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Gdc Extra Strength Alkums Antacid 127af

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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 2024
Label revision date
August 13, 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 2024
Label revision date
August 13, 2024
Manufacturer
Guardian Drug Company
Registration number
M001
NDC root
53041-102
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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Drug Overview

GUARDIAN® is an extra strength antacid that comes in chewable tablet form, containing 750 mg of calcium carbonate. It is designed to help relieve symptoms of acid indigestion and heartburn, providing you with quick relief when you need it. Available in assorted fruit flavors, GUARDIAN® offers a pleasant way to manage 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. It's important to note that there are no known harmful effects on developing babies (teratogenic effects) associated with this medication, making it a safer option for those who may be pregnant.

Dosage and Administration

To use this medication effectively, start by wetting your mouth before chewing the tablets. For adults and children aged 12 and older, you should chew 2 to 4 tablets whenever symptoms arise, or follow your doctor's instructions if they have provided specific guidance.

Make sure to take the tablets as needed, ensuring that you chew them well for the best results. Always consult with your healthcare provider if you have any questions about how to use this medication or if your symptoms persist.

What to Avoid

It's important to use this product 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 directed and supervised by your doctor. Following these guidelines helps prevent potential health risks and ensures that you are using the product effectively. Always consult with your healthcare provider if you have any questions or concerns about your usage.

Side Effects

It's important to be aware of potential interactions when using this medication. If you are currently taking any prescription drugs, you should consult with your doctor or pharmacist before starting this treatment, as antacids can affect how some prescription medications work.

While specific side effects are not detailed here, always stay informed about how your body responds to any new medication and report any unusual symptoms to your healthcare provider. Your safety and well-being are paramount.

Warnings and Precautions

While there are no specific warnings or precautions associated with this medication, it's always important to stay informed about your health. If you experience any unusual symptoms or reactions while taking this medication, it’s wise to stop using it and consult your doctor for guidance.

Additionally, if you ever feel that you need immediate medical assistance, don’t hesitate to seek emergency help. Always prioritize your health and well-being by keeping open communication with your healthcare provider.

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 a possible 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 advice in these situations.

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 ensure that this medication is kept out of reach of younger children to prevent accidental ingestion. 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 GDC Extra Strength Alkums Antacid, there is no specific information available about how it should be used by older adults. This means that there are no special dosage adjustments, safety concerns, or precautions outlined for elderly patients.

If you are an older adult or a caregiver, it's always a good idea to consult with a healthcare professional before starting any new medication. They can provide personalized advice and ensure that the treatment is safe and appropriate for your individual health needs.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is particularly true if you have reduced creatinine clearance (a measure of how well your kidneys are filtering waste). Regular monitoring of your kidney function through tests is essential to ensure your safety and the effectiveness of your treatment.

For those with severe renal impairment, there is a higher risk of toxicity, which means that your doctor may need to prescribe a lower dose of your medication. Always communicate with your healthcare provider about your kidney health, as they will guide you on the necessary precautions and adjustments to 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, so don't hesitate to ask questions or express any concerns you may have.

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 performance of your product, store it at room temperature and make sure the container is tightly closed. This helps maintain its effectiveness and prevents contamination. Always handle the product with care to avoid any damage or exposure to harmful elements. Following these simple storage and handling guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is GUARDIAN®?

GUARDIAN® is an extra strength antacid tablet that contains 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 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, and do not use the maximum dosage for more than 2 weeks unless advised by a doctor.

Are there any contraindications for GUARDIAN®?

No specific contraindications are mentioned for GUARDIAN®.

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

You should ask a health professional before using GUARDIAN® if you are pregnant or breastfeeding.

What should I do if I am taking prescription drugs?

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

How should I store GUARDIAN®?

Store GUARDIAN® at room temperature and keep the container tightly closed.

What flavors are available for GUARDIAN®?

GUARDIAN® is available in assorted fruit flavors.

Is there any special consideration for patients with kidney problems?

Yes, renal impairment may require dosage adjustments, and patients should be closely monitored.

