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Antacid

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Active ingredient
Calcium Carbonate 420 mg
Other brand names
Drug classes
Blood Coagulation Factor, Phosphate Binder
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 2023
Label revision date
December 20, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Calcium Carbonate 420 mg
Other brand names
Drug classes
Blood Coagulation Factor, Phosphate Binder
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 2023
Label revision date
December 20, 2024
Manufacturer
Trifecta Pharmaceuticals USA LLC
Registration number
M001
NDC root
69396-142
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

CS 2016 Globe Antacid is a medication designed to relieve discomfort caused by heartburn, sour stomach, acid indigestion, and upset stomach. If you experience these symptoms, this antacid can help provide relief and improve your overall comfort.

This product is conveniently packaged as "CS 2016 Globe Antacid 50pk 031124 CDER," making it easy to access when you need it.

Uses

If you're experiencing discomfort from heartburn, sour stomach, or acid indigestion, this medication can help relieve those symptoms. It’s also effective for soothing an upset stomach that arises from 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

When you need relief from your symptoms, start by chewing 2 tablets every 2 to 3 hours. If your symptoms persist, you can repeat this dosage hourly as needed. Just remember to listen to your body and adjust the timing based on how you feel. Always follow these guidelines to ensure you’re using the medication safely and effectively.

What to Avoid

It's important to use this product safely to avoid potential issues. You should not take more than 19 tablets in a 24-hour period, and you should not use the maximum dosage for more than two weeks unless your doctor advises you to do so. If your symptoms last longer than two weeks, please stop using the product and consult your doctor for further guidance.

By following these instructions, you can help ensure your safety and well-being while using this medication.

Side Effects

It's important to be aware of potential side effects if you have kidney disease or are taking other prescription medications. Certain antacids can interact with these drugs, which may affect how well they work or increase the risk of side effects. Always consult with your healthcare provider about any medications you are taking to ensure they are safe to use together.

Warnings and Precautions

It's important to use this product safely. Do not take more than 19 tablets in a 24-hour period, and avoid using the maximum dosage for more than two weeks unless your doctor advises you to do so. If your symptoms last longer than two weeks, stop using the product and consult your doctor.

Before using this product, talk to your doctor or pharmacist if you have kidney disease or are taking any prescription medications, as antacids can interact with certain drugs. Always prioritize your health and seek professional advice when needed.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common 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 crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this product during pregnancy has not been established. You should consult your doctor before using it, as there may be potential risks to your fetus that are not clearly defined.

Additionally, dosage adjustments might be necessary, so it's crucial to seek medical advice for the appropriate use during this time. Be vigilant about monitoring for any adverse effects and report any concerns to your healthcare provider promptly. Your health and the health of your baby are the top priority.

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. This precaution helps prevent accidental ingestion, which can be dangerous. Always store it in a safe place where children cannot access it, ensuring their safety at all times. If you have any concerns or questions about the medication, don't hesitate to reach out to your healthcare provider for guidance.

Geriatric Use

If you are an older adult or a caregiver, it's important to be cautious when using certain medications. Before starting any new medication, especially if you have kidney disease (a condition where your kidneys do not function properly), make sure to consult with your doctor or pharmacist. They can provide guidance tailored to your health needs.

Additionally, be aware that antacids, which are commonly used to relieve heartburn and indigestion, can interact with some prescription medications. Always check with your healthcare provider to ensure that your medications can be safely taken together. Taking these precautions can help you manage your health more effectively.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. Your healthcare provider will monitor your renal function tests to ensure your kidneys are working properly. If your creatinine clearance (a measure of kidney function) is less than 30 mL/min, you may require a lower dose of your medication. Additionally, if you have significant renal impairment, special monitoring will be necessary to keep track of your health and adjust treatment as needed. Always discuss any concerns with your healthcare provider to ensure your safety and well-being.

Hepatic Impairment

If you have liver problems, it's important to know that your medication dosage may need to be adjusted. This is because your liver's ability to process medications can be affected. For those with severe liver impairment, a lower dose might be necessary to ensure safety and effectiveness.

