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Regular Strength Antacid

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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 2016
Label revision date
June 28, 2024
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 2016
Label revision date
June 28, 2024
Manufacturer
Amerisource Bergen
Registration number
part331
NDC root
24385-478
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 an antacid that comes in a 500 mg chewable tablet form. It is commonly used to relieve symptoms of acid indigestion and heartburn, helping to neutralize stomach acid and provide quick relief. Available in assorted fruit flavors, it offers a pleasant way to manage discomfort related to excess stomach acid.

You may find calcium carbonate similar to the active ingredient in Tums® Regular Strength, making it a familiar option for those seeking relief from occasional heartburn or indigestion. Each bottle contains 150 chewable tablets, making it convenient for regular use when needed.

Uses

If you're experiencing discomfort from acid indigestion or heartburn, this medication can help relieve those symptoms. Acid indigestion is a common issue that can cause a burning sensation in your stomach or chest, while heartburn is the feeling of warmth or pain that can occur after eating.

You can use this medication to find relief from these uncomfortable sensations, allowing you to feel more at ease after meals. It's important to note that there are no known harmful effects on fetal development (teratogenic effects) associated with this medication, making it a safer option for those who are pregnant.

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 when you start to feel symptoms. It's important to follow your doctor's advice if they have given you specific instructions on how to use it. Make sure to only take the amount recommended to help manage your symptoms effectively.

What to Avoid

It's important to use this medication responsibly to ensure your safety. You should not take more than 15 tablets within a 24-hour period. Additionally, avoid using the maximum dosage for more than 2 weeks unless your doctor has advised you to do so. Following these guidelines helps prevent potential health risks and ensures the medication works effectively for you. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

You may experience some side effects when using this medication, although no specific adverse reactions have been listed. It's important to be aware that if you are currently taking any prescription drugs, you should consult with your doctor or pharmacist before using this medication, as antacids can interact with certain prescription medications.

Always keep an open line of communication with your healthcare provider to ensure your safety and well-being while using this product.

Warnings and Precautions

It's important to use this medication safely. You should not take more than 15 tablets in a 24-hour period, and you should not use the maximum dosage for more than 2 weeks unless your doctor advises you to do so.

If you experience any unusual symptoms or have concerns about your health while using this medication, stop taking it and call your doctor for guidance. Always prioritize your health and safety by following these instructions closely.

Overdose

If you suspect an overdose, it's important to act quickly. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, seek immediate medical help.

Since there is no specific information provided about overdose for this medication, it's crucial to contact a healthcare professional or poison control center for guidance. Always keep emergency contact numbers handy and do not hesitate to reach out if you have concerns about your health or medication use.

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

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 symptoms, or follow your doctor's instructions.

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 your healthcare provider.

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 your medication dosage may need to be adjusted. This is because renal impairment (kidney issues) can affect how your body processes certain drugs. To ensure your safety, your healthcare provider will monitor your creatinine clearance (a test that measures how well your kidneys are filtering waste) regularly.

Additionally, regular renal function tests are essential to keep track of your kidney health. If you have significant renal impairment, you will require special monitoring to manage your treatment effectively. Always communicate with your healthcare team about your kidney function 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, 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 and keep the container tightly closed when not in use. This helps maintain its quality and prevents contamination.

Before using the product, check that the printed seal under the cap is intact. If the seal is torn or missing, do not use the product, as this may indicate that it has been compromised. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally. Before using it, consult with your doctor or pharmacist, especially if you are currently taking any prescription drugs, as antacids can interact with some medications. If you are pregnant or breastfeeding, it's important to seek advice from a healthcare professional before use.

FAQ

What is Calcium Carbonate used for?

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

How should I take Calcium Carbonate?

Adults and children 12 years of age and over should chew 2-4 tablets as symptoms occur, or as directed by a doctor.

Are there any dosage limits for Calcium Carbonate?

Do not take more than 15 tablets in a 24-hour period, or use the maximum dosage for more than 2 weeks without a doctor's advice.

Can I use Calcium Carbonate if I am pregnant or breastfeeding?

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

Are there any interactions with other medications?

Yes, antacids like Calcium Carbonate may interact with certain prescription drugs, so consult a doctor or pharmacist if you are taking other medications.

What should I do if I have renal impairment?

