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Calcium carbonate

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Active ingredient
Calcium Carbonate 1250 mg/5 mL
Other brand names
Drug classes
Blood Coagulation Factor, Phosphate Binder
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2004
Label revision date
November 12, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Calcium Carbonate 1250 mg/5 mL
Other brand names
Drug classes
Blood Coagulation Factor, Phosphate Binder
Dosage form
Suspension
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 2004
Label revision date
November 12, 2024
Manufacturer
PAI Holdings, LLC dba PAI Pharma
Registration number
M001
NDC roots
0121-0766, 0121-4766
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

Calcium carbonate is an oral suspension that serves as a maximum strength antacid, providing relief from heartburn, acid indigestion, sour stomach, and upset stomach associated with these symptoms. In addition to its role in alleviating discomfort, it also acts as a daily source of calcium, which is essential for maintaining strong bones and overall health.

This sugar-free, alcohol-free, and sodium-free formulation is designed to be gentle on your system while effectively addressing digestive issues. If you're looking for a way to soothe your stomach while also supporting your calcium intake, calcium carbonate may be a suitable option for you.

Uses

If you're experiencing discomfort from heartburn, acid indigestion, or a sour stomach, 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

Before using the medication, make sure to shake the bottle well. This helps to mix the ingredients properly. When you're ready to take it, you can measure out 1 to 2 teaspoonfuls, which is equivalent to 5 to 10 milliliters (mL). You should take this dosage as your symptoms arise, or follow your doctor's specific instructions if they have provided any.

It's important to pay attention to how often you need to take the medication based on your symptoms. Always consult with your healthcare provider if you have any questions or concerns about your dosage.

What to Avoid

It's important to use this medication responsibly to ensure your safety and well-being. You should not take more than 6 teaspoonfuls (30 mL) within a 24-hour period, and avoid using the maximum dosage for longer than 2 weeks. Following these guidelines helps prevent potential issues related to misuse or overuse.

While there are no specific contraindications or concerns about dependence (which means relying on a substance), it's always best to use medications as directed. If you have any questions or concerns about your treatment, please consult your healthcare provider for personalized advice.

Side Effects

When using this product, it's important to follow the recommended dosage. You should not take more than 6 teaspoonfuls (30 mL) in a 24-hour period, and avoid using the maximum dosage for more than 2 weeks. Additionally, keep this product out of reach of children to ensure their safety.

If you experience any unusual reactions or side effects, please consult your healthcare provider for guidance.

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 cautious not to exceed 6 teaspoonfuls (30 mL) in a 24-hour period, and avoid using the maximum dosage for more than 2 weeks. This will help ensure your safety while using the product. If you experience any unusual symptoms or have concerns, please reach out to your healthcare provider for guidance.

Overdose

Taking more than 6 teaspoonfuls (30 mL) of this medication in a 24-hour period, or using the maximum dosage 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.

If you experience any concerning symptoms or if you have taken too much of the medication, contact your healthcare provider or go to the nearest emergency room right away. Always remember to follow the recommended dosage guidelines to ensure your safety.

Pregnancy Use

While the information provided does not specify any particular safety concerns or dosage modifications for pregnant individuals, it is always important to consult with your healthcare provider before taking any medication during pregnancy. They can offer personalized advice based on your health and circumstances.

Since there are no special precautions mentioned regarding use during pregnancy, maintaining open communication with your doctor about any medications you are considering is essential. This ensures that you receive the best care for both you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of Calcium Carbonate. The information available does not indicate any concerns about it being passed into breast milk or posing any risk to your infant.

As always, if you have any questions or concerns about medications while nursing, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

It's important to keep this medication out of reach of children to ensure their safety. If your child is taking any prescription medications, be sure to consult with a doctor or pharmacist before using this product. For symptom relief, the recommended dosage for children is 1 to 2 teaspoonfuls (5 to 10 mL) as needed, or as directed by a healthcare professional. Always follow their guidance to ensure the best care for your child.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns or questions with your doctor, especially regarding potential interactions with other medications or existing health conditions.

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 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 (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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 a temperature between 20° and 25°C (68° and 77°F). It's important to keep it away from freezing temperatures, as freezing can damage the product.

When handling the product, make sure to maintain a clean environment to avoid contamination. Always follow any specific instructions provided for safe use and disposal to ensure your safety and the effectiveness of the product.

Additional Information

You should take 1 to 2 teaspoonfuls (5 to 10 mL) of the medication as symptoms occur, or follow your doctor's instructions for use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Calcium Carbonate used for?

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

How should I take Calcium Carbonate?

You should take 1 to 2 teaspoonfuls (5 to 10 mL) as symptoms occur, or as directed by a doctor.

What is the maximum dosage for Calcium Carbonate?

Do not take more than 6 teaspoonfuls (30 mL) in a 24-hour period or use the maximum dosage for more than 2 weeks.

Are there any contraindications for Calcium Carbonate?

No contraindications are listed for Calcium Carbonate.

Can Calcium Carbonate interact with other medications?

Yes, antacids like Calcium Carbonate may interact with certain prescription drugs, so consult your doctor or pharmacist before use.

