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Major Regular Strength

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Active ingredient
Calcium Carbonate 500 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 2014
Label revision date
September 19, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Calcium Carbonate 500 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 2014
Label revision date
September 19, 2025
Manufacturer
Major Pharmaceuticals
Registration number
M001
NDC root
0904-6412
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

Major Regular Strength Antacid Tablets are chewable tablets that contain 500 mg of calcium carbonate, a substance that helps relieve symptoms like upset stomach, heartburn, and acid indigestion. These tablets are designed to provide fast relief and come in an assorted fruit flavor, making them a pleasant option for those seeking comfort from digestive discomfort.

When you take these antacid tablets, they work by neutralizing stomach acid, which can help alleviate the burning sensation associated with heartburn and the sour feeling of an upset stomach. They are gluten-free and come in a convenient bottle containing 150 tablets, making it easy to have on hand whenever you need relief.

Uses

If you're experiencing discomfort from heartburn, sour stomach, or acid indigestion, this medication can help relieve those symptoms. It is also effective for upset stomachs that are 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. This makes it a safe option for managing your digestive discomfort.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should chew 2 to 4 tablets when you experience symptoms, 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.

Additionally, if your symptoms last longer than 2 weeks, you should consult with your doctor before continuing to take the medication. This ensures that you are using it safely and effectively.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or risks of abuse or misuse associated with this medication. Additionally, there are no concerns regarding dependence (a condition where the body becomes reliant on a substance).

Since there are no "do not take" or "do not use" instructions provided, it suggests that this medication is generally safe for use as directed. However, always consult with your healthcare provider for personalized advice and to ensure it’s appropriate for your individual health needs.

Side Effects

When using this product, you may experience some side effects. It's important to be aware that taking more than 15 tablets in a 24-hour period can lead to serious issues, and if you are pregnant, you should limit your intake to no more than 10 tablets in the same timeframe. Additionally, using the maximum dosage for more than two weeks should only be done under a doctor's guidance.

Before starting 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 15 tablets in a 24-hour period, and if you are pregnant, limit your intake to no more than 10 tablets in that same timeframe. Additionally, avoid using the maximum dosage for more than two weeks unless directed by your doctor.

While there are no specific laboratory tests required for safe use, it's crucial to follow these guidelines to ensure your safety and well-being. If you experience any unusual symptoms or have concerns, please reach out to your healthcare provider for advice.

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 an overdose, it’s crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant, it is important to be cautious with your medication. You should not take more than 10 tablets in a 24-hour period. This guideline helps ensure your safety and the safety of your developing baby. Always consult with your healthcare provider before taking any medication during pregnancy to discuss potential risks and appropriate dosages.

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 intended for use in children aged 12 years and older. For this age group, the recommended dosage is to chew 2 to 4 tablets when symptoms arise, or as directed by a healthcare professional. Always consult with your child's doctor to ensure the appropriate use and dosage for their specific needs.

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 always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to ensure safe and effective care.

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 determine the best approach for managing your health, especially if you have concerns about your kidneys.

Hepatic Impairment

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

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to be aware that antacids can interact with some prescription medications. If you are taking other medications, it's a good idea to talk to your doctor or pharmacist before using antacids. They can help ensure that your treatments work effectively together and avoid any potential issues.

Always discuss any medications or tests you are undergoing with your healthcare provider. This way, you can receive personalized advice and maintain your health safely.

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 to protect its contents. Before using, check that the safety seal (a printed seal under the cap) is intact; do not use the product if this 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 Major Regular Strength Antacid Tablets used for?

Major Regular Strength Antacid Tablets are used to relieve heartburn, sour stomach, acid indigestion, and upset stomach associated with these symptoms.

What is the active ingredient in Major Regular Strength Antacid Tablets?

The active ingredient is Calcium Carbonate, with each tablet containing 500mg.

How should I take Major Regular Strength Antacid Tablets?

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

Are there any warnings I should be aware of?

