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Maximum Strength Gas Relief

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This product has been discontinued

Active ingredient
Dimethicone 250 mg
Other brand names
Dosage form
Capsule, Gelatin Coated
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2021
Label revision date
December 13, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 250 mg
Other brand names
Dosage form
Capsule, Gelatin Coated
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 2021
Label revision date
December 13, 2024
Manufacturer
Spirit Pharmaceuticals LLC
Registration number
M002
NDC root
68210-4165
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

VALUMEDS MAXIMUM STRENGTH GAS RELIEF contains simethicone, a medication designed to help relieve bloating, pressure, or fullness that is commonly associated with gas. By breaking up gas bubbles in the stomach and intestines, simethicone helps you feel more comfortable after meals or during times of digestive discomfort.

This product is available in a convenient softgel form, making it easy to take when you need relief from gas-related symptoms. If you're experiencing discomfort due to gas, VALUMEDS MAXIMUM STRENGTH GAS RELIEF may be a helpful option for you.

Uses

If you're experiencing discomfort from bloating, pressure, or a feeling of fullness often associated with gas, this medication can help relieve those symptoms. It works by targeting the underlying causes of gas, providing you with the comfort you need. Whether it's after a meal or due to certain foods, this treatment aims to ease that uncomfortable sensation and help you feel more at ease.

Dosage and Administration

You should take one or two softgels after a meal. It's important not to exceed two softgels in a 24-hour period unless your doctor advises you otherwise. Always follow your healthcare provider's guidance 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. If your condition does not improve or continues to persist, you should stop using the medication and consult your doctor for further advice. This ensures that you receive the appropriate care and support for your health needs.

Currently, there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always prioritize your health and safety by following these recommendations.

Side Effects

If you experience any persistent symptoms while using this medication, it's important to stop using it and consult your doctor. Additionally, be sure to keep this medication out of reach of children to ensure their safety.

While specific side effects are not detailed here, always be aware of how you feel while taking any medication and communicate any concerns with your healthcare provider.

Warnings and Precautions

It's important to be cautious when using this medication. If your condition does not improve or continues to persist, you should stop taking the medication and consult your doctor for further guidance.

Additionally, make sure to keep this medication out of reach of children to prevent any accidental ingestion. Always prioritize safety and seek professional advice if you have any concerns.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be aware that there is no specific information available regarding the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been established.

Before taking this medication, you should consult with your healthcare provider to discuss any potential risks and to ensure that you are making informed decisions for your health and the health of your baby. Always prioritize open communication with your doctor about any medications you are considering during pregnancy.

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. If your child needs to take this medication, make sure they do not exceed the recommended dosage of two softgels in a 24-hour period, unless a doctor has specifically advised otherwise. Always consult with a healthcare professional if you have any questions or concerns about its use in children.

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. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness. If you notice any unusual side effects or changes in health, be sure to report these to your healthcare team promptly.

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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can provide guidance based on your individual situation.

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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and medication use. They can help ensure that your treatment is safe and effective based on your individual health needs.

Drug Interactions

It's great to know that there are no reported interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you may start. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 59°F and 86°F (15°C and 30°C). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided with the product for safe use and disposal. Keeping these guidelines in mind will help you use the product safely and effectively.

Additional Information

You should take this medication orally by swallowing one or two softgels after a meal. It's important not to exceed two softgels in a 24-hour period unless your doctor advises otherwise. Always follow your healthcare provider's guidance to ensure safe and effective use.

FAQ

What is VALUMEDS MAXIMUM STRENGTH GAS RELIEF?

VALUMEDS MAXIMUM STRENGTH GAS RELIEF is an anti-gas medication containing SIMETHICONE 250 mg, which relieves bloating, pressure, or fullness commonly referred to as gas.

How should I take VALUMEDS MAXIMUM STRENGTH GAS RELIEF?

You should swallow one or two softgels after a meal. Do not exceed two softgels per 24 hours unless advised by a physician.

Are there any contraindications for using this product?

No specific contraindications are mentioned for VALUMEDS MAXIMUM STRENGTH GAS RELIEF.

What should I do if my condition persists?

You should stop using the product and ask a doctor if your condition persists.

Is there any information regarding use during pregnancy or nursing?

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

How should I store VALUMEDS MAXIMUM STRENGTH GAS RELIEF?

Store the product at room temperature between 59°-86°F (15°-30°C).

Is this product safe for children?

You should keep VALUMEDS MAXIMUM STRENGTH GAS RELIEF out of reach of children.

Packaging Info

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

Packaging configurations for Maximum Strength Gas Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

VALUMEDS MAXIMUM STRENGTH GAS RELIEF contains simethicone as its active ingredient, with a concentration of 250 mg per softgel. This formulation is designed to provide effective anti-gas relief. The product is comparable to the active ingredient found in PHAZYME® Maximum Strength. It is important to note that VALUMEDS is not manufactured or distributed by C.B. Fleet Company Inc., the distributor of PHAZYME®. Each bottle contains a total of 70 softgels.

Uses and Indications

This drug is indicated for the relief of bloating, pressure, or fullness commonly referred to as gas. It is intended for use in patients experiencing these gastrointestinal symptoms.

Dosage and Administration

Patients should swallow one or two softgels after a meal. The maximum recommended dosage is two softgels within a 24-hour period, unless otherwise directed by a physician. It is important for healthcare professionals to advise patients not to exceed this dosage without medical supervision.

Contraindications

There are no specified contraindications for the use of this product. However, it is advised to discontinue use and consult a healthcare professional if the condition persists.

Warnings and Precautions

Healthcare professionals should be aware of the following important considerations regarding the safe use of this medication.

Patients are advised to discontinue use and consult a healthcare provider if their condition persists. This precaution is essential to ensure that any underlying issues are appropriately addressed and managed.

Additionally, it is crucial to keep this medication out of the reach of children to prevent accidental ingestion or misuse. Proper storage and handling practices should be emphasized to safeguard against potential risks associated with pediatric exposure.

Side Effects

Patients should be advised to discontinue use and consult a healthcare professional if their condition persists. It is also important to keep this product out of reach of children to prevent accidental ingestion or misuse.

Drug Interactions

No drug interactions have been identified in the available data. Additionally, there are no reported interactions between drugs and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Maximum Strength Gas Relief.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. The recommended dosage for pediatric patients is limited to a maximum of two softgels per 24 hours, unless otherwise directed by a physician. Careful supervision is advised to ensure adherence to this dosage guideline.

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

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in consultation with the patient. Women of childbearing potential should be informed of the absence of established safety data during pregnancy.

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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide the management of the patient and to determine the most appropriate interventions.

Overall, vigilance and prompt action are critical in managing cases of suspected overdose, even in the absence of detailed information regarding specific overdosage effects.

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 safety profile in nonclinical settings.

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 or misuse. It is important to inform patients that they should discontinue use and consult a doctor if their condition persists, ensuring they understand the significance of seeking professional guidance in such cases.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, maintaining a range of 59°F to 86°F (15°C to 30°C). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally, with patients advised to swallow one or two softgels after a meal. It is important for patients not to exceed a dosage of two softgels within a 24-hour period unless directed by a physician. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Maximum Strength Gas Relief, 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 Maximum Strength Gas Relief, 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.