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Antacid

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This product has been discontinued

Active ingredient
Calcium Carbonate 750 mg
Other brand names
Dosage form
Tablet
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
December 30, 2019
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Calcium Carbonate 750 mg
Other brand names
Dosage form
Tablet
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
December 30, 2019
Manufacturer
Safetec of America, Inc.
Registration number
part331
NDC root
61010-4408
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

Calcium carbonate is an extra strength antacid that helps relieve common digestive discomforts. If you experience heartburn, acid indigestion, a sour stomach, or an upset stomach related to these symptoms, calcium carbonate can provide effective relief.

This medication works by neutralizing stomach acid, which helps to alleviate the discomfort associated with these conditions. It is available in chewable tablet form, making it easy to take when you need it.

Uses

If you're experiencing discomfort from heartburn, acid indigestion, or a sour stomach, this medication can help relieve those symptoms. It’s also effective for soothing 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) or other harmful effects reported.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can take 2 to 4 tablets by chewing them when you experience symptoms, or as your doctor recommends. It's important to pay attention to how long your symptoms last. If your symptoms continue for more than 2 weeks, you should consult your doctor before taking any more of the medication. This ensures that you are using the medication safely and effectively.

What to Avoid

It's important to be cautious when using this medication. You should not take it for symptoms that last longer than 2 weeks unless your doctor advises you to do so. Additionally, make sure not to exceed 10 tablets in a 24-hour period. If you are pregnant, limit your intake to no more than 6 tablets in 24 hours.

Also, avoid using the maximum dosage for more than 2 weeks unless you are under the guidance and supervision of a healthcare professional. Following these guidelines can help prevent potential misuse or dependence (a condition where your body becomes reliant on a substance). Always prioritize your health and consult with your doctor if you have any questions or concerns.

Side Effects

It's important to be aware of potential side effects when using this product. You should consult with your doctor or pharmacist if you are currently taking any prescription medications, as antacids can interact with them.

While using this product, do not exceed 10 tablets in a 24-hour period. 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 healthcare professional.

Warnings and Precautions

Before using this medication, it's important to consult with your doctor or pharmacist, especially if you are currently taking any prescription drugs, as antacids can interact with them. Be mindful 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 your doctor has advised you to do so.

If your symptoms last longer than 2 weeks, stop taking the medication and reach out to your doctor for further guidance. While there are no specific laboratory tests required for this medication, staying informed and cautious will help ensure your safety while using it.

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 and is supervising your treatment.

If you suspect an overdose, look out for signs such as unusual drowsiness, confusion, or difficulty breathing. In such cases, it’s crucial to seek immediate medical help. Always prioritize your health and consult with a healthcare professional if you have any concerns about your medication use.

Pregnancy Use

If you are pregnant, it is important to be cautious with your 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. This means that, according to the information available, it is considered safe for you to use without concerns about potential effects on your milk production or the nursing infant.

Additionally, there are no indications that this product is excreted in breast milk, which further supports its use during lactation. Always consult with your healthcare provider if you have any questions or concerns 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 when symptoms occur, or as directed by a healthcare professional. Always consult with your doctor if you have any questions about the appropriate use 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 before starting the medication. 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 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, ideally between 15° and 30°C (59° and 86°F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety and effectiveness.

Additional Information

No further information is available.

FAQ

What is Calcium Carbonate used for?

Calcium Carbonate is an extra strength antacid that relieves heartburn, acid indigestion, sour stomach, and upset stomach associated with these symptoms.

How should I take Calcium Carbonate?

Adults and children 12 years of age and over should chew 2-4 tablets as symptoms occur, or as directed by a doctor.

What is the maximum dosage for Calcium Carbonate?

Do not take more than 10 tablets in 24 hours. If pregnant, do not take more than 6 tablets in 24 hours.

How long can I use Calcium Carbonate?

Do not use the maximum dosage for more than 2 weeks unless advised by a doctor.

Are there any warnings for using Calcium Carbonate?

Ask a doctor or pharmacist before use if you are taking a prescription drug, as antacids may interact with certain medications.

What should I do if my symptoms persist?

Do not take Calcium Carbonate for symptoms that persist for more than 2 weeks unless advised by a doctor.

Is Calcium Carbonate safe during pregnancy?

While there are no teratogenic effects mentioned, pregnant women should not take more than 6 tablets in 24 hours.

How should I store Calcium Carbonate?

