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Calcium carbonate

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Active ingredient
Calcium Carbonate 648 mg
Other brand names
Drug classes
Blood Coagulation Factor, Phosphate Binder
Dosage form
Tablet
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
January 30, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Calcium Carbonate 648 mg
Other brand names
Drug classes
Blood Coagulation Factor, Phosphate Binder
Dosage form
Tablet
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 2018
Label revision date
January 30, 2025
Manufacturer
CitraGen Pharmaceuticals, Inc.
Registration number
M001
NDC root
70369-004
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 Tablets are a type of medication that serves two main purposes: they act as an antacid and provide calcium supplementation. You can use these tablets to relieve symptoms such as acid indigestion, heartburn, sour stomach, and upset stomach associated with these conditions.

By neutralizing stomach acid, Calcium Carbonate helps to alleviate discomfort and promote digestive health. It's important to note that this product is intended for households without young children.

Uses

If you're experiencing discomfort from acid indigestion, heartburn, or a sour stomach, this medication can help relieve those symptoms. It’s also effective for 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.

Dosage and Administration

You should take one to four tablets each day, depending on your needs. However, it's important not to exceed four tablets within a 24-hour period. This helps ensure your safety and the effectiveness of the medication.

If you find that you need to take the maximum dosage of four tablets, be cautious and do not continue this level of dosage for more than two weeks. Following these guidelines will help you use the medication safely and effectively.

What to Avoid

It's important to keep this product out of reach of children to ensure their safety. If your symptoms persist for more than two weeks, you should stop using the product and consult a doctor. Additionally, if you are currently taking any prescription medications, it's wise to speak with your doctor or pharmacist before using this product to avoid any potential interactions.

Side Effects

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

If you are pregnant or breastfeeding, please talk to a healthcare professional before using this medication. Additionally, ensure that this product is kept out of reach of children to prevent accidental ingestion.

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, as antacids can interact with them. If you are pregnant or breastfeeding, please seek advice from a healthcare professional before using this product.

Make sure to keep this medication out of reach of children. If your symptoms persist for more than two weeks, stop using the medication and contact your doctor for further guidance.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general 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 always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

It's important to keep this medication out of reach of children to ensure their safety. This package is specifically designed for households that do not have young children. If you have children at home, please consider alternative options or consult your healthcare provider for guidance. Always prioritize safety when it comes to medications and young ones.

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, it’s important to consult with a healthcare provider before starting the medication. 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 the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 need 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 best performance of your product, store it at room temperature, ideally between 15º and 30º C (59º and 86º F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety and effectiveness.

Additional Information

No further information is available.

FAQ

What is Calcium Carbonate Tablets used for?

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

How many Calcium Carbonate Tablets can I take daily?

You can take one to four tablets daily, but do not exceed four tablets in 24 hours.

How long can I use the maximum dosage of Calcium Carbonate Tablets?

Do not use the maximum dosage for more than 2 weeks.

Are there any contraindications for Calcium Carbonate Tablets?

No specific contraindications are mentioned for Calcium Carbonate Tablets.

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

Stop use and ask a doctor if your symptoms last more than 2 weeks.

Can I take Calcium Carbonate Tablets if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

What precautions should I take when using Calcium Carbonate Tablets?

Keep out of reach of children and ask a doctor or pharmacist before use if you are taking a prescription drug, as antacids may interact with certain medications.

What is the storage condition for Calcium Carbonate Tablets?

Store Calcium Carbonate Tablets at room temperature between 15º - 30º C (59º - 86º F).

Packaging Info

Below are the non-prescription pack sizes of Calcium Carbonate. 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

CitraGen Pharmaceuticals, Inc. produces Calcium Carbonate Tablets, USP, each containing 10 grams (648 mg) of calcium carbonate. This product serves as both an antacid and a calcium supplement. The package contains 1000 tablets and is specifically designed for households without young children. The National Drug Code (NDC) for this product is 70369-004-01.

Uses and Indications

This drug is indicated for the relief of acid indigestion, heartburn, sour stomach, and upset stomach associated with these symptoms.

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

Dosage and Administration

Patients are advised to take one to four tablets daily, with a maximum limit of four tablets within a 24-hour period. It is important to note that the maximum dosage should not be utilized for more than two consecutive weeks. Healthcare professionals should monitor patients for adherence to these guidelines to ensure safety and efficacy.

Contraindications

There are no specific contraindications identified for this product. However, it is advised to keep the product out of reach of children. Additionally, patients should discontinue use and consult a healthcare professional if symptoms persist for more than two weeks. It is also recommended that individuals consult a doctor or pharmacist prior to use if they are currently taking any prescription medications.

Warnings and Precautions

Patients should consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking any prescription drugs, as antacids may interact with certain medications.

In the event that symptoms persist for more than two weeks, it is imperative to discontinue use and seek medical advice.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional before using this product to ensure safety for both the mother and child.

Additionally, this medication should be kept out of reach of children to prevent accidental ingestion and potential harm.

Side Effects

Patients should be advised to consult a doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with certain prescription drugs.

In the event that symptoms persist for more than two weeks, patients are instructed to discontinue use and seek medical advice.

For individuals who are pregnant or breastfeeding, it is recommended to consult a health professional before using this product to ensure safety for both the mother and child.

Additionally, it is crucial to keep this product out of reach of children to prevent accidental ingestion or misuse.

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. Patients should be counseled to separate the dosing of antacids and other drugs by at least two hours when possible to ensure optimal therapeutic outcomes.

Packaging & NDC

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

Packaging configurations for Calcium Carbonate.
Details

Pediatric Use

Pediatric patients should be kept out of reach of children. This product is intended for use in households without young children.

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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with its use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage data, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

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 to keep the medication out of reach of children to prevent accidental ingestion. Patients should be informed that if their symptoms persist for more than two weeks, they should stop using the medication and consult a doctor for further evaluation.

Additionally, it is important for healthcare providers to recommend that patients consult with their doctor or pharmacist before using this medication if they are currently taking any prescription drugs. Patients should be made aware that antacids may interact with certain prescription medications, and this potential interaction should be discussed to ensure safe and effective use.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at room temperature, maintaining a range of 15º to 30º C (59º to 86º F). Care should be taken to ensure that the product is kept in a suitable container to protect its integrity. Special handling requirements should be observed to maintain the quality and efficacy of the product throughout its storage period.

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.