Patients with reduced renal function should have their creatinine clearance monitored and may need dosage adjustments.

How should I store Calcium Carbonate?

Store at room temperature, keep the container tightly closed, and do not use if the printed seal under the cap is torn or missing.

Are there any side effects associated with Calcium Carbonate?

No specific side effects are listed, but consult a doctor if you experience any unusual symptoms.

Packaging Info

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

Packaging configurations for Regular Strength Antacid.
Details

Drug Information (PDF)

This file contains official product information for Regular Strength Antacid, 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 its active ingredient, providing 500 mg per tablet. It is classified as a regular strength antacid, indicated for the soothing relief of acid indigestion and heartburn. The formulation is available in assorted fruit flavors and is presented in the form of 150 chewable tablets. The National Drug Code (NDC) for this product is 24385-478-47, and it is distributed by Good Neighbor Pharmacy.

Uses and Indications

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

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

Dosage and Administration

Adults and children 12 years of age and over are advised to chew 2 to 4 tablets as symptoms occur, or as directed by a healthcare professional. It is important to follow the recommended dosage and not exceed the maximum dosage unless specifically instructed by a physician.

Contraindications

Use of this product is contraindicated in patients who exceed the recommended dosage of 15 tablets within a 24-hour period or utilize the maximum dosage for more than 2 weeks without the advice and supervision of a healthcare professional.

Warnings and Precautions

Healthcare professionals should be aware of the following critical information regarding the safe use of this product.

It is imperative that patients do not exceed a maximum dosage of 15 tablets within a 24-hour period. Additionally, the use of this product should not extend beyond 2 weeks unless directed and supervised by a healthcare provider. This precaution is essential to prevent potential adverse effects associated with prolonged use or excessive dosage.

While specific warnings, general precautions, and laboratory tests have not been provided, healthcare professionals are encouraged to remain vigilant and monitor patients for any signs of adverse reactions or complications during the course of treatment. In the event of any concerning symptoms or if the patient requires emergency medical assistance, immediate action should be taken to ensure their safety and well-being.

Side Effects

Patients may experience adverse reactions when using this medication. It is important to note that no specific side effects have been listed in the warnings section. However, patients are advised to consult a doctor or pharmacist before use if they are currently taking a prescription drug, as antacids may interact with certain prescription medications.

No additional adverse reactions or important notes have been documented.

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 interaction risks. Specifically, antacids should be taken at least 2 hours apart from other drugs to ensure optimal therapeutic outcomes.

Packaging & NDC

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

Packaging configurations for Regular Strength Antacid.
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 children to prevent accidental ingestion.

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 and those who are breastfeeding should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice 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 health professional prior to using this medication. There is no specific data available regarding the excretion of this drug 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 may necessitate dosage adjustments to ensure safety and efficacy. It is essential for healthcare professionals to monitor creatinine clearance in patients with reduced renal function. Regular renal function tests should be performed to assess kidney health and guide treatment decisions. Additionally, special monitoring is required for patients with significant renal impairment to mitigate potential risks associated with medication use.

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 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.

Should an overdosage occur, the management approach should include supportive care tailored to the patient's clinical presentation. Healthcare providers are encouraged to implement standard protocols for the assessment and treatment of overdose, which may involve symptomatic management and monitoring of vital signs.

In the event of suspected overdosage, it is recommended that healthcare professionals consult local poison control centers or relevant medical authorities for guidance on appropriate interventions and management strategies.

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. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients not to exceed a maximum of 15 tablets within a 24-hour period. Additionally, patients should be informed that the maximum dosage of this product should not be used for more than 2 weeks unless directed by a healthcare professional.

It is also important for healthcare providers to encourage patients to consult with a doctor or pharmacist prior to using this product if they are currently taking any prescription medications. Patients should be made aware that antacids may interact with certain prescription drugs, and this interaction could affect the efficacy of their treatment.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature to ensure optimal stability and efficacy. Healthcare professionals are advised not to use the product if the printed seal under the cap is torn or missing, as this may indicate potential contamination or compromise of the product's safety.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to consult a doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with certain drugs. Additionally, patients who are pregnant or breastfeeding should seek guidance from a healthcare professional before using this medication.

Drug Information (PDF)

This file contains official product information for Regular Strength Antacid, 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 Regular Strength Antacid, 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.