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Guardian Extra Strength Assorted Berry 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 2023
Label revision date
December 5, 2023
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 2023
Label revision date
December 5, 2023
Manufacturer
Guardian Drug Company
Registration number
part331
NDC root
53041-184
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 in the form of chewable tablets, available in assorted berry flavors. Each tablet contains 750 mg of calcium carbonate, which works to relieve symptoms of acid indigestion and heartburn. This makes GUARDIAN a helpful option for those seeking quick relief from discomfort caused by excess stomach acid.

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. Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication.

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 chew the tablets rather than swallow them whole, as this helps the medication work more effectively.

You should take the tablets as needed based on how you feel. Just remember to follow your doctor’s instructions if they have provided specific guidance on how much to take.

What to Avoid

It's important to use this medication safely to avoid potential risks. You should not take more than 10 tablets in a 24-hour period. Additionally, do not use the maximum dosage for more than 2 weeks unless your doctor has advised you to do so.

Be aware that this medication can be a controlled substance, which means it has the potential for abuse or misuse. Misuse refers to using the medication in a way not prescribed by your healthcare provider, which can lead to dependence (a condition where your body becomes reliant on the drug). Always follow your healthcare provider's instructions to ensure your safety.

Side Effects

You should be aware that there are no specific side effects or additional adverse reactions listed for this medication. However, it’s important to consult with your doctor or pharmacist before using it, especially if you are currently taking any prescription drugs, as antacids may interact with certain medications. 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 avoid using the maximum dosage for more than 2 weeks unless your doctor advises you to do so.

Before starting this medication, consult with your doctor or pharmacist if you are currently taking any prescription drugs, as antacids can interact with some medications. If you experience any unusual symptoms or have concerns, it's best to stop taking the medication and reach out to your healthcare provider for guidance.

Overdose

If you suspect an overdose of this medication, it's important to stay calm and take immediate action. While the drug insert does not provide specific information about overdose, you should be aware of general signs that may indicate an overdose, such as unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about an overdose, 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 professional assistance if you think something might be wrong.

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 those aged 12 years and older. For both adults and children in this age group, the recommended dosage is to chew 2 to 4 tablets as symptoms arise 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 in your child, consult with your doctor for personalized advice.

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 healthcare providers may not have tailored guidelines for elderly patients.

If you are caring for an older adult, it's important to consult with their healthcare provider about any medications they are taking. They can help ensure that the treatment is safe and appropriate, considering the unique health needs of older individuals. Always prioritize open communication with healthcare professionals to address any concerns.

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 and what steps to take for your safety.

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

Additional Information

You can take this medication orally by chewing 2 to 4 tablets when symptoms occur, or as directed by your doctor. This dosage applies to both adults and children aged 12 years and older. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling information.

FAQ

What is GUARDIAN?

GUARDIAN is an extra strength antacid in chewable tablet form, available in assorted berry flavors.

What are the active ingredients in GUARDIAN?

GUARDIAN contains 750mg of Calcium Carbonate, which helps relieve acid indigestion and heartburn.

How should I take GUARDIAN?

Adults and children 12 years and older 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 side effects associated with GUARDIAN?

No specific side effects are listed for GUARDIAN.

Can I take GUARDIAN if I am on prescription medication?

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

Is GUARDIAN safe to use during pregnancy or breastfeeding?

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

How should I store GUARDIAN?

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

Packaging Info

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

Packaging configurations for Guardian Extra Strength Assorted Berry Antacid.
Details

Drug Information (PDF)

This file contains official product information for Guardian Extra Strength Assorted Berry 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 relief from acid indigestion and heartburn. Each tablet contains 750 mg of calcium carbonate as the active ingredient. The product is available in assorted berry flavors and is presented in a chewable dosage form. Each bottle contains 96 tablets. The National Drug Code (NDC) for this product is 53041-184-22.

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 older are instructed to chew 2 to 4 tablets as symptoms occur, or as directed by a healthcare professional. The tablets should be chewed thoroughly before swallowing to ensure optimal absorption and effectiveness. Administration is based on the presence of symptoms, allowing for flexibility in dosing as needed.

Contraindications

Use of this product is contraindicated in patients who exceed a 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. This restriction is in place to mitigate the risk of potential adverse effects associated with excessive use.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this product.

General precautions must be observed to ensure safe usage. It is imperative that patients do not exceed a maximum dosage of 10 tablets within a 24-hour period. Additionally, the maximum dosage should not be utilized for more than 2 weeks unless directed and supervised by a healthcare provider.

Before recommending this product, healthcare professionals should advise patients to consult with a doctor or pharmacist if they are currently taking any prescription medications. This is particularly important as antacids may interact with certain prescription drugs, potentially affecting their efficacy or safety.

No specific laboratory tests or emergency medical help instructions are provided in this context; however, ongoing monitoring of patient responses and interactions with other medications is advised.

Side Effects

Patients should be aware that there are no specific side effects listed for this medication. However, it is important to consult a healthcare professional before use, particularly if the patient is currently taking a prescription drug, as antacids may interact with certain prescription medications.

In clinical practice, no additional adverse reactions have been reported beyond those mentioned. Therefore, ongoing monitoring and communication with healthcare providers are recommended to ensure safe and effective use of the medication.

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. 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 Guardian Extra Strength Assorted Berry Antacid (calcium carbonate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guardian Extra Strength Assorted Berry Antacid.
Details

Pediatric Use

Pediatric patients aged 12 years and older may use the medication at a dosage of 2-4 tablets chewed as symptoms occur, or as directed by a healthcare professional.

It is important to keep the medication out of reach of children to ensure safety.

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, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and breastfeeding.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 context of overdosage, it is important to note that the available sections of the drug insert do not provide specific information regarding potential overdosage scenarios.

Healthcare professionals are advised to exercise caution and consider the possibility of overdosage when administering the medication. In the absence of detailed guidance, it is recommended that clinicians monitor patients closely for any unusual symptoms or adverse reactions that may arise following administration.

In the event of suspected overdosage, standard medical management protocols should be followed. This may include supportive care and symptomatic treatment as necessary. Healthcare providers should also consider consulting a poison control center or a medical toxicologist for further guidance on managing potential overdosage cases.

Given the lack of specific overdosage information, it is crucial for healthcare professionals to remain vigilant and to document any observed effects in order to contribute to the understanding of the drug's safety profile.

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 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 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 safety or efficacy.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is to chew 2-4 tablets as symptoms occur or as directed by a healthcare professional. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Guardian Extra Strength Assorted Berry 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 Assorted Berry 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.