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Gas Relief

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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 2023
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 2023
Label revision date
October 26, 2023
Manufacturer
STRATEGIC SOURCING SERVICES LLC
Registration number
M002
NDC root
70677-1067
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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, commonly associated with gas. If you experience discomfort from these symptoms, this drug can help ease that feeling and improve your overall comfort.

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 works by targeting the underlying causes of gas, providing you with the comfort you need.

Using this medication can make a significant difference in how you feel, allowing you to go about your day without the distraction of digestive discomfort.

Dosage and Administration

To take this medication, 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, you should consult a doctor before giving them this medication. Always follow these guidelines to ensure safe and effective use.

What to Avoid

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 to avoid using it, and it does not fall under any controlled substance regulations.

However, it's always important to consult with your healthcare provider before starting any new medication to ensure it is appropriate for your individual health needs. If you have any questions or concerns, don't hesitate to reach out to them for guidance.

Side Effects

It's important to be aware of potential side effects when using this medication. If you are pregnant or breastfeeding, you should consult a healthcare professional before using it to ensure safety for you and your baby.

Always keep an eye out for any unusual reactions and discuss any concerns with your doctor. Your health and well-being are the top priority.

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 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 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 have a child under 12 years old, it's important to consult with a doctor before giving them this medication. For adults and children aged 12 and older, the recommended dosage is 1 to 2 tablets as needed after meals and at bedtime. However, you should not exceed 6 tablets in a 24-hour period unless directed by a doctor. Always follow these guidelines to ensure safe use for your family.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°-25°C (68°-77°F). It’s acceptable for the temperature to occasionally range from 15°-30°C (59°-86°F), but try to keep it within the recommended limits. Make sure to protect the product from moisture, as this can affect its quality.

Before using the product, check the end flap for the expiration date and lot number to ensure it is still safe and effective. Proper storage and handling are key to maintaining the product's integrity and safety.

Additional Information

You should 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, consult a doctor for appropriate dosing.

FAQ

What does this drug relieve?

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

How should I take this medication?

You should chew or crush the tablet completely before swallowing. Adults and children 12 years and over can take 1-2 tablets as needed after meals and at bedtime.

What is the maximum dosage I can take?

Do not exceed 6 tablets in 24 hours unless advised and supervised 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 use.

Are there any warnings for pregnant or breastfeeding individuals?

If you are pregnant or breastfeeding, you should ask a health professional before use.

How should I store this medication?

Store the medication at 20°-25°C (68°-77°F) and protect it from moisture.

Are there any contraindications or risks associated with this drug?

No contraindications, abuse risks, or dependence concerns are listed for this drug.

Is there any information regarding drug interactions?

No drug interactions or laboratory test interactions are mentioned.

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

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the relief of pressure, bloating, and fullness commonly associated with gas. It is intended for use in patients experiencing these gastrointestinal symptoms.

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, consultation with a doctor is advised prior to 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 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 developing fetus or nursing infant.

No additional adverse reactions have been reported in clinical trials or postmarketing experiences. It is important for healthcare providers to monitor patients for any unexpected reactions and to report them as necessary.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

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, with a maximum of 6 tablets in a 24-hour period unless directed otherwise by a physician. Caution is advised to ensure adherence to these guidelines to prevent potential overdose or adverse effects.

Geriatric Use

There is no specific information available 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 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 associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

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 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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

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.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

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 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 children. Providers should emphasize the necessity of storing the medication in a secure location, away from the sight and reach of children, to ensure their safety.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which can be found on the packaging. It should be stored at a temperature range of 20°-25°C (68°-77°F), with permissible excursions between 15°-30°C (59°-86°F). It is essential to protect the product from moisture to maintain its integrity. For details regarding the expiration date and lot number, please refer to the end flap of the packaging.

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 of age, consultation with a doctor is advised prior to administration.

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

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.