Is Calcium Carbonate safe to use during pregnancy?

The insert does not specifically mention safety concerns regarding the use of Calcium Carbonate during pregnancy.

What should I do if I have children around?

Keep Calcium Carbonate out of reach of children.

How should I store Calcium Carbonate?

Store Calcium Carbonate at 20° - 25°C (68° - 77°F) and do not freeze.

What are the ingredients in Calcium Carbonate?

Calcium Carbonate is a sugar-free, alcohol-free, and sodium-free oral suspension.

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

Calcium Carbonate Oral Suspension is a maximum strength antacid formulation, providing 1250 mg of calcium carbonate per 5 mL. This product serves as a daily source of calcium and is presented in a 16 fl oz (473 mL) bottle. It is manufactured by Pharmaceutical Associates, Inc., located in Greenville, SC 29605. The formulation is sugar-free, alcohol-free, and sodium-free, ensuring suitability for a variety of dietary needs. The product is identified by NDC 0121-0766-16.

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

Healthcare professionals are advised to instruct patients to shake the medication well before use. The recommended dosage is 1 to 2 teaspoonfuls (5 to 10 mL) to be taken as symptoms occur, or as directed by a physician. It is essential to follow the prescribed dosing regimen to ensure optimal therapeutic outcomes.

Contraindications

There are no specific contraindications listed for this product. However, it is advised that patients do not exceed a dosage of 6 teaspoonfuls (30 mL) within a 24-hour period or use the maximum dosage for more than 2 weeks to avoid potential adverse effects.

Warnings and Precautions

Healthcare professionals should advise patients to consult with a doctor 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 leading to adverse effects or reduced efficacy of the medications.

It is important to adhere to the recommended dosage guidelines when using this product. Patients should not exceed 6 teaspoonfuls (30 mL) within a 24-hour period, nor should they utilize the maximum dosage for longer than 2 weeks. This limitation is crucial to prevent potential complications associated with overuse.

Currently, there are no specific laboratory tests indicated for monitoring the use of this product. However, healthcare professionals should remain vigilant for any signs of adverse reactions or interactions, particularly in patients with complex medication regimens.

Side Effects

When using this product, patients should adhere to the recommended dosage guidelines, which specify not to exceed 6 teaspoonfuls (30 mL) in a 24-hour period or to use the maximum dosage for more than 2 weeks. Failure to follow these instructions may lead to serious adverse reactions.

It is crucial to keep this product out of reach of children to prevent accidental ingestion, which could result in severe health consequences.

Patients are advised to monitor for any adverse reactions and to consult healthcare professionals if they experience any concerning symptoms.

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 and to avoid diminished efficacy of the prescribed treatments.

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 advised to keep this medication out of reach of children. Prior to administration, it is important for caregivers to consult a healthcare professional if the child is taking any prescription medications.

For symptomatic relief, the recommended dosage for pediatric patients is 1 to 2 teaspoonfuls (5 to 10 mL) as symptoms occur, or as directed by a healthcare provider.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients may use this medication as no specific safety concerns regarding pregnancy have been detailed in the prescribing information. There are no dosage modifications recommended for pregnant individuals, nor are there any special precautions regarding its use during pregnancy. Healthcare professionals should consider the overall clinical context when prescribing this medication to women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of Calcium Carbonate in lactating mothers. Additionally, there is no information available concerning the potential for excretion of Calcium Carbonate 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 prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.

Overdosage

In the event of overdosage, it is critical to adhere to the recommended dosage guidelines to prevent adverse effects. The maximum allowable dosage is 6 teaspoonfuls (30 mL) within a 24-hour period. Exceeding this limit or utilizing the maximum dosage for a duration exceeding 2 weeks may lead to potential health risks.

Healthcare professionals should be vigilant for symptoms that may arise from overdosage. While specific symptoms are not detailed in the provided information, it is advisable to monitor patients closely for any signs of toxicity or adverse reactions.

In cases of suspected overdosage, immediate medical attention is warranted. Management procedures should include supportive care and symptomatic treatment as necessary. It is essential to evaluate the patient's condition and implement appropriate interventions based on clinical judgment.

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

Serious side effects have been reported voluntarily or through surveillance programs. Healthcare professionals and patients are encouraged to report any serious adverse events to the designated phone number for further evaluation and monitoring.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion.

Patients should be informed about the importance of adhering to the recommended dosage. Specifically, they should not exceed 6 teaspoonfuls (30 mL) within a 24-hour period and should avoid using the maximum dosage for more than 2 weeks.

Additionally, it is crucial for patients to consult with their healthcare provider or pharmacist before using this product if they are currently taking any prescription medications. This is particularly important as antacids may interact with certain prescription drugs, which could affect their efficacy or lead to adverse effects.

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 temperature range of 20° to 25°C (68° to 77°F). Freezing the product is strictly prohibited, as it may compromise its integrity and efficacy. Proper storage conditions must be maintained to ensure the product remains effective and safe for use.

Additional Clinical Information

Patients are advised to take 1 to 2 teaspoonfuls (5 to 10 mL) as symptoms occur, or as directed by a clinician. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

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

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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.