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Extra Strength Smooth Antacid

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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
72476-132
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 calcium antacid that contains 750 mg of calcium carbonate, which helps relieve symptoms of acid indigestion and heartburn. It comes in a pleasant berry fusion flavor and is designed to dissolve smoothly for quick relief. This product is gluten-free and is available in a convenient pack of 60 chewable tablets, making it easy to take whenever you need it.

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 developing babies (teratogenic effects) associated with this medication, making it a safer option for those who may be pregnant.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should start by wetting your mouth before chewing the tablets. Chew 2 to 4 tablets whenever you experience symptoms, or follow your doctor's instructions if they have provided specific guidance. Make sure to take the tablets as needed to help manage your symptoms effectively.

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

Side Effects

You may experience some interactions if you take antacids alongside certain prescription medications. It's important to be aware that while no specific side effects are listed, these interactions could affect how well your other medications work. Always consult with your healthcare provider if you have concerns about combining medications.

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 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 about your health while using this medication, stop taking it and call your doctor for guidance. Always prioritize your health and safety by following these instructions closely.

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. 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 using this medication for children, it's important to note that it is intended for those aged 12 years and older. If your child falls within this age group, 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 concerns or questions 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 you may need a lower dose of the medication. Before starting treatment, your healthcare provider will assess your creatinine clearance (a test that measures how well your kidneys are filtering waste). Regular tests to monitor your kidney function are also recommended to ensure your safety while on this medication.

For those with significant renal impairment, special monitoring is necessary to prevent potential toxicity. Always communicate with your healthcare provider about your kidney health to ensure the best treatment plan for you.

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 for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can help ensure that your treatment is safe and effective for you.

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 may 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. It's important to keep the container tightly closed when not in use to protect its contents from contamination and maintain its effectiveness. By following these simple storage guidelines, you can help ensure the product remains safe and ready for use whenever you need it.

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 an extra strength calcium antacid that contains 750 mg of calcium carbonate and is designed to relieve heartburn and acid indigestion.

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.

What are the indications for using CAREOne™?

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

Are there any side effects associated with CAREOne™?

No specific side effects are listed for CAREOne™, but antacids may interact with certain prescription drugs.

What precautions should I take when using 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. If you are pregnant or breastfeeding, consult a health professional before use.

How should I store CAREOne™?

Store CAREOne™ at room temperature and keep the container tightly closed.

Is there any information regarding renal impairment and CAREOne™?

Yes, patients with renal impairment may need a reduced dose, and regular renal function tests are recommended for those with existing kidney problems.

Packaging Info

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

Packaging configurations for Extra Strength Smooth Antacid.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

NDC 72476-132-49. CAREOne™ is a calcium antacid formulated to provide relief from heartburn and indigestion. Each chewable tablet contains 750 mg of calcium carbonate, which is the active ingredient comparable to that found in Tums® Smoothies™. The product is designed for extra strength and features a smooth dissolve formulation, enhancing palatability with a berry fusion flavor. It is gluten-free and packaged in a bottle containing 60 chewable tablets.

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

Adults and children 12 years of age and older are advised to wet the tablets in their mouth prior to 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 guidance of a physician for any adjustments to the dosage based on individual patient needs.

Contraindications

There are no specific contraindications identified for this product. However, it is advised that patients do not exceed a maximum dosage of 10 tablets within a 24-hour period or use the maximum dosage for more than 2 weeks without the guidance and supervision of a healthcare professional. This recommendation is in place to mitigate potential risks associated with prolonged use or excessive dosage.

Warnings and Precautions

Healthcare professionals should be aware of the following critical considerations regarding the safe use of this product.

It is imperative that patients do not exceed a maximum dosage of 10 tablets within a 24-hour period. Additionally, the use of this product should not extend beyond 2 weeks unless directed and monitored by a healthcare provider. This precaution is essential to prevent potential adverse effects associated with prolonged use or excessive dosage.

In the event of any concerning symptoms or adverse reactions, patients should be advised to discontinue use and consult their healthcare provider promptly. This ensures that any potential complications can be addressed in a timely manner.

While specific warnings, general precautions, and laboratory tests have not been detailed, healthcare professionals are encouraged to maintain vigilance and exercise clinical judgment when prescribing this product. Regular monitoring of patient response and adherence to recommended guidelines is essential for ensuring safety and efficacy.

Side Effects

Patients should be aware that no specific side effects have been listed for this medication. However, it is important to note that antacids may interact with certain prescription drugs, which could lead to altered efficacy or increased risk of adverse reactions associated with those medications.

Healthcare providers should monitor patients for any potential interactions and advise them accordingly. As with any treatment, patients are encouraged to report any unexpected symptoms or concerns to their healthcare provider.

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 effects. Healthcare professionals should consider this timing when prescribing medications that may be affected by antacids.

Packaging & NDC

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

Packaging configurations for Extra Strength Smooth Antacid.
Details

Pediatric Use

Pediatric patients aged 12 years and older may use the medication by wetting it in the mouth before chewing. The recommended dosage for this age group 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 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully known. Therefore, it is essential for women of childbearing potential to seek medical advice prior to use to ensure appropriate management and consideration of any potential risks.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on 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 a reduced dose of the medication. It is essential for healthcare professionals to assess creatinine clearance prior to initiating therapy in these patients. Regular renal function tests are recommended for individuals with existing kidney problems to monitor their condition effectively. Additionally, special monitoring is required for patients with significant renal impairment to avoid potential toxicity associated with the medication.

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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, 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 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 stability and 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. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Extra Strength Smooth Antacid, 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 Smooth Antacid, 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.