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Antacid

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Active ingredient
Calcium Carbonate 1000 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 2024
Label revision date
October 14, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Calcium Carbonate 1000 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 2024
Label revision date
October 14, 2025
Manufacturer
CARDINAL HEALTH 110, LLC.
Registration number
M001
NDC root
70000-0683
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

LEADER™ is an ultra-strength antacid tablet designed to provide relief from heartburn, acid indigestion, and upset stomach. Each chewable tablet contains 1000 mg of calcium carbonate, which works by neutralizing stomach acid to help alleviate discomfort. Available in an assorted berry flavor, these gluten-free tablets come in a convenient pack of 72, making it easy for you to manage occasional digestive issues.

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 confident using this medication, as there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects reported.

Dosage and Administration

When you need relief from certain symptoms, you can take this medication by chewing 2 to 3 tablets completely. This is suitable for adults and children aged 12 years and older. It's important not to swallow the tablets whole, as they need to be chewed to work effectively.

If your symptoms continue for more than 2 weeks, you should consult with a doctor before continuing to use the medication. Always follow your doctor's advice regarding how to use this medication for the best results.

What to Avoid

It's important to follow specific guidelines when using this medication to ensure your safety. Do not use the product if the printed seal under the cap is torn or missing, as this indicates it may not be safe to consume. You should not take more than 7 tablets in a 24-hour period, and if you are pregnant, limit your intake to no more than 5 tablets in the same timeframe. Additionally, avoid using the maximum dosage for more than 2 weeks unless your doctor has advised you to do so.

By adhering to these instructions, 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 other medications, be sure to discuss this 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. You should not take more than 7 tablets in a 24-hour period. If you are pregnant, limit your intake to no more than 5 tablets in 24 hours. Additionally, avoid using the maximum dosage for more than 2 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 have any concerns or experience unusual symptoms, it's best to consult your doctor for guidance.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, if you suspect that you or someone else may have taken too much of a medication, it’s important to be aware of potential signs of an overdose. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms, or if you are unsure whether an overdose has occurred, seek immediate medical help. You can contact your local emergency services or go to the nearest hospital. Always keep medications out of reach and follow the prescribed dosage to prevent any risks associated with overdosage.

Pregnancy Use

If you are pregnant, it’s important to be cautious with medication. You should not take more than 5 tablets in a 24-hour period. Additionally, avoid using the maximum dosage for more than 2 weeks unless your doctor has advised and is supervising you. Always consult with your healthcare provider before taking any medication during pregnancy to ensure the safety of you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk and your nursing infant are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding. They can help you weigh the potential risks and benefits to ensure the safety of both you and your baby.

Pediatric Use

It's important to keep this medication out of reach of children to ensure their safety. For adults and children aged 12 years and older, the recommended use is to chew 2-3 tablets completely when symptoms occur, or as directed by a doctor. Please remember that the tablets should not be swallowed whole. Always consult with a healthcare professional if you have any questions about using this medication 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. If you or a loved one is an older adult, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach, considering factors like overall health and any other medications being taken. Always prioritize safety and open communication with your medical team when it comes to managing health in later years.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because your kidneys may not process the medication as effectively. To ensure your safety, your healthcare provider will monitor your kidney function regularly, especially by checking your creatinine clearance (a test that measures how well your kidneys are filtering waste).

Before starting any new treatment, your renal function should be tested, and these tests will continue periodically throughout your therapy. If your kidney function is significantly reduced, your doctor will take special care in managing your treatment plan. Always communicate with your healthcare team about your kidney health to ensure the best outcomes.

Hepatic Impairment

If you have liver problems, it's important to know that your dosage of this medication may need to be adjusted. This means that your healthcare provider might change how much of the medication you take to ensure it's safe and effective for you. Additionally, special monitoring of liver function tests (which check how well your liver is working) is recommended to keep an eye on your health.

Always exercise caution when taking this medication if you have liver dysfunction. Make sure to discuss your liver health with your doctor, as they will guide you on the best approach to manage your treatment safely.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. It's important to keep the container tightly closed when not in use to protect its contents from contamination and maintain its effectiveness. By following these simple storage guidelines, you can help ensure the product remains safe and ready for use whenever you need it.

Additional Information

You should take this medication orally. Before using it, make sure to ask your doctor or pharmacist if you are currently taking any prescription drugs, as antacids can interact with some medications. If your symptoms last longer than two weeks, consult your doctor before continuing use.

FAQ

What is LEADER™?

LEADER™ is an ultra strength antacid tablet that contains 1000 mg of calcium carbonate.

What symptoms does LEADER™ relieve?

LEADER™ relieves heartburn, acid indigestion, sour stomach, and upset stomach.

How should I take LEADER™?

Adults and children 12 years and older should chew 2-3 tablets completely as symptoms occur, or as directed by a doctor. Do not swallow tablets whole.

Are there any dosage restrictions for LEADER™?

