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Extra Strength Smooth Antacid Assorted Fruit

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Active ingredient
Calcium Carbonate 750 mg
Other brand names
Drug classes
Blood Coagulation Factor, Phosphate Binder
Dosage form
Tablet
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
March 28, 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
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
March 28, 2025
Manufacturer
Rite Aid
Registration number
M001
NDC root
11822-3530
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

This medication is designed to relieve discomfort caused by heartburn, acid indigestion, sour stomach, and upset stomach associated with these symptoms. It works by neutralizing stomach acid, providing you with quick relief from these common digestive issues. If you're experiencing any of these symptoms, this drug may help you feel more comfortable.

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

When you experience symptoms, you can take 2 to 4 tablets of this medication by chewing them completely. This can be done up to two times a day, or as your doctor directs. It's important not to swallow the tablets whole, as they need to be chewed for proper effectiveness.

If your symptoms last longer than two weeks, you should consult your doctor before continuing to use the medication. This ensures that you receive the appropriate care and guidance for your health.

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 longer than 2 weeks unless your doctor advises you to do so. If you are pregnant, limit your intake to no more than 5 tablets in a 24-hour period.

Always follow these guidelines to minimize any potential risks and ensure effective use of the medication. If you have any questions or concerns, please consult your healthcare provider for personalized advice.

Side Effects

When using this product, it's important to be aware of potential side effects and interactions. You should consult with a doctor or pharmacist if you are currently taking any prescription medications, as antacids can interact with them. It's also crucial not to exceed 10 tablets in a 24-hour period and to avoid using the maximum dosage for more than two weeks unless directed by a healthcare professional. If you are pregnant, limit your intake to no more than 5 tablets in 24 hours and seek advice from a health professional before use.

Additionally, keep this product out of reach of children to ensure their safety. If you have any concerns or experience unusual symptoms, please reach out to your healthcare provider.

Warnings and Precautions

Before using this product, it's important to consult with your doctor or pharmacist, especially if you are currently taking any prescription medications, as antacids can interact with them. Be mindful not to exceed 10 tablets in a 24-hour period, and avoid using the maximum dosage for more than two weeks unless directed by a healthcare professional. If you are pregnant, limit your intake to no more than 5 tablets in 24 hours, and always check with a health professional before using this product while pregnant or breastfeeding.

While there are no specific laboratory tests required for this product, it's essential to follow these guidelines to ensure your safety and well-being. If you experience any concerning symptoms or have questions about your health while using this product, don't hesitate to reach out to your healthcare provider for advice.

Overdose

Taking too much of a medication can lead to serious side effects. If you suspect an overdose, it’s important to seek medical help immediately or contact a Poison Control Center.

Signs of an overdose can vary, but they may include unusual symptoms that are more severe than what you typically experience with the medication. Always err on the side of caution and get help if you think you or someone else has taken too much. Your health and safety are the top priority.

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 adults and children aged 12 years and older. If your child falls within this age range, they should chew 2 to 4 tablets completely as symptoms arise, but not more than twice a day unless directed by a doctor. Remember, the tablets should not be swallowed whole.

Additionally, always keep this medication out of reach of younger children to ensure their safety. If you have any concerns or questions about its use, consult your healthcare provider for guidance.

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 if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so discussing any concerns with a doctor is essential for ensuring safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

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 treatments, 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, ideally between 20-25°C (68-75°F). It's important to keep the container tightly closed to protect its contents.

Before using the product, check the printed seal under the cap. If it is torn or missing, do not use the product, as this may compromise its safety and effectiveness. Following these guidelines will help you handle the product safely and effectively.

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 2-4 tablets completely as symptoms occur, up to 2 times daily, or as directed by a doctor. Do not swallow tablets whole.

What is the maximum dosage allowed in 24 hours?

You should not take more than 10 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.

What should I do if I am pregnant?

If you are pregnant, do not take more than 5 tablets in 24 hours and consult a health professional before use.

Are there any contraindications for this drug?

No specific contraindications are mentioned for this drug.

Can this drug interact with other medications?

Yes, antacids may interact with certain prescription drugs, so ask a doctor or pharmacist before use if you are taking any.

What should I do if symptoms persist?

