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Guardian Extra Strength Antacid

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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 2022
Label revision date
December 18, 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 2022
Label revision date
December 18, 2024
Manufacturer
Guardian Drug Company
Registration number
M001
NDC root
53041-130
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

Guardian® is an extra strength antacid tablet that comes in a refreshing wintergreen flavor. Its active ingredient, calcium carbonate (750 mg), works to relieve symptoms of acid indigestion and heartburn, helping you feel more comfortable after meals or during times of discomfort. Each package contains 96 chewable tablets, making it easy to manage your symptoms whenever they arise.

Uses

If you're experiencing discomfort from acid indigestion or heartburn, this medication can help relieve those symptoms. Acid indigestion is often characterized by a burning sensation in your stomach or chest, while heartburn is the feeling of warmth or pain that can occur after eating.

You can use this medication to find relief from these common digestive issues, allowing you to feel more comfortable throughout your day. It's important to note that there are no known harmful effects on fetal development (teratogenic effects) associated with this medication, making it a safer option for those who are pregnant.

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 advises. It's important to follow the recommended dosage to ensure the medication works effectively for you. Always consult with your healthcare provider if you have any questions about how to use this medication properly.

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 will help prevent potential issues and ensure the medication works effectively for you. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

You should be aware that while there are no specific side effects listed for this medication, it’s important to consult with your doctor or pharmacist if you are currently taking any prescription drugs. This is because antacids can interact with certain medications, which may affect how they work.

If you experience any unusual symptoms or reactions while using this medication, it's advisable to seek medical advice promptly. Always prioritize your health and safety by discussing any concerns with a healthcare professional.

Warnings and Precautions

It's important to use this medication safely. 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 health and seek professional advice when needed.

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 effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have any concerns about your health.

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 is important to note that it is only recommended for those aged 12 years and older. If your child falls within this age group, they can chew 2 to 4 tablets as needed for their symptoms, or as directed by a healthcare professional.

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, consult with your child's doctor for personalized advice.

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 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 keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because renal impairment (reduced kidney function) can affect how your body processes certain drugs. To ensure your safety, your healthcare provider will monitor your creatinine clearance (a test that measures how well your kidneys are filtering waste) regularly.

Additionally, regular renal function tests are essential to keep track of your kidney health. If you have significant renal impairment, special monitoring will be necessary to manage your treatment effectively. Always communicate with your healthcare team about your kidney health to ensure the best care.

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 monitor your liver function and determine the best approach for your treatment.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if you are currently taking any prescription drugs. Some antacids can interact with these medications, which may affect how well they work or increase the risk of side effects.

Always keep your healthcare provider informed about all the medications you are taking, including over-the-counter products, to ensure your safety and the effectiveness of your treatment.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and keep the container tightly closed when not in use. This helps maintain its effectiveness and prevents contamination.

Before using the product, check that the printed seal under the cap is intact. If the seal is torn or missing, do not use the product, as this may indicate that it has been compromised. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should take this medication orally. Before using it, consult with your doctor or pharmacist, especially if you are currently taking any prescription drugs, as antacids can interact with some medications. If you are pregnant or breastfeeding, it's important to seek advice from a healthcare professional before use.

FAQ

What is Guardian®?

Guardian® is an extra strength alkums antacid tablet available in wintergreen flavor, containing 750 mg of calcium carbonate.

What does Guardian® relieve?

Guardian® relieves acid indigestion and heartburn.

How should I take Guardian®?

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 Guardian®?

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.

Are there any contraindications for Guardian®?

No specific contraindications are mentioned for Guardian®.

Can I use Guardian® if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using Guardian®.

What should I do if I am taking prescription drugs?

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

How should I store Guardian®?

Store Guardian® at room temperature, keep the container tightly closed, and do not use if the printed seal under the cap is torn or missing.

Packaging Info

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

Packaging configurations for Guardian Extra Strength Antacid.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Guardian® Extra Strength Alkums Antacid Tablets are formulated to provide effective relief from heartburn and indigestion. Each tablet contains 750 mg of Calcium Carbonate as the active ingredient. The product is presented in a chewable dosage form, with a pleasant wintergreen flavor. Each bottle contains 96 chewable tablets. The National Drug Code (NDC) for this product is 53041-130-22.

Uses and Indications

This drug is indicated for the relief of acid indigestion and heartburn.

There are no teratogenic effects associated with this drug, nor are there any nonteratogenic effects mentioned.

Dosage and Administration

Adults and children 12 years of age and over are advised to chew 2 to 4 tablets as symptoms occur, or as directed by a healthcare professional. It is important to follow the recommended dosage and not exceed the maximum dosage unless specifically instructed by a physician.

Contraindications

Use of this product is contraindicated in patients who exceed the recommended dosage of 10 tablets within a 24-hour period or utilize the maximum dosage for more than 2 weeks without the guidance and supervision of a healthcare professional. Adherence to these guidelines is essential to prevent potential adverse effects associated with excessive use.

Warnings and Precautions

Healthcare professionals should be aware of the following critical considerations 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 mitigate the risk of potential adverse effects associated with prolonged use or excessive dosing.

While specific warnings, general precautions, and laboratory tests have not been detailed, healthcare professionals are encouraged to remain vigilant and monitor patients for any signs of adverse reactions or complications during the course of treatment. Should any concerning symptoms arise, immediate consultation with a healthcare provider is advised.

Side Effects

Patients should be aware that while no specific side effects are listed in the warnings section, it is important to consult a healthcare professional before use, particularly if they are currently taking a prescription drug. Antacids may interact with certain prescription medications, which could lead to adverse reactions.

No additional adverse reactions or important notes have been identified in clinical trials or postmarketing experiences. Therefore, ongoing monitoring and communication with healthcare providers are recommended to ensure safe and effective use of the product.

Drug Interactions

Patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking any prescription drugs.

Antacids may have the potential to interact with certain prescription medications, which could affect the efficacy of those drugs. It is important for patients to disclose all medications they are taking to ensure safe and effective use of antacids. Monitoring for any adverse effects or changes in therapeutic outcomes is recommended when antacids are used concurrently with prescription medications.

Packaging & NDC

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

Packaging configurations for Guardian Extra Strength Antacid.
Details

Pediatric Use

Pediatric patients aged 12 years and older may use the medication as directed for symptom relief. The recommended dosage for this age group is to chew 2-4 tablets as symptoms occur, or as advised by a healthcare professional.

It is important to keep the medication out of reach of younger children to prevent accidental ingestion.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and breastfeeding safety. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the health and safety of both the patient and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding 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 necessitate dosage adjustments based on their level of kidney function. It is essential for healthcare professionals to monitor creatinine clearance in patients with reduced renal function to ensure appropriate dosing. Regular renal function tests should be performed to assess kidney health and detect any changes that may impact treatment. Additionally, special monitoring is required for patients with significant renal impairment to mitigate potential risks associated with medication use.

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 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 maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Additionally, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section does not contain any relevant information at this time. Furthermore, there is no information available related to animal pharmacology and toxicology.

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 use 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 conditions. Healthcare professionals are advised not to use the product if the printed seal under the cap is torn or missing, as this may indicate compromised quality or safety.

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 any prescription medications, as antacids may interact with certain drugs. Additionally, patients who are pregnant or breastfeeding should seek guidance from a healthcare professional before using this medication.

Drug Information (PDF)

This file contains official product information for Guardian 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 Guardian 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.