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Calcium carbonate

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This product has been discontinued

Active ingredient
Calcium Carbonate 500 mg
Other brand names
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 2023
Label revision date
December 11, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Calcium Carbonate 500 mg
Other brand names
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 2023
Label revision date
December 11, 2024
Manufacturer
Spirit Pharmaceuticals LLC
Registration number
M001
NDC root
68210-5033
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, acid indigestion, sour stomach, or an upset stomach. This medication is designed to help relieve these symptoms, providing you with comfort and support when you need it most. By targeting the underlying causes of these digestive issues, it aims to restore your sense of well-being and ease your discomfort.

Uses

If you're experiencing discomfort from heartburn, acid indigestion, or a sour stomach, this medication can help relieve those symptoms. It is also effective for soothing an upset stomach that may be associated with these issues. You can feel more comfortable and get back to your daily activities without the nagging discomfort of these digestive problems.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take this medication by chewing 2 to 4 tablets whenever you experience symptoms, or as your doctor instructs. It's important to pay attention to how long your symptoms last. If your symptoms continue for more than 2 weeks, you should consult your doctor before taking more of the medication. Always follow your healthcare provider's advice to ensure safe and effective use.

What to Avoid

It's important to use this medication responsibly to ensure your safety. You should not take more than 14 tablets in a 24-hour period. 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 your doctor has advised and is supervising you.

By following these guidelines, you can help prevent potential risks associated with misuse or overuse of the medication. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

It's important to be aware that antacids can interact with some prescription medications, which may affect how well those medications work. If you are taking any prescription drugs, be sure to discuss your use of antacids with your healthcare provider to avoid any potential issues.

While specific side effects were not detailed, always monitor how you feel after taking any medication and report any unusual symptoms to your doctor. Your health and safety are paramount, so staying informed is key.

Warnings and Precautions

It's important to use this medication safely to avoid potential risks. You should not take more than 14 tablets in a 24-hour period. 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 your doctor has advised you to do so.

While there are no specific emergency instructions or lab tests mentioned, always be mindful of how your body responds to the medication. If you experience any unusual symptoms or have concerns, it's best to stop taking the medication and consult your doctor for guidance. Your health and safety are paramount, so don't hesitate to reach out for help if needed.

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

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 or planning to breastfeed, it's important to know that there is no specific information available about the use of Calcium Carbonate 500mg during nursing. This means that the effects on breast milk and your nursing infant are not well-studied or documented.

As always, it's a good idea 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

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 their symptoms, or follow the guidance of a doctor.

Always remember to keep this 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 with a healthcare professional.

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, which can be important given the unique health considerations that often come with aging.

If you or a caregiver are considering this medication for an older adult, it’s essential to consult with a healthcare professional. They can provide personalized advice and monitor for any potential issues, ensuring that the treatment is safe and effective for the individual’s specific health needs.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. Your healthcare provider will monitor your kidney function regularly, especially through tests that measure creatinine clearance (a way to assess how well your kidneys are filtering waste). If you have moderate to severe renal impairment, you might require a lower dose of your medication.

Before starting any new treatment, your renal function should be tested, and these tests will continue periodically to ensure your safety and the effectiveness of the therapy. Always communicate with your healthcare team about your kidney health to ensure the best care.

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, and your healthcare team is there to support you.

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 best performance and safety of your product, store it at a temperature between 20-25°C (68-77°F). This temperature range helps maintain the integrity of the device.

When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Proper storage and careful handling are essential for ensuring the product works effectively and safely.

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 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.

What is the maximum number of tablets I can take in a day?

Do not take more than 14 tablets in 24 hours.

What should I do if I am pregnant?

If you are 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.

Can this drug interact with other medications?

Yes, antacids may interact with certain prescription drugs.

What should I do if I have renal impairment?

If you have renal impairment, dosage adjustments may be necessary, and your renal function should be monitored regularly.

What is the storage temperature for this drug?

Store this drug between 20-25° C (68-77° F).

