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Antacid

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Active ingredient
Calcium Carbonate 750 mg
Other brand names
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2024
Label revision date
October 14, 2025
Active ingredient
Calcium Carbonate 750 mg
Other brand names
Dosage form
Tablet, Chewable
Route
Oral
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2024
Label revision date
October 14, 2025
Manufacturer
CARDINAL HEALTH 110, LLC.
Registration number
M001
NDC root
70000-0682

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 common digestive discomforts. Each chewable tablet contains 750 mg of calcium carbonate, which helps alleviate symptoms such as heartburn, sour stomach, acid indigestion, and upset stomach associated with these issues. With a tropical fruit flavor, LEADER™ offers a pleasant way to manage these uncomfortable sensations.

Uses

If you're experiencing discomfort from heartburn, sour stomach, or acid indigestion, this medication can help relieve those symptoms. It’s 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, adults and children aged 12 and older can chew 2 to 4 tablets completely as the symptoms occur, or follow your doctor's instructions. It's important to remember that you should not swallow the tablets whole; they need to be chewed to work effectively.

If your symptoms last longer than 2 weeks, it's crucial to consult with your doctor before continuing to take the medication. This ensures that you are using it safely and appropriately for your needs.

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. If you are pregnant, limit your intake to no more than 6 tablets in the same timeframe. Additionally, avoid using the maximum dosage for longer than 2 weeks unless your doctor has advised and is supervising you.

Always follow these guidelines to prevent potential health risks and ensure effective treatment. If you have any questions or concerns about your medication, don't hesitate to reach out to your healthcare provider for guidance.

Side Effects

When using this product, it's important to be aware of potential side effects and interactions. You should consult with a doctor or pharmacist if you are taking any prescription medications, as antacids may interact with them. It's also crucial not to exceed 10 tablets in a 24-hour period, and if you are pregnant, limit your intake to no more than 6 tablets in the same timeframe. Avoid using the maximum dosage for more than 2 weeks unless directed by a healthcare professional.

Additionally, keep this product out of reach of children to ensure their safety.

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.

While using this product, please remember not to exceed 10 tablets in a 24-hour period. If you are pregnant, limit your intake to no more than 6 tablets in 24 hours. Additionally, avoid using the maximum dosage for more than 2 weeks unless directed by your doctor. Always keep this product out of reach of children to ensure their safety.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, you should contact your local emergency services or go to the nearest hospital right away. Always keep the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, it's better to be safe and get checked out if you have any concerns about an overdose.

Pregnancy Use

If you are pregnant, it is important to limit your intake to no more than 6 tablets in a 24-hour period. Additionally, you should avoid using the maximum dosage for more than 2 weeks unless you are under the guidance and supervision of a doctor. 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, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If you are considering this medication for your child, it's important to note that it is approved for use in children aged 12 years and older. For this age group, the recommended dosage is to chew 2 to 4 tablets completely when symptoms arise, or as directed by a healthcare professional.

Always consult with your child's doctor before starting any new medication to ensure it is appropriate for their specific needs and to discuss any potential concerns.

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 considering this medication, it’s important to consult with a healthcare provider. 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 the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific condition. They can help you understand any necessary precautions or adjustments based on your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 tests you might be undergoing. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the best quality 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 printed seal under the cap is intact; do not use the product if the seal is torn or missing, as this indicates it may not be safe for use. Following these simple steps will help you maintain the product's effectiveness and safety.

Additional Information

You should chew 2 to 4 tablets completely when symptoms occur, or follow your doctor's instructions. Remember not to swallow the tablets whole, and avoid using them for symptoms that last more than 2 weeks unless your doctor advises otherwise.

If you are taking any prescription medications, consult with your doctor or pharmacist before using this product, as antacids can interact with certain drugs. If you are pregnant, limit your intake to no more than 6 tablets in a 24-hour period, and do not exceed the maximum dosage for more than 2 weeks without medical supervision.

FAQ

What is LEADER™?

LEADER™ is an extra strength antacid tablet that contains 750 mg of calcium carbonate.

What symptoms does LEADER™ relieve?

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

How should I take LEADER™?

Adults and children 12 years of age and over should chew 2 to 4 tablets completely as symptoms occur, or as directed by a doctor. Do not swallow tablets whole.

What is the maximum dosage for LEADER™?

Do not take more than 10 tablets in 24 hours, and if pregnant, do not take more than 6 tablets in 24 hours.

Can I use LEADER™ for more than 2 weeks?

