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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 25, 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 25, 2025
Manufacturer
Xiamen Kang Zhongyuan Biotechnology Co. , Ltd.
Registration number
M001
NDC root
83698-010
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 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 reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects. This makes it a safe option for managing your digestive discomfort.

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 safely to avoid potential risks. You should not take more than 8 tablets in a 24-hour period. Additionally, if you need to use the maximum dosage, do so for no longer than 2 weeks unless your doctor advises otherwise. If you are pregnant, limit your intake to no more than 4 tablets in 24 hours.

Always follow these guidelines to ensure your safety and well-being while using this product. If you have any questions or concerns, please consult your healthcare provider.

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 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 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, whether 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 find yourself needing to use the maximum dosage for more than 2 weeks, it’s important to consult with your doctor for guidance and supervision. If you are pregnant, you should limit your intake to no more than 4 tablets in a 24-hour period to avoid potential risks.

Signs of an overdose can vary, but if you experience unusual symptoms or feel unwell after taking the medication, it’s crucial to seek immediate medical help. Always prioritize your health and safety by following the recommended dosages and consulting with a healthcare professional if you have any concerns.

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, up to two times a day, or as directed by a healthcare professional. Make sure they do not swallow the tablets whole, as this can affect how the medication works.

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 your child's doctor 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. 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.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. They can monitor for any potential side effects and make recommendations based on individual health status. Always prioritize open communication with your healthcare team to ensure the best outcomes.

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 should be used 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 you understand how to manage your treatment effectively while considering your kidney 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 should be used if you have hepatic impairment (liver issues).

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

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 storage and handling guidelines will help ensure your product remains safe and effective for use.

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 should I do if I have 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, and sour stomach. It is also effective in alleviating 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.

  • The maximum dosage should not be used for more than 2 weeks unless under the advice and supervision of a healthcare professional.

  • Pregnant individuals should not take more than 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 under the guidance and supervision of 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 advice 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.

To ensure safety, this product should be kept out of reach of children.

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 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 the 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 weighed, 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 individuals.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 cases 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 qualified 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 mitigate potential risks to both the mother and the developing fetus.

In the event of suspected overdosage, immediate medical attention should be sought. Symptoms of overdosage may vary and can include a range of physiological responses. Management of overdosage should be conducted in a clinical setting, where healthcare professionals can provide appropriate interventions based on the severity of symptoms and the specific circumstances of the case.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. During pregnancy, it is recommended that no more than four tablets be taken within a 24-hour period. There is no relevant information available regarding nonclinical toxicology or animal pharmacology and toxicology.

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 configuration that includes specific NDC numbers. It should be stored at room temperature, within the range of 68-75ºF (20-25ºC). To ensure the integrity of the product, the container must be kept tightly closed at all times.

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.