Do not take more than 7 tablets in 24 hours, and if pregnant, do not take more than 5 tablets in 24 hours.

Can I use LEADER™ for more than 2 weeks?

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

Is LEADER™ safe during pregnancy?

LEADER™ does not have any teratogenic effects mentioned, but pregnant individuals should limit intake to 5 tablets in 24 hours.

What should I do if I have renal or hepatic impairment?

Patients with renal impairment may need dosage adjustments and should have their renal function monitored. Those with hepatic impairment may also require dosage adjustments and monitoring.

What should I do if the seal under the cap is torn or missing?

Do not use LEADER™ if the printed seal under the cap is torn or missing.

Is LEADER™ gluten-free?

Yes, LEADER™ is gluten-free.

What should I do if my symptoms persist?

Do not take LEADER™ for symptoms that persist for more than 2 weeks unless advised by a doctor.

Packaging Info

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

Packaging configurations for Antacid.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Calcium Carbonate is presented in a dosage form of 1000 mg.

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 12 years of age and over are instructed to chew 2 to 3 tablets completely as symptoms occur, or as directed by a healthcare professional. It is important to note that the tablets should not be swallowed whole.

Patients should refrain from using this medication for symptoms that persist for more than 2 weeks unless advised by a healthcare provider.

Contraindications

Use is contraindicated in the following situations:

  • Do not use if the printed seal under the cap is torn or missing, as this may indicate tampering or contamination.

  • Do not exceed 7 tablets within a 24-hour period to avoid potential adverse effects.

  • In pregnant individuals, do not exceed 5 tablets within a 24-hour period due to potential risks to the fetus.

  • The maximum dosage should not be used for more than 2 weeks unless advised and supervised by a healthcare professional to prevent complications associated with prolonged use.

Warnings and Precautions

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

It is imperative that patients do not exceed a maximum dosage of 7 tablets within a 24-hour period. For pregnant individuals, the dosage should not exceed 5 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.

These guidelines are essential to ensure the safe use of the medication and to mitigate potential risks associated with overuse. Regular assessment and patient education regarding these dosage limits are recommended to promote adherence and safety.

Side Effects

Patients should be aware of potential interactions between antacids and certain prescription medications. It is important for individuals to consult with their healthcare provider regarding the use of antacids in conjunction with other treatments to avoid adverse reactions stemming from these interactions.

No specific serious or common adverse reactions have been detailed in the provided information. Therefore, healthcare professionals should remain vigilant and monitor patients for any unexpected effects when antacids are used alongside other prescribed therapies.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Antacid.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. For dosing, children aged 12 years and older are instructed to chew 2-3 tablets completely as symptoms occur, or as directed by a healthcare professional. It is important to note that the tablets should not be swallowed whole.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should not exceed a dosage of 5 tablets within a 24-hour period. It is advised that the maximum dosage not be used for more than 2 weeks unless under the guidance and supervision of a healthcare professional. The potential risks associated with exceeding these recommendations during pregnancy have not been fully established, and caution is warranted to avoid any adverse fetal outcomes. Healthcare providers should carefully evaluate the benefits and risks when prescribing this medication to pregnant patients.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the effects on breastfed infants are not well characterized. It is advisable to monitor breastfed infants for any potential adverse effects if the mother is using 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, ensuring that appropriate modifications are made to optimize therapeutic outcomes. Special consideration should be given to patients with significantly reduced renal function, as they may require more careful management. Renal function tests should be performed prior to initiating therapy and periodically thereafter to assess any changes in renal status.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to compromised liver function. It is essential to monitor liver function tests closely in this population to ensure safety and efficacy. Caution should be exercised when administering this medication to patients with liver dysfunction, as their altered metabolic capacity may affect drug clearance and overall treatment outcomes.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory distress, or any other unusual clinical manifestations.

Management of an overdose should be tailored to the individual patient and may involve supportive care, symptomatic treatment, and, if applicable, the use of specific antidotes. It is crucial to consult local poison control guidelines and the product's prescribing information for detailed management protocols.

In all instances of suspected overdose, healthcare professionals should ensure that appropriate measures are taken to safeguard the patient's health and well-being.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is crucial to inform patients that they should not use the product if the printed seal under the cap is torn or missing, as this may indicate tampering.

Patients should be instructed not to exceed a dosage of 7 tablets within a 24-hour period. For those who are pregnant, it is important to limit the intake to no more than 5 tablets in a 24-hour period. Additionally, patients should be cautioned against using the maximum dosage for more than 2 weeks unless directed and supervised by a healthcare professional.

Healthcare providers should also discuss the potential for interactions with other medications, particularly for patients who are currently taking prescription drugs. It is advisable to inform patients that antacids may interact with certain prescription medications, and they should consult their healthcare provider for guidance.

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.

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. Patients are also cautioned not to use the medication for symptoms that persist for more than two weeks without medical advice.

Drug Information (PDF)

This file contains official product information for 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 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

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.