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Leader Extra Strength Antacid

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Active ingredient
Calcium Carbonate 750 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 2019
Label revision date
August 21, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Calcium Carbonate 750 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 2019
Label revision date
August 21, 2025
Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER
Registration number
part331
NDC root
70000-0430
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 extra strength antacid tablet designed to provide relief from heartburn and acid indigestion. Each chewable tablet contains 750 mg of calcium carbonate, which works by neutralizing stomach acid to help alleviate discomfort. Available in assorted fruit flavors, these tablets are a convenient option for managing occasional digestive issues.

Uses

If you're experiencing discomfort from acid indigestion or heartburn, this medication can help relieve those symptoms. Acid indigestion is often characterized by a burning sensation in your stomach or chest, while heartburn is the feeling of warmth or pain that can rise from your stomach to your throat.

You can use this medication to find relief from these common digestive issues, allowing you to feel more comfortable throughout your day. Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication.

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 whenever you experience symptoms, or you can follow your doctor's specific instructions. It's important to only take the amount recommended to ensure safety and effectiveness. Always consult with your healthcare provider if you have any questions about how to use this medication properly.

What to Avoid

It's important to use this medication responsibly to ensure your safety. You should not take more than 10 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 will help prevent potential issues and ensure the medication works effectively for you. 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 potential interactions when using this medication. If you are currently taking any prescription drugs, you should consult with your doctor or pharmacist before starting this treatment, as antacids can interact with certain medications.

While specific side effects are not detailed here, always monitor how you feel after taking any new medication and report any unusual symptoms to your healthcare provider. Your safety is a priority, so don't hesitate to seek guidance if you have concerns.

Warnings and Precautions

While there are no specific warnings or precautions listed for this medication, it's always important to stay informed about your health. If you experience any unusual symptoms or side effects while taking this medication, you should stop using it and consult your doctor for guidance.

Additionally, if you have any concerns or questions about your treatment, don't hesitate to reach out to your healthcare provider. They can provide you with the necessary information and support to ensure your safety and well-being.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the potential risks associated with taking more than the recommended dose. If you suspect an overdose, look out for any unusual symptoms or changes in your health.

In the event of an overdose, it is crucial to seek immediate medical attention. You can contact your local emergency services or go to the nearest hospital. Always keep the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, when in doubt, it's better to be safe and get help right away.

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 those aged 12 years and older. For both adults and children in this age group, the recommended dosage is to chew 2 to 4 tablets as symptoms arise or as directed by a healthcare professional.

Additionally, always ensure that this medication is kept out of reach of younger children to prevent accidental ingestion. Your vigilance in storing medications safely is crucial for your child's safety.

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, it’s wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

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 (issues with kidney function) can affect how your body processes certain medications. Regular monitoring of your kidney function is essential, and your healthcare provider will likely check your creatinine clearance (a measure of how well your kidneys are filtering waste) to determine if any changes to your dosage are necessary.

For those with significantly reduced kidney function, special considerations will be taken into account to ensure your treatment is safe and effective. Always communicate openly with your healthcare team about your kidney health, as they will guide you on the best approach for your specific situation.

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 for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can help ensure that your treatment is safe and effective for you.

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 feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and keep the container tightly closed. This helps maintain its effectiveness and prevents contamination.

Before using, check that the printed seal under the cap is intact; do not use the product if the seal is torn or missing, as this could indicate that the product is compromised. Following these simple steps 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 Leader™?

Leader™ is an extra strength antacid tablet that contains 750 mg of calcium carbonate and is available in assorted fruit flavors.

What symptoms does Leader™ relieve?

Leader™ relieves heartburn and acid indigestion.

How should I take Leader™?

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 Leader™?

Do not take more than 10 tablets in a 24-hour period, or use the maximum dosage for more than 2 weeks without a doctor's advice.

Is Leader™ safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using Leader™.

What should I do if I am taking other medications?

Ask a doctor or pharmacist before use if you are presently taking a prescription drug, as antacids may interact with certain medications.

How should I store Leader™?

Store Leader™ 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 contraindications for using Leader™?

No specific contraindications are mentioned for Leader™.

What should I do if I have renal impairment?

Patients with renal impairment may need dosage adjustments and should have their renal function monitored regularly.

Packaging Info

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

Packaging configurations for Leader Extra Strength Antacid.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

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

There are no teratogenic effects associated with this drug, nor are there any nonteratogenic effects mentioned.

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

There are no specific contraindications identified for this product. However, it is advised that patients do not exceed a maximum dosage of 10 tablets within a 24-hour period or use the maximum dosage for more than 2 weeks without the guidance and supervision of a healthcare professional. This precaution is to mitigate potential risks associated with prolonged use or excessive dosage.

Warnings and Precautions

Healthcare professionals should be aware that there are no specific warnings or general precautions associated with the use of this product as per the current data. Additionally, there are no laboratory tests recommended for monitoring during treatment.

In the absence of specific emergency medical help instructions, it is advisable for healthcare providers to remain vigilant and assess the patient's condition regularly. Should any unusual symptoms or adverse reactions occur, it is prudent to evaluate the need for discontinuation of the treatment and to consult with the prescribing physician.

Continued monitoring and clinical judgment are essential to ensure patient safety and effective management during the course of therapy.

Side Effects

Patients should be aware of potential adverse reactions associated with the use of this medication. It is important to consult a healthcare professional before use, particularly for individuals who are currently taking prescription drugs, as antacids may interact with certain medications.

While specific adverse reactions have not been detailed in the provided information, the necessity for caution suggests that serious interactions may occur. Therefore, patients are advised to seek guidance from a doctor or pharmacist to ensure safe use and to mitigate any risks associated with concurrent medication use.

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 Leader Extra Strength Antacid (calcium carbonate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Leader Extra Strength Antacid.
Details

Pediatric Use

Pediatric patients aged 12 years and older may use the medication at a dosage of 2-4 tablets chewed as symptoms occur, or as directed by a healthcare professional.

It is important to keep the medication out of reach of children to ensure safety.

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, given the lack of targeted data for this population.

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 currently no available data on the excretion of this medication in human 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 renal function regularly in these patients. Dosage adjustments should be based on creatinine clearance levels, with particular attention given to those with significantly reduced renal function. Special considerations are warranted to optimize treatment outcomes in this population.

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 overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate assessment of the patient's condition is crucial. Recommended actions include:

  1. Assessment: Conduct a thorough evaluation of the patient's vital signs and clinical status.

  2. Supportive Care: Initiate supportive measures as necessary, including airway management, oxygen supplementation, and intravenous fluids.

  3. Decontamination: If appropriate and within a reasonable timeframe, consider gastrointestinal decontamination methods such as activated charcoal, provided the patient is alert and able to protect their airway.

  4. Specific Antidotes: If a specific antidote is available for the substance involved, it should be administered according to established protocols.

Healthcare professionals are encouraged to consult local poison control centers or toxicology experts for guidance on management strategies tailored to the specific circumstances of the overdose. Continuous monitoring and supportive care are paramount until the patient stabilizes or further interventions are deemed necessary.

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

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients not to exceed a maximum of 10 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 conditions. Healthcare professionals are advised not to use the product if the printed seal under the cap is torn or missing, as this may indicate compromised safety or 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. 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 Leader Extra 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 Leader Extra 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

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.