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

Are there any warnings for using LEADER™?

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

Is LEADER™ safe during pregnancy?

While there are no teratogenic effects mentioned, pregnant individuals should not take more than 6 tablets in 24 hours.

What should I do if symptoms persist?

If symptoms persist for more than 2 weeks, consult a doctor.

How should I store LEADER™?

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

Where can I find more information about LEADER™?

You can visit the website at www.myleader.com or contact customer service at 1-800-200-6313.

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 750 mg is presented in the form of Extra Strength Antacid Tablets. These tablets are flavored with Tropical Fruit, incorporating both natural and artificial flavoring agents. The product contains a total of 96 chewable tablets.

Uses and Indications

This drug is indicated for the relief of heartburn, sour stomach, acid indigestion, 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 over are instructed to chew 2 to 4 tablets completely as symptoms occur, or as directed by a healthcare professional. It is essential that the tablets are not swallowed whole. Patients should refrain from using the medication for symptoms that persist for more than 2 weeks unless advised by a doctor.

Contraindications

There are no specific contraindications identified for this product. However, the following usage guidelines should be strictly adhered to:

  • Do not exceed 10 tablets within a 24-hour period.

  • In pregnant individuals, do not exceed 6 tablets within a 24-hour period.

  • The maximum dosage should not be used for more than 2 weeks unless directed and supervised by a healthcare professional.

Warnings and Precautions

Healthcare professionals should advise patients to consult a physician or pharmacist prior to using this product if they are currently taking any prescription medications, as antacids may interact with certain drugs.

When administering this product, it is crucial to adhere to the following guidelines:

  • The maximum recommended dosage is 10 tablets within a 24-hour period.

  • For pregnant individuals, the dosage should not exceed 6 tablets in a 24-hour timeframe.

  • The maximum dosage should not be utilized for more than 2 weeks unless directed and monitored by a healthcare provider.

Additionally, it is imperative to keep this product out of reach of children to prevent accidental ingestion.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. It is important to consult a doctor or pharmacist before use, particularly if patients are taking any prescription medications, as antacids may interact with certain drugs.

When using this product, patients are advised not to exceed a dosage of 10 tablets within a 24-hour period. For pregnant individuals, the maximum recommended dosage is limited to 6 tablets in 24 hours. Additionally, patients should not use the maximum dosage for more than 2 weeks unless under the advice and supervision of a healthcare professional.

To ensure safety, this product should be kept out of reach of children.

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

Packaging configurations for Antacid.
Details

Pediatric Use

Pediatric patients aged 12 years and older may chew 2 to 4 tablets completely as symptoms occur, or as directed by a healthcare professional. There are no specific dosage adjustments or safety concerns noted for this age group. Efficacy and safety in children under 12 years of age have not been established. Therefore, caution is advised when considering use in younger pediatric populations.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients should not exceed a dosage of 6 tablets within a 24-hour period. Additionally, the maximum dosage should not be used for more than 2 weeks unless under the advice and supervision of a healthcare professional. It is important for healthcare providers to consider these recommendations when prescribing this medication to pregnant patients to minimize potential risks to fetal outcomes.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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 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 treatment is determined.

Documentation of the incident, including the substance involved, estimated dose, time of ingestion, and any interventions performed, is critical for ongoing patient management and future reference.

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 text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to inform patients not to exceed a dosage of 10 tablets within a 24-hour period to avoid potential overdose.

For patients who are pregnant, healthcare providers should emphasize the need to limit intake to no more than 6 tablets in a 24-hour period. Additionally, patients should be cautioned against using the maximum dosage for more than 2 weeks unless under the guidance and supervision of a healthcare professional.

Providers should encourage patients to consult with a doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with certain drugs. This precaution is essential to ensure safe and effective use of the medication.

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. Additionally, the container is safety sealed; therefore, it should not be used if the printed seal under the cap is torn or missing.

Additional Clinical Information

Patients aged 12 years and older are advised to chew 2 to 4 tablets completely as symptoms occur or as directed by a healthcare professional. It is important that patients do not swallow the tablets whole and refrain from using the medication for symptoms that persist for more than 2 weeks unless directed by a doctor.

Clinicians should counsel patients to consult a doctor or pharmacist before use if they are taking any prescription medications, as antacids may interact with certain drugs. Pregnant patients should limit their intake to no more than 6 tablets in a 24-hour period and should not exceed the maximum dosage for more than 2 weeks without medical supervision.

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

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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.