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Extra Strength Antacid Smooth Dissolving - Berry Fusion Flavors

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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 2025
Label revision date
April 5, 2025
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 2025
Label revision date
April 5, 2025
Manufacturer
TARGET CORPORATION
Registration number
M001
NDC root
11673-568
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

You may find this medication helpful if you experience discomfort from heartburn, acid indigestion, sour stomach, or an upset stomach related to these symptoms. It works by providing relief from these common digestive issues, helping you feel more comfortable. If you're dealing with any of these conditions, this medication could be a supportive option for you.

Uses

If you're experiencing discomfort from heartburn, acid indigestion, or a sour stomach, this medication can help relieve those symptoms. It is also effective for soothing an upset stomach that may be associated with these issues.

You can feel confident using this medication, as there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects reported. This makes it a safe option for managing your digestive discomfort.

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 when you start to feel symptoms. It's important to follow your doctor's advice regarding the dosage. However, if your symptoms last longer than 2 weeks, you should consult your doctor before continuing to take the medication. This ensures that you are using it safely and effectively.

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. If you are pregnant, limit your intake to no more than 6 tablets in the same timeframe. Additionally, do not use the maximum dosage for more than 2 weeks unless your doctor has advised and is supervising you.

By following these guidelines, you can help ensure your safety while using this medication. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

It's important to be aware that antacids can interact with some prescription medications, which may affect how well those medications work. If you are taking any other medications, be sure to discuss this with your healthcare provider to avoid any potential issues.

While antacids are generally safe for most people, always monitor how you feel and report any unusual symptoms to your doctor. Your health and safety are the top priority.

Warnings and Precautions

It's important to use this product safely. You should not take more than 10 tablets in a 24-hour period. If you are pregnant, limit your intake to no more than 6 tablets in 24 hours. Additionally, avoid using the maximum dosage for more than 2 weeks unless your doctor advises you to do so.

Before using this product, consult with your doctor or pharmacist if you are currently taking any prescription medications, as antacids can interact with certain drugs. If you experience any concerning symptoms or have questions about your health, don't hesitate to reach out to your healthcare provider for guidance.

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 signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are concerned about a possible overdose, seek medical help right away.

In case of an overdose, contacting your local emergency services or going to the nearest hospital is crucial. Always keep the medication packaging with you, as it can help healthcare professionals understand what you've taken. Remember, it's better to be safe and get checked out if you have any doubts about your health.

Pregnancy Use

If you are pregnant, it’s important to be cautious with medication. You should not take more than 6 tablets in a 24-hour period. Additionally, avoid using the maximum dosage for more than 2 weeks unless your doctor has advised and is supervising you. Always consult with your healthcare provider before taking any medication during pregnancy to ensure the safety of you and your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your baby. Since the effects on nursing infants have not been thoroughly studied, it's best to exercise caution. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

When it comes to using this medication for children, it's important to note that it is intended for adults and children aged 12 years and older. If your child is within this age range, they can chew 2 to 4 tablets as needed for their symptoms, or follow the guidance of a doctor.

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, don't hesitate to consult with a healthcare professional.

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 always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Remember, even if there are no specific dosage adjustments or safety concerns mentioned, your healthcare provider may still recommend monitoring for any potential side effects or interactions with other medications you may be taking. Always prioritize open communication with your healthcare team to ensure the best care.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. If your creatinine clearance (a measure of kidney function) is reduced, your healthcare provider will closely monitor your condition. Regular renal function tests will be necessary to keep track of how well your kidneys are working.

For those with significant renal impairment, a lower dose of medication is typically recommended. Additionally, if you have end-stage renal disease, special considerations will be necessary to ensure your treatment is safe and effective. Always discuss your kidney health with your doctor to ensure the best care.

Hepatic Impairment

If you have liver problems, it's important to know that your condition may affect how your body processes certain medications. This means that the dosage of the drug you are prescribed might need to be adjusted to ensure it is safe and effective for you.

Your healthcare provider will likely monitor your liver function tests (which are blood tests that check how well your liver is working) to keep an eye on your liver health while you are taking the medication. Special precautions will be taken when administering the drug to ensure your safety, so be sure to discuss any concerns with your doctor.

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 performance of your product, store it at room temperature. This helps maintain its effectiveness and safety. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep the product in a clean environment to ensure it remains safe for use. If you have any questions about disposal or specific handling procedures, please refer to the guidelines provided with your product.

Additional Information

No further information is available.

FAQ

What symptoms does this drug relieve?

This drug relieves heartburn, acid indigestion, sour stomach, and upset stomach associated with these symptoms.

What is the recommended dosage for adults and children over 12?

You should chew 2 to 4 tablets as symptoms occur, or as directed by a doctor.

What is the maximum number of tablets I can take in a day?

Do not take more than 10 tablets in 24 hours.

Are there any restrictions for pregnant women?

If you are pregnant, do not take more than 6 tablets in 24 hours.

How long can I use this drug at maximum dosage?

Do not use the maximum dosage for more than 2 weeks unless advised by a doctor.

Can this drug interact with other medications?

