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Premier Value Maximum Strength

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Active ingredients
  • Dimethicone, Unspecified 60 mg
  • 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 2019
Label revision date
October 25, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Dimethicone, Unspecified 60 mg
  • 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 2019
Label revision date
October 25, 2024
Manufacturer
PHARMACY VALUE ALLIANCE, LLC
Registration number
M001
NDC root
68016-249
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 a maximum strength antacid and anti-gas medication available in chewable tablet form with an assorted fruit flavor. It is designed to relieve symptoms such as acid indigestion, heartburn, sour stomach, and upset stomach, as well as bloating and pressure commonly associated with gas.

This product works by neutralizing stomach acid and providing quick relief from discomfort, making it a helpful option for those experiencing these common digestive issues.

Uses

You can use this medication to help relieve several uncomfortable digestive issues. It is effective for easing acid indigestion, heartburn, and a sour stomach. If you're experiencing an upset stomach due to these symptoms, this medication can provide relief. Additionally, it helps with bloating and the pressure often associated with gas.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects (which refers to other types of harmful effects during pregnancy) associated with this medication.

Dosage and Administration

When you need relief from your symptoms, you can take 1 to 2 tablets if you are an adult or a child aged 12 years and older. Make sure to chew the tablets completely; do not swallow them whole. You can take these tablets as symptoms occur or follow your doctor's instructions for use.

It's important to remember not to exceed 8 tablets in a 24-hour period. Additionally, you should not use the maximum dosage for more than 2 weeks unless your doctor advises you to do so. Always follow these guidelines to ensure safe and effective use of the medication.

What to Avoid

It's important to be aware of certain guidelines when using this medication. While there are no specific contraindications or concerns regarding abuse, misuse, or dependence, you should stop using the medication and consult your doctor if your symptoms last longer than two weeks. This ensures that you receive the appropriate care and support for your health needs. Always prioritize your well-being and seek professional advice when necessary.

Side Effects

When using this product, be aware that taking the maximum dose can lead to constipation. It's important not to exceed 8 tablets in a 24-hour period or use the highest dosage for more than 2 weeks without consulting your doctor. If your symptoms last longer than 2 weeks, you should stop using the product and seek medical advice.

Before starting this medication, talk to your doctor if you have kidney stones or follow a calcium-restricted diet, as these conditions may require special consideration. Additionally, if you are currently taking any prescription medications, consult with your doctor or pharmacist, as antacids can interact with certain drugs.

Warnings and Precautions

It's important to use this medication safely. You should not take more than 8 tablets in a 24-hour period or use the maximum dosage for more than 2 weeks unless your doctor advises you to do so. If you have kidney stones or are on a calcium-restricted diet, please consult your doctor before using this product.

Additionally, if you are currently taking any prescription medications, check with your doctor or pharmacist first, as antacids can interact with some drugs. If your symptoms continue for more than 2 weeks, stop using the medication and contact your doctor for further guidance. Always prioritize your health and safety.

Overdose

Taking more than 8 tablets in a 24-hour period or using the maximum dosage for longer than 2 weeks without your doctor's guidance can lead to an overdose. Signs of an overdose may include unusual symptoms that could affect your health. If you suspect an overdose, it’s important to seek immediate medical help.

If you experience any concerning symptoms or if you have taken too much of the medication, contact your healthcare provider or go to the nearest emergency room right away. Always follow your doctor's instructions regarding medication use to ensure your safety.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this product during pregnancy has not been established. You should consult your doctor before using it, as there may be potential risks to your fetus that are not clearly defined.

Additionally, dosage adjustments might be necessary, so it's crucial to seek medical advice for the appropriate use during this time. Be vigilant and monitor for any adverse effects, and report them to your healthcare provider if they occur. Your health and the health of your baby are the top priority, so always communicate openly with your doctor about any concerns.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could pass to your baby. Since the effects on nursing infants have not been thoroughly studied, it's best to approach this with caution. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

Pediatric Use

This medication is not recommended for children under 12 years of age. If your child is 12 years or older, they can take 1 to 2 tablets as needed for symptoms, but it's important to follow your doctor's guidance. Be cautious 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.

Always keep this medication out of reach of younger children to ensure their safety. If you have any concerns or questions about its use, consult your doctor for personalized advice.