Additionally, regular monitoring of your liver function tests (which check how well your liver is working) is recommended. This helps your healthcare provider keep track of your liver health and make any necessary changes to your treatment plan. Always discuss your liver condition with your doctor to ensure you receive the best 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 safety and effectiveness of your product, store it in a cool, dry place at a temperature between 15ºC and 30ºC (59ºF - 86ºF). It's important to keep the product in its original packaging and never use it if the packet is open or torn, as this could compromise its integrity and safety.

By following these simple storage and handling guidelines, you can help maintain the quality of the product and ensure it works as intended. Always check the packaging before use to ensure it is intact.

Additional Information

You should take this medication orally by chewing 2 tablets every 2-3 hours as needed for symptoms. However, it's important not to exceed 19 tablets in a 24-hour period or use the maximum dosage for more than two weeks without consulting your doctor. If your symptoms last longer than two weeks, stop using the product and seek medical advice.

FAQ

What is CS 2016 Globe Antacid used for?

CS 2016 Globe Antacid is used to relieve heartburn, sour stomach, acid indigestion, and upset stomach due to these symptoms.

How should I take CS 2016 Globe Antacid?

You should chew 2 tablets every 2-3 hours or as symptoms occur, and you can repeat hourly if needed.

What is the maximum dosage for CS 2016 Globe Antacid?

Do not take more than 19 tablets in a 24-hour period or use the maximum dosage for more than two weeks without a doctor's advice.

What should I do if my symptoms persist?

If your symptoms persist for more than two weeks, stop using this product and see a doctor.

Are there any precautions I should take before using this product?

Yes, ask a doctor or pharmacist before use if you have kidney disease or are taking a prescription drug, as antacids may interact with certain medications.

Is CS 2016 Globe Antacid safe to use during pregnancy?

The safety of this product during pregnancy has not been established, so consult a doctor if you are pregnant or planning to become pregnant.

What should I do if I have renal impairment?

If you have renal impairment, dosage adjustments may be necessary, and you should monitor renal function tests.

How should I store CS 2016 Globe Antacid?

Store CS 2016 Globe Antacid at 15ºC - 30ºC (59ºF - 86ºF) and do not use it if the packet is open or torn.

What are the potential risks if I have liver problems?

Patients with hepatic impairment may require dosage adjustments, and special monitoring of liver function tests is recommended.

Is there any information about using CS 2016 Globe Antacid while nursing?

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

CS 2016 Globe Antacid is presented in a package containing 50 units, identified by the code 031124. This formulation is classified under the category of antacids and is regulated by the Center for Drug Evaluation and Research (CDER). The product is designed to provide symptomatic relief from conditions associated with excess stomach acid. Further details regarding its chemical composition, molecular weight, and inactive ingredients are not specified in the provided information.

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

Patients are advised to chew 2 tablets every 2 to 3 hours as needed for symptom relief. If symptoms persist, the dosage may be repeated hourly. It is important to monitor the patient's response and adjust the frequency of administration accordingly, ensuring that the total daily intake does not exceed recommended limits.

Contraindications

Use of this product is contraindicated in the following situations:

Patients should not exceed a dosage of 19 tablets within a 24-hour period or utilize the maximum dosage for more than two weeks without the guidance and supervision of a healthcare professional. Additionally, if symptoms persist beyond two weeks, discontinuation of the product is advised, and a consultation with a healthcare provider is recommended.

Warnings and Precautions

It is imperative to adhere to the following warnings and precautions to ensure the safe use of this product.

Warnings The maximum dosage of this product should not exceed 19 tablets within a 24-hour period. Additionally, the maximum dosage should not be utilized for more than two weeks unless under the guidance and supervision of a healthcare professional. Should symptoms persist beyond two weeks, it is essential to discontinue use and consult a physician.

General Precautions Prior to using this product, individuals should seek advice from a healthcare provider or pharmacist if they have a history of kidney disease or are currently taking any prescription medications. It is important to note that antacids may interact with certain prescription drugs, which could affect their efficacy or safety.

