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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
21130-516
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 contain 750 mg of calcium carbonate, which is a common ingredient used to relieve digestive discomfort. These tablets are flavored with assorted fruit, making them a pleasant option for those seeking relief from heartburn, acid indigestion, and upset stomach.

You can use Extra Strength Smooth Antacid Tablets for fast relief from these symptoms, as they work by neutralizing stomach acid. They are comparable to the active ingredient found in Extra Strength Tums® Smoothies™, providing a convenient solution for managing occasional digestive issues.

Uses

If you're experiencing discomfort from heartburn, sour stomach, or acid indigestion, this medication can help relieve those symptoms. It is also effective for upset stomachs that are 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

If you are an adult or a child aged 12 years and older, you should chew 2 to 4 tablets completely whenever you experience symptoms, or follow your doctor's instructions. It's important not to swallow the tablets whole, as they need to be chewed to work effectively.

Make sure to pay attention to how long you are experiencing symptoms. If your symptoms last more than 2 weeks, you should consult with a doctor before continuing to take the medication. This ensures that you are using the medication safely and effectively.

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

You may experience some side effects when using this product. It's important to be aware that taking more than 10 tablets in a 24-hour period can lead to complications. 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 a doctor.

Before using this product, consult with your doctor or pharmacist, especially if you are currently taking any prescription medications, as antacids can interact with certain drugs.

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, it's best to stop taking it and reach out to your healthcare provider for guidance. Always prioritize your health and safety by following these recommendations.

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 crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, your safety is the top priority, so don’t hesitate to get help.

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. This guideline helps ensure your safety and the safety of your developing baby. Always consult with your healthcare provider before taking any medication during pregnancy to discuss potential risks and appropriate dosages.

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

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using medications while breastfeeding. Your health and the well-being of your baby are important, and your provider can help guide you in making the best choices.

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 falls within this age range, they should chew 2 to 4 tablets completely when symptoms arise, or follow your doctor's instructions. Make sure they do not swallow the tablets whole, as this can affect how the medication works.

Always 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 healthcare provider for guidance.

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. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with a healthcare provider. They can help determine the best approach, considering any unique health needs or conditions.

Always ensure that your healthcare team is aware of all medications being taken, as older adults may have different responses to treatments. Regular check-ins with your doctor can help monitor for any side effects or necessary adjustments in dosage.

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 for the medication do not change based on liver function. 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.

Make sure to keep your doctor informed about any liver issues you may have, as they may want to monitor your liver function regularly to ensure your safety while using the medication.

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 lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

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 will take this medication orally. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

FAQ

What is Extra Strength Smooth Antacid Tablets used for?

Extra Strength Smooth Antacid Tablets are used to relieve heartburn, sour stomach, acid indigestion, and upset stomach associated with these symptoms.

What is the active ingredient in Extra Strength Smooth Antacid Tablets?

The active ingredient is Calcium Carbonate, with each tablet containing 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, do not take more than 10 tablets in 24 hours, and if pregnant, do not take more than 6 tablets in 24 hours. Consult a doctor if you are taking a prescription drug, as antacids may interact with certain medications.

Can I use Extra Strength Smooth Antacid Tablets if I am pregnant?

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

How should I store Extra Strength Smooth Antacid Tablets?

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

Are there any side effects associated with Extra Strength Smooth Antacid Tablets?

The provided text does not list any specific side effects for Extra Strength Smooth Antacid Tablets.

Is there any information about the use of Extra Strength Smooth Antacid Tablets in nursing mothers?

There are no specific warnings or recommendations regarding the use of this product in nursing mothers.

What should I do if my symptoms persist?

Do not take Extra Strength Smooth Antacid Tablets for symptoms that persist for more than 2 weeks unless advised by a doctor.

Packaging Info

Below are the non-prescription pack sizes of Extra Strength Smooth (antacid tablets). 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

No description information is available for the drug.

Uses and Indications

This drug is indicated for the relief of heartburn, sour stomach, acid indigestion, and 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 essential that the tablets are not 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

Healthcare professionals should advise patients to consult 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 administering this product, it is critical to adhere to the following dosage guidelines: patients 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 utilized for more than 2 weeks unless directed and monitored by a healthcare provider.

No specific general precautions or laboratory tests are required for the safe use of this product. Additionally, there are no outlined instructions for obtaining emergency medical assistance or for discontinuing use and contacting a physician.

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 ensure the safe use of the product and to minimize the risk of adverse reactions.

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 (antacid tablets). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Extra Strength Smooth.
Details

Pediatric Use

Pediatric patients aged 12 years and older are advised to chew 2-4 tablets completely as symptoms occur, or as directed by a healthcare professional. It is important that the tablets are not swallowed whole.

Additionally, this product should be kept out of reach of 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 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.

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 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 overdosage information, it is essential for healthcare professionals to remain vigilant and consider general principles of management in cases of suspected overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate assessment of the patient's condition is crucial. Recommended actions include:

  1. Assessment and Monitoring: Conduct a thorough evaluation of the patient's vital signs and level of consciousness. Continuous monitoring may be necessary to detect any changes in the patient's status.

  2. Supportive Care: Provide supportive care as needed, which may involve airway management, oxygen supplementation, intravenous fluids, and other interventions to stabilize the patient.

  3. Decontamination: If the overdose is recent and the patient is alert and able to protect their airway, consider gastrointestinal decontamination methods such as activated charcoal, following established protocols.

  4. Consultation with Poison Control: Engage with a poison control center for guidance on specific management strategies tailored to the substance involved in the overdose.

  5. Symptomatic Treatment: Address any specific symptoms that arise, utilizing appropriate pharmacological interventions as indicated.

  6. Hospitalization: Depending on the severity of the overdose and the patient's response to initial management, hospitalization may be warranted for further observation and treatment.

In summary, while specific overdosage information is not available, healthcare professionals should apply general overdose management principles and remain prepared to respond to a variety of clinical scenarios.

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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

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

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 compromise in safety or efficacy.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

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.