Packaging Info

Below are the non-prescription pack sizes of Gdc Extra Strength Alkums Antacid 127af (calcium carbonate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Gdc Extra Strength Alkums Antacid 127af.
Details

Drug Information (PDF)

This file contains official product information for Gdc Extra Strength Alkums Antacid 127af, 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 available in two packaging options: 96 chewable tablets (NDC 53041-102-22) and 48 chewable tablets (NDC 53041-102-13). Each tablet contains 750 mg of calcium carbonate, which is indicated for the relief of acid indigestion and heartburn. The tablets are formulated in assorted fruit flavors, providing a palatable option for users.

Uses and Indications

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

There are no teratogenic or nonteratogenic effects associated with this medication.

Dosage and Administration

Adults and children 12 years of age and over should wet the tablets in their mouth before chewing. The recommended dosage is to chew 2 to 4 tablets as symptoms occur, or as directed by a healthcare professional. It is important to follow the prescribed instructions to ensure effective symptom management.

Contraindications

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

Warnings and Precautions

There are currently no specific warnings or general precautions associated with the use of this product. Healthcare professionals are advised to remain vigilant and monitor patients for any unexpected reactions or side effects during treatment.

In the absence of specified laboratory tests, it is recommended that healthcare providers consider routine monitoring based on the individual patient's clinical status and any relevant comorbidities.

In the event of any adverse reactions or concerns regarding the patient's health, it is imperative to seek emergency medical assistance promptly. Additionally, if a patient experiences any troubling symptoms or side effects, they should be instructed to discontinue use and contact their healthcare provider immediately for further evaluation and guidance.

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, before use, especially if currently taking a prescription drug, as antacids may interact with certain medications.

While specific adverse reactions have not been detailed in the provided information, the necessity for caution indicates that there may be serious interactions or effects that warrant attention. Therefore, patients are advised to discuss their complete medication regimen with their healthcare provider to mitigate any risks associated with concurrent use of this medication and other prescription drugs.

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 their healthcare provider to ensure safe and effective use of antacids alongside other treatments. Monitoring for any adverse effects or changes in therapeutic outcomes may be necessary when these interactions are suspected.

Packaging & NDC

Below are the non-prescription pack sizes of Gdc Extra Strength Alkums Antacid 127af (calcium carbonate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Gdc Extra Strength Alkums Antacid 127af.
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 regarding the use of GDC Extra Strength Alkums Antacid in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful monitoring for potential adverse effects. It is advisable to consider the overall health status and comorbidities of geriatric patients when determining the appropriateness of this antacid for their use.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

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

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential that patients with reduced creatinine clearance are closely monitored to ensure safety and efficacy. Regular renal function tests should be performed in patients with kidney problems to assess their condition. Special considerations for patients with severe renal impairment include the potential for toxicity and the need for reduced dosing to mitigate risks associated with their compromised renal function.

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.

Given the absence of detailed guidance, healthcare professionals are advised to exercise caution and consider general principles of management for suspected overdosage. In the event of an overdose, it is recommended that healthcare providers monitor the patient closely for any adverse effects or symptoms that may arise, even if they are not explicitly outlined in the drug insert.

Should an overdosage be suspected, supportive care should be initiated as necessary. This may include symptomatic treatment and monitoring of vital signs. Additionally, healthcare professionals should consult local poison control centers or relevant toxicology resources for further guidance on management strategies tailored to the specific circumstances of the overdose.

In summary, while specific overdosage information is lacking, vigilance and appropriate supportive measures are essential in managing any potential cases of overdose.

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 compound in these areas.

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 under the advice and supervision of a healthcare professional.

Patients currently taking prescription medications should be counseled about the potential interactions between antacids and certain prescription drugs. It is important for healthcare providers to encourage patients to discuss all medications they are taking to ensure safe and effective use of this product.

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, ensuring that it is protected from extreme temperatures and humidity. Proper storage conditions are essential to preserve the quality and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Gdc Extra Strength Alkums Antacid 127af, 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 Gdc Extra Strength Alkums Antacid 127af, 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.