Yes, antacids may interact with certain prescription drugs, so consult your doctor or pharmacist before use.

What should I do if I have renal impairment?

If you have renal impairment, dosage adjustments may be necessary, and renal function should be monitored regularly.

What precautions should be taken for patients with hepatic impairment?

Patients with hepatic impairment may require dosage adjustments and should have their liver function monitored.

What should nursing mothers do before using this product?

Nursing mothers should consult a doctor before using this product due to potential excretion in breast milk.

How should I store this drug?

Store the drug at room temperature.

Packaging Info

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

Packaging configurations for Extra Strength Antacid Smooth Dissolving - Berry Fusion Flavors.
Details

Drug Information (PDF)

This file contains official product information for Extra Strength Antacid Smooth Dissolving - Berry Fusion Flavors, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The SPL code for this product is 34089-3. It is identified as 658R_60ct and is presented in a media type of image/jpeg. A reference image for this product is available at 658R_60ct.jpg.

Uses and Indications

This drug is indicated for the relief of heartburn, acid indigestion, and sour stomach. It is also indicated for the relief of upset stomach associated with these symptoms.

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

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 important to note that this medication should not be taken for symptoms that persist for more than 2 weeks unless advised by a doctor.

Contraindications

Use of this product is contraindicated in the following situations:

Patients should not exceed a dosage of 10 tablets within a 24-hour period. In pregnant individuals, the maximum dosage is limited to 6 tablets in 24 hours. Additionally, the maximum dosage should not be used for more than 2 weeks unless under the advice and supervision of a healthcare professional.

Warnings and Precautions

The use of this product necessitates adherence to specific warnings and precautions to ensure patient safety and efficacy.

Warnings It is imperative to follow the recommended dosage guidelines strictly.

General Precautions When utilizing this product, it is crucial to observe the following precautions:

  • The maximum dosage should not exceed 10 tablets within a 24-hour period.

  • For individuals who are pregnant, the dosage must be limited to no more than 6 tablets in a 24-hour timeframe.

  • The maximum dosage should not be maintained for longer than 2 weeks unless directed and monitored by a healthcare professional.

Drug Interactions Prior to using this product, individuals should consult with a healthcare provider or pharmacist if they 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.

Adhering to these guidelines will help mitigate risks and promote safe usage of the product.

Side Effects

Patients should be aware of potential interactions between antacids and certain prescription medications. It is important for individuals to consult with their healthcare provider regarding the use of antacids in conjunction with other treatments to avoid adverse reactions stemming from these interactions.

No specific serious or common adverse reactions have been detailed in the provided information. Therefore, healthcare professionals should remain vigilant and monitor patients for any unexpected effects when antacids are used alongside other prescribed therapies.

Drug Interactions

Antacids may interact with certain 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. Healthcare professionals should consider advising patients to space the administration of antacids and other medications to ensure optimal therapeutic outcomes.

Packaging & NDC

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

Packaging configurations for Extra Strength Antacid Smooth Dissolving - Berry Fusion Flavors.
Details

Pediatric Use

Pediatric patients aged 12 years and older may chew 2 to 4 tablets as symptoms occur, or as directed by a healthcare professional. It is important to keep this medication out of reach of 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 should not exceed a dosage of 6 tablets within a 24-hour period. It is advised that the maximum dosage not be used for more than 2 weeks unless under the guidance and supervision of a healthcare professional. The potential risks associated with exceeding these dosage recommendations during pregnancy have not been fully established, and caution is warranted to avoid any adverse fetal outcomes. Healthcare providers should carefully evaluate the benefits and risks when prescribing this medication to pregnant patients.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on nursing infants are not well studied; therefore, caution is advised.

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 to assess kidney function adequately. For patients with significant renal impairment, a reduced dose is recommended to mitigate potential risks. Additionally, special considerations should be taken into account for patients with end-stage renal disease to ensure appropriate management and dosing.

Hepatic Impairment

Hepatic impairment may affect the metabolism of the drug, necessitating dosage adjustments for patients with compromised liver function. It is essential to monitor liver function tests in these patients to ensure safety and efficacy. Special precautions should be taken when administering the drug to individuals with hepatic impairment, as their altered metabolic capacity may influence therapeutic outcomes.

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.

Additionally, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous monitoring of vital signs and laboratory parameters may be necessary to assess the patient's condition and guide further treatment decisions.

In summary, while specific overdosage information is not available, healthcare professionals should remain vigilant and prepared to implement standard overdose management strategies to ensure patient safety and optimal outcomes.

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.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion.

When using this product, patients should be instructed not to exceed a maximum of 10 tablets within a 24-hour period. For pregnant patients, it is crucial to limit the intake to no more than 6 tablets in a 24-hour period. Additionally, patients should be cautioned against using the maximum dosage for more than 2 weeks unless under the advice and supervision of a healthcare professional.

Patients should also be encouraged to consult with their doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with certain prescription drugs. This precaution is important to ensure safe and effective use of the product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers assigned for identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Extra Strength Antacid Smooth Dissolving - Berry Fusion Flavors, 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 Extra Strength Antacid Smooth Dissolving - Berry Fusion Flavors, 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.