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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 12, 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 12, 2021
Manufacturer
PHARMACY VALUE ALLIANCE, LLC
Registration number
part331
NDC root
68016-695
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

EXTRA STRENGTH Smooth Antacid Tablets are chewable tablets that provide fast relief from upset stomach, heartburn, and acid indigestion. Each tablet contains 750 mg of calcium carbonate, which works by neutralizing stomach acid to alleviate discomfort. These tablets come in an assorted berry flavor and are gluten-free, making them a convenient option for those seeking quick relief from digestive issues.

You can use these tablets to help relieve symptoms such as heartburn, sour stomach, and upset stomach associated with acid indigestion. With 60 chewable tablets in each package, they are designed to be easy to take whenever you need them.

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 known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects reported. 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 4 tablets completely as the symptoms arise, or follow your doctor's instructions. It's important to remember that you should not swallow the tablets whole; they need to be chewed to work effectively.

If your symptoms last longer than 2 weeks, it's crucial to consult with your doctor before continuing to take the medication. This ensures that you receive the appropriate care and guidance for your health.

What to Avoid

You can feel reassured that 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 known reasons that would prevent you from using it safely. Always remember to 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 can interact with them. It's also crucial not to exceed 10 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.

Always prioritize your health and safety by following these guidelines closely.

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 10 tablets in a 24-hour period, and if you are pregnant, limit your intake to no more than 6 tablets in that same timeframe. Additionally, avoid using the maximum dosage for more than 2 weeks unless directed by your doctor.

If you experience any unusual symptoms or have concerns while using this product, it's best to stop taking it and reach out to your healthcare provider for guidance. Always prioritize your health and safety by following these recommendations.

Overdose

Taking more than the recommended dosage of this medication can lead to serious health issues. You should not take more than 10 tablets in a 24-hour period. If you are pregnant, it’s important to 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 your doctor has advised you to do so.

If you suspect an overdose, look out for signs such as unusual drowsiness, confusion, or difficulty breathing. In such cases, it’s crucial to seek immediate medical help. Always prioritize your health and consult 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. This guideline helps ensure your safety and the safety of your developing baby. Always consult with your healthcare provider before taking any medication during pregnancy to discuss potential risks and appropriate dosages.

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

It's important to keep this medication out of reach of children to ensure their safety. For adults and children aged 12 years and older, the recommended dosage is to chew 2 to 4 tablets completely when symptoms occur, or as directed by a doctor. Please remember that the tablets should not be swallowed whole, as they need to be chewed for proper effectiveness. Always consult with a healthcare professional if you have any questions or concerns about using this medication for yourself or your child.

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, it’s important to consult with a healthcare provider before starting the medication. 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 issues, 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 for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney problems).

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall health.

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, and your healthcare team is there to support you.

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, 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 safety and reliability of the product. Always handle it with care to avoid any damage.

Additional Information

You will take this medication orally. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

FAQ

What is the active ingredient in EXTRA STRENGTH Smooth Antacid Tablets?

The active ingredient is Calcium Carbonate USP 750 mg.

What symptoms does this antacid relieve?

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

How should I take EXTRA STRENGTH Smooth Antacid Tablets?

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

Are there any warnings I should be aware of?

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 dosage I can take?

Do not take more than 10 tablets in 24 hours, and if pregnant, do not take more than 6 tablets in 24 hours.

Can I use this product for more than 2 weeks?

Do not use the maximum dosage for more than 2 weeks unless advised by a doctor.

Is this product gluten-free?

Yes, EXTRA STRENGTH Smooth Antacid Tablets are gluten-free.

Where is this product distributed from?

It is distributed by Pharmacy Value Alliance, LLC, located in Wayne, PA.

Is there any information regarding use during pregnancy?

No teratogenic effects are mentioned, but pregnant individuals should limit intake to 6 tablets in 24 hours.

How should I store this product?

Store at room temperature and keep the container tightly closed.

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

NDC# 68016-695-60. This product is an Extra Strength Smooth Antacid Tablet containing Calcium Carbonate USP at a dosage of 750 mg per tablet. It is formulated for the fast relief of upset stomach, heartburn, and acid indigestion. The tablets are flavored with assorted berry, utilizing both natural and artificial flavoring agents. Each bottle contains 60 chewable tablets. The product is certified K Pareve and is gluten-free. It 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, the distributor of 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 12 years of age and over are instructed to chew 2 to 4 tablets completely as symptoms occur, or as directed by a healthcare professional. It is important that the tablets are not swallowed whole.

Patients should not use this medication for symptoms that persist for more than 2 weeks unless advised by a doctor.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

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 crucial to adhere to the following dosage guidelines: patients should not exceed 10 tablets within a 24-hour period. For pregnant individuals, the maximum 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 directed and monitored by a healthcare provider.

No specific general precautions or laboratory tests are indicated for the safe use of this product. Additionally, there are no outlined instructions for seeking emergency medical assistance or for discontinuing use and contacting a physician.

Side Effects

Patients should be aware of potential adverse reactions associated with the use of this product. It is important to consult a healthcare professional before use, especially for individuals currently taking prescription medications, as antacids may interact with certain drugs.

In clinical settings, participants have been advised not to exceed a dosage of 10 tablets within a 24-hour period. For pregnant individuals, the recommended maximum is limited to 6 tablets in 24 hours. Furthermore, the maximum dosage should not be utilized for more than 2 weeks unless under the guidance and supervision of a healthcare provider.

Patients are encouraged to adhere to these guidelines 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 Smooth (calcium carbonate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pv Extra Strength Smooth.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. For adolescents aged 12 years and older, the recommended dosage is to chew 2-4 tablets completely as symptoms occur, or as directed by a healthcare professional. It is important to note that the tablets should not be 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, given the lack of targeted data for this population.

Pregnancy

Pregnant patients should not exceed a dosage of 6 tablets within a 24-hour period. This limitation is crucial to minimize potential risks to fetal outcomes. Healthcare professionals are advised to counsel women of childbearing potential regarding the importance of adhering to this dosage recommendation 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 in nursing 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 data 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 the lack of information necessitates careful clinical judgment and monitoring of these patients.

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 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 cases of overdosage, it is critical to adhere to the recommended dosage guidelines to prevent adverse effects. The maximum allowable dosage for adults is 10 tablets within a 24-hour period. For pregnant individuals, the dosage should not exceed 6 tablets in the same timeframe to mitigate potential risks to both the mother and the fetus.

Prolonged use of the maximum dosage is not advised; it should not be maintained for more than 2 weeks unless under the direct supervision and guidance of a healthcare professional. This precaution is essential to avoid complications associated with excessive intake.

Healthcare professionals should monitor for symptoms of overdosage, which may include but are not limited to gastrointestinal disturbances, neurological effects, or other systemic reactions. In the event of suspected overdosage, immediate medical attention is warranted. Management may involve supportive care and symptomatic treatment, tailored to the specific symptoms presented by the patient.

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 limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

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 for patients to understand the potential risks associated with improper access to the medication by 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

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

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.