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Pv Extra Strength

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Active ingredient
Calcium Carbonate 750 mg
Other brand names
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 2020
Label revision date
October 25, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Calcium Carbonate 750 mg
Other brand names
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 2020
Label revision date
October 25, 2024
Manufacturer
PHARMACY VALUE ALLIANCE, LLC
Registration number
M001
NDC root
68016-700
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

Premier Value Extra Strength Antacid Tablets are chewable tablets designed to provide relief from common digestive discomforts. Each tablet contains 750 mg of calcium carbonate, which helps alleviate symptoms such as heartburn, acid indigestion, sour stomach, and upset stomach associated with these issues. These tablets are sugar-free, gluten-free, and come in a variety of flavors, making them a convenient option for managing occasional digestive upset.

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 experience symptoms, you can take 2 to 4 chewable tablets if you are an adult or a child aged 12 years and older. It's important to chew the tablets thoroughly instead of swallowing them whole. You should only take these tablets as needed, based on your symptoms, or follow your doctor's instructions.

If your symptoms last longer than two weeks, it's essential to consult with your doctor before continuing to use the medication. This ensures that you are using it safely and effectively.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular conditions or risks that would prevent you from using it.

However, it's always important to consult with your healthcare provider before starting any new medication to ensure it is appropriate for your individual health needs. If you have any questions or concerns, don’t hesitate to reach out to them for guidance.

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. Common side effects may include stomach discomfort or changes in bowel habits.

It's crucial not to exceed 9 tablets in a 24-hour period, and if you are pregnant, limit your intake to no more than 6 tablets in the same timeframe. Additionally, avoid using the maximum dosage for more than 2 weeks unless directed by a healthcare professional.

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 of the dosage: do not exceed 9 tablets in a 24-hour period, and if you are pregnant, limit your intake to no more than 6 tablets in the same timeframe. Additionally, avoid using the maximum dosage for more than 2 weeks unless directed by your doctor.

While there are no specific laboratory tests required for safe use, always prioritize your health and safety. If you experience any unusual symptoms or have concerns while using this product, it's best to reach out to your healthcare provider for guidance.

Overdose

Taking more than 9 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 6 tablets in the same timeframe. Additionally, using the maximum dosage for more than 2 weeks should only be done under the guidance of a doctor.

If you suspect an overdose, look out for signs such as unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, seek immediate medical help. Always prioritize your health and consult with a healthcare professional if you have any concerns about your medication use.

Pregnancy Use

If you are pregnant, it is important to be cautious with medication. You should not take more than 6 tablets in a 24-hour period. Always consult with your healthcare provider before taking any medication to ensure it is safe for you and your baby. Your health and the health of your child are the top priority, so make sure to follow these guidelines closely.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

When it comes to 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 group, they should chew 2 to 4 tablets as needed for their symptoms, or follow the instructions provided by their doctor. Remember, the tablets should not be swallowed whole; they need to be chewed to work effectively. Always consult with a healthcare professional if you have any questions or concerns about the appropriate use for your child.

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. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations for patients with renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment and what steps to take for your safety.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

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. It's important to keep the container tightly closed when not in use to protect its contents from contamination and maintain its effectiveness.

By following these simple storage guidelines, you can help ensure the product remains safe and ready for use whenever you need it.

Additional Information

You should chew 2 to 4 tablets when symptoms occur, or follow your doctor's instructions. Remember not to swallow the tablets whole. If you are currently taking any prescription medications, it's important to consult with your doctor or pharmacist before using this product, as antacids can interact with certain drugs.

If your symptoms last longer than 2 weeks, seek medical advice. Pregnant individuals should limit their intake to no more than 6 tablets in a 24-hour period. Additionally, avoid using the maximum dosage for more than 2 weeks unless directed by a healthcare professional.

FAQ

What is Premier Value Extra Strength Antacid Tablets used for?

It is used to relieve heartburn, acid indigestion, sour stomach, and upset stomach associated with these symptoms.

What is the active ingredient in Premier Value Extra Strength Antacid Tablets?

The active ingredient is Calcium Carbonate USP 750 mg.

How should I take Premier Value Extra Strength Antacid Tablets?

Adults and children 12 years of age and over should chew 2-4 tablets as symptoms occur, or as directed by a doctor. Do not swallow tablets whole.

Are there any dosage restrictions for pregnant women?

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

What should I do if my symptoms persist?

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

Are there any warnings associated with this product?

Yes, ask a doctor or pharmacist before use if you are taking a prescription drug, as antacids may interact with certain medications.

