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Alka-Seltzer Ultra Strength Heartburn Reliefchews

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Active ingredient
Calcium Carbonate 1000 mg
Other brand names
Drug classes
Blood Coagulation Factor, Phosphate Binder
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
December 4, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Calcium Carbonate 1000 mg
Other brand names
Drug classes
Blood Coagulation Factor, Phosphate Binder
Dosage form
Tablet, Chewable
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 2019
Label revision date
December 4, 2025
Manufacturer
Bayer HealthCare LLC.
Registration number
M001
NDC root
0280-0059
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

Alka-Seltzer® is an antacid that contains calcium carbonate, which works by neutralizing stomach acid almost immediately. This medication is designed to provide relief from common digestive discomforts such as acid indigestion, heartburn, sour stomach, and upset stomach associated with these symptoms.

Available in the form of chewable tablets, Alka-Seltzer® comes in delicious flavors like strawberry and orange crème. It is specifically formulated to offer ultra-strength relief from heartburn, helping you feel more comfortable after meals.

Uses

If you're experiencing discomfort from acid indigestion, heartburn, sour stomach, or an upset stomach related to these symptoms, this medication can help provide relief. It’s designed to ease the discomfort associated with these common digestive issues, allowing you to feel more comfortable throughout your day.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safer option for those concerned about potential risks.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should chew and swallow 2 to 3 chewable tablets when you experience symptoms, or follow your doctor's instructions. It's important to remember that you should not exceed 5 chewable tablets in a 24-hour period.

For children under 12 years, it's best to consult a doctor before giving them any medication. Additionally, if you are pregnant, you should also adhere to the same maximum limit of 5 chewable tablets in a 24-hour period to ensure safety. Always follow these guidelines to use the medication effectively and safely.

What to Avoid

It's important to use this product safely to avoid potential issues. You should not take more than 5 chewable tablets in a 24-hour period. If you are pregnant, the same limit applies—do not exceed 5 chewable tablets in 24 hours. Additionally, you should not use the maximum dosage for more than 2 weeks unless your doctor advises and supervises you.

By following these guidelines, you can help ensure your safety while using this product. If you have any questions or concerns, please consult your healthcare provider.

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 allergies or side effects related to this medication. 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. It's important to talk to your doctor or pharmacist before using this product, especially if you are currently taking any prescription medications, as antacids can interact with certain drugs.

If you are pregnant, please inform your doctor that you are using this product. While there are no specific emergency medical help instructions or laboratory tests required, staying in communication with your healthcare provider is essential for your safety.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the 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. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember that when it comes to medications, it's better to be safe and get help if you have any concerns.

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 ensure your safety and the well-being of your baby, as certain medications can affect pregnancy or breastfeeding. Always consult your healthcare provider for guidance tailored to your specific situation.

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 giving them this medication. For those aged 12 and older, you can give them 2 to 3 chewable tablets as needed for symptoms, but they should fully chew and swallow the tablets. Remember, the maximum dosage for anyone, including adults and pregnant women, is 5 chewable tablets in a 24-hour period.

Always keep this medication out of reach of children to ensure their safety. If you have any concerns or questions about the appropriate use for your child, don't hesitate to reach out to a healthcare professional.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially since older individuals may have different health needs and responses to treatments.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach based on individual health conditions and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective care.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to be adjusted based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific condition. They can help monitor your kidney health and make any necessary changes to your medications.

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 may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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, keeping it away from excessive heat—specifically, temperatures above 40°C (104°F). This helps maintain its effectiveness and safety.

After each use, make sure to close the cap tightly. This simple step helps prevent contamination and preserves the integrity of the product. Always handle it with care to ensure your safety and the product's reliability.

Additional Information

No further information is available.

FAQ

What is Alka-Seltzer®?

Alka-Seltzer® is a calcium carbonate-based antacid used for the relief of acid indigestion, heartburn, sour stomach, and upset stomach.

How does Alka-Seltzer® work?

It starts neutralizing acid in seconds, providing quick relief from symptoms.

What are the available forms and flavors of Alka-Seltzer®?

Alka-Seltzer® comes in the form of 50 chewable tablets and is available in Strawberry and Orange Creme flavors.

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

You should fully chew and swallow 2 to 3 chewable tablets as symptoms occur, or as directed by a doctor, without exceeding 5 tablets in a 24-hour period.

What should children under 12 do?

Consult a doctor before use if you are under 12 years old.

Are there any precautions for pregnant individuals?

Pregnant individuals should not take more than 5 chewable tablets in a 24-hour period and should inform their doctor that they 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.

Can Alka-Seltzer® interact with other medications?

Yes, antacids like calcium carbonate may interact with certain prescription drugs, potentially affecting their absorption and efficacy.

How should I store Alka-Seltzer®?

Store at room temperature and avoid excessive heat above 40°C (104°F). Close the cap tightly after use.

Is there a maximum duration for using Alka-Seltzer®?

Do not use the maximum dosage for more than 2 weeks unless advised and supervised by a physician.

Packaging Info

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

Packaging configurations for Alka-Seltzer Ultra Strength Heartburn Reliefchews.
Details

Drug Information (PDF)

This file contains official product information for Alka-Seltzer Ultra Strength Heartburn Reliefchews, 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.

