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Extra Strength Smooth

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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 2020
Label revision date
October 29, 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 2020
Label revision date
October 29, 2025
Manufacturer
SAFEWAY
Registration number
M001
NDC root
21130-515
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

EXTRA STRENGTH Smooth Antacid Tablets are chewable tablets that provide fast relief from upset stomach, heartburn, and acid indigestion. Each tablet contains 750 mg of calcium carbonate, which works to neutralize stomach acid, helping to alleviate discomfort associated with these symptoms.

These tablets come in an assorted berries flavor and are gluten-free, making them a convenient option for those seeking quick relief from digestive issues. With a total of 60 tablets in each package, they are designed to help you feel better when experiencing common stomach-related discomforts.

Uses

If you're experiencing discomfort from heartburn, acid indigestion, or a sour stomach, this medication can help relieve those symptoms. It is also effective for soothing an upset stomach that may be associated with these issues.

You can feel confident using this medication, as there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects reported. This makes it a safe option for managing your digestive discomfort.

Dosage and Administration

When you need relief from certain symptoms, adults and children aged 12 and older can chew 2 to 4 tablets completely as the symptoms occur. It's important not to swallow the tablets whole, as they need to be chewed to work effectively.

If your symptoms last longer than 2 weeks, you should consult with a doctor before continuing to take the medication. This ensures that you are using it safely and appropriately for your needs.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Additionally, there are no explicit instructions indicating that you should not take or use this medication. Always consult with your healthcare provider for personalized advice and to ensure this medication is appropriate for you.

Side Effects

When using this product, you may experience some side effects. It's important to be aware that taking more than 10 tablets in a 24-hour period can lead to adverse reactions. If you are pregnant, you should limit your intake to no more than 6 tablets in 24 hours. Additionally, using the maximum dosage for more than 2 weeks should only be done under the guidance of a doctor.

Before starting this product, consult with your doctor or pharmacist, especially if you are currently taking any prescription medications, as antacids can interact with certain drugs. Always prioritize your health and safety by following these guidelines.

Warnings and Precautions

Before using this product, it's important to consult with your doctor or pharmacist, especially if you are currently taking any prescription medications, as antacids can interact with them. Be mindful of the dosage: do not exceed 10 tablets in a 24-hour period, and 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 directed by your doctor.

If you experience any unusual symptoms or have concerns while using this product, stop taking it and reach out to your doctor for guidance. Your health and safety are paramount, so always follow these precautions to ensure safe use.

Overdose

If you suspect an overdose, it's important to act quickly. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, seek immediate medical help.

In the event of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get professional assistance if you have concerns about your health. Remember, timely action can make a significant difference.

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. Always consult with your healthcare provider before taking any medication to ensure it is safe for you and your baby. Your health and the health of your developing child are the top priority, so make sure to follow these guidelines closely.

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. Currently, there is also no information available about whether this product is excreted in breast milk or any potential risks to your infant.

As always, if you have any concerns or questions about using this product while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

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 chew 2 to 4 tablets completely when symptoms occur, or as directed by a doctor. Please remember that the tablets should not be swallowed whole. Always consult with a healthcare professional if you have any questions or concerns about using this medication for your child.

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 for personalized advice. 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any tests you might be undergoing. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature. It's important to keep the container tightly closed to protect its contents. Before using, check that the safety seal (a printed seal under the cap) is intact; do not use the product if this seal is torn or missing, as this could indicate that the product is compromised. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally and be mindful of a few important guidelines. Before using it, consult with your doctor or pharmacist if you are currently taking any prescription drugs, as antacids can interact with some medications. It's important not to exceed 10 tablets in a 24-hour period, and if you are pregnant, limit your intake to no more than 6 tablets in the same timeframe. Avoid using the maximum dosage for more than 2 weeks unless directed by a healthcare professional, and do not use it for symptoms that last longer than 2 weeks without consulting a doctor.

FAQ

What is EXTRA STRENGTH Smooth Antacid Tablets used for?

EXTRA STRENGTH Smooth Antacid Tablets are used for fast relief of upset stomach, heartburn, acid indigestion, and sour stomach.

