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Ultra Strength Antacid Assorted Fruit

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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 2025
Label revision date
March 5, 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 2025
Label revision date
March 5, 2025
Manufacturer
DeMoulas Market Basket
Registration number
M001
NDC root
53942-171
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

Calcium Carbonate is an ultra-strength antacid that helps relieve symptoms of acid indigestion and heartburn. Each tablet contains 1000 mg of Calcium Carbonate, which is the same active ingredient found in TUMS®. This medication is available in a variety of fruit flavors, making it a more pleasant option for those seeking relief from uncomfortable digestive issues.

You can find Calcium Carbonate packaged in bottles containing 72 tablets, providing a convenient way to manage occasional heartburn and acid-related discomfort.

Uses

If you're experiencing discomfort from acid indigestion or heartburn, this medication can help relieve those symptoms. Acid indigestion refers to the burning sensation in your stomach or chest, often caused by excess stomach acid, while heartburn is a similar feeling that can occur when acid flows back into the esophagus.

This medication is specifically designed to provide you with relief from these common digestive issues, helping you feel more comfortable throughout your day.

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 advice regarding how often to take it. Make sure to chew the tablets well before swallowing for the best effect. Always consult with your healthcare provider if you have any questions or concerns about your dosage.

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 issues and ensures that the medication works effectively for you. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

It's important to be aware of potential interactions when using this medication. If you are currently taking any prescription drugs, you should consult with your doctor or pharmacist before starting this treatment, as antacids can interact with certain medications.

While specific side effects are not detailed here, always stay informed about how any new medication may affect you, and don't hesitate to reach out to a healthcare professional with any concerns.

Warnings and Precautions

While there are no specific warnings, precautions, or instructions provided for this medication, it's always important to stay informed about your health. If you experience any unusual symptoms or have concerns while taking this medication, it's best to consult your doctor for guidance.

In general, if you ever feel that you need immediate medical attention, don't hesitate to seek emergency help. Additionally, if your doctor advises you to stop taking this medication for any reason, make sure to follow their instructions and reach out for further advice. Your health and safety are the top priority.

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 have concerns about a possible overdose, seek medical help right away. It's always better to err on the side of caution when it comes to your health. Remember, if you are ever in doubt, contacting a healthcare professional or poison control center can provide you with the guidance you need.

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 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 this 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 your healthcare provider.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to discuss any new prescriptions with your healthcare provider. They can help ensure that the medication is safe and appropriate for you or your loved one, considering any existing health conditions or medications.

If you have concerns about how this medication might affect you or an older adult in your care, please consult with a healthcare professional for personalized advice.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. Your healthcare provider will monitor your renal function tests, which help assess how well your kidneys are working. If your creatinine clearance (a measure of kidney function) falls below a specific level, a reduced dose of your medication may be necessary. Additionally, if you have severe renal impairment, special monitoring will be advised to ensure your safety and the effectiveness of your treatment. Always discuss any concerns with your healthcare provider to ensure the best care for your condition.

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 you understand how to manage your health while considering your liver condition.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if you are currently taking any prescription drugs. Some antacids can interact with these medications, which may affect how well they work or increase the risk of side effects.

Always keep your healthcare provider informed about all the medications you are taking, including over-the-counter products, to ensure your safety and the effectiveness of your treatment.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and keep the container tightly closed. This helps maintain its effectiveness and prevents contamination.

Before using, always 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 steps will help you use the product safely and effectively.

Additional Information

You should take this medication orally. Before using it, consult with your doctor or pharmacist, especially if you are currently taking any prescription drugs, as antacids can interact with some medications. If you are pregnant or breastfeeding, it's important to seek advice from a healthcare professional before use.

FAQ

What is Calcium Carbonate used for?

Calcium Carbonate is an antacid that relieves acid indigestion and heartburn.

How should I take Calcium Carbonate?

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

What is the maximum dosage for Calcium Carbonate?

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

Are there any contraindications for Calcium Carbonate?

No specific contraindications are mentioned for Calcium Carbonate.

Can I use Calcium Carbonate if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

What should I do if I am taking other prescription drugs?

Ask a doctor or pharmacist before use, as antacids may interact with certain prescription drugs.

How should I store Calcium Carbonate?

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

Is there any special monitoring required for patients with kidney problems?

Yes, renal function tests should be monitored, and dosage adjustments may be necessary for patients with renal impairment.

Packaging Info

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

Packaging configurations for Ultra Strength Antacid Assorted Fruit.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This ultra-strength antacid formulation contains 1000 mg of calcium carbonate per tablet. It is available in assorted fruit flavors and is packaged in a bottle containing 72 tablets.

Uses and Indications

This drug is indicated for the relief of acid indigestion and heartburn.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

Adults and children 12 years of age and over are advised to chew 2 to 3 tablets as symptoms occur, or as directed by a healthcare professional. It is important to follow the recommended dosage and not exceed the advised amount unless specifically instructed by a physician.

Contraindications

Use of this product is contraindicated in patients who exceed the recommended dosage of more than 7 tablets within a 24-hour period or who utilize the maximum dosage for longer than 2 weeks without the guidance and supervision of a healthcare professional. Adherence to these guidelines is essential to prevent potential adverse effects associated with excessive use.

Warnings and Precautions

There are currently no specific warnings or precautions associated with the use of this medication. Healthcare professionals are advised to remain vigilant and monitor patients for any adverse effects or unusual symptoms that may arise during treatment.

In the absence of defined laboratory tests, it is recommended that healthcare providers consider routine monitoring based on the individual patient's clinical status and any relevant comorbidities. Regular assessments may help in identifying potential complications early.

In the event of any concerning symptoms or adverse reactions, healthcare professionals should instruct patients to seek immediate medical assistance. Additionally, if a patient experiences significant side effects or has concerns regarding their treatment, they should be advised to discontinue use and consult their healthcare provider for further evaluation and guidance.

Side Effects

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

While specific adverse reactions have not been detailed in the provided information, the necessity for caution suggests that serious interactions may occur. Therefore, patients are advised to seek guidance from a doctor or pharmacist to ensure safe use and to mitigate any risks associated with concurrent medication use.

Drug Interactions

Patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking any prescription drugs.

Antacids may have the potential to interact with certain prescription medications, which could affect the efficacy of those drugs. It is important for patients to disclose all medications they are taking to ensure safe and effective use of antacids. Monitoring for any adverse effects or changes in therapeutic outcomes is recommended when antacids are used concurrently with prescription medications.

Packaging & NDC

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

Packaging configurations for Ultra Strength Antacid Assorted Fruit.
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 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 and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this drug 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 require dosage adjustments to ensure safety and efficacy. It is essential to monitor renal function tests in these patients to assess their kidney status. For patients with a creatinine clearance below a specified threshold, a reduced dose should be considered to mitigate the risk of adverse effects. Additionally, special monitoring is advised for patients with severe renal impairment to ensure appropriate management of their treatment regimen.

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 and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of antidotes or specific treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Additionally, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section lacks any specific information. Furthermore, there is no information available related to animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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

The medication is administered orally. Clinicians should advise patients to consult a doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with certain drugs. Additionally, patients who are pregnant or breastfeeding should seek guidance from a healthcare professional before using the medication.

Drug Information (PDF)

This file contains official product information for Ultra Strength Antacid Assorted Fruit, 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 Ultra Strength Antacid Assorted Fruit, 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.