Store Calcium Carbonate at room temperature between 15°-30°C (59°-86°F).

What should I do if the pouch is torn or damaged?

Do not use Calcium Carbonate if the pouch is torn or damaged.

Is there any specific information for nursing mothers?

There are no specific warnings or recommendations regarding the use of Calcium Carbonate by nursing mothers.

Packaging Info

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

Packaging configurations for Antacid.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Safetec is an EXTRA STRENGTH Antacid formulation manufactured by Safetec of America, Inc., located in Buffalo, NY 14215. Each dosage form consists of 2 chewable tablets, with each tablet containing 750 mg of the active ingredient Calcium Carbonate. It is important to note that the product should not be used if the pouch is torn or damaged.

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 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 the following situations:

Patients experiencing symptoms that persist for more than 2 weeks should not use this product unless advised by a healthcare professional. Additionally, the maximum dosage of 10 tablets in a 24-hour period is not to be exceeded. For pregnant individuals, the dosage should not exceed 6 tablets in 24 hours. Furthermore, the maximum dosage should not be utilized for more than 2 weeks without the guidance and supervision of a healthcare provider.

Warnings and Precautions

Healthcare professionals should advise patients to consult a doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with certain drugs.

It is crucial to adhere to the recommended 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.

Patients are advised to discontinue use and seek medical advice if symptoms persist for more than 2 weeks, unless directed otherwise by a physician. No specific laboratory tests are required for monitoring during the use of this medication.

Side Effects

Patients should be aware of potential adverse reactions associated with the use of this product. It is important to consult a doctor or pharmacist prior to use if currently taking any prescription medications, as antacids may interact with certain drugs.

When using this product, patients are advised not to exceed a dosage of 10 tablets within a 24-hour period. For pregnant individuals, the maximum recommended dosage is limited to 6 tablets in a 24-hour timeframe. Additionally, the maximum dosage should not be utilized for more than 2 weeks unless under the guidance and supervision of a healthcare professional.

Drug Interactions

Antacids may interact with various prescription medications, potentially affecting their absorption and efficacy. It is advisable to separate the administration of antacids and other medications by at least two hours to minimize the risk of interaction. Monitoring for therapeutic effectiveness of the affected medications is recommended when antacids are used concurrently.

Packaging & NDC

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

Packaging configurations for Antacid.
Details

Pediatric Use

Pediatric patients should be kept out of reach of children. For adolescents aged 12 years and older, the recommended dosage is to chew 2-4 tablets as symptoms occur, or as directed by a healthcare professional. There is no specific dosing information provided for children under 12 years of age.

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.

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 by lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any effects on breastfed infants. Healthcare professionals should consider this lack of data when advising nursing mothers on the use of this product.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 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. Exceeding this limit may lead to serious health complications.

For pregnant individuals, the recommended maximum dosage is further restricted to 6 tablets in a 24-hour period. This precaution is essential to mitigate potential risks to both the mother and the developing fetus.

It is also advised that the maximum dosage should not be utilized for more than 2 weeks unless under the guidance and supervision of a healthcare professional. Prolonged use at maximum dosage without medical oversight may increase the risk of overdosage and associated complications.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare professionals should assess the patient's condition and provide appropriate management based on the severity of symptoms and the specific circumstances of the overdosage.

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 provided data.

Patient Counseling

Healthcare providers should advise patients aged 12 years and older to chew 2 to 4 tablets as symptoms occur, or as directed by their physician. It is important to inform patients that they should not take the medication for symptoms that persist for more than 2 weeks unless specifically advised by a healthcare professional.

Patients should be cautioned against exceeding a maximum dosage of 10 tablets within a 24-hour period. For pregnant patients, it is essential to limit the intake to no more than 6 tablets in a 24-hour timeframe. Additionally, patients should be made aware that the maximum dosage should not be used for more than 2 weeks unless under the guidance and supervision of a healthcare provider.

Healthcare providers should encourage patients to consult with a doctor or pharmacist before use if they are currently taking any prescription medications, as antacids may interact with certain prescription drugs. This precaution is vital to ensure patient safety and the effectiveness of their treatment regimen.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, within the range of 15° to 30°C (59° to 86°F). Care should be taken to ensure that the product is kept in a suitable container to maintain its integrity. Special handling requirements should be observed to prevent exposure to extreme temperatures or conditions that may compromise the product's quality.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for 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 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.