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Ultra Strength Antacid Assorted Fruit

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Active ingredient
Calcium Carbonate 1000 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 2016
Label revision date
June 26, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Calcium Carbonate 1000 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 2016
Label revision date
June 26, 2024
Manufacturer
Amerisource Bergen
Registration number
part331
NDC root
24385-595
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

Calcium carbonate is an antacid that provides ultra-strength relief for acid indigestion and heartburn. Each tablet contains 1000 mg of calcium carbonate, which works by neutralizing stomach acid to help alleviate discomfort.

This medication is available in assorted fruit flavors and comes in a convenient package of 72 chewable tablets, making it easy to take when you need relief from those uncomfortable symptoms.

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 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

If you are an adult or a child aged 12 years and older, you can take this medication by chewing 2 to 3 tablets whenever you experience symptoms, or as your doctor advises. It's important to follow your doctor's instructions to ensure you are using the medication safely and effectively. Always remember to chew the tablets thoroughly before swallowing for the best results.

What to Avoid

It's important to use this medication responsibly to ensure your safety. You should not take more than 7 tablets within a 24-hour period, and you should avoid using the maximum dosage for more than 2 weeks unless your doctor has advised you to do so. Following these guidelines helps prevent potential risks associated with misuse and ensures that you are using the medication effectively. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

It's important to be aware of potential interactions if you are currently taking prescription medications. Antacids, which are commonly used to relieve heartburn and indigestion, may interact with some prescription drugs, potentially affecting how well they work.

If you experience any unusual symptoms or side effects while using antacids, it's a good idea to consult your healthcare provider for guidance. They can help ensure that your medications are working effectively and safely together.

Warnings and Precautions

It's important to use this medication safely. You should not take more than 7 tablets in a 24-hour period, and you should not use the maximum dosage for more than 2 weeks unless your doctor advises you to do so.

If you experience any unusual symptoms or have concerns about your health while using this product, it's best to consult your doctor for guidance. Always prioritize your well-being and seek professional advice when needed.

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 unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

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 this medication. They can provide guidance on any potential risks and help ensure the safety of both you and your baby. Always prioritize open communication with your doctor regarding your health and any medications you may be considering while nursing.

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 3 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, don't hesitate to consult with your healthcare provider.

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. 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.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to help manage your care effectively.

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 are essential to ensure your kidneys are working properly.

For those with moderate to severe renal impairment, a lower dose of medication is typically recommended. Additionally, if you have end-stage renal disease, special considerations will be necessary regarding your treatment. Always discuss your kidney health with your doctor to ensure you receive 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).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 safety and effectiveness of your product, store it at room temperature and keep the container tightly closed when not in use. This helps maintain its quality and prevents contamination.

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

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 use.

FAQ

What is Calcium Carbonate used for?

Calcium Carbonate is an antacid that relieves acid indigestion and heartburn.

How should I take Calcium Carbonate?

Adults and children 12 years of age and over should chew 2-3 tablets as symptoms occur, or as directed by a doctor.

What is the maximum dosage for Calcium Carbonate?

Do not take more than 7 tablets in a 24-hour period, and do not use the maximum dosage for more than 2 weeks without a doctor's advice.

Are there any contraindications for Calcium Carbonate?

No specific contraindications are mentioned for Calcium Carbonate.

Can I take Calcium Carbonate if I am pregnant or breastfeeding?

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

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 Calcium Carbonate?

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

What flavors does Calcium Carbonate come in?

Calcium Carbonate is available in assorted fruit flavors.

What should I do if I have kidney problems?

Patients with renal impairment may need dosage adjustments and should be closely monitored.

Packaging Info

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

Packaging configurations for Ultra Strength Antacid Assorted Fruit.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This product is identified by NDC 24385-595-23 and is marketed by Good Neighbor Pharmacy. It is formulated as an ultra strength antacid, containing 1000 mg of Calcium Carbonate per tablet. The product is designed to provide soothing relief for symptoms of acid indigestion and heartburn. It is available in assorted fruit flavors and is packaged in a bottle containing 72 chewable tablets. This formulation is comparable to the active ingredient found in Tums® Ultra Strength.

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 are advised to chew 2 to 3 tablets as symptoms occur, or as directed by a healthcare professional. It is important to follow the recommended dosage and not exceed the advised amount unless specifically instructed by a physician.

Contraindications

The use of this product is contraindicated in patients who exceed the recommended dosage of 7 tablets within a 24-hour period or utilize the maximum dosage for more than 2 weeks without the guidance and supervision of a healthcare professional. Adherence to these dosage recommendations is essential to prevent potential adverse effects.

Warnings and Precautions

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

General precautions must be observed to ensure patient safety. It is imperative that patients do not exceed a maximum intake of 7 tablets within a 24-hour period. Additionally, the maximum dosage should not be utilized for more than 2 weeks unless directed and monitored by a healthcare provider. This limitation is crucial to prevent potential adverse effects associated with prolonged use or excessive dosage.

No specific laboratory tests or emergency medical help instructions are provided in the current guidelines. However, healthcare professionals should remain vigilant and assess the need for further evaluation based on individual patient circumstances.

Side Effects

Patients should be aware of potential adverse reactions associated with the use of this medication. While specific serious adverse reactions are not detailed, it is important to note that interactions may occur with other medications.

In particular, patients who are currently taking prescription drugs should exercise caution, as antacids may interact with certain prescription medications. This interaction could potentially alter the effectiveness of the prescribed treatment or lead to unexpected side effects.

Healthcare providers should be consulted to ensure safe and effective use of this medication, especially in the context of concurrent therapies. Monitoring for any unusual symptoms or changes in health status is advised for all patients.

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

Packaging configurations for Ultra Strength Antacid Assorted Fruit.
Details

Pediatric Use

Pediatric patients aged 12 years and older may chew 2-3 tablets as symptoms occur, or as directed by a healthcare professional. It is important to keep this medication out of reach of younger children to ensure safety.

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 potential 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 before 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 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 medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients. Those with reduced creatinine clearance should be closely monitored to ensure safety and efficacy. Regular renal function tests are recommended for patients with kidney problems to assess their condition. A reduced dose is advised for patients with moderate to severe renal impairment. Additionally, special considerations should be taken into account for patients with end-stage renal disease to optimize treatment outcomes.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no 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, 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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 7 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. 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. No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Ultra Strength 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 Ultra Strength 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

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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.