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Premier Value Extra Strength

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Active ingredients
  • Calcium Carbonate 675 mg
  • Magnesium Hydroxide 135 mg
Other brand names
Drug classes
Blood Coagulation Factor, Calculi Dissolution Agent, Osmotic Laxative, 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 2019
Label revision date
October 25, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Calcium Carbonate 675 mg
  • Magnesium Hydroxide 135 mg
Other brand names
Drug classes
Blood Coagulation Factor, Calculi Dissolution Agent, Osmotic Laxative, 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 2019
Label revision date
October 25, 2024
Manufacturer
CHAIN DRUG CONSORTIUM, LLC
Registration number
M001
NDC root
68016-678
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 heartburn, sour stomach, and acid indigestion. These tablets come in a fresh mint flavor and are gluten-free, making them a convenient option for those seeking quick relief from uncomfortable digestive symptoms.

By neutralizing stomach acid, these antacid tablets help alleviate the discomfort associated with excess acidity in the stomach, allowing you to feel more comfortable throughout your day.

Uses

If you're experiencing discomfort from heartburn, a sour stomach, or acid indigestion, this medication can help relieve those symptoms. It works effectively to ease the burning sensation in your chest and the uncomfortable feeling in your stomach that can occur after eating.

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 potential risks.

Dosage and Administration

When you experience symptoms, you should chew 2 to 4 tablets completely. It's important not to swallow the tablets whole, as they need to be chewed to work effectively. You can take these tablets as needed or follow your doctor's instructions on how often to use them. Always make sure to follow the guidance provided to ensure you get the best results.

What to Avoid

It's important to use this medication responsibly to ensure your safety and well-being. You should not take more than 10 tablets within a 24-hour period, as exceeding this limit can lead to serious health issues. Additionally, avoid using the maximum dosage for longer than 2 weeks to prevent potential complications.

While there are no specific contraindications or concerns about abuse, misuse, or dependence (a condition where your body becomes reliant on a substance), it's crucial to follow these guidelines to maintain your health. Always consult with your healthcare provider if you have any questions or concerns about your medication.

Side Effects

It's important to be aware of potential interactions and side effects when using this product. Before you start, consult with your doctor or pharmacist, especially if you are currently taking any prescription medications, as antacids can interact with them.

While using this product, remember not to exceed 10 tablets in a 24-hour period, and avoid using the maximum dosage for more than two weeks. If you experience any unusual symptoms or side effects, contact your healthcare provider for guidance.

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.

While using this product, please remember not to exceed 10 tablets in a 24-hour period, and avoid using the maximum dosage for more than two weeks. This will help ensure your safety and the effectiveness of the treatment. If you have any concerns or experience unusual symptoms, it's best to reach out to your healthcare provider for guidance.

Overdose

Taking more than 10 tablets in a 24-hour period can lead to an overdose, which is a serious situation. It's important to follow the recommended dosage guidelines and not use the maximum dosage for more than 2 weeks. Doing so can increase the risk of harmful effects on your body.

If you suspect an overdose, look out for signs such as unusual drowsiness, confusion, or difficulty breathing (respiratory depression). If you notice any of these symptoms or if you have taken too many tablets, seek immediate medical help. Always prioritize your health and safety by adhering to the dosage instructions provided.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with any medications you consider taking. Currently, there is no specific information available about the safety or dosage adjustments for this medication during pregnancy. Therefore, it’s best to consult with your doctor or pharmacist before using it, especially if you are also taking any prescription drugs, as antacids can interact with certain medications.

Additionally, ensure that the product's inner seal is intact before use. If the seal is broken or missing, do not use the product. Always prioritize your health and the health of your baby by seeking professional advice when it comes to medication during pregnancy.

Lactation Use

If you are breastfeeding, it's important to talk to your healthcare professional before using this product. There is a possibility that it can be passed into your breast milk, and the effects on your nursing infant have not been thoroughly studied. Therefore, exercising caution is recommended to ensure the safety and well-being of both you and your baby.

Pediatric Use

It's important to keep this medication out of reach of children to ensure their safety. If your child needs to take this medication, they should not exceed 10 tablets in a 24-hour period. Additionally, the maximum dosage should not be used for more than 2 weeks.

When administering the medication, have your child chew 2 to 4 tablets completely as their symptoms occur or as directed by a 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 your child's use of this medication.

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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for 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 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 and safety of your product, store it at room temperature, away from high humidity. This helps maintain its effectiveness and integrity.

When handling the product, be sure to check the inner seal. If the printed inner seal is broken or missing, do not use the product, as this indicates it may have been tampered with. Following these guidelines will help you use the product safely and effectively.

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 Premier Value Extra Strength Antacid Tablets used for?

It is used to relieve heartburn, sour stomach, and acid indigestion.

How should I take Premier Value Extra Strength Antacid Tablets?

You should chew 2-4 tablets completely as symptoms occur or as directed by a doctor. Do not swallow the tablet whole.

What is the maximum dosage for this antacid?

Do not take more than 10 tablets in a 24-hour period and do not use the maximum dosage for more than 2 weeks.

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.

Is this product safe to use during pregnancy?

No specific information regarding pregnancy use is provided, so consult a healthcare professional before use.

Can nursing mothers use this product?

