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Extra Strength Antacid

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Active ingredient
Calcium Carbonate 750 mg
Other brand names
Drug class
Blood Coagulation Factor
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 2017
Label revision date
December 13, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Calcium Carbonate 750 mg
Other brand names
Drug class
Blood Coagulation Factor
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 2017
Label revision date
December 13, 2017
Manufacturer
PuraCap Pharmaceutical LLC
Registration number
part331
NDC root
51013-323
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 Antacid Tablets are a type of medication designed to help relieve discomfort caused by heartburn, acid indigestion, sour stomach, and upset stomach associated with these symptoms. These tablets work by neutralizing stomach acid, providing quick relief from the burning sensation and discomfort that can occur after eating or drinking.

Each package contains 30 tablets, conveniently organized into 15 pouches with 2 tablets per pouch, making it easy for you to take them on the go. If you're experiencing any of these digestive issues, Extra Strength Antacid Tablets may be a helpful option to consider for relief.

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

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 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 your doctor has advised and is supervising you.

By following these guidelines, you can help prevent potential issues related to misuse or dependence (a condition where your body becomes reliant on a substance). Always consult with your healthcare provider if you have any questions or concerns about your medication.

Side Effects

It's important to be aware of potential interactions when using this medication. Before starting, you should consult with your doctor or pharmacist, especially if you are currently taking any prescription drugs, as antacids can interact with them.

While specific side effects are not detailed here, being informed about possible interactions can help ensure your safety and the effectiveness of your treatment. Always prioritize open communication with your healthcare provider regarding any medications you are taking.

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 certain medications.

Make sure to keep this product out of reach of children to ensure their safety. If you have any concerns or experience unusual symptoms, don’t hesitate to reach out to your healthcare provider for guidance.

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, 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 or planning to breastfeed, it's important to know that the drug insert for Extra Strength Antacid (calcium carbonate tablet, chewable) does not provide specific information about its use during nursing. This means that there are no established guidelines or known effects on breast milk or your nursing infant.

Since there is no detailed information available, it's a good idea to consult with your healthcare provider before using this medication while breastfeeding. They can help you weigh the benefits and any potential risks to ensure the safety of both you and your baby.

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 this 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

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 considering this medication, it’s important to consult with a healthcare provider. 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 the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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, and there are no special monitoring requirements or precautions outlined for patients with liver impairment.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe for your liver health. They can provide guidance based on your individual situation and help monitor your liver function as needed.

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, 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

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 Antacid Tablets used for?

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

How should I take Extra Strength Antacid Tablets?

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

What is the maximum dosage for Extra Strength Antacid Tablets?

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 using Extra Strength Antacid Tablets?

No specific contraindications are mentioned for Extra Strength Antacid Tablets.

Can I use Extra Strength Antacid Tablets if I am taking other prescription drugs?

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

Is there any information about using Extra Strength Antacid Tablets during pregnancy?

There are no teratogenic effects mentioned, but if pregnant, do not take more than 6 tablets in 24 hours.

What should I do if my symptoms persist?

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

How should I store Extra Strength Antacid Tablets?

Store Extra Strength Antacid Tablets at room temperature between 15° - 30°C (59° - 86°F).

What should I keep in mind regarding children and Extra Strength Antacid Tablets?

Keep Extra Strength Antacid Tablets out of reach of children.

Packaging Info

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

Packaging configurations for Extra Strength Antacid.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Extra Strength Antacid Tablets are formulated to provide effective relief from heartburn and indigestion. Each package contains 30 tablets, distributed in 15 pouches, with 2 tablets per pouch. The product is identified by the National Drug Code (NDC) 51013-323-54.

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 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:

Exceeding the recommended dosage of more than 10 tablets within a 24-hour period is contraindicated due to the potential for adverse effects. In pregnant individuals, the use of more than 6 tablets in a 24-hour period is contraindicated to mitigate risks to the fetus. Additionally, the maximum dosage should not be used for more than 2 weeks unless under the advice and supervision of a healthcare professional, to prevent potential complications associated with prolonged high-dose use.

Warnings and Precautions

Healthcare professionals are advised to exercise caution when recommending this product. It is imperative to consult a physician or pharmacist prior to use if the patient is currently taking any prescription medications, as antacids may interact with certain drugs, potentially altering their efficacy or safety.

In addition, it is crucial to ensure that this product is stored out of reach of children to prevent accidental ingestion and potential harm.

No specific laboratory tests have been identified for monitoring during the use of this product. However, healthcare providers should remain vigilant for any signs of adverse reactions or interactions, particularly in patients on concurrent medications.

Side Effects

Patients should be aware of potential adverse reactions associated with the use of this medication. It is important to consult a healthcare professional, such as a doctor or pharmacist, prior to use, especially if the patient is currently taking a prescription drug. Antacids may interact with certain prescription medications, which could lead to adverse effects or reduced efficacy of the prescribed treatment.

While specific adverse reactions were not detailed in the provided information, the interaction with prescription drugs underscores the necessity for careful consideration and monitoring. Patients are encouraged to report any unusual symptoms or reactions to their healthcare provider to ensure appropriate management and care.

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 treatment.

Packaging & NDC

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

Packaging configurations for Extra Strength Antacid.
Details

Pediatric Use

Pediatric patients aged 12 years and older may chew 2 to 4 tablets as symptoms occur, or as directed by a healthcare professional. It is important to keep this medication out of reach of children to prevent accidental ingestion.

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 is no specific information regarding the use of Extra Strength Antacid (calcium carbonate tablet, chewable) in lactating mothers or lactation considerations. The prescribing information does not address the excretion of this medication in breast milk or its effects on breastfed infants. Healthcare professionals should exercise caution and consider the potential risks and benefits when recommending this medication to lactating mothers.

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 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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the substance involved in the overdose. It is crucial for healthcare professionals to consult relevant clinical guidelines and toxicology resources to determine the most appropriate management strategies.

In summary, while no specific overdosage information is available, vigilance and prompt intervention are paramount in managing potential overdose situations.

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 question. Further studies may be necessary to fully evaluate the nonclinical toxicology profile.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to inform patients not to exceed a dosage of 10 tablets within a 24-hour period. For pregnant patients, they should be cautioned to limit their intake to no more than 6 tablets in a 24-hour period.

Providers should emphasize that the maximum dosage should not be used for more than 2 weeks unless directed and supervised by a healthcare professional. Additionally, patients should be encouraged to consult with their doctor or pharmacist before using this medication if they are currently taking any prescription drugs, as antacids may interact with certain medications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, maintaining a range of 15° to 30°C (59° to 86°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

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 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 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.