Is there any information regarding use in elderly patients?

No specific information regarding geriatric use or dosage adjustments is provided.

Packaging Info

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

Packaging configurations for Calcium Carbonate 500mg.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as microcrystalline cellulose, magnesium stearate, and silicon dioxide.

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 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 important to note that the medication should not be taken for symptoms that persist for more than 2 weeks unless advised by a doctor.

Contraindications

There are no specific contraindications listed for this product. However, the following usage instructions should be adhered to in order to ensure safety:

  • Do not exceed 14 tablets within a 24-hour period.

  • In pregnant individuals, do not exceed 10 tablets within a 24-hour period.

  • The maximum dosage should not be used for more than 2 weeks unless advised and supervised by a healthcare professional.

Warnings and Precautions

Healthcare professionals should be aware of the following precautions associated with the use of this medication.

General precautions must be strictly adhered to in order to ensure patient safety. It is imperative that patients do not exceed a maximum dosage of 14 tablets within a 24-hour period. For pregnant individuals, the dosage should not exceed 10 tablets in a 24-hour timeframe. Furthermore, the maximum dosage should not be utilized for more than 2 weeks unless specifically advised and monitored by a healthcare provider.

While no specific laboratory tests are required for monitoring, healthcare professionals should remain vigilant for any adverse effects or complications that may arise during treatment. Regular patient assessments are recommended to ensure adherence to the outlined dosage guidelines and to evaluate the overall effectiveness of the therapy.

In the event of any concerning symptoms or adverse reactions, patients should be instructed to discontinue use and consult their healthcare provider for further evaluation and guidance.

Side Effects

Patients should be aware of potential adverse reactions associated with the use of this medication. While specific serious adverse reactions are not detailed, it is important to note that antacids may interact with certain prescription drugs, which could lead to altered efficacy or increased risk of side effects from those medications.

Healthcare providers should monitor patients for any unusual symptoms or reactions, particularly when antacids are used concurrently with other treatments. It is advisable for patients to inform their healthcare provider of all medications they are taking to mitigate the risk of adverse interactions.

In clinical practice, awareness of these interactions is crucial for ensuring patient safety and optimizing therapeutic outcomes.

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 effects. 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 500mg. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Calcium Carbonate 500mg.
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 younger children to ensure safety.

Geriatric Use

There is no specific information available 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.

Pregnancy

Pregnant patients are 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 counsel women of childbearing potential regarding the importance of adhering to this dosage limit to ensure the safety of both the mother and the developing fetus.

Lactation

There is no specific information regarding the use of Calcium Carbonate 500mg in lactating mothers or its effects on breastfed infants. Healthcare professionals should consider the lack of data when advising lactating mothers on the use of this medication.

Renal Impairment

Patients with renal impairment may necessitate dosage adjustments based on their level of renal function. It is essential for healthcare professionals to monitor renal function regularly in these patients. Dosage adjustments should be guided by creatinine clearance levels, with reduced doses potentially required for those with moderate to severe renal impairment. Additionally, renal function tests should be performed prior to initiating therapy and periodically thereafter to ensure appropriate management of the patient's condition.

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.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for appropriate treatment and follow-up care.

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 question.

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. It is important to instruct patients not to exceed a maximum dosage of 14 tablets within a 24-hour period. For pregnant patients, it is crucial to limit the intake to no more than 10 tablets in a 24-hour period.

Providers should emphasize that the maximum dosage should not be used for more than 2 weeks unless under the guidance and supervision of a healthcare professional. Additionally, patients should be encouraged to consult with their doctor or pharmacist before using this medication if they are currently taking any prescription drugs, as antacids may interact with certain medications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20-25°C (68-77°F) to maintain its efficacy and stability. Proper container requirements must be adhered to, ensuring that the product is kept in its original packaging to prevent exposure to environmental factors. Special handling needs should be observed to avoid any conditions that may compromise the integrity of the product.

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 500mg, 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 500mg, 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.