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Guardian Extra Strength Smooth Alkum Antacid 173bf

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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
May 1, 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
May 1, 2024
Manufacturer
Guardian Drug Company
Registration number
part331
NDC root
53041-717
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® Extra Strength Smooth is a type of antacid tablet that comes in a pleasant Berry Fusion flavor. Its active ingredient, calcium carbonate (750 mg), works to relieve symptoms of acid indigestion and heartburn, helping you feel more comfortable after meals. Each bottle contains 60 chewable tablets, making it easy to take when you need relief.

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 rise from your stomach to your throat.

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 reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects 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 follow the recommended dosage to ensure you get the best results from the treatment. Always consult with your healthcare provider if you have any questions or concerns about how to use this medication effectively.

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 you use the medication effectively while minimizing any potential risks.

Side Effects

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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 consult your doctor for guidance.

Although there are no required lab tests or emergency help instructions mentioned, you should always be proactive about your health. If you have any concerns or questions about your treatment, don’t hesitate to reach out to your healthcare provider. They are there to help you navigate your health journey safely.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the drug insert does not provide specific information about overdose symptoms or treatment, general signs of an overdose can include 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 you or someone else may have taken too much of a medication.

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 intended for those aged 12 years and older. If your child is within this age range, they can chew 2 to 4 tablets as needed for symptoms, or follow your doctor's instructions.

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 healthcare provider for guidance.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

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 (kidney issues) 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, you will require special monitoring to manage your treatment effectively. Always communicate with your healthcare team about your kidney function to ensure the best care.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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. It's important to keep the container tightly closed to protect its contents from contamination and maintain its effectiveness. By following these simple storage guidelines, you can help ensure the product remains safe and ready for use when you need it.

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 using this medication.

FAQ

What is Guardian® Extra Strength Smooth?

Guardian® Extra Strength Smooth is an antacid tablet that helps relieve acid indigestion and heartburn. It comes in a Berry Fusion flavor.

What is the active ingredient in Guardian® Extra Strength Smooth?

The active ingredient is Calcium Carbonate, with a dosage of 750 mg per tablet.

How should I take Guardian® Extra Strength Smooth?

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

Are there any dosage limits for Guardian® Extra Strength Smooth?

Do not take more than 10 tablets in a 24-hour period, and do not use the maximum dosage for more than 2 weeks without a doctor's advice.

Can I use Guardian® Extra Strength Smooth if I am pregnant or breastfeeding?

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

Are there any contraindications for Guardian® Extra Strength Smooth?

No specific contraindications are mentioned for this product.

What should I do if I am taking other prescription drugs?

Ask a doctor or pharmacist before use, as antacids may interact with certain prescription drugs.

How should I store Guardian® Extra Strength Smooth?

Store at room temperature and keep the container tightly closed.

Is there any special monitoring required for patients with renal impairment?

Yes, patients with reduced renal function should have their creatinine clearance monitored and renal function tests performed regularly.

Packaging Info

Below are the non-prescription pack sizes of Guardian Extra Strength Smooth Alkum Antacid 173bf (calcium carbonate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guardian Extra Strength Smooth Alkum Antacid 173bf.
Details

Drug Information (PDF)

This file contains official product information for Guardian Extra Strength Smooth Alkum Antacid 173bf, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Guardian® Extra Strength Smooth is an antacid formulation designed to relieve symptoms of acid indigestion and heartburn. Each chewable tablet contains 750 mg of Calcium Carbonate as the active ingredient, comparable to the active ingredient in Tums® Smoothies EX. The product is available in a Berry Fusion flavor and is packaged in a bottle containing 60 chewable tablets. The National Drug Code (NDC) for this product is 53041-717-23.

Uses and Indications

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

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

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 recommended that the tablets be chewed thoroughly before swallowing to ensure optimal absorption and efficacy.

Contraindications

Use of this product is contraindicated in patients who exceed the recommended dosage of 10 tablets within a 24-hour period or who utilize the maximum dosage for more than 2 weeks without the guidance and supervision of a healthcare professional.

Warnings and Precautions

There are currently no specific warnings or general precautions associated with the use of this product. Additionally, no laboratory tests have been identified as necessary for monitoring during treatment.

Healthcare professionals are advised to remain vigilant and to consider the individual patient's health status and medical history when prescribing this medication. In the absence of specific emergency medical instructions, it is prudent to maintain a standard protocol for patient safety and to ensure that patients are informed about the importance of reporting any unusual symptoms or adverse effects promptly.

Should any concerns arise during treatment, healthcare providers should encourage patients to communicate openly and seek guidance as needed.

Side Effects

There are currently no specific adverse reactions, warnings, or additional important notes provided for this medication. As such, no information regarding serious or common adverse reactions, clinical trial data, or postmarketing experiences is available at this time. It is essential for healthcare professionals to monitor patients for any potential adverse effects and report them as necessary. Further information may be obtained from ongoing clinical studies or postmarketing surveillance.

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 Smooth Alkum Antacid 173bf (calcium carbonate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Guardian Extra Strength Smooth Alkum Antacid 173bf.
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 directed by a healthcare professional.

It is important to keep the medication out of reach of younger 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 and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered, 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 currently no available data on 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 special monitoring is required for patients with significant renal impairment to mitigate potential risks associated with altered drug clearance.

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 in the available sections of the drug insert, healthcare professionals are advised to exercise caution and consider general principles of management for suspected overdosage cases.

Recommended Actions In the event of an overdosage, it is essential for healthcare providers to assess the patient's clinical status and initiate appropriate supportive care. Monitoring of vital signs and symptomatic treatment should be prioritized.

Potential Symptoms While specific symptoms related to overdosage are not detailed, healthcare professionals should remain vigilant for any unusual or severe reactions that may arise, given the lack of documented information.

Management Procedures In the case of suspected overdosage, it is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for guidance on management strategies. Supportive measures, including intravenous fluids and symptomatic treatment, may be necessary based on the patient's condition.

Healthcare providers should document any overdosage incidents and report them to the appropriate regulatory authorities to contribute to the ongoing assessment of the drug's safety profile.

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 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. This is particularly crucial as antacids may interact with certain prescription drugs, potentially affecting their efficacy or safety.

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 stability and efficacy.

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 Smooth Alkum Antacid 173bf, 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 Smooth Alkum Antacid 173bf, 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.