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 advised to fully chew and then swallow 2 to 3 chewable tablets as symptoms occur, or as directed by a healthcare professional. For children under 12 years of age, consultation with a doctor is recommended prior to administration.

The maximum dosage for all individuals, including pregnant individuals, is limited to 5 chewable tablets within a 24-hour period. It is essential to adhere to this maximum dosage to avoid potential adverse effects.

Contraindications

Use of this product is contraindicated in the following situations:

Taking more than 5 chewable tablets within a 24-hour period is contraindicated due to the potential for adverse effects associated with excessive dosage.

In pregnant individuals, the use of more than 5 chewable tablets in a 24-hour period is contraindicated to avoid potential risks to the fetus.

The maximum dosage of this product should not be used for more than 2 weeks unless under the advice and supervision of a physician, as prolonged use at maximum dosage may lead to unforeseen complications.

Warnings and Precautions

Patients should not use this product if they have a history of allergic reactions to it or any of its ingredients. This contraindication is critical to prevent potential adverse effects.

Before initiating treatment, it is advisable for patients to consult with a healthcare professional, such as a doctor or pharmacist, particularly if they are currently taking any prescription medications. This precaution is essential as antacids may interact with certain prescription drugs, potentially altering their effectiveness or increasing the risk of side effects.

In the context of pregnancy, it is imperative for patients to inform their healthcare provider if they are using this product. This communication is vital to ensure the safety of both the patient and the developing fetus.

No specific laboratory tests are required for the safe use of this product; however, ongoing monitoring of the patient's overall health and medication interactions is recommended.

Side Effects

Patients should be aware that the use of this product is contraindicated in individuals who have a history of allergic reactions to this product or any of its ingredients.

In clinical trials and postmarketing experiences, adverse reactions have been reported; however, specific data regarding the frequency or seriousness of these reactions has not been provided. It is essential for patients to discuss any previous allergic reactions with their healthcare provider prior to initiating treatment.

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 reported.

Packaging & NDC

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

Packaging configurations for Alka-Seltzer Ultra Strength Heartburn Reliefchews.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is to fully chew and then swallow 2 to 3 chewable tablets as symptoms occur, or as directed by a healthcare provider. The maximum dosage for this age group is not to exceed 5 chewable tablets within a 24-hour period.

It is important to note that safety precautions should be observed, including 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 efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should inform their healthcare provider about the use of this product. It is important for healthcare professionals to assess the potential risks and benefits associated with the use of this product during pregnancy and lactation. The safety of this product in pregnant women has not been established, and caution is advised. Women of childbearing potential should be counseled on the importance of discussing any medication use with their healthcare provider to ensure appropriate management and monitoring throughout pregnancy and breastfeeding.

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 available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate assessment of the patient's condition is crucial. Recommended actions include:

  1. Assessment: Conduct a thorough evaluation of the patient's vital signs and clinical status.

  2. Supportive Care: Initiate supportive measures as necessary, including airway management, oxygen supplementation, and intravenous fluids.

  3. Decontamination: If appropriate and within a reasonable timeframe, consider gastrointestinal decontamination methods such as activated charcoal, provided the patient is alert and able to protect their airway.

  4. Specific Antidotes: If a specific antidote is available for the substance involved, it should be administered according to established protocols.

Healthcare professionals are encouraged to consult local poison control centers or toxicology experts for guidance on management strategies tailored to the specific circumstances of the overdose. Continuous monitoring and supportive care are paramount until the patient stabilizes or further treatment is initiated.

Documentation of the incident, including the substance involved, estimated dose, time of exposure, and clinical findings, is essential for ongoing management and future reference.

Nonclinical Toxicology

If pregnant, it is advised not to exceed five chewable tablets within a 24-hour period. Additionally, individuals who are pregnant or breastfeeding should inform their healthcare provider about the use of this product.

No relevant information regarding carcinogenicity, mutagenicity, or impairment of fertility has been provided in the insert. Furthermore, there is no available data concerning animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has revealed reports of allergic reactions, including anaphylaxis, angioedema, and urticaria. Additionally, other adverse reactions reported include gastrointestinal disturbances such as nausea, vomiting, and diarrhea. There have also been reports of hypercalcemia and metabolic alkalosis associated with excessive use of calcium carbonate.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion.

When using this product, patients should be instructed not to exceed a maximum of 5 chewable tablets within a 24-hour period. It is particularly important for pregnant patients to adhere to this same limit of 5 chewable tablets in 24 hours. Additionally, patients should be cautioned against using the maximum dosage of this product for more than 2 weeks unless under the advice and supervision of a physician.

Patients should also be encouraged to consult with their doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with certain prescription drugs.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It is crucial to store the product at room temperature, ensuring that it is kept away from excessive heat, particularly temperatures exceeding 40°C (104°F).

To maintain the integrity of the product, the cap must be closed tightly after each use. This practice helps to prevent contamination and preserves the quality of the contents.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Alka-Seltzer Ultra Strength Heartburn Reliefchews, 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 Ultra Strength Heartburn Reliefchews, 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.