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Calcium Carbonate 500 mg

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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 2015
Label revision date
January 15, 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 2015
Label revision date
January 15, 2025
Manufacturer
Reliable 1 Laboratories LLC
Registration number
M001
NDC root
69618-020
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 is a chewable antacid that comes in 500 mg tablets and is available in assorted flavors. It is commonly used to relieve symptoms such as acid indigestion, heartburn, and a sour stomach. By neutralizing stomach acid, calcium carbonate helps provide quick relief from discomfort associated with these conditions.

Uses

If you're experiencing discomfort from acid indigestion, heartburn, or a sour stomach, this medication can help provide relief. It works effectively to ease these common digestive issues, allowing you to feel more comfortable after meals or during times of stress.

You can trust that this medication does not have any known teratogenic effects, meaning it does not cause harm to a developing fetus. This makes it a safer option for those who may be pregnant or planning to become pregnant.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can chew 2 to 4 tablets when you experience symptoms. However, it's important not to exceed 8 tablets in a 24-hour period. Additionally, you should avoid using the maximum dosage for more than 2 weeks to ensure your safety.

For children under 12 years old, it's best to consult a doctor before giving them this medication. This way, you can ensure they receive the appropriate care and dosage tailored to their needs.

What to Avoid

It's important to be aware of certain guidelines when using this medication. While there are no specific contraindications or concerns regarding abuse, misuse, or dependence, you should stop using the medication and consult your doctor if your symptoms persist for more than two weeks. This ensures that you receive the appropriate care and guidance for your health needs. Always prioritize your well-being and communicate openly with your healthcare provider.

Side Effects

Before using this medication, it's important to consult with your doctor or pharmacist, especially if you are currently taking any prescription drugs, as antacids can interact with them. If your symptoms persist for more than two weeks, you should stop using the medication and seek medical advice. Additionally, keep this product out of reach of children to ensure their safety.

Warnings and Precautions

Before using this medication, it's important to consult with your doctor or pharmacist, especially if you are currently taking any prescription drugs. Some antacids can interact with these medications, which may affect how well they work.

If your symptoms persist for more than two weeks, you should stop using the medication and reach out to your doctor for further advice. Additionally, make sure to keep this product out of reach of children to ensure their safety.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

There is no specific information available about the use of Calcium Carbonate 500 mg during pregnancy, including safety concerns, dosage adjustments, or any special precautions you should take. If you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this medication to ensure it is safe for you and your baby. Always prioritize open communication with your doctor regarding any medications you are considering during this time.

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 also 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 this product while breastfeeding. Your health and the health of your baby are important, and your provider can help you make informed decisions.

Pediatric Use

If you are considering this medication for your child, it's important to know that it is not recommended for children under 12 years old without consulting a doctor first. Always reach out to your child's healthcare provider to discuss any concerns or questions you may have regarding their treatment. This ensures that your child receives the safest and most effective care tailored to their age and health needs.

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 the drug insert does not provide guidelines tailored for elderly patients.

If you are caring for an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach to medication management, considering any unique health needs or conditions that may be present. Always prioritize open communication with healthcare professionals 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 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 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 may affect how well those medications work.

To ensure your safety and the effectiveness of your treatment, always discuss any medications you are taking, 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 safety and effectiveness of your product, store it at room temperature. It's important to keep it out of reach of children to prevent any accidental use. Once you open the product, be sure to discard it after use to maintain safety and hygiene. Following these guidelines will help you use the product safely and effectively.

Additional Information

You will 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 is Calcium Carbonate used for?

Calcium Carbonate is an antacid that relieves acid indigestion, heartburn, and sour stomach.

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

You should chew 2-4 tablets as symptoms occur, but do not take more than 8 tablets in 24 hours or use the maximum dosage for more than 2 weeks.

What should I do if symptoms last more than 2 weeks?

You should stop use and ask a doctor if symptoms last more than 2 weeks.

Is Calcium Carbonate safe for children under 12?

For children under 12 years, you should ask a doctor before use.