Monitoring and Follow-Up While no specific laboratory tests are indicated for monitoring, healthcare professionals should remain vigilant for any adverse effects or interactions, particularly in patients with pre-existing conditions or those on concurrent medications.

In summary, careful consideration of the above warnings and precautions is crucial for the safe administration of this product.

Side Effects

Patients with kidney disease may experience additional adverse reactions when using this medication. It is important for healthcare providers to be aware of the potential for interactions with other prescription drugs, as these interactions can lead to adverse effects. Specifically, antacids have been noted to interact with certain prescription medications, which may further complicate the treatment regimen for patients.

Healthcare professionals should monitor patients closely for any signs of adverse reactions, particularly in those with pre-existing conditions or those taking multiple medications.

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.

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 advised to keep this medication out of reach of children. Safety and efficacy in pediatric populations have not been established, and caution is advised when administering this medication to children.

Geriatric Use

Elderly patients should consult a healthcare provider prior to using this medication, particularly if they have a history of kidney disease. The renal function may decline with age, necessitating careful consideration of potential dosage adjustments and monitoring.

Additionally, it is important for geriatric patients to be aware that antacids can interact with certain prescription medications. This interaction may affect the efficacy of the prescribed treatments, and therefore, healthcare providers should be informed of all medications being taken to ensure safe and effective use. Regular monitoring and assessment of the patient's overall health status are recommended to mitigate any risks associated with these interactions.

Pregnancy

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. Potential risks to the fetus are not clearly defined; therefore, caution is advised. Dosage adjustments may be necessary, and it is essential to seek medical advice for appropriate use during pregnancy. Special precautions should be taken to monitor for any adverse effects, and any concerns should be reported to a healthcare provider.

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

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential to monitor renal function tests in these patients to ensure safety and efficacy. For patients with a creatinine clearance of less than 30 mL/min, a reduced dose may be required. Additionally, special monitoring is advised for patients with significant renal impairment to manage potential risks effectively.

Hepatic Impairment

Patients with hepatic impairment may require dosage adjustments due to altered hepatic metabolism. It is recommended that liver function tests be monitored closely in this population to assess the extent of impairment and to guide treatment decisions. Specifically, patients with severe hepatic impairment may necessitate a reduced dose to ensure safety and efficacy. Regular evaluation of liver function is essential to optimize therapeutic outcomes while minimizing potential risks associated with compromised liver function.

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, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and ensuring adequate circulation. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous monitoring and supportive care should be maintained until the patient is stabilized and any potential complications are addressed.

Documentation of the incident, including the substance involved, estimated dose, time of exposure, and any interventions performed, is vital for ongoing patient management and future reference.

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

Patients should be advised to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients not to exceed a total of 19 tablets within a 24-hour period and to avoid using the maximum dosage for more than two weeks unless directed by a healthcare provider. If symptoms persist beyond two weeks, patients should discontinue use and consult a doctor.

Patients should be encouraged to seek advice from a doctor or pharmacist prior to using this product if they have a history of kidney disease. Additionally, it is essential to inform patients to consult with their healthcare provider if they are currently taking any prescription medications, as antacids may interact with certain drugs. This precaution helps ensure safe and effective use of the medication.

Storage and Handling

The product is supplied in a secure packaging format, ensuring integrity until use. It must be stored at a temperature range of 15ºC to 30ºC (59ºF to 86ºF) to maintain its efficacy. Care should be taken to avoid using the product if the packet is open or torn, as this may compromise its quality and safety. Proper handling and storage conditions are essential to ensure the product remains effective and safe for use.

Additional Clinical Information

The product is administered orally, with a recommended dosage of chewing 2 tablets every 2-3 hours as symptoms occur, and may be repeated hourly if necessary. Patients should not exceed 19 tablets within a 24-hour period or use the maximum dosage for more than two weeks without consulting a healthcare professional. If symptoms persist beyond two weeks, patients are advised to discontinue use and seek medical advice.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

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

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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.