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Regular Strength

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Active ingredient
Calcium Carbonate 500 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 2025
Label revision date
September 23, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Calcium Carbonate 500 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 2025
Label revision date
September 23, 2025
Manufacturer
AKRON PHARMA INC
Registration number
M001
NDC root
71399-9939
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

You may be experiencing discomfort from heartburn, sour stomach, acid indigestion, or an upset stomach. This medication is designed to relieve these symptoms, helping you feel more comfortable. It works by addressing the underlying causes of these digestive issues, providing you with the relief you need to go about your day. If you're looking for a solution to these common stomach problems, this medication could be a helpful option for you.

Uses

If you're experiencing discomfort from heartburn, sour stomach, or acid indigestion, this medication can help relieve those symptoms. It is also effective for upset stomachs that are associated with these issues.

You can feel confident using this medication, as there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects reported.

Dosage and Administration

When you need relief from certain symptoms, adults and children aged 12 and older can chew 2 to 4 tablets as needed. It's important to remember that you should not swallow the tablets whole; they need to be chewed to work effectively.

If your symptoms last longer than 2 weeks, it's crucial to consult with a doctor before continuing to take the medication. Always follow your doctor's advice for the best results.

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

When using this product, it's important to be aware of potential side effects and interactions. You should consult with a doctor or pharmacist if you are currently taking any prescription medications, as antacids can interact with them. Common side effects may include discomfort or changes in digestion.

It's crucial not to exceed 15 tablets in a 24-hour period, and if you are pregnant, limit your intake to no more than 10 tablets in the same timeframe. Additionally, avoid using the maximum dosage for more than two weeks unless directed by a healthcare professional.

Warnings and Precautions

Before using this product, it's important to consult with your doctor or pharmacist, especially if you are currently taking any prescription medications, as antacids can interact with them. Be mindful of the dosage: do not exceed 15 tablets in a 24-hour period, and if you are pregnant, limit your intake to no more than 10 tablets in the same timeframe. Additionally, avoid using the maximum dosage for more than two weeks unless directed by your doctor.

If you experience any unusual symptoms or have concerns while using this product, stop taking it and reach out to your doctor for guidance. Your health and safety are paramount, so always follow these precautions to ensure safe use.

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 potential risks associated with taking any medication. If you suspect that you or someone else may have taken too much of a medication, look for signs such as unusual drowsiness, confusion, or difficulty breathing.

In the event of an overdose, it is crucial to seek immediate medical help. You can do this by calling your local emergency number or going to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to minimize the risk of an overdose. 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, it is important to be cautious with medication. You should not take more than 10 tablets in a 24-hour period. This guideline helps ensure your safety and the safety of your developing baby. Always consult with your healthcare provider before taking any medication during pregnancy to discuss potential risks and appropriate dosages.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant.

As always, if you have any concerns or questions about using this product while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

If you are considering this medication for your child, it's important to note that it is intended for use in children aged 12 years and older. For this age group, the recommended dosage is to chew 2 to 4 tablets when symptoms occur, or as directed by a healthcare professional. Always consult with your child's doctor to ensure the correct dosage and to discuss any specific health concerns.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it's important to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and circumstances. Always prioritize open communication with your doctor to ensure safe and effective treatment.

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 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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

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 health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature. It's important to keep the container tightly closed to protect its contents. Before using, check that the safety seal (a printed seal under the cap) is intact; do not use the product if this seal is torn or missing, as this could indicate that the product is compromised. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

FAQ

What symptoms does this drug relieve?

This drug relieves heartburn, sour stomach, acid indigestion, and upset stomach associated with these symptoms.

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

Adults and children 12 years of age and over should chew 2-4 tablets as symptoms occur, or as directed by a doctor. Do not swallow the tablets whole.

What is the maximum dosage for this drug?

You should not take more than 15 tablets in 24 hours. If pregnant, do not take more than 10 tablets in 24 hours.

How long can I use the maximum dosage?

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

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What should I do if I am taking other prescription drugs?

Ask a doctor or pharmacist before use, as antacids may interact with certain prescription drugs.

Is this drug safe to use during pregnancy?

While there are no teratogenic effects mentioned, pregnant women should not take more than 10 tablets in 24 hours.

What precautions should I take when using this drug?

Store at room temperature, keep the container tightly closed, and do not use if the printed seal under the cap is torn or missing.

Packaging Info

Below are the non-prescription pack sizes of Regular Strength (antacid calcium carbonate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Regular Strength.
Details

Drug Information (PDF)

This file contains official product information for Regular Strength, 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 heartburn, sour stomach, acid indigestion, 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 2 to 4 tablets as symptoms occur, or as directed by a healthcare professional. It is essential that the tablets are not swallowed whole. Patients should refrain from using this medication for symptoms that persist for more than 2 weeks unless advised by a doctor.

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

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

When administering this product, it is imperative to adhere to the following dosage guidelines: patients should not exceed 15 tablets within a 24-hour period. For pregnant individuals, the maximum dosage should not exceed 10 tablets in a 24-hour period. Furthermore, the maximum dosage should not be utilized for more than 2 weeks unless directed and monitored by a healthcare provider.

These precautions are essential to ensure the safe and effective use of the product, minimizing the risk of adverse effects and potential drug interactions.

Side Effects

Patients should be aware of potential adverse reactions associated with the use of this product. It is important to consult a healthcare professional before use, particularly if patients are currently taking prescription medications, as antacids may interact with certain drugs.

In clinical settings, participants have been advised not to exceed a dosage of 15 tablets within a 24-hour period. For pregnant individuals, the maximum recommended dosage is limited to 10 tablets in a 24-hour timeframe. Furthermore, patients are cautioned against using the maximum dosage for more than two weeks unless under the guidance and supervision of a healthcare provider.

These precautions are essential to minimize the risk of adverse effects and ensure safe usage of the product.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding 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 Regular Strength (antacid calcium carbonate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Regular Strength.
Details

Pediatric Use

Pediatric patients aged 12 years and older may chew 2-4 tablets as symptoms occur, or as directed by a healthcare professional. There are no specific dosage recommendations for children under 12 years of age. Caution is advised when administering this medication to pediatric patients, and healthcare providers should consider individual patient needs and circumstances when prescribing.

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 should not exceed a dosage of 10 tablets within a 24-hour period. This limitation is crucial to minimize potential risks to fetal outcomes. Healthcare professionals are advised to counsel women of childbearing potential regarding the importance of adhering to this dosage recommendation to ensure the safety of both the mother and the developing fetus.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance 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 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 indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

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. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific 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 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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with children accessing the medication, including serious health consequences. Patients should be encouraged to store the medication in a secure location, such as a locked cabinet or high shelf, to ensure safety.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature to ensure optimal conditions. Additionally, the product features a safety seal; it is imperative not to use the product if the printed seal under the cap is torn or missing, as this may indicate potential tampering or contamination.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Regular Strength, 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 Regular Strength, 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.