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Ultra Strength Antacid Wintergreen Flavor

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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 2025
Label revision date
February 28, 2025
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 2025
Label revision date
February 28, 2025
Manufacturer
7-ELEVEN
Registration number
M001
NDC root
10202-010
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 be experiencing discomfort from heartburn, acid indigestion, or a sour stomach. This medication is designed to help relieve these symptoms, providing you with comfort and relief from an upset stomach associated with these issues. It works by addressing the underlying causes of these digestive disturbances, allowing you to feel better and enjoy your day.

Uses

If you're experiencing discomfort from heartburn, acid indigestion, or a sour stomach, this medication can help relieve those symptoms. It’s also effective for soothing an upset stomach that comes along 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) associated with it. Enjoy relief from your stomach discomfort and get back to feeling your best.

Dosage and Administration

When you need relief from certain symptoms, adults and children aged 12 and older can chew 2 to 3 tablets as soon as symptoms appear. You can take this dose up to two times a day, or follow your doctor's instructions. It's important to chew the tablets completely; do not swallow them whole.

If your symptoms last longer than two 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 responsibly to ensure your safety. You should not take more than 8 tablets in a 24-hour period. Additionally, avoid using the maximum dosage for more than 2 weeks unless your doctor advises you to do so. If you are pregnant, limit your intake to no more than 4 tablets in 24 hours.

By following these guidelines, you can help prevent potential issues and ensure that you are using the medication safely. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

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 may interact with them. It's also crucial not to exceed 8 tablets in a 24-hour period and to avoid using the maximum dosage for more than 2 weeks unless directed by a healthcare professional. If you are pregnant, limit your intake to no more than 4 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 experience any unusual symptoms or reactions, contact your healthcare provider promptly.

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 8 tablets in a 24-hour period, and avoid using the maximum dosage for more than 2 weeks unless directed by a healthcare professional. If you are pregnant, limit your intake to 4 tablets in 24 hours and consult a health professional before use if you are pregnant or breastfeeding.

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

Overdose

Taking more than 8 tablets in a 24-hour period can lead to an overdose, which is a serious situation. If you are pregnant, it’s important to limit your intake to no more than 4 tablets in 24 hours. Additionally, you should not use the maximum dosage of this product for more than 2 weeks unless your doctor has advised you to do so.

Signs of an overdose can include unusual symptoms, and if you suspect that you or someone else has taken too much, it’s crucial to seek immediate medical help. Always prioritize your health and safety by following the recommended dosage guidelines. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider.

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 using this medication for children, it's important to note that it is intended for those aged 12 years and older. If your child falls within this age range, they should chew 2 to 3 tablets completely as symptoms arise, but not more than twice a day unless directed by a doctor. Make sure they do not swallow the tablets whole, as they need to be chewed for proper effectiveness.

Always keep this medication out of reach of younger children to prevent accidental ingestion. If you have any concerns or questions about its use, consult with 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 prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

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

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help determine the best course of action based on your kidney function and overall health.

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.

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, ideally between 68-75ºF (20-25ºC). It's important to keep the container tightly closed when not in use to protect the contents from contamination and maintain their effectiveness.

When handling the product, always do so with clean hands and in a clean environment to avoid introducing any harmful substances. Following these simple guidelines will help you use 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 2-3 tablets completely as symptoms occur, up to 2 times daily, or as directed by a doctor. Do not swallow the tablets whole.

What is the maximum dosage allowed in 24 hours?

You should not take more than 8 tablets in 24 hours.

How long can I use this product 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 4 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 between 68-75ºF (20-25ºC) and keep the container tightly closed.

What precautions should I take regarding children?

Keep this drug out of reach of children.

Packaging Info

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

Packaging configurations for Ultra Strength Antacid Wintergreen Flavor.
Details

Drug Information (PDF)

This file contains official product information for Ultra Strength Antacid Wintergreen Flavor, 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 3 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:

Patients should not exceed a maximum dosage of 8 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 professional. In pregnant patients, the dosage should not exceed 4 tablets in a 24-hour period.

Warnings and Precautions

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

Patients are advised to consult a doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with certain drugs, potentially affecting their efficacy or safety.

In terms of general precautions, it is imperative that patients do not exceed a maximum dosage of 8 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 4 tablets in a 24-hour period. Additionally, those who are pregnant or breastfeeding should seek guidance from a health professional before using this product.

Currently, there are no specific laboratory tests recommended for monitoring the use of this product.

Healthcare professionals should remain vigilant and ensure that patients are informed of these guidelines to promote safe and effective use.

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.

When using this product, patients are advised not to exceed a maximum dosage of 8 tablets within a 24-hour period. Additionally, the maximum dosage should not be used for more than 2 weeks unless under the guidance and supervision of a healthcare provider. Pregnant individuals should limit their intake to no more than 4 tablets in a 24-hour period and should seek advice from a health professional before 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 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 Ultra Strength Antacid Wintergreen Flavor (calcium carbonate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ultra Strength Antacid Wintergreen Flavor.
Details

Pediatric Use

Pediatric patients aged 12 years and older are advised to chew 2-3 tablets completely as symptoms occur, up to 2 times daily or as directed by a healthcare professional. It is important that these tablets are not swallowed whole.

Additionally, the product should be kept out of reach of 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 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 no specific data available regarding the excretion of this medication in 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 drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as there is no available data to guide dosing or monitoring in this population.

Hepatic Impairment

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

Overdosage

In the event of overdosage, it is critical to adhere to the recommended dosage guidelines to prevent adverse effects. The maximum allowable dosage for this product is 8 tablets within a 24-hour period. Exceeding this limit may lead to serious health complications.

Healthcare professionals should advise patients against using the maximum dosage for more than 2 weeks unless under the guidance and supervision of a physician. Prolonged use at maximum dosage can increase the risk of toxicity and other adverse reactions.

For pregnant individuals, it is particularly important to limit intake to no more than 4 tablets in a 24-hour period. This precaution is essential to safeguard both maternal and fetal health.

In cases of suspected overdosage, immediate medical attention should be sought. Management may include supportive care and symptomatic treatment, depending on the severity of the symptoms presented. Monitoring and intervention should be tailored to the individual patient's condition and the specific circumstances of the overdosage event.

Nonclinical Toxicology

If taken during pregnancy, it is advised not to exceed four tablets within a 24-hour period. Pregnant or breastfeeding individuals should consult a healthcare professional prior to use.

No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 8 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 4 tablets in a 24-hour period. Furthermore, healthcare providers should encourage patients to consult with a doctor or pharmacist prior to use 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 68-75ºF (20-25ºC). Proper storage conditions are essential to ensure the product's efficacy and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Ultra Strength Antacid Wintergreen Flavor, 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 Wintergreen Flavor, 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.