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Pv Extra Strength Smooth

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This product has been discontinued

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 13, 2021
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 13, 2021
Manufacturer
PHARMACY VALUE ALLIANCE, LLC
Registration number
part331
NDC root
68016-697
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 is an extra strength smooth antacid that contains 750 mg of calcium carbonate (a compound that helps neutralize stomach acid). It is designed to provide fast relief from symptoms such as heartburn, acid indigestion, sour stomach, and upset stomach. Available in a tasty assorted fruit flavor, this gluten-free product comes in the form of chewable tablets, making it easy to take when you need relief from discomfort.

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 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. This makes it a safer option for those who may be concerned about such risks.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you should chew 2 to 4 tablets completely whenever you experience symptoms, or follow your doctor's instructions. It's important not to swallow the tablets whole, as they need to be chewed to work effectively.

Be mindful that if your symptoms last longer than 2 weeks, you should consult with a doctor before continuing to take 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. If you are pregnant, limit your intake to no more than 6 tablets in the same timeframe. Additionally, avoid using the maximum dosage for longer than 2 weeks unless your doctor has advised and is supervising you.

Always follow these guidelines to minimize 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

It's important to be aware that antacids can interact with some prescription medications, which may affect how well those medications work. If you are taking any other medications, be sure to discuss this with your healthcare provider to avoid any potential issues.

While specific side effects were not detailed, always monitor how you feel after taking any medication and report any unusual symptoms to your doctor. Your health and safety are paramount, so staying informed is key.

Warnings and Precautions

It's important to use this medication safely. You should not take more than 10 tablets in a 24-hour period. If you are pregnant, limit your intake to no more than 6 tablets in 24 hours. Additionally, avoid using the maximum dosage for more than 2 weeks unless your doctor has advised you to do so.

While there are no specific emergency instructions or lab tests required, always be mindful of how your body responds to the medication. If you have any concerns or experience unusual symptoms, it's best to consult your doctor for guidance.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there are no specific signs or symptoms of overdose mentioned, you should be aware that an overdose can lead to serious health issues. Common signs of overdose may include unusual drowsiness, confusion, or difficulty breathing.

If you or someone else may have taken too much of a medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get professional assistance if you have any concerns about an overdose.

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 developing 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 completely when symptoms arise, or follow the guidance of their doctor. Make sure they do not swallow the tablets whole, as they need to be chewed for proper effectiveness. 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 responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is particularly true if you have reduced creatinine clearance (a measure of how well your kidneys are filtering waste). Regular monitoring of your kidney function through tests is essential to ensure your safety and the effectiveness of your treatment.

For those with significant renal impairment, a lower dose of medication is recommended. Staying in close contact with your healthcare provider and following their guidance on monitoring and dosage adjustments will help manage your condition effectively.

Hepatic Impairment

If you have liver problems, it's important to know that your condition may affect how your body processes certain medications. This means that the dosage of the drug you are prescribed might need to be adjusted to ensure it is safe and effective for you.

Additionally, your healthcare provider will likely monitor your liver function tests (which check how well your liver is working) to keep an eye on your health while you are taking the medication. Special precautions will be taken when administering the drug to ensure your safety, so be sure to discuss any concerns with your doctor.

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 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 guidelines will help you use the product safely and effectively.

Additional Information

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

If your symptoms last more than 2 weeks, seek medical advice before continuing use. Pregnant individuals should limit their intake to no more than 6 tablets in a 24-hour period, and the maximum dosage should not be used for more than 2 weeks unless directed by a healthcare professional.

FAQ

What is Premier Value?

Premier Value is an extra strength smooth antacid that contains 750 mg of calcium carbonate per tablet and is available in assorted fruit flavors.

What symptoms does Premier Value relieve?

It relieves heartburn, acid indigestion, sour stomach, and upset stomach associated with these symptoms.

How should I take Premier Value?

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

Are there any dosage restrictions for Premier Value?

Do not take more than 10 tablets in a 24-hour period, and if pregnant, do not take more than 6 tablets in 24 hours. Do not use the maximum dosage for more than 2 weeks unless advised by a doctor.

Can I use Premier Value if I am pregnant?

If you are pregnant, do not take more than 6 tablets in a 24-hour period and consult your doctor for advice.

Are there any interactions with other medications?