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

Do not take more than 9 tablets in 24 hours.

Is Premier Value Extra Strength Antacid Tablets gluten-free?

Yes, it is gluten-free.

How should I store Premier Value Extra Strength Antacid Tablets?

Store at room temperature and keep the container tightly closed.

Is there any information regarding the use of this product by nursing mothers?

There are no specific warnings or recommendations regarding the use of this product by nursing mothers.

Packaging Info

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

Packaging configurations for Pv Extra Strength.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

NDC 68016-700-90. This product is an Extra Strength Antacid Tablet formulation containing Calcium Carbonate USP at a dosage of 750 mg per tablet. It is designed to provide fast relief from upset stomach, heartburn, and acid indigestion. The tablets are sugar-free, gluten-free, and flavored with orange cream, both naturally and artificially. Each bottle contains 90 chewable tablets. The product is distributed by Pharmacy Value Alliance, LLC, located at 407 East Lancaster Avenue, Wayne, PA 19087. This product is not manufactured or distributed by GlaxoSmithKline LLC, the owner of the registered trademark, Extra Strength Tums.

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 as symptoms occur, or as directed by a healthcare professional. It is essential that the tablets are chewed thoroughly and not swallowed whole.

Patients should not use this medication for symptoms that persist for more than 2 weeks without consulting a healthcare provider.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

Healthcare professionals should advise patients to consult a doctor or pharmacist prior to using this product if they are currently taking any prescription medications, as antacids may interact with certain drugs.

When administering this product, it is critical to adhere to the following dosage guidelines: patients should not exceed 9 tablets within a 24-hour period. For pregnant individuals, the maximum dosage should not exceed 6 tablets in a 24-hour period. Furthermore, the maximum dosage should not be utilized for more than 2 weeks unless directed and monitored by a healthcare provider.

No specific general precautions or laboratory tests are required for the safe use of this product. Additionally, there are no emergency medical help instructions or specific directives to discontinue use and contact a physician included in the current guidelines.

Side Effects

Patients may experience various adverse reactions when using this product. It is important to note that antacids may interact with certain prescription drugs; therefore, patients should consult a doctor or pharmacist before use if they are currently taking any prescription medications.

In clinical practice, patients are advised not to exceed a dosage of 9 tablets within a 24-hour period. For pregnant individuals, the maximum recommended dosage is limited to 6 tablets in a 24-hour timeframe. Additionally, patients should refrain from using the maximum dosage for more than 2 weeks unless under the guidance and supervision of a healthcare professional.

These precautions are essential to minimize the risk of adverse effects and ensure safe usage of the product.

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 Pv Extra Strength (calcium carbonate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pv Extra Strength.
Details

Pediatric Use

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

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients are advised not to exceed a dosage of 6 tablets within a 24-hour period. This precaution is essential to minimize potential risks to fetal outcomes. Healthcare professionals should counsel women of childbearing potential regarding the importance of adhering to this dosage limit during pregnancy to ensure the safety of both the mother and the developing fetus.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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 the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions 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 event of overdosage, it is critical to adhere to the established dosage guidelines to mitigate potential risks. The maximum recommended dosage for adults is 9 tablets within a 24-hour period. Exceeding this limit may lead to adverse effects that require immediate medical attention.

For pregnant individuals, the dosage should not exceed 6 tablets in a 24-hour period. This precaution is essential to ensure the safety of both the mother and the developing fetus.

Furthermore, it is advised that the maximum dosage should not be utilized for more than 2 weeks unless under the guidance and supervision of a healthcare professional. Prolonged use at maximum dosage without medical oversight may increase the risk of serious complications.

In cases of suspected overdosage, healthcare professionals should assess the patient for symptoms associated with excessive intake and initiate appropriate management procedures. Immediate consultation with a poison control center or medical professional is recommended to determine the necessary interventions.

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

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 or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young individuals.

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 stability and efficacy.

Additional Clinical Information

Adults and children aged 12 years and older are advised to chew 2-4 tablets as symptoms occur or as directed by a healthcare professional, ensuring that the tablets are not swallowed whole. Patients should consult a doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with certain drugs.

It is important for patients to refrain from using the product for symptoms that persist beyond 2 weeks unless directed by a physician. Pregnant individuals should limit their intake to no more than 6 tablets in a 24-hour period and should not exceed the maximum dosage for more than 2 weeks without medical supervision.

Drug Information (PDF)

This file contains official product information for Pv Extra Strength, 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 Pv Extra Strength, 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.