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Extra Strength Antacid Assorted Fruit

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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 2025
Label revision date
February 4, 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 2025
Label revision date
February 4, 2025
Manufacturer
Retail Business Services, LLC.
Registration number
M001
NDC root
72476-142
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

CAREOne™ is a chewable antacid that contains calcium carbonate (750 mg), which helps relieve symptoms of acid indigestion and heartburn. It comes in assorted fruit flavors and is gluten-free, making it a convenient option for those seeking quick relief from discomfort caused by excess stomach acid.

When you chew CAREOne™, the calcium carbonate works to neutralize stomach acid, providing fast relief from heartburn and acid indigestion. With 96 chewable tablets in each package, it’s designed to be an easy-to-use solution for managing these common digestive issues.

Uses

If you're experiencing discomfort from acid indigestion or heartburn, this medication can help relieve those symptoms. Acid indigestion is often characterized by a burning sensation in your stomach or chest, while heartburn is the feeling of warmth or pain that can rise from your stomach to your throat.

You can use this medication to find relief from these common digestive issues, allowing you to feel more comfortable throughout your day. Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication.

Dosage and Administration

When you need relief from your symptoms, start by wetting your mouth before chewing the tablets. For adults and children aged 12 and older, chew 2 to 4 tablets as needed, or follow your doctor's instructions. This method helps ensure that the medication works effectively to alleviate your discomfort. Remember to only take the amount recommended to avoid any potential issues.

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. Additionally, avoid using the maximum dosage for more than 2 weeks unless your doctor has advised you to do so. Following these guidelines will help you minimize any potential risks associated with the medication. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

You should be aware that certain prescription drugs can interact with antacids, which may affect how well your medications work. It's important to discuss any current medications with your healthcare provider to avoid potential complications.

Currently, there are no specific adverse reactions or warnings listed, but staying informed about your medications is always a good practice. If you experience any unusual symptoms while taking a new medication, be sure to reach out to your healthcare professional.

Warnings and Precautions

It's important to use this medication safely. You should not take more than 10 tablets in a 24-hour period, and avoid using the maximum dosage for more than 2 weeks unless your doctor advises you to do so.

Before starting this medication, consult with your doctor or pharmacist if you are currently taking any prescription drugs, as antacids can interact with some medications. If you experience any unusual symptoms or have concerns, stop taking the medication and reach out to your healthcare provider 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, 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 err on the side of caution when it comes to your health. Remember, timely intervention can make a significant difference.

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 those aged 12 years and older. If your child is within this age range, they should wet the tablets in their mouth before chewing and can take 2 to 4 tablets as needed for symptoms, or as directed by a healthcare professional.

Always remember to keep this medication out of reach of younger children to ensure their safety. If you have any questions or concerns about its use, consult your child's doctor for guidance.

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 your medication dosage may need to be adjusted. This is because renal impairment (kidney issues) can affect how your body processes certain drugs. To ensure your safety, your healthcare provider will monitor your creatinine clearance (a test that measures how well your kidneys are filtering waste) regularly.

Additionally, regular renal function tests are essential to keep track of your kidney health. If you have significant renal impairment, special monitoring will be necessary to manage your treatment effectively. Always communicate with your healthcare team about your kidney function to ensure the best care.

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 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 could 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 safety and effectiveness of your product, store it at room temperature and keep the container tightly closed when not in use. This helps maintain its quality and prevents contamination.

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

Additional Information

You should take this medication orally. For adults and children aged 12 and older, wet the tablets in your mouth before chewing. Chew 2 to 4 tablets as symptoms occur, or follow your doctor's instructions. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is CAREOne™?

CAREOne™ is a calcium carbonate-based antacid that provides fast relief from heartburn and acid indigestion. It comes in assorted fruit flavors and is gluten-free.

What are the indications for using CAREOne™?

CAREOne™ is indicated for the relief of acid indigestion and heartburn.

How should I take CAREOne™?

For adults and children 12 years and older, wet the tablet in your mouth before chewing and take 2-4 tablets as symptoms occur, or as directed by a doctor.

Are there any dosage limitations for CAREOne™?

Do not take more than 10 tablets in a 24-hour period or use the maximum dosage for more than 2 weeks without a doctor's advice.

Can I use CAREOne™ if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using CAREOne™.

