Symptom checker
Select audience type

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

ADD CONDITION

items per page

Simethicone Infant

Last content change checked dailysee data sync status

Active ingredient
Dimethicone 20 mg/0.3 mL
Other brand names
Dosage form
Suspension
Route
Oral
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
March 18, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 20 mg/0.3 mL
Other brand names
Dosage form
Suspension
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 2025
Label revision date
March 18, 2026
Manufacturer
Atlantic Biologicals Corp.
Registration number
M002
NDC root
17856-1017
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (9 NDCs)
Packaging & NDC Codes (9)

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 help relieve symptoms associated with gas, which can cause discomfort and bloating. By targeting the underlying causes of gas, it aims to provide you with relief and improve your overall comfort. If you're experiencing issues related to gas, this drug may be a helpful option to consider.

Uses

If you're experiencing discomfort from gas, this medication can help relieve those symptoms. It's designed specifically to address the feelings of bloating and pressure that can come from excess gas in your digestive system.

You can feel confident using this product, as there are no known teratogenic effects (which means it doesn't cause birth defects) associated with it. Additionally, there are no reported nonteratogenic effects, ensuring a focus on your comfort without unnecessary concerns.

Dosage and Administration

Before using the medication, make sure to shake the bottle well. For infants under 2 years old who weigh less than 24 pounds, the recommended dose is 0.3 mL. If your child is 2 years or older and weighs 24 pounds or more, the dose increases to 0.6 mL. You can give the medication directly by filling the enclosed dropper to the recommended level and dispensing the liquid slowly into your baby's mouth, aiming for the inner cheek.

If you prefer, you can mix the dose with 1 ounce of cool water, infant formula, or another suitable liquid to make it easier for your child to take. You can repeat the dosage as needed, especially around mealtimes and at bedtime, but be sure not to exceed 12 doses in a single day. Always follow your physician's directions for the best results.

What to Avoid

It's important to be aware of certain precautions when using this medication. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center. This is crucial for your safety and well-being.

Currently, there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. However, always follow the guidance of your healthcare provider and use the medication as directed.

Side Effects

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center for assistance.

Warnings and Precautions

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center for assistance.

Always be cautious when using this medication and follow your healthcare provider's instructions closely. If you experience any unusual symptoms or side effects, stop using the medication and call your doctor for guidance. Your safety is the top priority, so don't hesitate to reach out for help if needed.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are more severe than typical side effects.

Always err on the side of caution—if you or someone else is experiencing concerning symptoms after taking medication, don’t hesitate to get help right away. Your safety is the top priority.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that the potential risks and benefits have not been clearly established for pregnant individuals.

If you are pregnant or planning to become pregnant, it’s important to discuss any medications you are taking with your healthcare provider. They can help you understand the best options for your health and the health of your baby. Always prioritize open communication with your doctor regarding any concerns you may have.

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 can be passed into your breast milk, and the effects on your nursing infant have not been thoroughly studied. Therefore, exercising caution is recommended to ensure the safety and well-being of both you and your baby.

Pediatric Use

When giving this medication to your child, it's important to follow the recommended dosages based on their age and weight. For infants under 2 years old, the suggested dose is 0.3 mL if they weigh less than 24 pounds. For children aged 2 years and older, the recommended dose increases to 0.6 mL for those who weigh 24 pounds or more. You can mix the dosage with 1 ounce of cool water, infant formula, or another suitable liquid to make it easier for your child to take.

Always keep this medication out of reach of children. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center. Your child's safety is the top priority, so be sure to follow 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 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 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 your treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall health.

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 liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any health conditions you have to receive the best care possible.

Storage and Handling

To ensure the safety and effectiveness of your product, always check that the printed seal under the cap is intact—do not use it if the seal is broken or punctured. Store the product at room temperature, and avoid freezing it, as extreme temperatures can affect its quality. For your reference, the lot number and expiration date can be found on the bottom panel of the packaging, so be sure to check these details before use.

