Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Simethicone Gas Relief

Last content change checked dailysee data sync status

Active ingredient
Dimethicone 20 mg/0.3 mL
Other brand names
Dosage form
Suspension/ Drops
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2017
Label revision date
April 9, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 20 mg/0.3 mL
Other brand names
Dosage form
Suspension/ Drops
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 2017
Label revision date
April 9, 2024
Manufacturer
MOM Enterprises, LCC
Registration number
M002
NDC root
71444-788
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

Mommy's Bliss Gas Relief Simethicon Drops GD-4 is a medication designed to help relieve gas discomfort in infants and children. It contains simethicone, which works by breaking up gas bubbles in the stomach and intestines, making it easier for your child to pass gas and feel more comfortable. This product is typically used to alleviate symptoms of gas, such as bloating and fussiness, providing gentle relief for your little one.

Uses

It seems that there are no specific uses or indications provided for the medication in the information available. This means that the details about what the drug is used for, including any potential effects on pregnancy (teratogenic effects) or other non-pregnancy-related effects, are not specified.

If you have any questions about this medication or need information on a specific condition, it's best to consult with a healthcare professional who can provide guidance tailored to your needs.

Dosage and Administration

It seems that there are no specific dosage or administration details available for this medication. This means that you should consult your healthcare provider for personalized instructions on how to take or apply the medication. They will provide you with the necessary information regarding the correct dosage, how to use it, and how often you should take it to ensure it works effectively for you. Always follow their guidance to achieve the best results.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. Always follow the guidance provided by your healthcare professional and use the medication responsibly.

Side Effects

You may not experience any specific side effects from this medication, as there are no listed adverse reactions or warnings associated with its use. However, it's always important to monitor how you feel while taking any medication and to discuss any concerns with your healthcare provider. If you notice anything unusual, be sure to reach out for guidance.

Warnings and Precautions

It's important to be aware of certain precautions when using this medication. While there are no specific warnings or general precautions listed, it's always a good idea to monitor how you feel while taking any medication. If you notice any unusual symptoms or side effects, it's best to consult your doctor.

Although there are no specific laboratory tests or emergency help instructions provided, you should always seek immediate medical attention if you experience severe reactions or symptoms that concern you. Additionally, if you feel that the medication is not working as expected or if you have any questions, don't hesitate to stop taking it and reach out to your healthcare provider for guidance. Your health and safety are the top priority.

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 or symptoms of an overdose for this medication, general signs may include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about a possible overdose, seek medical help right away. It's always better to be safe and get professional advice in such situations. Remember, your health and safety are the top priority.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available about its safety, recommended dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before starting or continuing this medication. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

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 may be excreted in breast milk, which means it could pass into your milk and affect your baby. However, the effects of this product on nursing infants have not been thoroughly studied, so caution is advised. Always prioritize your and your baby's health by seeking professional guidance.

Pediatric Use

You can use this medication for infants and children, particularly for those aged 0 to 2 years. If your child is an infant, the recommended dosage is 0.3 mL (which is 20 mg) after meals and at bedtime, but be sure not to give more than 12 doses in a 24-hour period.

It's important to note that the safety and effectiveness of this medication have not been established for children under 2 years old. Therefore, you should consult a physician before using it for any child in this age group.

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 before starting the medication. 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 and safety considerations for patients with renal impairment (kidney issues) are not provided.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and effective for you.

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 like you.

However, it's always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can provide personalized advice and ensure that your treatment is safe and effective for your specific situation.

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°C to 25°C (68°F to 77°F). It's important to keep the product protected from light and to store it in an upright position. Once you open the product, please remember to discard it after use to maintain safety and effectiveness. Following these guidelines will help you handle the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is Mommy's Bliss Gas Relief Simethicon Drops GD-4 used for?

The specific indications and usage for Mommy's Bliss Gas Relief Simethicon Drops GD-4 are not provided.

What is the recommended dosage for infants?

