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Leader Ultra Strength

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Active ingredient
Calcium Carbonate 1000 mg
Other brand names
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 2018
Label revision date
February 2, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Calcium Carbonate 1000 mg
Other brand names
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 2018
Label revision date
February 2, 2026
Manufacturer
Cardinal Health
Registration number
M001
NDC root
70000-0459
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 common digestive discomforts. Each chewable tablet contains 1000 mg of calcium carbonate, which helps alleviate heartburn, acid indigestion, sour stomach, and upset stomach associated with these symptoms.

These tablets come in a refreshing peppermint flavor and are gluten-free, making them a convenient option for those seeking quick relief from 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 other harmful effects noted.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take 2 to 3 tablets by chewing them when you start to feel symptoms. It's important to follow your doctor's advice regarding how often to take the medication.

However, if your symptoms last longer than 2 weeks, you should not continue taking the tablets without consulting your doctor first. This ensures that you receive the appropriate care and guidance for your health.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with it. This means that, based on the available information, there are no known risks that would prevent you from taking this medication safely. Always remember to follow your healthcare provider's instructions and reach out to them if you have any questions or concerns about your treatment.

Side Effects

You may experience some side effects when using this product. It's important to be aware that taking more than 7 tablets in a 24-hour period can lead to adverse reactions. If you are pregnant, you should limit your intake to no more than 5 tablets in 24 hours. Additionally, using the maximum dosage for more than 2 weeks should only be done under the guidance of a doctor.

Before using this product, consult with your doctor or pharmacist, especially if you are currently taking any prescription medications, as antacids can interact with certain drugs. Always prioritize your health and safety by following these guidelines.

Warnings and Precautions

Before using this product, it's important to consult with your doctor or pharmacist, especially if you are currently taking any prescription medications, as antacids can interact with them. Be mindful of the dosage: do not exceed 7 tablets in a 24-hour period, and 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 directed by your doctor.

If you experience any unusual symptoms or have concerns while using this product, it's best to stop taking it and reach out to your healthcare provider for guidance. Always prioritize your health and safety by following these recommendations.

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.

In the event of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide healthcare professionals with as much information as possible about the substance taken and the amount. Remember, your safety is the top priority, so don’t hesitate to reach out for help.

Pregnancy Use

If you are pregnant, it is important to be cautious with medication. You should not take more than 5 tablets in a 24-hour period. Always consult with your healthcare provider before taking any medication to ensure it is safe for you and your baby. Your health and the health of your baby are the top priority, so make sure to follow these guidelines closely.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your baby. Since the effects on nursing infants have not been thoroughly studied, it's best to exercise caution and discuss any concerns with your healthcare provider.

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 3 tablets as needed for symptoms, or follow your doctor's instructions.

Always remember to keep the 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

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. As you age, your body may process medications differently, and factors like kidney function (renal impairment) and changes in cognition can affect how well a drug works or how it may impact you.

If you are an older adult or a caregiver, it’s wise to discuss any concerns with your healthcare provider. They can help determine the best approach for your individual health needs, ensuring that any medication you take is safe and effective for you. Always keep your doctor informed about all medications you are taking, as this can help prevent potential interactions or side effects.

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 usual recommendations for monitoring or safety considerations for patients with renal impairment (kidney issues) are not provided.

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

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, so don't hesitate to ask questions or express any concerns you may have.

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 performance and safety 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. Before using, check that the safety 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 guidelines will help you use the product safely and effectively.

Additional Information

You will take this medication orally. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

FAQ

What is LEADER™?

LEADER™ is an ultra strength antacid tablet that contains 1000mg of Calcium Carbonate USP.

What symptoms does LEADER™ relieve?

LEADER™ relieves heartburn, acid indigestion, sour stomach, and upset stomach associated with these symptoms.

How should I take LEADER™?

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

Are there any warnings for using LEADER™?

Yes, do not take more than 7 tablets in 24 hours, and if pregnant, do not take more than 5 tablets in 24 hours. Consult a doctor if you are taking prescription drugs.

Is LEADER™ safe to use during pregnancy?

If pregnant, do not take more than 5 tablets in 24 hours, and consult your doctor before use.

What should I do if symptoms persist?

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

What is the flavor of LEADER™?

LEADER™ has a peppermint flavor and is naturally and artificially flavored.

Is LEADER™ gluten-free?

Yes, LEADER™ is gluten-free.

What should I do if I am nursing?

Nursing mothers should consult a doctor before using LEADER™, as there is a potential for excretion in breast milk.

How should I store LEADER™?

Store LEADER™ at room temperature and keep the container tightly closed.

Packaging Info

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

Packaging configurations for Leader Ultra Strength.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Calcium Carbonate USP is presented in a dosage form of chewable tablets, each containing 1000 mg of calcium carbonate. The product is flavored with peppermint and includes both natural and artificial flavoring agents. It is gluten-free and packaged in a container containing 72 chewable tablets.

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 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 important to note that this medication should not be taken for symptoms that persist for more than 2 weeks unless advised by a doctor.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

It is essential for healthcare professionals to be aware of the following warnings and precautions associated with the use of this product.

Patients should be advised to consult a doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with certain drugs.

When administering this product, it is critical to adhere to the following dosage guidelines: patients should not exceed 7 tablets within a 24-hour period. For pregnant individuals, the maximum dosage should not exceed 5 tablets in a 24-hour period. Furthermore, the maximum dosage should not be utilized for more than 2 weeks unless under the guidance and supervision of a healthcare provider.

No specific general precautions or laboratory tests are required for the safe use of this product. However, it remains imperative for healthcare professionals to monitor patients for any potential interactions with other medications and to ensure adherence to the recommended dosage guidelines.

Side Effects

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

When using this product, patients are advised not to exceed a dosage of 7 tablets within a 24-hour period. For pregnant individuals, the maximum recommended dosage is limited to 5 tablets in 24 hours. Additionally, the maximum dosage should not be utilized for more than 2 weeks unless under the guidance and supervision of a healthcare provider.

These precautions are essential to minimize the risk of adverse effects and ensure safe usage of the product.

Drug Interactions

There are currently no documented drug interactions associated with 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 Ultra Strength (chewable antacid tablets). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Leader Ultra Strength.
Details

Pediatric Use

Pediatric patients aged 12 years and older may chew 2-3 tablets as symptoms occur, or as directed by a healthcare professional. It is important to keep this medication out of reach of younger 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 should not exceed a dosage of 5 tablets within a 24-hour period. This limitation is crucial to minimize potential risks to fetal outcomes. Healthcare professionals are advised to counsel women of childbearing potential regarding the importance of adhering to this dosage recommendation to ensure the safety of both the mother and the developing fetus.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on the nursing infant are not well studied; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient 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 regarding the potential for overdose with this medication.

Healthcare providers should be aware that symptoms of overdosage may vary depending on the individual and the circumstances surrounding the exposure. In cases where an overdose is suspected, it is recommended to monitor the patient closely for any adverse effects or unusual symptoms that may arise.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and healthcare professionals should ensure that the patient receives appropriate medical attention. This may include symptomatic treatment and monitoring of vital signs, as well as any necessary interventions based on the severity of the symptoms observed.

In the event of an overdose, it is advisable to contact a poison control center or seek specialized medical assistance to determine the most appropriate course of action.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young children.

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. Users are advised to check the safety seal; the product should not be used if the printed seal under the cap is torn or missing.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Leader Ultra Strength, 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, 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.