What is the active ingredient in EXTRA STRENGTH Smooth Antacid Tablets?

The active ingredient is Calcium Carbonate USP 750 mg.

How should I take EXTRA STRENGTH Smooth Antacid Tablets?

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

Are there any warnings I should be aware of?

Yes, ask a doctor or pharmacist before use if you are taking a prescription drug, as antacids may interact with certain medications. Do not take more than 10 tablets in 24 hours.

Can I take this product if I am pregnant?

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

What should I do if my symptoms persist?

Do not use the maximum dosage for more than 2 weeks unless advised by a doctor, and do not take for symptoms that persist for more than 2 weeks.

Is EXTRA STRENGTH Smooth Antacid Tablets gluten-free?

Yes, the tablets are gluten-free.

How should I store EXTRA STRENGTH Smooth Antacid Tablets?

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

Packaging Info

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

Packaging configurations for Extra Strength Smooth.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Calcium Carbonate USP is presented in a dosage form of 750 mg.

Uses and Indications

This drug is indicated for the relief of heartburn, acid indigestion, and sour stomach. It is also effective in alleviating 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 completely as symptoms occur, or as directed by a healthcare professional. It is important to note that the tablets should not be swallowed whole.

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

Contraindications

There are no contraindications listed for the use of this product. It is important to evaluate each patient's individual circumstances and medical history when considering treatment options.

Warnings and Precautions

Patients should consult a healthcare professional, such as a doctor or pharmacist, prior to using this product if they are currently taking any prescription medications, as antacids may interact with certain drugs.

When utilizing this product, it is imperative to adhere to the following dosage guidelines: individuals should not exceed 10 tablets within a 24-hour period. For pregnant individuals, the maximum dosage should not exceed 6 tablets in a 24-hour timeframe. Furthermore, the maximum dosage should not be used for more than 2 weeks unless directed and monitored by a healthcare provider.

Healthcare professionals are advised to monitor patients for adherence to these guidelines to ensure safe usage and to mitigate potential risks associated with excessive intake.

Side Effects

Patients may experience various adverse reactions when using this product. It is important to note that certain warnings are associated with its use. Patients should consult a doctor or pharmacist before using this product if they are currently taking a prescription drug, as antacids may interact with specific medications.

When using this product, patients are advised not to exceed a dosage of 10 tablets within a 24-hour period. Additionally, pregnant patients should limit their intake to no more than 6 tablets in a 24-hour timeframe. It is also recommended that the maximum dosage not be used for more than 2 weeks unless under the guidance and supervision of a healthcare professional.

These precautions are essential to minimize the risk of adverse reactions and ensure safe usage of the product.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Extra Strength Smooth.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. For dosing, children aged 12 years and older are instructed to chew 2-4 tablets completely as symptoms occur, or as directed by a healthcare professional. It is important to note that the tablets should not be swallowed whole.

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 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

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 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 overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving excessive administration of the medication.

Should an overdosage occur, it is recommended that healthcare providers assess the patient’s clinical status and monitor for any adverse effects. Symptoms of overdosage may vary depending on the medication's pharmacological profile and the individual patient's response.

Management of overdosage should include supportive care, which may involve symptomatic treatment and monitoring of vital signs. In cases where the specific antidote or treatment protocol is known, it should be administered as per established guidelines.

Healthcare professionals are advised to consult local poison control centers or relevant medical literature for guidance on managing overdosage situations effectively.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young children.

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. Additionally, the product features a safety seal; it is imperative not to use the product if the printed seal under the cap is torn or missing, as this may indicate a compromised product.

Additional Clinical Information

The product is administered orally. Clinicians should advise patients to consult a doctor or pharmacist before use if they are currently taking any prescription medications, as antacids may interact with certain drugs. Patients are instructed not to exceed 10 tablets within a 24-hour period, and if pregnant, to limit intake to no more than 6 tablets in 24 hours. It is also recommended that the maximum dosage not be used for more than 2 weeks unless under medical supervision, and patients should refrain from using the product for symptoms persisting beyond 2 weeks without consulting a doctor.

Drug Information (PDF)

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