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 for personalized advice. They can help determine the best approach to using this medication safely and effectively, taking into account any unique health needs or conditions that may be present. Always prioritize open communication with your healthcare team to ensure the best outcomes.

Renal Impairment

If you have kidney problems, it's important to consult your doctor before using this medication, especially if you have kidney stones or are on a calcium-restricted diet. Your healthcare provider can help determine if this medication is safe for you and may suggest necessary adjustments to your treatment plan. Always prioritize open communication with your doctor regarding your kidney health to ensure the best care.

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 if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to talk to your doctor or pharmacist before using this medication, especially if you are currently taking any prescription drugs. Some medications, like antacids, can interact with your prescription medications, potentially affecting how well they work or increasing the risk of side effects.

Always keep your healthcare provider informed about all the medications you are taking to ensure your treatment is safe and effective. This way, you can avoid any unexpected interactions and get the best possible care.

Storage and Handling

To ensure the best performance of your product, store it at room temperature in a dry place. It's important to keep the container tightly closed to protect its contents. Avoid exposing the product to freezing temperatures, as this can affect its quality.

Before using, check that the printed inner seal is intact; do not use the product if the seal is broken or missing, as this could compromise safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

For adults and children aged 12 years and older, you should chew 1 to 2 tablets completely when symptoms occur or as directed by your doctor. It's important not to swallow the tablets whole. There is no additional information available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Premier Value?

Premier Value is an antacid and anti-gas medication that provides maximum strength relief for symptoms like acid indigestion, heartburn, and bloating.

How should I take Premier Value?

Adults and children 12 years and older should chew 1 to 2 tablets completely as symptoms occur or as directed by a doctor. Do not swallow the tablets whole.

What is the maximum dosage for Premier Value?

Do not take more than 8 tablets in 24 hours or use the maximum dosage for more than 2 weeks unless advised by a doctor.

Are there any side effects associated with Premier Value?

At maximum dose, constipation may occur. If symptoms persist for more than 2 weeks, stop use and consult a doctor.

Is Premier Value safe to use during pregnancy?

The safety of Premier Value during pregnancy has not been established. Consult a doctor if you are pregnant or planning to become pregnant.

Can I use Premier Value while breastfeeding?

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

What should I do if I have kidney stones?

Ask a doctor before using Premier Value if you have kidney stones or a calcium-restricted diet.

Where should I store Premier Value?

Store at room temperature, keep tightly closed and dry, and avoid freezing. Do not use if the printed inner seal is broken or missing.

Packaging Info

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

Packaging configurations for Premier Value Maximum Strength.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Premier Value® is an antacid and anti-gas formulation that compares to the active ingredients in Maalox® Advanced Maximum Strength. Each package contains 90 chewable tablets, flavored with assorted fruit and containing both natural and artificial flavors. The product is designed for maximum strength relief from heartburn, acid indigestion, and symptoms of pressure and bloating. The National Drug Code (NDC) for this product is 68016-249-00. It is distributed by Pharmacy Value Alliance, LLC, located at 407 East Lancaster Avenue, Wayne, PA 19087. This product is independently tested, with satisfaction guaranteed, and is not manufactured or distributed by Novartis Consumer Health, Inc., the distributor of Maalox® Advanced Maximum Strength.

Uses and Indications

This drug is indicated for the relief of symptoms associated with acid indigestion, heartburn, sour stomach, and upset stomach. It is also effective in alleviating bloating and pressure commonly referred to as gas.

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 1 to 2 tablets completely as symptoms occur or as directed by a healthcare professional. It is important that the tablets are not swallowed whole.

The maximum recommended dosage is 8 tablets within a 24-hour period. Additionally, the maximum dosage should not be used for more than 2 weeks unless advised and supervised by a healthcare provider.

Contraindications

There are no specified contraindications for this product. However, it is advised to discontinue use and consult a healthcare professional if symptoms persist for more than two weeks.

Warnings and Precautions

Patients should not exceed a maximum dosage of 8 tablets within a 24-hour period or utilize the maximum dosage for longer than 2 weeks without the guidance and supervision of a healthcare professional.

Prior to use, individuals should consult a physician if they have a history of kidney stones or are on a calcium-restricted diet, as these conditions may influence the safety and efficacy of the treatment.

It is also advisable for patients to seek counsel from a healthcare provider or pharmacist if they are currently taking any prescription medications, as antacids may interact with certain drugs, potentially leading to adverse effects or reduced therapeutic efficacy.

