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Regular Strength Antacid

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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
March 2, 2026
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
March 2, 2026
Manufacturer
AKRON PHARMA INC
Registration number
M001
NDC root
71399-9940
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

You may be experiencing discomfort from heartburn, acid indigestion, sour stomach, 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, acid indigestion, sour stomach, or an upset stomach related to these symptoms, this medication can help relieve your discomfort. It’s designed to provide quick relief from 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) 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 take 2 to 4 tablets by chewing them when you experience symptoms, or as your doctor recommends. It's important to follow this guidance closely to ensure you are using the medication safely and effectively.

However, if your symptoms last longer than 2 weeks, you should not continue taking the medication without consulting your doctor. This is crucial to avoid any potential complications and to ensure you receive the appropriate care. Always prioritize your health and seek professional advice when needed.

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, you may experience some side effects. It's important to be aware that taking more than 15 tablets in a 24-hour period can lead to serious issues. If you are pregnant, you should limit your intake to no more than 10 tablets in 24 hours. Additionally, using the maximum dosage for more than two weeks should only be done under the guidance of a doctor.

Before starting this product, consult with your doctor or pharmacist, especially if you are currently taking any prescription medications, as antacids can interact with certain drugs. Always prioritize your health and safety by following these guidelines.

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. Always prioritize your health and safety by following these precautions.

Overdose

If you suspect an overdose, it's important to act quickly. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, seek immediate medical help.

In the event of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide healthcare professionals with as much information as possible about the substance taken and the amount. Remember, your safety is the top priority, so don’t hesitate to get help.

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. Always consult with your healthcare provider before taking any medication to ensure it is safe for you and your baby. Your health and the health of your developing child are the top priority, so make sure to follow these guidelines closely.

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. Currently, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using medications while breastfeeding. Your health and the well-being of your baby are important, and your provider can help guide you in making the best choices.

Pediatric Use

When it comes to using this medication for children, it's important to note that it is intended for adults and children aged 12 years and older. If your child is within this age range, they can chew 2 to 4 tablets as needed for symptoms, or follow your doctor's instructions.

Always remember to keep the medication out of reach of younger children to ensure their safety. If you have any concerns or questions about its use, don't hesitate to consult your healthcare provider.

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 if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team 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 and what steps to take for your safety.

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. Currently, there are no specific drug interactions or laboratory test interactions noted for this medication. However, every individual’s health situation is unique, and your healthcare provider can help ensure that your treatment plan is safe and effective for you. Always feel free to ask questions and share all the medications and supplements you are using to avoid any potential issues.

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. Before using it, consult with your doctor or pharmacist, especially if you are currently taking any prescription drugs, as antacids can interact with some medications. If your symptoms last longer than two weeks, seek advice from your doctor before continuing use.

FAQ

What symptoms does this drug relieve?

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

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

You should chew 2-4 tablets as symptoms occur, or as directed by a doctor.

Are there any warnings for using this product?

Yes, ask a doctor or pharmacist before use if you are taking a prescription drug, as antacids may interact with certain medications.

What is the maximum dosage I can take?

Do not take more than 15 tablets in 24 hours, and if pregnant, do not take more than 10 tablets in 24 hours.

How long can I use this product?

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

Is this drug safe to use during pregnancy?

There are no teratogenic effects mentioned, but you should limit intake to 10 tablets in 24 hours if pregnant.

What should I do if symptoms persist?

Do not take this product for symptoms that persist for more than 2 weeks unless advised by a doctor.

How should I store this drug?

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

Is there any specific information for nursing mothers?

There are no specific warnings or recommendations regarding the use of this product in nursing mothers.

What should I do if I have questions about drug interactions?

Consult with a doctor or pharmacist, especially if you are taking other prescription drugs, as interactions may occur.

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 Antacid.
Details

Drug Information (PDF)

This file contains official product information for Regular Strength Antacid, 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, acid indigestion, 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 12 years of age and over are instructed to chew 2 to 4 tablets as symptoms occur, or as directed by a healthcare professional. It is important to note that this medication should not be taken 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 critical 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 may experience various adverse reactions when using this product. It is important to note that certain warnings should be heeded to minimize risks associated with its use.

Patients are advised to consult a doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with specific drugs. When using this product, patients should not exceed a dosage of 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 under the guidance and supervision of a healthcare professional.

These precautions are essential to ensure the safe use of the product and to mitigate potential adverse reactions.

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 Regular Strength Antacid (calcium carbonate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Regular Strength Antacid.
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. It is important to keep this medication out of reach of children to prevent accidental ingestion.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should be advised not to exceed a dosage of 10 tablets within a 24-hour period. This precaution is essential to minimize potential risks to fetal outcomes. Healthcare professionals should carefully evaluate the benefits and risks of treatment in pregnant patients, considering the potential for adverse effects on both the mother and the developing fetus. It is recommended that women of childbearing potential discuss their treatment options with their healthcare provider to ensure safe use during pregnancy.

Lactation

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

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the available data. Therefore, healthcare professionals should exercise caution when prescribing to this population, as the lack of information necessitates careful clinical judgment regarding the use of the medication in individuals with reduced kidney function. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic 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 risks associated with excessive administration of the medication.

Healthcare providers are advised to monitor patients closely for any signs of adverse effects that may arise from overdosage. Symptoms may vary depending on the medication's pharmacological profile and the individual patient's response.

In the event of suspected overdosage, it is recommended that healthcare professionals initiate appropriate management procedures. This may include supportive care, symptomatic treatment, and, if necessary, the implementation of specific antidotes or interventions based on the clinical scenario.

For further guidance, healthcare professionals should consult relevant clinical resources or poison control centers to ensure optimal management of any overdosage situation.

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 a compromise in safety or efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to consult a doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with certain drugs. Patients are also cautioned not to use the medication for symptoms that persist for more than two weeks without medical advice.

Drug Information (PDF)

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