Yes, consult a doctor or pharmacist before use if you are taking prescription drugs, as antacids may interact with them. Do not exceed 15 tablets in 24 hours, and if pregnant, do not take more than 10 tablets in 24 hours.

Is Major Regular Strength Antacid safe to use during pregnancy?

While there are no teratogenic effects mentioned, pregnant individuals should not take more than 10 tablets in 24 hours.

What should I do if my symptoms persist?

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

How should I store Major Regular Strength Antacid Tablets?

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

Are there any side effects associated with Major Regular Strength Antacid Tablets?

The insert does not list specific side effects, but you should consult a doctor if you experience any unusual symptoms.

Packaging Info

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

Packaging configurations for Major Regular Strength.
Details

Drug Information (PDF)

This file contains official product information for Major Regular Strength, 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 heartburn, sour stomach, acid indigestion, and upset stomach associated with these symptoms.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Adults and children aged 12 years and older are instructed to chew 2 to 4 tablets 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 healthcare provider.

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

Healthcare professionals should advise patients to consult a doctor 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 critical to adhere to the following dosage guidelines: patients should not exceed 15 tablets within a 24-hour period. For pregnant individuals, the maximum dosage should not exceed 10 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. Additionally, there are no emergency medical help instructions or specific directives to stop taking the product and contact a doctor included in the current guidelines.

Side Effects

Patients may experience various adverse reactions when using this product. It is important to note that certain warnings should be heeded to minimize risks associated with its use.

Patients are advised to consult a doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with specific drugs. When using this product, patients should not exceed a maximum of 15 tablets within a 24-hour period. For pregnant individuals, the maximum dosage should not exceed 10 tablets in a 24-hour period. Additionally, the maximum dosage should not be utilized for more than 2 weeks unless under the guidance and supervision of a healthcare professional.

These precautions are essential to ensure the safe use of the product and to mitigate potential adverse reactions.

Drug Interactions

Antacids may interact with certain prescription medications, potentially affecting their efficacy. It is advisable for patients to consult a healthcare professional, such as a doctor or pharmacist, prior to using antacids if they are currently taking other medications. This precaution helps ensure safe and effective use of both antacids and concurrent therapies.

No specific drug interactions or laboratory test interactions have been identified for the medication in question.

Packaging & NDC

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

Packaging configurations for Major Regular Strength.
Details

Pediatric Use

Pediatric patients aged 12 years and older may chew 2-4 tablets as symptoms occur, or as directed by a healthcare professional. There are no specific dosage adjustments or safety concerns noted for this age group. Further studies may be warranted to evaluate efficacy and safety in younger populations.

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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should not exceed a dosage of 10 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 guideline to ensure the safety of both the mother and the developing fetus.

Lactation

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

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 excessive administration of the medication.

Should an overdosage occur, it is recommended that healthcare providers assess the patient for any signs or symptoms that may arise. Commonly, symptoms of overdosage can vary widely depending on the medication involved and may include, but are not limited to, increased severity of known side effects, altered mental status, or physiological disturbances.

Management of an overdosage situation should involve immediate supportive care. Healthcare professionals are advised to monitor the patient closely, providing symptomatic treatment as necessary. In cases where the specific antidote or treatment protocol is known, it should be administered promptly.

Additionally, contacting a poison control center or consulting the relevant medical literature for guidance on managing overdosage is strongly recommended. Documentation of the incident and any interventions performed should be meticulously recorded to ensure continuity of care and for future reference.

In summary, while no specific overdosage information is provided, healthcare professionals should be prepared to act swiftly and effectively in the event of an overdosage, prioritizing patient safety and appropriate management strategies.

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 text.

Patient Counseling

Healthcare providers should advise patients to keep this 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 individuals.

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 product features a safety seal; it is imperative not to use the product if the printed seal under the cap is torn or missing, as this may indicate a compromise in safety or efficacy.

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 Major Regular 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 Major Regular 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.