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Extra Strength

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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
July 18, 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
July 18, 2025
Manufacturer
BJWC
Registration number
M001
NDC root
68391-102
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

Berkley Jensen Extra Strength Antacid Tablets are chewable tablets available in assorted berry flavors designed to provide fast relief from common digestive discomforts. These tablets help alleviate heartburn, acid indigestion, sour stomach, and upset stomach associated with these symptoms, making them a convenient option for quick relief when you need it.

Similar to the active ingredient found in TUMs® Extra Strength, these antacid tablets are formulated to effectively neutralize stomach acid, helping you feel better quickly. Each bottle contains 200 tablets, ensuring you have plenty on hand for when digestive issues arise.

Uses

You can use this medication to help relieve heartburn, acid indigestion, and a sour stomach. If you're experiencing an upset stomach related to these symptoms, this medication can also provide relief. It's designed to help you feel more comfortable when dealing with these common digestive issues.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

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 the treatment safely and effectively.

What to Avoid

It's important to follow specific guidelines when using this medication to ensure your safety. Do not use the product if the printed seal under the cap is torn or missing, as this indicates it may not be safe. You should not take more than 10 tablets in a 24-hour period, and if you are pregnant, limit your intake to no more than 6 tablets in that same timeframe. Additionally, avoid using the maximum dosage for more than 2 weeks unless your doctor has advised and is supervising you.

By adhering to these instructions, you can help prevent potential risks associated with misuse or overuse of the medication. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

It's important to be aware that antacids can interact with some prescription medications, which may affect how well those medications work. If you are taking any prescription drugs, be sure to discuss your use of antacids with your healthcare provider to avoid any potential issues.

While antacids are generally safe for most people, always stay informed about how they might affect your overall treatment plan. If you notice any unusual symptoms or have concerns, reach out to your healthcare professional for guidance.

Warnings and Precautions

It's important to use this medication safely. You should not take more than 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 your doctor has advised you to do so.

While there are no specific emergency instructions or lab tests required, always be mindful of how your body responds to the medication. If you experience any unusual symptoms or have concerns, it's best to consult your doctor for guidance.

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 signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

Pregnancy Use

If you are pregnant, it is important to be cautious with medication. You should not take more than 6 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

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 4 tablets as needed for their symptoms, or follow the guidance of a doctor.

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 a healthcare professional.

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 before starting the medication. 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 your medication dosage may need to be adjusted. If your creatinine clearance (a measure of kidney function) is reduced, you should be closely monitored by your healthcare provider. Before starting treatment, and periodically during it, renal function tests should be conducted to ensure your kidneys are handling the medication appropriately.

For those with moderate to severe renal impairment, a lower dose is recommended to avoid potential complications. Additionally, if you have a history of kidney disease, special caution is advised. Always communicate openly with your healthcare team about your kidney health to ensure safe and effective treatment.

Hepatic Impairment

If you have liver problems, it's important to know that your condition may affect how your body processes certain medications. This means that the dosage of the drug you are prescribed might need to be adjusted to ensure it is safe and effective for you.

Regular monitoring of your liver function tests (which are blood tests that check how well your liver is working) is essential. If you have severe liver impairment, your healthcare provider will take extra precautions when prescribing medications to ensure your safety. Always discuss your liver health with your doctor to receive the best care tailored to your needs.

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 might 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 best performance of your product, store it at room temperature and make sure the container is tightly closed. This helps maintain its effectiveness and safety.

When handling the product, always do so with care to avoid contamination. Keeping the container sealed until you are ready to use it is essential for maintaining a sterile environment (a clean area free from germs). Following these simple guidelines will help you use the product safely and effectively.

Additional Information

For adults and children aged 12 and older, you should chew 2 to 4 tablets when symptoms occur, or follow your doctor's instructions. It's important not to swallow the tablets whole, as they are designed to be chewed for proper effectiveness.

Currently, there is no additional information available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Berkley Jensen?

Berkley Jensen is an extra strength antacid tablet available in assorted berry flavors.

What symptoms does Berkley Jensen relieve?

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

How should I take Berkley Jensen?

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

What is the maximum dosage for Berkley Jensen?

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

Are there any contraindications for Berkley Jensen?

No specific contraindications are mentioned for Berkley Jensen.

Can Berkley Jensen interact with other medications?

Yes, antacids may interact with certain prescription drugs.

What should I do if symptoms persist?

Do not use Berkley Jensen for symptoms that persist for more than 2 weeks unless advised by a doctor.

Is there any information about using Berkley Jensen during pregnancy?

If pregnant, do not take more than 6 tablets in 24 hours, and consult your doctor for advice.

How should I store Berkley Jensen?