Do not take this drug for symptoms that persist for more than 2 weeks unless advised by a doctor.

How should I store this drug?

Store at room temperature (20-25°C or 68-75°F) and keep the container tightly closed. Do not use if the printed seal under the cap is torn or missing.

Is there any information regarding use in elderly patients?

No specific information regarding geriatric use or safety concerns for elderly patients is provided.

Packaging Info

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

Packaging configurations for Extra Strength Smooth Antacid Assorted Fruit.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

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

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

Dosage and Administration

Adults and children aged 12 years and older are instructed to chew 2 to 4 tablets completely as symptoms occur, with a maximum frequency of 2 times daily or as directed by a healthcare professional. It is essential that the tablets are not swallowed whole.

Patients should refrain from using this medication for symptoms that persist for more than 2 weeks unless advised by a healthcare provider.

Contraindications

Use of this product is contraindicated in the following situations:

Exceeding a dosage of 10 tablets within a 24-hour period is contraindicated due to the potential for adverse effects. Additionally, the maximum dosage should not be used for more than 2 weeks unless under the advice and supervision of a healthcare professional, as prolonged use may lead to complications. In pregnant individuals, a maximum of 5 tablets in 24 hours is advised to mitigate risks to both the mother and fetus.

Warnings and Precautions

Healthcare professionals 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.

In terms of general precautions, it is imperative that patients do not exceed a maximum dosage of 10 tablets within a 24-hour period. Furthermore, the maximum dosage should not be utilized for more than 2 weeks unless directed and supervised by a healthcare provider. For pregnant individuals, it is recommended to limit intake to no more than 5 tablets in a 24-hour period. Additionally, those who are pregnant or breastfeeding should seek guidance from a health professional before using this product.

There are no specific laboratory tests recommended for monitoring the use of this product.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. It is important to consult a healthcare professional before use, particularly for individuals who are currently taking prescription medications, as antacids may interact with certain drugs.

In terms of usage guidelines, patients are advised not to exceed a maximum dosage of 10 tablets within a 24-hour period. Additionally, the maximum dosage should not be used for more than 2 weeks unless under the advice and supervision of a healthcare provider. Pregnant individuals should limit their intake to no more than 5 tablets in a 24-hour period and are encouraged to seek guidance from a health professional prior to use.

As with any medication, it is crucial to keep this product out of reach of children to prevent accidental ingestion.

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 outcomes. 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 Extra Strength Smooth Antacid Assorted Fruit (calcium carbonate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Extra Strength Smooth Antacid Assorted Fruit.
Details

Pediatric Use

Pediatric patients aged 12 years and older are advised to chew 2-4 tablets completely as symptoms occur, up to 2 times daily or as directed by a healthcare professional. It is important that the tablets are not swallowed whole.

Care should be taken 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 in these populations to ensure the safety of both the mother 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 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 have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

Overdosage may lead to serious side effects that require immediate medical attention. Healthcare professionals should be vigilant in recognizing the signs and symptoms associated with an overdose, as timely intervention is critical.

In the event of an overdose, it is imperative to seek medical help or contact a Poison Control Center without delay. Prompt action can significantly mitigate the potential risks and complications associated with overdosage.

Healthcare providers are advised to monitor the patient closely for any adverse reactions and to initiate appropriate management procedures based on the clinical presentation and severity of the overdose.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Serious side effects have been reported voluntarily or through surveillance programs. Individuals are encouraged to report these events to the designated phone number available Monday through Friday from 9:00 AM to 5:00 PM Eastern Time.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients not to exceed a maximum dosage of 10 tablets within a 24-hour period. Additionally, patients should be cautioned against using the maximum dosage for more than 2 weeks unless directed and supervised by a healthcare professional.

For patients who are pregnant, it is essential to recommend that they do not take more than 5 tablets in a 24-hour period. Furthermore, healthcare providers should encourage patients to consult with a doctor or pharmacist before using this product if they are currently taking any prescription medications, as antacids may interact with certain drugs.

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, specifically within the range of 20-25°C (68-75°F).

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the printed seal under the cap is torn or missing.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Extra Strength Smooth Antacid Assorted Fruit, 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 Smooth Antacid Assorted Fruit, 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.