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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 2019
Label revision date
October 30, 2024
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 2019
Label revision date
October 30, 2024
Manufacturer
RITE AID CORPORATION
Registration number
M001
NDC root
11822-1166
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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If you are a consumer or patient please visit this version.

Drug Overview

Extra Strength Smooth Antacid is a chewable tablet designed to provide relief from common stomach discomforts. Each tablet contains 750 mg of calcium carbonate, which helps alleviate heartburn, acid indigestion, sour stomach, and upset stomach associated with these symptoms. Available in a pleasant Assorted Berries flavor, this gluten-free product comes in a package of 60 tablets, making it a convenient option for managing occasional digestive issues.

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.

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. Always follow your healthcare provider's advice for the best results.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, you can use it without concerns about these particular issues. However, always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

When using this product, it's important to be aware of potential side effects and interactions. You should consult with a doctor or pharmacist if you are currently taking any prescription medications, as antacids can interact with them. Common side effects may include discomfort or changes in digestion.

It's crucial 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. Additionally, avoid using the maximum dosage for more than 2 weeks unless directed by a healthcare professional.

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

Taking more than 10 tablets in a 24-hour period can lead to an overdose, which is a serious situation. If you are pregnant, it’s important to limit your intake to no more than 6 tablets in the same timeframe. Additionally, you should not use the maximum dosage for more than 2 weeks unless your doctor has advised you to do so.

Signs of an overdose may include unusual symptoms, and if you suspect that you or someone else has taken too much, it’s crucial to seek immediate medical help. Always prioritize your health and safety by following dosage guidelines carefully. If you have any concerns or experience any adverse effects, don’t hesitate to contact a healthcare professional.

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. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to keep this medication out of reach of children to ensure their safety. For adults and children aged 12 years and older, the recommended dosage 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 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. If you or a loved one is an older adult, it’s wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach, considering any unique health needs or conditions that may be present.

Always ensure that your doctor is aware of all medications being taken, as older adults often have different health considerations that may affect how a drug works. Regular check-ins with your healthcare team can help monitor for any side effects or changes in health.

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 and safety considerations for patients with renal impairment (kidney issues) are not provided.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and appropriate for your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver condition and the use of this medication. They can help ensure that you receive the safest and most effective treatment.

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 treatments, always discuss any medications, 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 chew 2 to 4 tablets completely when symptoms occur, or follow your doctor's instructions. It's important not to swallow the tablets whole. If you are taking any prescription medications, consult with your doctor or pharmacist before using this product, as antacids can interact with certain drugs.

If your symptoms last more than 2 weeks, seek medical advice before continuing use. Pregnant individuals should limit their intake to no more than 6 tablets in a 24-hour period, and the maximum dosage should not be used for more than 2 weeks unless directed by a healthcare professional.

FAQ

What is Extra Strength Smooth Antacid?

Extra Strength Smooth Antacid is a chewable tablet that contains 750 mg of Calcium Carbonate and is designed to relieve heartburn, acid indigestion, sour stomach, and upset stomach.

How should I take Extra Strength Smooth Antacid?

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.

What are the warnings associated with this product?

You should 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, and if pregnant, do not take more than 6 tablets in 24 hours.

Are there any contraindications for Extra Strength Smooth Antacid?

No specific contraindications are listed for Extra Strength Smooth Antacid.

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

If you are 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 Extra Strength Smooth Antacid for symptoms that persist for more than 2 weeks unless advised by a doctor.

How should I store Extra Strength Smooth Antacid?

Store Extra Strength Smooth Antacid at room temperature and keep the container tightly closed.

Is Extra Strength Smooth Antacid gluten-free?

Yes, Extra Strength Smooth Antacid is gluten-free.

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

NDC# 11822-1166-0. This product is an extra strength smooth antacid tablet formulation containing 750 mg of calcium carbonate per tablet. It is designed for the fast relief of upset stomach, heartburn, and acid indigestion. The tablets are chewable and flavored with assorted berries, incorporating both natural and artificial flavoring agents. Each bottle contains 60 tablets. The product is certified K Pareve and is gluten-free. It is distributed by Rite Aid, located at 30 Hunter Lane, Camp Hill, PA 17011. This product is not manufactured or distributed by GlaxoSmithKline, the owner of the registered trademark, Tums® Smoothies™ Extra Strength.

Uses and Indications

This drug is indicated for the relief of heartburn, acid indigestion, sour stomach, and upset stomach associated with these symptoms.

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

Dosage and Administration

Adults and children 12 years of age and over are instructed to chew 2 to 4 tablets completely as symptoms occur, or as directed by a healthcare professional. It is important that the tablets are not swallowed whole.

Patients should not use this medication for symptoms that persist for more than 2 weeks unless advised by a healthcare provider.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

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 under the guidance and supervision of a healthcare provider.

No specific general precautions or laboratory tests are indicated for the safe use of this product.

Side Effects

Patients should be aware of potential adverse reactions associated with the use of this product. It is important to consult a healthcare professional before use, especially for individuals currently taking prescription medications, as antacids may interact with certain drugs.

In clinical settings, participants have been advised not to exceed a dosage of 10 tablets within a 24-hour period. For pregnant individuals, the recommended maximum is limited to 6 tablets in 24 hours. Furthermore, the maximum dosage should not be utilized for more than 2 weeks unless under the guidance and supervision of a healthcare provider.

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

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 and to avoid diminished efficacy of the prescribed medications.

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 adolescents aged 12 years and older, the recommended dosage is 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

There is no specific information available 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 are advised not to exceed a dosage of 6 tablets within a 24-hour period. This precaution is essential to minimize potential risks to fetal outcomes. Healthcare professionals should counsel women of childbearing potential regarding the importance of adhering to this dosage limit 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 absence of detailed information necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding 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 warranted based on clinical judgment.

Overdosage

In cases of overdosage, it is critical to adhere to the recommended dosage guidelines to prevent adverse effects. The maximum allowable dosage for adults is 10 tablets within a 24-hour period. For pregnant individuals, the dosage should not exceed 6 tablets in the same timeframe to mitigate potential risks to both the mother and the fetus.

Prolonged use of the maximum dosage is not advised; it should not be taken for more than 2 weeks unless under the guidance and supervision of a healthcare professional. This precaution is essential to avoid complications associated with excessive intake.

Healthcare professionals should monitor for symptoms of overdosage, which may include but are not limited to gastrointestinal disturbances, central nervous system effects, or other systemic reactions. In the event of suspected overdosage, immediate medical attention is warranted. Management may involve supportive care and symptomatic treatment, tailored to the specific symptoms presented by the patient.

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 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 to ensure the safety of young individuals.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It should be stored at room temperature, maintaining a stable environment to preserve its integrity. The container must be kept tightly closed to prevent contamination and ensure the product remains effective.

Additional Clinical Information

Patients aged 12 years and older are advised to chew 2-4 tablets completely as symptoms occur or as directed by a healthcare professional, ensuring that the tablets are not swallowed whole. Clinicians should counsel patients to consult a doctor or pharmacist before use if they are currently taking prescription medications, as antacids may interact with certain drugs. Patients should refrain from using the medication for symptoms that persist beyond two weeks unless directed by a healthcare provider. Pregnant patients should limit their intake to no more than six tablets in a 24-hour period and should not exceed the maximum dosage for more than two weeks without medical supervision.

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.