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Calcium carbonate

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Active ingredient
Calcium Carbonate 1 g/1 g
Other brand names
Drug classes
Blood Coagulation Factor, Phosphate Binder
Dosage form
Powder
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2008
Label revision date
December 15, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Calcium Carbonate 1 g/1 g
Other brand names
Drug classes
Blood Coagulation Factor, Phosphate Binder
Dosage form
Powder
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 2008
Label revision date
December 15, 2023
Manufacturer
Humco Holding Group, Inc.
Registration number
M001
NDC root
0395-0431
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

If you're experiencing heartburn, acid ingestion, or an upset stomach, this medication can help provide relief from these uncomfortable symptoms. It is designed to alleviate the discomfort associated with excess stomach acid, making it easier for you to go about your day without the distraction of digestive issues.

While the specific mechanism of action isn't detailed, you can trust that this medication works to soothe your stomach and reduce the feelings of acidity and discomfort. Always consult with a healthcare professional for personalized advice and to ensure this treatment is right for you.

Uses

If you're experiencing heartburn, acid ingestion, or an upset stomach, this medication can help provide relief from these uncomfortable symptoms. It works by neutralizing stomach acid, which can ease the burning sensation and discomfort you may feel. Whether it's after a meal or due to certain foods, this treatment is designed to help you feel better quickly.

Dosage and Administration

If you are an adult or a child aged 6 years and older, you should take half a level teaspoon of the medication mixed in half a glass (4 fluid ounces) of water. This can be done every two hours, but be sure not to exceed the maximum dosage recommended or what your doctor has directed.

It's important to follow these instructions carefully to ensure you are using the medication safely and effectively. If you have any questions or concerns about your dosage, don't hesitate to reach out to your healthcare provider for guidance.

What to Avoid

It's important to use this product responsibly. You should not take the maximum dosage for more than 2 weeks unless a doctor or health professional advises you to do so. This guideline helps ensure your safety and well-being while using the medication.

Currently, there are no specific contraindications, risks of abuse or misuse, or concerns about dependence associated with this product. However, 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 when using this medication. You should not give it to children under 6 years of age unless a doctor supervises the treatment. Additionally, you should not exceed 3 teaspoonfuls in a 24-hour period to avoid potential risks.

If you are pregnant or nursing, it's advisable to consult with your doctor before using this medication to ensure it is safe for you and your baby. Always prioritize your health and safety by seeking professional guidance when needed.

Warnings and Precautions

It's important to use this medication safely. You should not give it to children under 6 years old without a doctor's supervision. Additionally, avoid taking more than 3 teaspoonfuls in a 24-hour period. If you find that you need to use the maximum dosage, do not do so for more than 2 weeks unless directed by a healthcare professional.

If you accidentally take too much, seek emergency medical help or contact Poison Control right away. Also, if you are pregnant or nursing, make sure to consult your doctor before using this product. Your health and safety are the top priority, so don’t hesitate to reach out for guidance when needed.

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 effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have any concerns about your health.

Pregnancy Use

If you are pregnant or nursing a baby, it’s important to consult with your doctor before using this medication. Your healthcare provider can help you understand any potential risks and ensure that you make the safest choices for you and your baby. Always prioritize open communication with your doctor regarding any medications you may be considering during this time.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using any medication. This is to ensure that it is safe for you and your baby. Your healthcare provider can help you understand any potential risks and make informed decisions about your health and your baby's well-being. Always prioritize open communication with your doctor regarding your breastfeeding status when considering new treatments.

Pediatric Use

It's important to be cautious when giving this medication to children. You should not give it to children under 6 years of age unless a doctor is supervising. For children aged 6 years and older, the recommended dosage is 1/2 level teaspoon mixed in 1/2 glass (4 fluid ounces) of water every 2 hours. However, make sure to follow the maximum dosage guidelines or any specific instructions provided by your doctor. Always consult with a healthcare professional if you have any questions or concerns about administering this medication to your child.

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 for personalized advice. 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your situation. They can help you understand how your kidney health may affect your treatment.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have about your liver function and how it relates to your treatment. They can help ensure that your care is safe and effective.

Drug Interactions

It's great to know that there are no known interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you may start. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place. It's important to keep the container tightly closed to prevent any contamination or exposure to moisture, which can affect the product's effectiveness. By following these simple storage guidelines, you can help maintain the quality and safety of the device.

Additional Information

No further information is available.

FAQ

What is this drug used for?

