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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
February 4, 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
February 4, 2025
Manufacturer
Retail Business Services, LLC.
Registration number
M001
NDC root
72476-170
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 an ultra-strength calcium antacid that contains 1000 mg of calcium carbonate, which helps relieve symptoms of acid indigestion and heartburn. This medication is designed to provide fast relief, making it a convenient option for those experiencing discomfort from excess stomach acid.

Available in a chewable tablet form, CAREOne™ is also gluten-free, ensuring it can be consumed by individuals with gluten sensitivities. If you're looking for a quick solution to alleviate heartburn or acid indigestion, CAREOne™ may be a suitable choice for you.

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 occur after eating.

You can use this medication to find relief from these common digestive issues, allowing you to feel more comfortable throughout your day. It's important to note that there are no known harmful effects on fetal development (teratogenic effects) associated with this medication, making it a safer option for those who may be pregnant.

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 3 tablets as your symptoms arise, or follow your doctor's instructions if they have provided specific guidance. This method helps ensure that the medication works effectively to alleviate your discomfort.

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 you are using the medication effectively. 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 side effects when taking this medication. If you are currently on a prescription drug, be cautious, as antacids may interact with certain medications, which could affect how well they work or increase the risk of side effects.

Always consult with your healthcare provider if you have concerns about interactions or if you experience any unusual symptoms while taking this medication. Your safety and well-being are paramount, so staying informed is key.

Warnings and Precautions

It's important to use this medication safely. You should not take more than 7 tablets in a 24-hour period, and you should not use the maximum dosage for more than 2 weeks unless your doctor advises you to do so.

If you experience any unusual symptoms or have concerns while using this product, it's best to consult your doctor for guidance. Always prioritize your health and well-being by following these precautions.

Overdose

If you suspect an overdose of this medication, it's important to stay calm and take immediate action. While the drug insert does not provide specific information about overdose, you should be aware of general signs that may indicate an overdose, such as unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about an overdose, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get professional assistance if you think something might be wrong.

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

It's important to keep this medication out of reach of children to ensure their safety. For children aged 12 years and older, the recommended use is to wet the tablets in their mouth before chewing. They should chew 2-3 tablets as symptoms occur or follow the instructions provided by a doctor. Always consult with a healthcare professional if you have any questions about using this medication for your child.

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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. Specifically, if you have reduced creatinine clearance (a measure of how well your kidneys are filtering waste), your healthcare provider will closely monitor your condition. Regular renal function tests (tests that check how well your kidneys are working) should be performed to ensure your safety.

For those with significant renal impairment, a reduced dose of medication is recommended. Always communicate with your healthcare team about your kidney health to ensure you receive the appropriate care and adjustments needed for your treatment.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

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 safety and effectiveness of your product, store it at room temperature and keep the container tightly closed. This helps maintain its quality and prevents contamination. Before using, always check that the printed seal under the cap is intact; do not use the product if the seal is torn or missing, as this could indicate that the product is 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 starting this medication.

FAQ

What is CAREOne™?

CAREOne™ is an ultra strength calcium antacid that contains 1000 mg of Calcium Carbonate and is gluten-free.

What does CAREOne™ relieve?

CAREOne™ relieves acid indigestion and heartburn.

How should I take CAREOne™?

For adults and children 12 years and older, wet in mouth before chewing and chew 2-3 tablets as symptoms occur, or as directed by a doctor.

Are there any dosage restrictions for CAREOne™?

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.

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

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

Are there any interactions with prescription drugs?

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

How should I store CAREOne™?

Store CAREOne™ 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 information on renal impairment?

Yes, patients with renal impairment may need dosage adjustments and should be closely monitored.

What should I do if I experience side effects?

If you experience any adverse reactions or have concerns, consult your doctor.

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

CAREOne™ is a calcium antacid formulated to provide fast relief from heartburn and acid indigestion. Each chewable tablet contains 1000 mg of calcium carbonate, offering an ultra-strength dosage. The product is gluten-free and is packaged in a bottle containing 72 chewable tablets. The National Drug Code (NDC) for this product is 72476-170-23. This formulation is comparable to the active ingredient found in Tums® Ultra Strength 1000 Assorted Fruit.

Uses and Indications

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

There are no teratogenic effects associated with this drug, nor are there any nonteratogenic effects mentioned.

Dosage and Administration

For adults and children aged 12 years and over, the recommended administration involves wetting the tablets in the mouth prior to chewing. Patients should chew 2 to 3 tablets as symptoms occur, or as directed by a healthcare professional. It is important to follow the prescribed instructions to ensure optimal efficacy and safety.

Contraindications

Use of this product is contraindicated in patients who exceed the recommended dosage of 7 tablets within a 24-hour period or utilize the maximum dosage for more than 2 weeks without the advice and supervision of a healthcare professional.

Warnings and Precautions

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

It is imperative that patients do not exceed a maximum dosage of 7 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 qualified healthcare provider. This precaution is essential to prevent potential adverse effects associated with prolonged use or excessive dosing.

Currently, there are no specific laboratory tests or emergency medical help instructions associated with this product. Healthcare professionals are encouraged to monitor patients for any unusual symptoms or side effects and to provide appropriate guidance based on individual patient needs.

Side Effects

Patients should be aware of potential adverse reactions associated with the use of this medication. While specific serious adverse reactions are not detailed, it is important to note that interactions may occur with other medications.

In particular, patients currently taking prescription drugs should exercise caution, as antacids may interact with certain prescription medications. This interaction could potentially alter the effectiveness of the prescribed treatment or lead to unexpected side effects.

Healthcare providers should be consulted to ensure safe and effective use of this medication, especially in the context of concurrent therapies. Monitoring for any unusual symptoms or changes in health status is advised for all patients.

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 should be advised to keep this medication out of reach of children. For children aged 12 years and older, the recommended dosage is to wet the tablets in the mouth before chewing and to chew 2-3 tablets as symptoms occur, or as directed by a healthcare professional.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The potential risks and benefits must be carefully considered, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to ensure safe use during pregnancy and lactation.

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 medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential that patients with reduced creatinine clearance are closely monitored to ensure safety and efficacy. Regular renal function tests should be performed in patients with kidney problems to assess their condition. A reduced dose is recommended for patients with significant renal impairment to mitigate the risk of adverse effects.

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 context of overdosage, it is important to note that the available sections of the drug insert do not provide specific information regarding potential overdosage scenarios.

Healthcare professionals are advised to exercise caution and consider the possibility of overdosage when administering the medication. In the absence of detailed guidance, it is recommended that clinicians monitor patients closely for any unusual symptoms or adverse reactions that may arise following administration.

In the event of suspected overdosage, standard supportive measures should be implemented. This includes ensuring the patient's safety, providing symptomatic treatment, and considering the need for further medical evaluation. Healthcare providers should remain vigilant and prepared to manage any complications that may occur as a result of overdosage, even in the absence of specific symptoms outlined in the drug insert.

For further management, consultation with a poison control center or a medical toxicologist may be beneficial to guide treatment decisions and ensure optimal patient care.

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.

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 use if they are currently taking any prescription medications. This is crucial as antacids may interact with certain prescription drugs, potentially leading to adverse effects or reduced efficacy of the medications.

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.