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Leader Ultra Strength 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 2019
Label revision date
August 22, 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 2019
Label revision date
August 22, 2025
Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER
Registration number
M001
NDC root
70000-0436
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 and acid indigestion. Each chewable tablet contains 1000 mg of calcium carbonate, which works by neutralizing stomach acid to help alleviate discomfort. With a pleasant assorted berry flavor, these tablets are easy to take and come in a package of 72, making them 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 occur after eating.

You can use this medication to find relief from these common digestive issues, allowing you to feel more comfortable throughout your day. 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 3 tablets whenever you experience symptoms. It's important to follow your doctor's instructions if they have provided specific guidance on how to use the medication.

Make sure to chew the tablets thoroughly before swallowing to ensure the medication works effectively. Always keep track of how often you take the tablets and consult your doctor if you have any questions or if your symptoms persist.

What to Avoid

It's important to use this medication responsibly to ensure your safety. You should not take more than 7 tablets within a 24-hour period, and you should 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 risks associated with misuse and ensures that you are using the medication effectively. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

You may not experience specific side effects from this medication, but it's important to be aware that antacids can interact with certain prescription drugs. This means that if you are taking other medications, the effectiveness of those drugs could be affected. Always consult with your healthcare provider if you have concerns about potential interactions or if you notice any unusual symptoms while using this medication.

Warnings and Precautions

It's important to use this medication responsibly. You should not take more than 7 tablets in a 24-hour period, and you should avoid using the maximum dosage for more than 2 weeks unless your doctor advises you to do so.

If you have any concerns or experience unusual symptoms while using this product, it's best to consult your doctor for guidance. Always prioritize your health and safety by following these precautions.

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 concerns about an overdose.

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 12 or older, they can chew 2-3 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 in your child, consult with your healthcare provider for guidance.

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 to using this medication safely and effectively, considering any unique health needs or conditions that may be present. Always prioritize open communication with your healthcare team to ensure the best outcomes.

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. Keeping track of these levels helps your doctor make the best decisions regarding your medication and dosage.

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 best to discuss your individual situation with your healthcare provider, as they can offer personalized advice and monitor your health closely.

Make sure to keep your doctor informed about your liver condition, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using this medication.

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 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 consult a healthcare professional before using this medication if you are pregnant or breastfeeding. This is important to ensure the safety of both you and your baby. There are no additional details available regarding laboratory tests, abuse potential, or the specific methods of administration for this medication.

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 and acid indigestion.

How should I take LEADER™?

Adults and children 12 years and older should chew 2-3 tablets as symptoms occur, or as directed by a doctor.

What is the maximum dosage for LEADER™?

Do not take more than 7 tablets in a 24-hour period, and do not use the maximum dosage for more than 2 weeks without a doctor's advice.

Are there any teratogenic effects associated with LEADER™?

No teratogenic effects are mentioned for LEADER™.

Can LEADER™ interact with other medications?

Yes, antacids like LEADER™ may interact with certain prescription drugs.

What should I do if I am pregnant or breastfeeding?

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

How should I store LEADER™?

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

Is there any specific information for patients with renal impairment?

Yes, patients with reduced renal function should have their renal function monitored regularly and may need dosage adjustments based on creatinine clearance levels.

Packaging Info

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

Packaging configurations for Leader Ultra Strength Antacid.
Details

Drug Information (PDF)

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

View product document (PDF)

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 aged 12 years and older are instructed to chew 2 to 3 tablets as symptoms occur, or as directed by a healthcare professional. It is recommended that the tablets be chewed thoroughly before swallowing to ensure optimal absorption and efficacy.

Contraindications

Use of this product is contraindicated in patients who exceed the recommended dosage of 7 tablets within a 24-hour period or who 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 precautions associated with the use of this product.

General precautions must be observed to ensure safe usage. It is imperative that patients do not exceed a maximum intake of 7 tablets within a 24-hour period. Additionally, the maximum dosage should not be utilized for more than 2 weeks unless specifically advised and monitored by a healthcare provider. This limitation is crucial to prevent potential adverse effects associated with prolonged use or excessive dosage.

No specific laboratory tests or emergency medical help instructions are provided in the current guidelines. However, healthcare professionals should remain vigilant and assess the patient's overall health and response to treatment during the course of therapy.

Side Effects

Patients may experience various adverse reactions when using this medication. Notably, there are no specific side effects listed in the warnings section. However, it is important to note that antacids may interact with certain prescription drugs, which could lead to unintended effects or reduced efficacy of the medications involved.

In clinical practice, healthcare providers should be vigilant about potential interactions and monitor patients accordingly. It is advisable for patients to inform their healthcare providers about all medications they are taking, including over-the-counter products such as antacids, to ensure safe and effective treatment.

Drug Interactions

Antacids may interact with various prescription medications, potentially affecting their absorption and efficacy. It is advisable to separate the administration of antacids and other medications by at least two hours to minimize the risk of interaction. Monitoring for therapeutic effectiveness of the affected medications is recommended when antacids are used concurrently.

Packaging & NDC

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

Packaging configurations for Leader Ultra Strength Antacid.
Details

Pediatric Use

Pediatric patients aged 12 years and older may use the medication at a dosage of 2-3 tablets chewed as symptoms occur, or as directed by a healthcare professional. It is important to keep this medication out of reach of children to ensure safety.

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 breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding 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 based on their level of renal function. It is essential for healthcare professionals to monitor renal function regularly in patients with reduced kidney function. Dosage adjustments should be guided by creatinine clearance levels, ensuring that therapy is tailored to the patient's specific renal status. Renal function tests should be performed prior to initiating therapy and periodically thereafter to assess any changes in renal function that may impact dosing.

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 nonclinical data does not indicate any teratogenic or non-teratogenic effects associated with the substance. Additionally, there is no information provided regarding animal pharmacology and toxicology. As such, no specific findings related to carcinogenesis, mutagenesis, or impairment of fertility are available in the current dataset.

Postmarketing Experience

No postmarketing experience details are available for this product. There have been no reported adverse events or additional information from voluntary reports or surveillance programs.

Patient Counseling

Healthcare providers should advise patients not to exceed a maximum of 7 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

Patients should consult a health professional prior to use if they are pregnant or breastfeeding. No further information is available regarding laboratory tests, abuse potential, route, method, and frequency of administration, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Leader Ultra 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 Ultra 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.