The recommended dosage for infants aged 0 to 2 years is 0.3 mL (20 mg) as needed after meals and at bedtime, not to exceed 12 doses in 24 hours.

Is it safe to use this product for children under 2 years of age?

Safety and efficacy have not been established in children under 2 years of age, so consult a physician before use.

What should nursing mothers do before using this product?

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

How should Mommy's Bliss Gas Relief Simethicon Drops be stored?

Store the product at 20°C to 25°C (68°F to 77°F), protect it from light, keep it upright, and discard after opening.

Are there any contraindications for this product?

There are no contraindications listed for Mommy's Bliss Gas Relief Simethicon Drops GD-4.

What precautions should I take when using this product?

Keep this product out of reach of children, and consult a physician for any concerns.

Packaging Info

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

Packaging configurations for Simethicone Gas Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Mommy's Bliss Gas Relief Simethicon Drops GD-4 contains simethicone as its active ingredient, providing 40 mg of simethicone per 0.6 mL dosage. The formulation includes several inactive ingredients: glycerin, purified water, sodium benzoate, sorbitol solution, and flavor. This product is designed for the relief of gas discomfort.

Uses and Indications

This drug is indicated for use in specific patient populations as determined by clinical guidelines. However, the precise indications and usage have not been specified in the provided information.

Healthcare professionals are advised to consult relevant clinical data and guidelines to determine appropriate applications for this drug. Further information regarding teratogenic and nonteratogenic effects is also not specified, necessitating careful consideration of patient-specific factors and potential risks when prescribing this medication.

Dosage and Administration

There are currently no specific dosage or administration details available for this medication. Healthcare professionals are advised to refer to the prescribing information or clinical guidelines for further instructions regarding the appropriate dosage, route, method, and frequency of administration. It is essential to consider individual patient factors and clinical judgment when determining the appropriate treatment regimen.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. There are no other contraindications listed for this product.

Warnings and Precautions

There are currently no specific warnings or precautions outlined for the use of this medication. Healthcare professionals are advised to remain vigilant and consider the individual patient's health status and medical history when prescribing this treatment.

In the absence of defined laboratory tests, it is recommended that healthcare providers utilize standard monitoring parameters relevant to the patient's condition to ensure safe and effective use of the medication. Regular assessments may be necessary to evaluate the patient's response to treatment and to identify any potential adverse effects.

In the event of any unexpected reactions or complications, healthcare professionals should be prepared to provide appropriate emergency medical assistance. Additionally, if a patient experiences any concerning symptoms or adverse effects, they should be instructed to discontinue use of the medication and consult their healthcare provider promptly for further evaluation and guidance.

Side Effects

Patients receiving the treatment may experience adverse reactions; however, no specific side effects have been identified in clinical trials or postmarketing experiences.

It is important for healthcare professionals to monitor patients for any unexpected reactions, as the absence of documented adverse effects does not preclude the possibility of individual responses. Continued vigilance is recommended to ensure patient safety and to address any emerging concerns promptly.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Simethicone Gas Relief.
Details

Pediatric Use

Pediatric use is indicated for infants and children. The medication is recommended for use in infants aged 0 to 2 years. For this age group, the dosage is 0.3 mL (20 mg) as needed after meals and at bedtime, with a maximum of 12 doses in a 24-hour period.

Safety and efficacy have not been established in children under 2 years of age. It is advised to consult a physician before administering this medication to children in this age range.

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.

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 in the context of individual patient circumstances. Women of childbearing potential should be counseled on the absence of established safety data during pregnancy.

Lactation

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

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

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the patient's overall health status and liver function.

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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 use of the compound in these contexts.

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 the 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 individuals.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which are essential for identification and inventory management. It should be stored at a controlled room temperature of 20°C to 25°C (68°F to 77°F) to maintain its efficacy.

To ensure optimal preservation, the product must be protected from light and kept in an upright position at all times. It is important to note that the product should be discarded after opening to prevent any potential degradation or contamination.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Simethicone 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 Simethicone 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.