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Extra Strength Smooth Antacid

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This product has been discontinued

Active ingredient
Calcium Carbonate 750 mg
Other brand names
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
January 6, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Calcium Carbonate 750 mg
Other brand names
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
January 6, 2022
Manufacturer
Thirty Madison Inc
Registration number
part331
NDC root
71713-204
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, a substance that helps neutralize stomach acid. These tablets are flavored with Chill Berries, making them a pleasant option for those seeking relief from discomfort.

You can use Extra Strength Smooth Antacid Tablets to alleviate symptoms such as acid indigestion, heartburn, sour stomach, and upset stomach associated with these issues. They are designed to provide quick relief, helping you feel more comfortable after meals or during times of digestive distress.

Uses

If you're experiencing discomfort from acid indigestion, heartburn, or a sour stomach, this medication can help relieve those symptoms. It’s also effective for an upset stomach that comes along 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) associated with it. This makes it a safer option for those who may be concerned about such risks.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take this medication by chewing 2 to 4 tablets whenever you experience symptoms, or as your doctor recommends. It's important to follow these guidelines closely to ensure safe and effective use.

However, if your symptoms last longer than 2 weeks, you should not continue taking the medication without consulting your doctor. This precaution helps ensure that any underlying issues are properly addressed. Always prioritize your health and seek professional advice when needed.

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 helps prevent potential risks associated with misuse 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 interactions and side effects when taking 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 about any concerns or questions regarding your medications to ensure your safety and well-being.

Warnings and Precautions

It's important to use this medication responsibly. 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 safety and well-being when using any medication.

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 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 is within this age range, they can chew 2 to 4 tablets as needed for their symptoms, or follow the guidance of a doctor.

Always remember to keep the medication out of reach of younger children to ensure their safety. If you have any concerns or questions about its use, don't hesitate to consult with a healthcare professional.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it's important to approach any new treatment with caution. If you or a loved one is an older adult, it's always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider may still want to monitor your response to the medication closely. This is especially true if there are any existing health concerns or if you are taking other medications. Always feel free to ask questions and express any concerns during your medical appointments.

Renal Impairment

If you have kidney problems, it's important to know that you may need a lower dose of this medication. Your doctor will determine the right dosage based on your creatinine clearance levels, which is a test that measures how well your kidneys are filtering waste from your blood.

To ensure your kidneys remain healthy while taking this medication, regular renal function tests are recommended. If you have severe kidney impairment, your healthcare provider will need to monitor you more closely to adjust your treatment as necessary. Always communicate with your doctor about your kidney health to ensure safe and effective use of the medication.

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 if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 the contents from contamination and maintain their effectiveness. By following these simple storage guidelines, you can help ensure the safety and reliability of the product.

Additional Information

You should take this medication orally. Before using it, make sure to ask your doctor or pharmacist if you are currently taking any prescription drugs, as antacids can interact with some medications. If you are pregnant or breastfeeding, consult a healthcare professional before use. Additionally, do not use this medication for symptoms that last longer than two weeks unless directed by a doctor.

FAQ

What is Extra Strength Smooth Antacid Tablets used for?

Extra Strength Smooth Antacid Tablets are used to relieve acid indigestion, heartburn, sour stomach, 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 as symptoms occur, or as directed by a doctor.

Are there any precautions for using Extra Strength Smooth Antacid Tablets?

You should ask a health professional before use if you are pregnant, breastfeeding, or taking a prescription drug, as antacids may interact with certain medications.

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.

Is there a maximum dosage for Extra Strength Smooth Antacid Tablets?

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.

How should I store Extra Strength Smooth Antacid Tablets?

Store the tablets at room temperature and keep the container tightly closed.

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

No teratogenic effects are mentioned for Extra Strength Smooth Antacid Tablets.

What should I do if I have renal impairment?

Patients with renal impairment may require a reduced dose, and regular renal function tests are recommended to monitor kidney health.

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

Extra Strength Chill Berries Antacid Tablets are chewable tablets formulated to provide effective relief from heartburn and indigestion. Each tablet contains 750 mg of Calcium Carbonate as the active ingredient, which is comparable to the active ingredient in TUMS® Smoothies™ EX. The product is presented in a smooth texture and is available in a package containing 60 chewable tablets.

Uses and Indications

This drug is indicated for the relief of acid indigestion, heartburn, 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 aged 12 years and older are instructed to chew 2 to 4 tablets as symptoms occur, or as directed by a healthcare professional. It is important to note that this medication should not be taken for symptoms that persist for more than 2 weeks unless advised by a doctor.

Contraindications

Use of this product is contraindicated in patients who exceed the maximum dosage of 10 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 critical information 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 supervised by a healthcare provider. This precaution is essential to prevent potential adverse effects associated with prolonged use or excessive dosage.

Currently, there are no specific warnings, general precautions, or laboratory tests associated with this product. However, healthcare professionals should remain vigilant and monitor patients for any unusual symptoms or reactions during the course of treatment. In the event of any concerning symptoms, it is advisable to reassess the patient's treatment plan and consider alternative options as necessary.

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, and patients should report any concerns to their healthcare professional promptly.

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 outcomes. 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 chew 2-4 tablets as symptoms occur, or as directed by a healthcare professional. It is important to keep this medication out of reach of younger 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 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 require a reduced dose of the medication. Dosage adjustments should be based on creatinine clearance levels to ensure safety and efficacy. Regular renal function tests are recommended to monitor kidney health in patients receiving this medication. Additionally, special monitoring is necessary for patients with severe renal impairment to mitigate potential risks associated with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and follow-up 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 these contexts.

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. Clinicians should advise patients to consult a doctor or pharmacist prior to use if they are currently taking a prescription drug, as antacids may interact with certain medications. Additionally, patients who are pregnant or breastfeeding should seek professional guidance before use. It is important to inform patients not to use the medication for symptoms that persist for more than two weeks unless directed by a healthcare provider.

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

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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.