Store Berkley Jensen at room temperature and keep the container tightly closed.

What should I do if the seal under the cap is torn or missing?

Do not use Berkley Jensen if the printed seal under the cap is torn or missing.

Packaging Info

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

Packaging configurations for Extra Strength.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Berkley Jensen® Extra Strength Antacid Tablets are formulated to provide fast relief from acid indigestion, upset stomach, and heartburn. Each tablet is available in assorted berry flavors and is presented in a chewable dosage form. The product contains 200 tablets per package and is certified kosher (K Pareve). It is distributed by BJ’S Wholesale Club, located at 25 Research Drive, Westborough, MA 01581, and is manufactured in the USA. This product is comparable to the active ingredient in TUMs® Extra Strength. It is important to note that this product is not manufactured or distributed by GlaxoSmithKline LLC, the owner of the registered trademark, Extra Strength Tums®. For customer inquiries, a contact number is provided: 1-800-934-1204. The National Drug Code (NDC) for this product is 68391-102-00.

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 4 tablets as symptoms occur, or as directed by a healthcare professional. It is essential that the tablets are chewed thoroughly and not swallowed whole.

Patients should refrain from using this medication for symptoms that persist for more than 2 weeks unless specifically advised to do so by a healthcare provider.

Contraindications

Use is contraindicated in the following situations:

  • Patients should not use the product if the printed seal under the cap is torn or missing, as this may indicate tampering or contamination.

  • The product should not be taken in excess of 10 tablets within a 24-hour period to avoid potential overdose.

  • Pregnant individuals should limit their intake to no more than 6 tablets in a 24-hour period to mitigate risks to fetal health.

  • The maximum dosage should not be used for more than 2 weeks unless advised and supervised by a healthcare professional, to prevent adverse effects associated with prolonged high-dose use.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this medication.

General precautions must be strictly adhered to in order to ensure patient safety. It is imperative that patients do not exceed a maximum dosage of 10 tablets within a 24-hour period. For pregnant individuals, the dosage should not exceed 6 tablets in a 24-hour timeframe. Furthermore, the maximum dosage should not be utilized for more than 2 weeks unless specifically advised and monitored by a healthcare provider.

No specific laboratory tests have been identified for monitoring during the use of this medication. However, healthcare professionals should remain vigilant for any potential adverse effects and ensure that patients are informed about the importance of adhering to the recommended dosage guidelines.

Side Effects

Patients should be aware of potential interactions when using antacids alongside certain prescription medications. It is important to consult healthcare providers regarding the use of antacids to avoid any adverse reactions that may arise from these interactions.

No specific serious or common adverse reactions have been detailed in the available data; however, the potential for drug interactions underscores the necessity for careful management of medication regimens in patients who may require antacid therapy.

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

Packaging configurations for Extra 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. It is important to keep this medication out of reach of children to prevent accidental ingestion.

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, given the lack of targeted data.

Pregnancy

Pregnant patients should not exceed a dosage of 6 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 during pregnancy 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 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

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential that renal function tests be performed prior to the initiation of treatment and periodically during therapy to ensure appropriate dosing. Patients with reduced creatinine clearance should be closely monitored, as a reduced dose is recommended for those with moderate to severe renal impairment. Additionally, special caution is advised in patients with a history of renal disease to mitigate potential risks associated with treatment.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism of the drug, necessitating potential dosage adjustments. It is essential to monitor liver function tests regularly in this patient population to ensure safety and efficacy. Caution is advised when prescribing to patients with severe hepatic impairment, as their compromised liver function may significantly impact the drug's pharmacokinetics and overall therapeutic outcomes.

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

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to avoid using the product if the printed seal under the cap is torn or missing, as this may indicate that the product is compromised.

Patients should be informed not to exceed a dosage of 10 tablets within a 24-hour period. For those who are pregnant, it is crucial to limit the intake to no more than 6 tablets in a 24-hour period to ensure safety for both the mother and the developing fetus.

Additionally, healthcare providers should counsel patients against using the maximum dosage for more than 2 weeks unless under the advice and supervision of a doctor. This precaution is important to prevent potential adverse effects associated with prolonged high-dose use.

Finally, patients should be made aware that antacids may interact with certain prescription drugs they are currently taking. It is essential for patients to disclose all medications they are using to their healthcare provider to avoid any harmful interactions.

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, ensuring that it is protected from extreme temperatures and humidity. Proper storage conditions are essential to preserve the quality and efficacy of the product.

Additional Clinical Information

For adults and children aged 12 years and over, the recommended administration involves chewing 2-4 tablets as symptoms occur or as directed by a healthcare professional. It is important to note that the tablets should not be swallowed whole.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Extra 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 Extra 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

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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.