Are there any contraindications for CAREOne™?

There are no specific contraindications mentioned for CAREOne™.

Can CAREOne™ interact with other medications?

Yes, antacids like CAREOne™ may interact with certain prescription drugs, so consult a doctor or pharmacist if you are taking other medications.

How should I store CAREOne™?

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

What should I do if I experience adverse reactions?

If you experience any adverse reactions or have concerns, contact your healthcare provider for guidance.

Packaging Info

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

Packaging configurations for Extra Strength Antacid Assorted Fruit.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

NDC 72476-142-80, CAREone™ is an extra strength calcium antacid formulation containing 750 mg of calcium carbonate per chewable tablet. It is designed to provide fast relief from heartburn and acid indigestion. The product is available in assorted fruit flavors and is gluten-free. Each package contains 96 chewable tablets. This formulation is comparable to the active ingredient in Tums® Extra Strength 750 Assorted Fruit.

Uses and Indications

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

There are no teratogenic or nonteratogenic effects associated with this medication.

Dosage and Administration

Adults and children 12 years of age and over should wet the tablets in their mouth before chewing. The recommended dosage is to chew 2 to 4 tablets as symptoms occur, or as directed by a healthcare professional. It is important to follow the prescribed instructions to ensure effective symptom management.

Contraindications

Use of this product is contraindicated in patients who exceed the recommended dosage of 10 tablets within a 24-hour period or utilize the maximum dosage for more 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 prolonged or excessive use.

Warnings and Precautions

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

General precautions must be observed to ensure safe usage. It is imperative that patients do not exceed a maximum dosage of 10 tablets within 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 provider.

Before recommending this product, it is essential to advise patients to consult with a doctor or pharmacist if they are currently taking any prescription medications. This is particularly important as antacids may interact with certain prescription drugs, potentially leading to adverse effects or reduced efficacy of the medications.

No specific warnings or laboratory tests have been identified in the current guidelines. However, healthcare professionals should remain vigilant and monitor patients for any unusual symptoms or interactions that may arise during treatment.

Side Effects

Patients may experience various adverse reactions while undergoing treatment. It is important to note that the use of antacids may interact with certain prescription drugs, which could lead to altered efficacy or increased side effects of the medications involved.

Currently, there are no specific serious adverse reactions or common adverse reactions listed in the available data. However, healthcare providers should remain vigilant for any unexpected reactions in patients, particularly those who are concurrently taking other prescription medications.

Monitoring for potential interactions and adverse effects is essential to ensure patient safety and the effectiveness of the treatment regimen.

Drug Interactions

Antacids may interact with various prescription medications, potentially affecting their absorption and efficacy. It is advisable to monitor the timing of antacid administration in relation to other medications to minimize these interactions. Specifically, antacids should be taken at least 2 hours apart from other drugs to ensure optimal therapeutic outcomes.

Packaging & NDC

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

Packaging configurations for Extra Strength Antacid Assorted Fruit.
Details

Pediatric Use

Pediatric patients aged 12 years and older are advised to wet the tablets in their mouth before chewing. The recommended dosage is 2 to 4 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 and those who are breastfeeding should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data 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 necessitate dosage adjustments based on their level of kidney function. It is essential for healthcare professionals to monitor creatinine clearance in patients with reduced renal function to ensure appropriate dosing. Regular renal function tests should be performed to assess kidney health and detect any changes that may impact treatment. Additionally, special monitoring is required for patients with significant renal impairment to mitigate potential risks associated with medication use.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no 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 and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, healthcare professionals should consider contacting a poison control center for guidance on specific management protocols tailored to the substance involved in the overdose.

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

Nonclinical Toxicology

Pregnant or breastfeeding individuals are advised to consult a health professional prior to use due to potential teratogenic effects. There are no specific non-teratogenic effects or detailed nonclinical toxicology data available. Additionally, no specific information regarding animal pharmacology and toxicology has been provided.

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 10 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 use if they are currently taking any prescription medications. This is particularly crucial as antacids may interact with certain prescription drugs, which could affect the efficacy of the treatment or lead to adverse effects.

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. For adults and children aged 12 years and older, patients should wet the tablets in their mouth before chewing and can chew 2 to 4 tablets as symptoms occur, or as directed by a healthcare professional. 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 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 Extra 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.