Are there any warnings associated with Calcium Carbonate?

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

What should I do if I accidentally take too much Calcium Carbonate?

If you take more than the recommended dosage, you should seek medical advice.

Is there any information about using Calcium Carbonate during pregnancy or while nursing?

There are no specific warnings or recommendations regarding the use of Calcium Carbonate during pregnancy or for nursing mothers.

How should I store Calcium Carbonate?

Store Calcium Carbonate at room temperature, keep it out of reach of children, and discard it after opening.

Packaging Info

Below are the non-prescription pack sizes of Calcium Carbonate 500 mg (calcium carbonate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Calcium Carbonate 500 mg.
Details

Drug Information (PDF)

This file contains official product information for Calcium Carbonate 500 mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

This product contains Calcium Carbonate as the active ingredient, providing 500 mg per chewable tablet. It is classified as an antacid and is available in assorted flavors. Each bottle contains 150 chewable tablets. The National Drug Code (NDC) for this product is 69618-020-15. Reliable-1 Laboratories LLC is not affiliated with the owner of the trademark Tums®.

Uses and Indications

This drug is indicated for the relief of acid indigestion, heartburn, and sour stomach.

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

Dosage and Administration

Adults and children aged 12 years and over are advised to chew 2 to 4 tablets as symptoms occur. The total dosage should not exceed 8 tablets within a 24-hour period. It is important to note that the maximum dosage should not be utilized for more than 2 consecutive weeks.

For children under 12 years of age, it is recommended to consult a physician before administration.

Contraindications

There are no specified contraindications for this product. However, it is advised to discontinue use and consult a healthcare professional if symptoms persist for more than two weeks.

Warnings and Precautions

Healthcare professionals should advise patients to consult with a physician or pharmacist prior to using this product if they are currently taking any prescription medications. This precaution is essential as antacids may interact with certain prescription drugs, potentially affecting their efficacy or safety.

Patients should be instructed to discontinue use and seek medical advice if their symptoms persist for more than two weeks. Prolonged symptoms may indicate an underlying condition that requires further evaluation.

It is imperative to keep this product out of reach of children to prevent accidental ingestion and potential harm.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. It is important to consult a doctor or pharmacist prior to use if patients are currently taking any prescription drugs, as antacids may interact with certain medications.

In the event that symptoms persist for more than two weeks, patients are advised to discontinue use and seek medical advice. Additionally, this product should be kept out of reach of children to prevent accidental ingestion.

The information provided is crucial for ensuring safe and effective use of the medication, and adherence to these guidelines is recommended to mitigate potential risks.

Drug Interactions

Antacids have the potential to interact with various prescription medications, which may affect the absorption and efficacy of these drugs. It is advisable for healthcare professionals to monitor patients closely when antacids are co-administered with other medications.

In cases where antacids are prescribed alongside other drugs, dosage adjustments may be necessary to mitigate the risk of reduced therapeutic effects. Patients should be counseled on the timing of antacid administration relative to their other medications to optimize therapeutic outcomes.

Packaging & NDC

Below are the non-prescription pack sizes of Calcium Carbonate 500 mg (calcium carbonate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Calcium Carbonate 500 mg.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information regarding the use of Calcium Carbonate 500 mg 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 discussing any medications with their healthcare provider prior to 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 have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Overall, vigilance and prompt intervention are critical in managing any suspected overdose scenario.

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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion.

Patients should be informed to discontinue use and consult a doctor if their symptoms persist for more than two weeks, as this may indicate a need for further evaluation or alternative treatment options.

Additionally, it is important for patients to seek guidance from a healthcare professional, such as a doctor or pharmacist, before using this medication if they are currently taking any prescription drugs. This is particularly crucial as antacids may interact with certain prescription medications, potentially affecting their efficacy or safety.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It should be stored at room temperature to maintain its efficacy. It is essential to keep the product out of reach of children to prevent accidental ingestion. Once opened, the product must be discarded to ensure safety and effectiveness.

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 Calcium Carbonate 500 mg, 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 500 mg, 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.