated with the use of this medication during pregnancy have not been fully established. Therefore, it is essential for women of childbearing potential to discuss their treatment options with their healthcare provider to ensure the safety of both the mother and the fetus.

Lactation

Lactating mothers should inform their healthcare provider if they are using this product while breastfeeding. There is currently no available data on the excretion of this product in human breast milk or its effects on breastfed infants. Therefore, healthcare professionals should exercise caution when recommending this product to lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data 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 have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.

Overdosage

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on the clinical presentation.

For further guidance, healthcare professionals may refer to established protocols for managing drug overdosage or consult a poison control center.

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 reported voluntarily or through surveillance programs: allergic reactions, which include anaphylaxis, angioedema, and urticaria.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Patients should be informed not to use the product if they have a history of allergic reactions to it or any of its ingredients.

When discussing the usage of this product, healthcare providers should emphasize that patients must not exceed the recommended dosage of 5 pieces within a 24-hour period. This guideline applies equally to pregnant patients, who should also adhere to the same dosage limit. Additionally, patients should be cautioned against using the maximum dosage for more than 2 weeks unless directed by a physician, highlighting the importance of medical supervision in such cases.

It is essential for healthcare providers to encourage patients to consult with a doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with certain drugs. This precaution can help ensure safe and effective use of the product.

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 in a dry environment. Care should be taken to avoid exposure to humidity and excessive heat, with a maximum temperature limit of 40ºC (104ºF) to maintain product integrity. Proper handling and storage conditions are crucial for preserving the quality and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Alka-Seltzer Cool Action Heartburn 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 Alka-Seltzer Cool Action Heartburn 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

Last AI update:

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.