Should symptoms persist beyond a duration of 2 weeks, it is imperative to discontinue use and consult a healthcare professional for further evaluation and management.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. Serious adverse reactions may occur, particularly if the maximum dosage is exceeded. It is crucial not to take more than 8 tablets in a 24-hour period or to use the maximum dosage for more than 2 weeks without the advice and supervision of a healthcare professional.

Common adverse reactions include constipation, which may occur when the product is used at the maximum dose. Patients are advised to monitor their symptoms closely and to discontinue use and consult a doctor if symptoms persist for more than 2 weeks.

Additionally, patients should seek medical advice before using this product if they have a history of kidney stones or are on a calcium-restricted diet. It is also recommended that patients consult with a doctor or pharmacist if they are currently taking any prescription medications, as antacids may interact with certain drugs.

Drug Interactions

Patients are advised to consult a healthcare professional, such as a doctor or pharmacist, prior to using antacids if they are currently taking any prescription medications. Antacids have the potential to interact with various prescription drugs, which may alter the effectiveness of the medications or lead to unintended side effects.

It is essential for healthcare providers to evaluate the specific medications involved to determine the need for dosage adjustments or enhanced monitoring during concurrent use.

Packaging & NDC

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

Packaging configurations for Premier Value Maximum Strength.
Details

Pediatric Use

Pediatric patients under 12 years of age are not recommended to use this medication. For children aged 12 years and older, the recommended dosage is to chew 1 to 2 tablets completely as symptoms occur or as directed by a healthcare professional. The maximum dosage should not exceed 8 tablets in a 24-hour period, and the maximum dosage should not be used for more than 2 weeks unless advised and supervised by a doctor. It is important to keep this medication 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

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. Potential risks to the fetus are not clearly defined; therefore, caution is advised. Dosage adjustments may be necessary, and it is essential to seek medical advice for appropriate use during pregnancy. Additionally, healthcare professionals should monitor for any adverse effects and advise patients to report such occurrences promptly.

Lactation

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

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use if they have kidney stones or are on a calcium-restricted diet. These conditions may necessitate careful consideration of the medication's safety and efficacy in individuals with reduced kidney function. Monitoring and potential dosing adjustments may be required based on the patient's specific renal status and dietary restrictions.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. Consequently, there is no available information regarding 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.

Overdosage

In the event of overdosage, it is critical to adhere to the recommended dosage guidelines to prevent adverse effects. Patients should not exceed a total of 8 tablets within a 24-hour period. Furthermore, the maximum dosage should not be utilized for longer than 2 weeks unless specifically directed and monitored by a healthcare professional.

Healthcare providers are advised to closely monitor patients for any signs of overdosage, which may include symptoms related to the active ingredients of the medication. In cases where overdosage is suspected, immediate medical attention should be sought.

Management of overdosage may involve supportive care and symptomatic treatment, tailored to the specific symptoms presented by the patient. It is essential for healthcare professionals to evaluate the patient's condition and implement appropriate interventions based on clinical judgment and established protocols.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Patients should be informed to discontinue use and consult a doctor if their symptoms persist for more than two weeks, as this may indicate a need for further evaluation.

When discussing the use of this product, healthcare providers should highlight that, at the maximum recommended dose, constipation may occur. It is important for patients to be aware of this potential side effect.

Additionally, healthcare providers should encourage patients to seek medical advice before using this product if they have a history of kidney stones or if they are on a calcium-restricted diet. This is crucial to ensure the safe use of the product in these specific health conditions.

Lastly, patients should be advised to consult with their doctor or pharmacist prior to use if they are currently taking any prescription medications, as antacids may interact with certain drugs. This precaution helps to prevent any adverse interactions and ensures the safe and effective use of the product.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at room temperature, ensuring that the container remains tightly closed and dry to maintain product integrity. It is essential to avoid exposure to freezing temperatures. Additionally, the product must not be used if the printed inner seal is broken or missing, as this may compromise safety and efficacy.

Additional Clinical Information

For patients aged 12 years and older, the recommended administration involves chewing 1 to 2 tablets completely as symptoms occur or as directed by a healthcare professional. It is important that patients do not swallow the tablets whole.

No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Premier Value Maximum 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 Maximum 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.

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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.