Nursing mothers should consult a healthcare professional before using this product, as there is potential for excretion in breast milk.

What should I do if the inner seal is broken or missing?

Do not use the product if the printed inner seal is broken or missing.

How should I store Premier Value Extra Strength Antacid Tablets?

Store at room temperature and avoid high humidity.

What flavor do these antacid tablets come in?

They come in a freshmint flavor.

Is this product gluten-free?

Yes, Premier Value Extra Strength Antacid Tablets are gluten-free.

Packaging Info

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

Packaging configurations for Premier Value Extra Strength.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Premier Value® Extra Strength Antacid Tablets are formulated to provide relief from heartburn and acid indigestion. Each tablet is a chewable dosage form with a freshmint flavor, designed for convenient consumption. The product is gluten-free and contains 100 tablets per package. It serves as both an antacid and a calcium supplement. The National Drug Code (NDC) for this product is 68016-678-00. It is important to note that this product is not manufactured or distributed by Chattem Inc., the owner of the registered trademark Extra Strength Rolaids®. The product is distributed by Pharmacy Value Alliance, LLC, located at 407 East Lancaster Avenue, Wayne, PA 19087. The packaging includes a tamper-evident feature; do not use if the printed inner seal is broken or missing.

Uses and Indications

This drug is indicated for the relief of heartburn, sour stomach, and acid indigestion.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

Patients should 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 to ensure proper administration and effectiveness.

Contraindications

Use is contraindicated in patients who exceed the recommended dosage of 10 tablets within a 24-hour period. Additionally, prolonged use of the maximum dosage for more than 2 weeks is contraindicated due to potential risks associated with extended high-dose administration.

Warnings and Precautions

Healthcare professionals should advise patients to consult with a physician 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 precautions: patients should not exceed a maximum dosage of 10 tablets within a 24-hour period. Additionally, the maximum dosage should not be utilized for more than two consecutive weeks to avoid potential adverse effects.

There are no specific laboratory tests recommended for monitoring the use of this product. However, healthcare providers should remain vigilant for any signs of adverse reactions or interactions, particularly in patients taking concurrent medications.

Side Effects

Patients should be aware of potential interactions when using this product. It is advised to consult a doctor or pharmacist prior to use if currently taking any prescription medications, as antacids may interact with certain prescription drugs.

While using this product, it is important to adhere to the recommended dosage guidelines. Patients should not exceed 10 tablets within a 24-hour period. Additionally, the maximum dosage should not be used for more than 2 weeks to avoid potential adverse effects.

Drug Interactions

Antacids may interact with various prescription medications, potentially affecting their absorption and efficacy. It is advisable to separate the administration of antacids and other medications by at least two hours to minimize the risk of interaction. Monitoring for therapeutic effectiveness of the affected drugs is recommended when antacids are used concurrently.

Packaging & NDC

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

Packaging configurations for Premier Value Extra Strength.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. The recommended dosage for children involves chewing 2-4 tablets completely as symptoms occur or as directed by a healthcare professional. It is important to note that pediatric patients should not exceed a maximum dosage of 10 tablets within a 24-hour period. Additionally, the maximum dosage should not be used for more than 2 weeks to ensure safety and efficacy. Swallowing the tablets whole is contraindicated; they must be chewed completely before ingestion.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients should be aware that there is no specific information regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Due to the lack of data, healthcare professionals are advised to exercise caution when considering this medication for pregnant patients.

Additionally, it is important to note that antacids may interact with certain prescription drugs; therefore, pregnant patients should consult with their healthcare provider or pharmacist before use, especially if they are currently taking any prescription medications.

As a precaution, pregnant patients should not use the product if the printed inner seal is broken or missing, as this may indicate compromised product integrity.

Lactation

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

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 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 the event of overdosage, it is critical to adhere to the recommended dosage guidelines to prevent adverse effects. The maximum allowable dosage is 10 tablets within a 24-hour period. Exceeding this limit may lead to serious health complications.

Healthcare professionals should also be aware that the maximum dosage should not be utilized for more than 2 weeks. Prolonged use at this level may increase the risk of toxicity and other associated health risks.

In cases of suspected overdosage, immediate medical attention is advised. Symptoms of overdosage may vary and should be monitored closely. Management procedures may include supportive care and symptomatic treatment, tailored to the specific symptoms presented by the patient. It is essential to consult relevant medical guidelines and protocols for the management of overdosage in such scenarios.

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 insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to inform patients not to exceed a maximum dosage of 10 tablets within a 24-hour period to avoid potential overdose and adverse effects. Additionally, patients should be cautioned against using the maximum dosage for more than 2 weeks, as prolonged use may lead to complications.

Providers should encourage patients to consult with a doctor or pharmacist prior to use if they are currently taking any prescription medications. This is particularly crucial as antacids may interact with certain prescription drugs, which could affect the efficacy of the treatment or lead to unwanted side effects.

Storage and Handling

The product is supplied in a configuration that ensures tamper evidence; it should not be used if the printed inner seal is broken or missing.

Storage conditions require the product to be kept at room temperature, with a specific emphasis on avoiding high humidity to maintain product integrity. Proper handling is essential to ensure the safety and efficacy of the product.

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 Premier Value 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 Premier Value 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.