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Calcium Carbonate

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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 2022
Label revision date
May 1, 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 2022
Label revision date
May 1, 2025
Manufacturer
Allegiant Health
Registration number
M001
NDC root
69168-124
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

Calcium carbonate 500mg is a medication commonly used to relieve symptoms such as heartburn, sour stomach, acid indigestion, and upset stomach. It works by neutralizing stomach acid, providing quick relief from discomfort associated with these conditions.

If you're experiencing any of these symptoms, calcium carbonate can be a helpful option to consider for easing your discomfort. Always consult with a healthcare professional if you have any questions or concerns about using this medication.

Uses

If you're experiencing discomfort from heartburn, sour stomach, or acid indigestion, this medication can help relieve those symptoms. It’s also effective for soothing an upset stomach that comes along 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) associated with it. This makes it a safer option for those who may be concerned about such risks.

Dosage and Administration

When you experience symptoms, you can take 2 to 4 tablets by chewing them. If your symptoms persist, you can repeat this dosage every hour as needed. Just remember to listen to your body and adjust the amount based on how you feel. Always ensure you’re following the recommended guidelines for your health and safety.

What to Avoid

It's important to use this medication responsibly to ensure your safety and well-being. You should not take more than 15 tablets within a 24-hour period. Additionally, avoid using the maximum dosage of this product for longer than 2 weeks. Following these guidelines helps prevent potential issues and ensures the medication works effectively for you. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

It's important to be aware of certain warnings before using this product. If you have kidney disease or are taking any prescription medications, including antacids, consult your doctor first, as there may be interactions.

While using this product, do not exceed 15 tablets in a 24-hour period, and avoid using the maximum dosage for more than two weeks. Always keep this product out of reach of children to ensure their safety.

Warnings and Precautions

Before using this product, it's important to consult your doctor if you have kidney disease or if you are taking any prescription medications, as antacids can interact with certain drugs.

While using this product, make sure not to exceed 15 tablets in a 24-hour period, and avoid using the maximum dosage for more than 2 weeks. This will help ensure your safety and well-being while using the medication.

Overdose

Taking more than 15 tablets in a 24-hour period or using the maximum dosage of this product for more than 2 weeks can lead to an overdose. Signs of an overdose may include unusual symptoms that could affect your health. If you suspect an overdose, it’s important to seek immediate medical help.

To ensure your safety, always follow the recommended dosage guidelines. If you experience any concerning symptoms or if you have taken too much, contact your healthcare provider or local emergency services right away. Your health is important, and getting prompt assistance can make a difference.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be aware that there is no specific information available regarding the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been established.

Before taking this medication, you should consult with your healthcare provider to discuss any potential risks and to ensure that you are making informed decisions for your health and the health of your baby. Always prioritize open communication with your doctor about any medications you are considering during pregnancy.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that the drug insert for Calcium Carbonate does not provide specific information about its use in nursing mothers or any considerations related to lactation (the process of producing milk). This means there is no established guidance on how this medication may affect your milk production or your nursing infant.

As always, it's best to consult with your healthcare provider before taking any medication while breastfeeding to ensure the safety and well-being of both you and your baby.

Pediatric Use

It's important to keep this medication out of reach of children. This precaution helps prevent accidental ingestion, which can be dangerous. Always store it in a safe place where children cannot access it, ensuring their safety at all times. If you have any concerns or questions about the medication, don't hesitate to reach out to your healthcare provider for guidance.

Geriatric Use

If you are an older adult or caring for one, it's important to be cautious when using this medication. Before starting, make sure to consult with a doctor, especially if you have kidney disease, as this can affect how your body processes the medication.

Additionally, be mindful of the dosage: do not exceed 15 tablets in a 24-hour period, and avoid using the maximum dosage for more than 2 weeks. Following these guidelines can help ensure safe and effective use of the product.

Renal Impairment

If you have kidney disease, it's important to consult your doctor before using this medication. Your healthcare provider can help determine if it's safe for you and if any adjustments to your dosage are necessary. Always prioritize open communication with your doctor regarding your kidney health to ensure the best care.

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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

Drug Interactions

It's important to be aware that antacids, which are commonly used to relieve heartburn and indigestion, can interact with some prescription medications. This means that taking antacids at the same time as certain drugs could affect how well those medications work.

To ensure your safety and the effectiveness of your treatments, always discuss any medications, including over-the-counter products like antacids, with your healthcare provider. They can help you understand potential interactions and adjust your treatment plan if necessary.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place at a temperature between 15°-30°C (59°-86°F). This temperature range helps maintain the product's effectiveness.

Before using the product, always check that the safety seal under the cap is intact. If the seal is broken or missing, do not use the product, as this could indicate that it has been compromised. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Calcium Carbonate used for?

Calcium Carbonate is used to relieve heartburn, sour stomach, acid indigestion, and upset stomach associated with these symptoms.

How should I take Calcium Carbonate?

You should chew 2-4 tablets as symptoms occur and can repeat hourly if needed, but do not take more than 15 tablets in a 24-hour period or use the maximum dosage for more than 2 weeks.

Are there any warnings I should be aware of?

Yes, ask a doctor before use if you have kidney disease or are taking any prescription drugs, as antacids may interact with certain medications.

Is Calcium Carbonate safe to use during pregnancy?

No specific information regarding the use of Calcium Carbonate during pregnancy is provided, so consult your doctor for advice.

What should I do if the safety seal is broken or missing?

Do not use Calcium Carbonate if the imprinted safety seal under the cap is broken or missing.

How should I store Calcium Carbonate?

Store Calcium Carbonate at a temperature between 15°-30°C (59°-86°F).