Yes, antacids like Premier Value may interact with certain prescription drugs, so consult your doctor or pharmacist before use.

How should I store Premier Value?

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

Is there any information regarding use in elderly patients?

The insert does not provide specific information regarding geriatric use, dosage adjustments, or safety concerns for elderly patients.

What should I do if symptoms persist?

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

Packaging Info

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

Packaging configurations for Pv Extra Strength Smooth.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Premier Value® is a smooth antacid formulation containing Calcium Carbonate USP at a strength of 750 mg per chewable tablet. The product is available in an assorted fruit flavor, which is both naturally and artificially flavored. Each bottle contains 60 chewable tablets, providing fast relief from upset stomach, heartburn, and acid indigestion. This formulation is gluten-free. The product is distributed by Pharmacy Value Alliance, LLC, located at 407 East Lancaster Avenue, Wayne, PA 19087. The National Drug Code (NDC) for this product is 68016-697-60. It is important to note that this product is not manufactured or distributed by GlaxoSmithKline LLC, the owner of the registered trademark Extra Strength Tums® Smoothies™.

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, 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

There are no specific contraindications identified for this product. However, the following usage instructions should be adhered to in order to ensure safety:

  • The maximum dosage should not exceed 10 tablets within a 24-hour period.

  • For pregnant individuals, the dosage should not exceed 6 tablets in a 24-hour period.

  • The maximum dosage should not be used for more than 2 weeks unless directed and supervised by a healthcare professional.

Warnings and Precautions

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

General precautions must be strictly adhered to in order to ensure patient safety. It is imperative that patients do not exceed a maximum dosage of 10 tablets within a 24-hour period. For pregnant individuals, the dosage should not exceed 6 tablets in a 24-hour timeframe. Furthermore, the maximum dosage should not be utilized for more than 2 weeks unless specifically advised and monitored by a healthcare provider.

No specific laboratory tests have been identified for monitoring during the use of this medication. However, healthcare professionals should remain vigilant and assess the patient's overall health and response to treatment regularly.

In the absence of specific emergency medical help instructions or directives to discontinue use, healthcare providers are encouraged to maintain open communication with patients regarding any adverse effects or concerns that may arise during treatment.

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 antacids may interact with certain prescription drugs, which could lead to altered efficacy or increased risk of side effects from those medications.

Healthcare providers should monitor patients for any unusual symptoms or reactions, particularly when antacids are used concurrently with other treatments. It is advisable for patients to inform their healthcare provider of all medications they are taking to mitigate the risk of adverse interactions.

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 effects and to avoid diminished efficacy of the prescribed treatment.

Packaging & NDC

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

Packaging configurations for Pv Extra Strength Smooth.
Details

Pediatric Use

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

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 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

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential that patients with reduced creatinine clearance are closely monitored to ensure safety and efficacy. Regular renal function tests should be performed in patients with kidney problems to assess their condition. A reduced dose is recommended for patients with significant renal impairment to mitigate the risk of adverse effects.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism of the drug, necessitating dosage adjustments to ensure safety and efficacy. It is essential to monitor liver function tests in this population to assess the degree of impairment and guide treatment decisions. Special precautions should be taken when administering the drug to patients with compromised liver function, as their response to therapy may differ from that of patients with normal liver function. Regular evaluation of liver parameters is recommended to mitigate potential risks associated with hepatic impairment.

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 amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

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 not to exceed a maximum of 10 tablets within a 24-hour period. It is important to emphasize that for pregnant patients, the maximum dosage should be limited to 6 tablets in a 24-hour period.

Additionally, healthcare providers should inform patients that the maximum dosage should not be used for more than 2 weeks unless specifically directed and supervised by a physician. This guidance is crucial to ensure patient safety and to prevent potential adverse effects associated with prolonged high-dose usage.

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

Patients aged 12 years and older are advised to chew 2-4 tablets completely as symptoms occur or as directed by a healthcare professional, ensuring that the tablets are not swallowed whole. Clinicians should counsel 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.

Patients should not use the product for symptoms that persist beyond two weeks without medical advice. Pregnant individuals are cautioned not to exceed six tablets in a 24-hour period, and the maximum dosage should not be used for more than two weeks unless under the guidance and supervision of a healthcare provider.

Drug Information (PDF)

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