This drug is used for relief of heartburn, acid ingestion, and upset stomach associated with these symptoms.

Who can take this medication?

Adults and children 6 years of age and older can take this medication.

What is the recommended dosage?

The recommended dosage is 1/2 level teaspoon in 1/2 glass (4 fl oz) of water every 2 hours, up to the maximum dosage or as directed by a doctor.

Are there any warnings for this drug?

Yes, do not administer to children under 6 years of age and do not take more than 3 teaspoonfuls in a 24-hour period without a doctor's supervision.

How long can I use the maximum dosage?

You should not use the maximum dosage for more than 2 weeks unless advised and supervised by a doctor.

What should I do in case of an accidental overdose?

In case of accidental overdose, seek professional assistance or contact a Poison Control immediately.

Should I consult a doctor before using this drug?

Yes, you should ask a doctor before use if you are pregnant or nursing a baby.

How should I store this medication?

Store in a cool, dry place, keep the container tightly closed, and protect from moisture.

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

The product is identified by the SPL code 34089-3. No additional specific description details are provided.

Uses and Indications

This drug is indicated for the relief of heartburn, acid ingestion, and upset stomach associated with these symptoms. It is intended for use in patients experiencing discomfort related to excess stomach acid.

Dosage and Administration

Adults and children 6 years of age and older are instructed to take 1/2 level teaspoon of the medication dissolved in 1/2 glass (4 fluid ounces) of water. This dosage should be administered every 2 hours, not exceeding the maximum dosage as directed by a healthcare professional. It is essential to follow the prescribed instructions and consult a physician for any adjustments or concerns regarding the dosage.

Contraindications

The use of this product is contraindicated in patients who exceed the maximum dosage for more than 2 weeks without the advice and supervision of a healthcare professional. Prolonged use at maximum dosage may pose risks that necessitate medical oversight.

Warnings and Precautions

Administration of this product is contraindicated in children under 6 years of age unless under the direct supervision of a healthcare professional. It is imperative that the dosage does not exceed 3 teaspoonfuls within a 24-hour period to mitigate the risk of adverse effects.

General precautions should be observed, particularly regarding the duration of maximum dosage. The maximum dosage should not be utilized for more than 2 weeks unless specifically advised and monitored by a healthcare provider. This is essential to prevent potential complications associated with prolonged use.

In the event of an accidental overdose, immediate medical assistance should be sought. Healthcare professionals are advised to contact Poison Control for guidance in such situations.

Patients are strongly encouraged to consult with their healthcare provider prior to using this product if they are pregnant or nursing. This precaution is vital to ensure the safety of both the patient and the infant.

Side Effects

Patients should be aware of the following warnings and precautions regarding the use of this medication. It is contraindicated for administration to children under 6 years of age unless under the supervision of a doctor. Additionally, patients should not exceed a dosage of more than 3 teaspoonfuls within a 24-hour period to avoid potential adverse effects.

Before using this medication, it is advisable for patients who are pregnant or nursing to consult with a healthcare professional. This precaution is essential to ensure the safety of both the patient and the child.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

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 under 6 years of age should not be administered this medication except under the supervision of a healthcare professional. For children aged 6 years and older, the recommended dosage is 1/2 level teaspoon mixed in 1/2 glass (4 fl oz) of water every 2 hours, not to exceed the maximum dosage or as directed by a physician.

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 and those who are nursing should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully known. Therefore, it is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication if they are nursing a baby. 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 considering the use of this medication during lactation.

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 this population, as the absence of detailed guidance necessitates careful clinical judgment regarding the use of the medication in individuals with reduced kidney function. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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 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 information, 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

The available data indicate that there are no non-teratogenic effects reported in the insert. However, it is advised that individuals who are pregnant or nursing consult a healthcare professional prior to use, as teratogenic effects may be a concern. No additional information regarding nonclinical toxicology or animal pharmacology and toxicology has been provided in the insert.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek professional assistance or contact a Poison Control center immediately in the event of an accidental overdose. It is important to emphasize that patients should not use the maximum dosage of this product for more than 2 weeks unless directed by a doctor or other qualified health professional. Additionally, patients should be encouraged to consult with their healthcare provider before using this product if they are pregnant or nursing a baby, ensuring that they receive appropriate guidance tailored to their specific circumstances.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored in a cool, dry place, away from moisture to ensure optimal stability and efficacy. Proper handling is essential to prevent exposure to conditions that may compromise the product's quality.

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.