What should I do if I have kidney disease?

If you have kidney disease, you should ask a doctor before using Calcium Carbonate.

Is there any information about using Calcium Carbonate while nursing?

No specific information regarding nursing mothers or lactation considerations is provided for Calcium Carbonate.

Are there any contraindications for Calcium Carbonate?

No specific contraindications are mentioned for Calcium Carbonate.

What should I do if I have questions about Calcium Carbonate?

If you have any questions or concerns about using Calcium Carbonate, consult your healthcare provider.

Packaging Info

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

Packaging configurations for Calcium Carbonate.
Details

Drug Information (PDF)

This file contains official product information for Calcium Carbonate, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Calcium Carbonate is a chemical compound with the molecular formula CaCO₃. Each dosage unit contains 500 mg of Calcium Carbonate. This compound is commonly used as a dietary supplement and antacid. It appears as a white, odorless powder or crystalline solid.

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

Patients should chew 2 to 4 tablets as symptoms occur. If necessary, the dosage may be repeated hourly. It is important to monitor the patient's response and adjust the frequency of administration accordingly, ensuring that the total daily intake does not exceed recommended limits.

Contraindications

Use of this product is contraindicated in patients who exceed the recommended dosage of 15 tablets within a 24-hour period or utilize the maximum dosage for more than 2 weeks. Adhering to these guidelines is essential to prevent potential adverse effects associated with prolonged or excessive use.

Warnings and Precautions

It is imperative that healthcare professionals advise patients to consult a physician prior to using this product if they have a history of kidney disease or are currently taking any prescription medications, as antacids may interact with certain drugs.

Patients should be cautioned against exceeding a maximum dosage of 15 tablets within a 24-hour period. Furthermore, the use of this product should not extend beyond 2 weeks at the maximum dosage to mitigate the risk of potential adverse effects.

No specific laboratory tests are recommended for monitoring during the use of this product; however, healthcare providers should remain vigilant for any signs of complications, particularly in patients with pre-existing conditions or those on concurrent medications.

Side Effects

Patients should be advised to consult a healthcare professional prior to using this product if they have kidney disease or are taking any prescription medications, as antacids may interact with certain prescription drugs.

When using this product, it is important for patients to adhere to the recommended dosage guidelines. Specifically, patients should not exceed 15 tablets within a 24-hour period and should not use the maximum dosage for more than 2 weeks.

Additionally, this product should be kept out of reach of children to prevent accidental ingestion.

Drug Interactions

Antacids may interact with various prescription medications, potentially affecting their absorption and efficacy. It is advisable to monitor the timing of antacid administration in relation to other medications to minimize these interactions. Specifically, antacids should be taken at least 2 hours apart from other drugs to ensure optimal therapeutic outcomes. Healthcare professionals should consider this timing when prescribing medications that may be affected by antacids.

Packaging & NDC

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

Packaging configurations for Calcium Carbonate.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. This precaution is essential to ensure safety and prevent accidental ingestion.

Geriatric Use

Elderly patients should consult a healthcare provider prior to using this product, particularly if they have a history of kidney disease. It is essential to monitor renal function closely in this population, as age-related decline in kidney function may necessitate dosage adjustments.

When using this product, elderly patients should adhere to the recommended maximum dosage, which is not to exceed 15 tablets within a 24-hour period. Additionally, the maximum dosage should not be utilized for more than 2 weeks. Prolonged use or exceeding the recommended dosage may increase the risk of adverse effects, particularly in geriatric patients who may be more susceptible to complications. Regular assessment and monitoring are advised to ensure safety and efficacy in this demographic.

Pregnancy

There is no specific information regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and should be informed of the need to discuss any plans for pregnancy with their healthcare provider.

Lactation

There is no specific information regarding the use of Calcium Carbonate in lactating mothers or any lactation considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution and consider the lack of data when advising lactating mothers about the use of this medication. The potential effects on breastfed infants have not been established.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

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 event of overdosage, it is critical to adhere to the recommended dosage guidelines to prevent adverse effects. Healthcare professionals should advise patients not to exceed 15 tablets within a 24-hour period. Additionally, the maximum dosage of this product should not be utilized for more than 2 weeks consecutively.

Symptoms of overdosage may vary and can include a range of adverse effects. It is essential for healthcare providers to monitor patients closely for any signs of toxicity or overdose.

Management of overdosage should involve immediate medical evaluation. Healthcare professionals are encouraged to initiate supportive care and symptomatic treatment as necessary. In cases of suspected overdose, contacting a poison control center or seeking emergency medical assistance is recommended to ensure appropriate intervention and management.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients not to exceed a maximum of 15 tablets within a 24-hour period and to refrain from using the maximum dosage of this product for more than 2 weeks. It is important for patients to understand the significance of adhering to these dosage recommendations to avoid potential adverse effects.

Patients should be encouraged to consult with their healthcare provider prior to use if they have a history of kidney disease. This precaution is essential to ensure the safe use of the product in individuals with compromised kidney function.

Additionally, healthcare providers should inform patients to seek medical advice before using this product if they are currently taking any prescription medications. Antacids may interact with certain prescription drugs, and it is crucial for patients to disclose their medication regimen to prevent any possible drug interactions.

Storage and Handling

The product is supplied in a configuration that includes an imprinted safety seal under the cap. It is essential to ensure that this seal is intact before use, as the product should not be utilized if the seal is broken or missing.

For optimal storage, the product must be kept at a temperature range of 15° to 30°C (59° to 86°F). Proper handling and storage conditions are crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Calcium Carbonate, 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 Calcium Carbonate, 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.