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Gas Relief

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This product has been discontinued

Active ingredient
Dimethicone 80 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 2021
Label revision date
October 26, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 80 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 2021
Label revision date
October 26, 2023
Manufacturer
NORTHEAST PHARMA
Registration number
M002
NDC root
80136-791
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

This medication is designed to relieve pressure, bloating, and fullness in your stomach. It is commonly known as gas, which can be uncomfortable and sometimes embarrassing. By taking this drug, you can help alleviate these symptoms and feel more at ease.

Uses

If you're experiencing discomfort from pressure, bloating, or a feeling of fullness often associated with gas, this medication can help relieve those symptoms. It's designed to ease the discomfort that can come from excess gas in your digestive system.

You can feel confident using this medication, as there are no known teratogenic effects (which means it doesn't cause birth defects) or other harmful effects noted. This makes it a safe option for managing your gas-related discomfort.

Dosage and Administration

To take your medication correctly, start by chewing or crushing the tablet completely before swallowing it. If you are an adult or a child aged 12 years and older, you can take 1 to 2 tablets as needed after meals and at bedtime. However, it's important not to exceed 6 tablets in a 24-hour period unless your doctor has advised you otherwise.

If the patient is a child under 12 years old, it's essential to consult a doctor before giving them this medication. Always follow these guidelines to ensure safe and effective use of the medication.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. This ensures that you receive the best advice for your health and the health of your baby.

Always be aware of how your body responds to any medication, and don’t hesitate to reach out to your doctor if you have any concerns.

Warnings and Precautions

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. This ensures that you understand any potential risks to you or your baby.

Always keep this medication out of reach of children to prevent accidental ingestion or misuse. If you suspect that a child has taken this medication, seek emergency help immediately.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common 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 crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If you are considering this medication for your child, it's important to know that you should consult a doctor if your child is under 12 years old. For children aged 12 and older, the recommended dosage is 1 to 2 tablets as needed after meals and at bedtime. However, be cautious not to exceed 6 tablets in a 24-hour period unless directed by a doctor. Always prioritize your child's safety by following these guidelines closely.

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 healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and conditions. Always prioritize open communication with your doctor 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, and there are no special monitoring or precautions outlined for patients with hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe for your liver health. They can provide guidance based on your individual situation and any other health considerations you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that, based on the available information, this medication is not known to interfere with other drugs or lab tests. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you.

Always discuss any new medications or tests with your healthcare provider to avoid potential issues and to get personalized advice tailored to your health needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 15°C and 30°C (59°F - 86°F). It's important to keep it away from moisture, as this can affect its effectiveness.

When handling the product, check the tamper-evident seal under the cap. If this seal is missing or broken, do not use the product, as it may not be safe. Following these guidelines will help you use the product safely and effectively.

Additional Information

You can take this medication orally. For adults and children aged 12 years and older, the recommended dose is 1-2 tablets as needed after meals and at bedtime, but do not exceed 6 tablets in a 24-hour period unless directed by a doctor. If the patient is under 12 years old, it's important to consult a doctor before use.

FAQ

What does this drug relieve?

This drug relieves pressure, bloating, and fullness, commonly referred to as gas.

How should I take this medication?

Adults and children 12 years and over should take 1-2 tablets as needed after meals and at bedtime. Do not exceed 6 tablets in 24 hours unless advised by a doctor.

What should I do if I am under 12 years old?

If you are under 12 years old, you should ask a doctor before using this medication.

Are there any teratogenic effects associated with this drug?

No teratogenic effects are mentioned for this drug.

What precautions should I take if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using this medication.

How should I store this medication?

Store the medication at room temperature, between 15°C - 30°C (59˚F - 86˚F), and protect it from moisture.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

Is there any information on drug interactions?

No specific drug interactions are mentioned in the provided information.

What should I do if the seal under the cap is broken?

Do not use the medication if the imprinted seal under the cap is missing or broken.

Packaging Info

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

Packaging configurations for Gas Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the available data.

Uses and Indications

This drug is indicated for the relief of pressure, bloating, and fullness commonly associated with gas.

There are no teratogenic or nonteratogenic effects reported for this medication.

Dosage and Administration

Patients should chew or crush the tablet completely before swallowing to ensure proper absorption. For adults and children aged 12 years and older, the recommended dosage is 1 to 2 tablets taken as needed after meals and at bedtime. It is important not to exceed 6 tablets within a 24-hour period unless directed by a healthcare professional.

For children under 12 years of age, it is advised to consult a doctor before administration.

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 with a healthcare provider prior to use if they are pregnant or breastfeeding. This precaution is essential to ensure the safety of both the mother and the child.

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

Side Effects

Patients should be advised to consult a health professional if they are pregnant or breastfeeding before using this medication. This precaution is essential to ensure the safety of both the patient and the child during these sensitive periods.

No additional adverse reactions have been reported in clinical trials or postmarketing experiences. It is important for patients to be aware of this warning and to seek guidance from healthcare providers to mitigate any potential risks associated with the use of this medication during pregnancy or lactation.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Gas Relief.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 1-2 tablets as needed after meals and at bedtime. It is important not to exceed 6 tablets in a 24-hour period unless directed by a healthcare provider.

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. Consideration of individual patient factors, including comorbidities and concurrent medications, is essential in managing treatment effectively in elderly patients.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 is no information available 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide valuable assistance in managing potential overdosage cases.

Continued vigilance and adherence to recommended dosing guidelines are crucial to minimize the risk of overdosage and ensure patient safety.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Similarly, no data has been provided concerning non-teratogenic effects. Additionally, there is no information available in the nonclinical toxicology section. Furthermore, no details have been reported regarding animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 to emphasize the necessity of proper storage and handling to ensure the safety of young individuals.

Storage and Handling

The product is supplied in a configuration that includes a tamper-evident seal. It is essential to inspect the seal before use; the product should not be utilized if the imprinted seal under the cap is missing or broken.

For optimal storage, the product must be kept at room temperature, within the range of 15°C to 30°C (59°F to 86°F). It is crucial to protect the product from moisture to maintain its integrity and effectiveness.

Additional Clinical Information

The medication is administered orally. For adults and children aged 12 years and older, the recommended dosage is 1-2 tablets as needed after meals and at bedtime, with a maximum of 6 tablets in a 24-hour period unless directed otherwise by a physician. For children under 12 years, consultation with a doctor is advised before administration.

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 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 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.