Additional Information

You will take this medication orally, and you can repeat the dosage as needed, either with meals or at bedtime, unless your doctor advises otherwise. It's important to follow your physician's instructions regarding how often to take it. If you have any questions about your treatment or how to take the medication, be sure to consult your healthcare provider for guidance.

FAQ

What symptoms does this drug relieve?

This drug relieves symptoms referred to as gas.

What is the recommended dosage for infants?

For infants under 2 years weighing under 24 lbs, the recommended dose is 0.3 mL.

What is the recommended dosage for children?

For children 2 years and over weighing 24 lbs and over, the recommended dose is 0.6 mL.

How should the dosage be administered?

Fill the enclosed dropper to the recommended dosage level and dispense the liquid slowly into the baby's mouth, toward the inner cheek. You can also mix the dosage with 1 oz. of cool water, infant formula, or other suitable liquids.

Are there any warnings associated with this drug?

Yes, keep this drug out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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

Do not use the product if the printed seal under the cap is broken or punctured.

Is this drug safe to use during pregnancy?

No specific information regarding safety concerns or dosage modifications during pregnancy is provided, so consult a healthcare professional.

Can nursing mothers use this drug?

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

What should I do if I exceed the recommended dosage?

If you exceed the recommended dosage, get medical help or contact a Poison Control Center immediately.

How should this drug be stored?

Store the drug at room temperature and do not freeze.

Packaging Info

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

Packaging configurations for Simethicone Infant.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the relief of symptoms associated with gas.

There are no teratogenic effects associated with this drug, and no nonteratogenic effects have been reported.

Dosage and Administration

Shake the product well before use. The recommended dosages may be repeated as needed, particularly during meals and at bedtime, or as directed by a physician. It is important not to exceed 12 doses in a 24-hour period.

For administration, fill the enclosed dropper to the recommended dosage level and dispense the liquid slowly into the baby's mouth, directing it toward the inner cheek. Alternatively, the dosage may be mixed with 1 ounce of cool water, infant formula, or other suitable liquids to facilitate administration.

Dosage by Age and Weight:

  • Infants (under 2 years): For infants weighing under 24 lbs, the recommended dose is 0.3 mL.

  • Children (2 years and over): For children weighing 24 lbs and over, the recommended dose is 0.6 mL.

Contraindications

There are no specific contraindications listed for this product. However, in the event of an overdose, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

It is imperative to keep this medication out of reach of children to prevent accidental ingestion and potential harm.

In the event of an overdose, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and intervention.

Side Effects

Patients should be advised to keep this medication out of reach of children. In the event of an overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Simethicone Infant.
Details

Pediatric Use

Pediatric patients under 2 years of age are recommended to receive a dose of 0.3 mL if they weigh less than 24 lbs. For children aged 2 years and older, the recommended dose is 0.6 mL for those weighing 24 lbs and above. The dosage may be mixed with 1 oz. of cool water, infant formula, or other suitable liquids to facilitate administration.

Healthcare professionals should advise caregivers to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay.

Geriatric Use

There is no specific information 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

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment.

Lactation

Nursing 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; therefore, caution is advised.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with the overdose.

Healthcare professionals should be vigilant in monitoring for symptoms that may arise from an overdose. While specific symptoms are not detailed in the provided information, it is essential to remain alert to any signs of toxicity or adverse reactions that may develop.

Management of an overdose should be guided by established protocols, which may include supportive care and symptomatic treatment as necessary. The involvement of a Poison Control Center can provide additional guidance on the appropriate management strategies tailored to the specific circumstances of the overdose.

In summary, immediate medical attention is essential in cases of overdose, and healthcare providers should be prepared to implement appropriate management procedures while remaining attentive to the patient's condition.

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 question.

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. It is important to emphasize the potential risks associated with overdose. Patients should be instructed to seek medical help or contact a Poison Control Center immediately in the event of an overdose. This information is crucial for ensuring patient safety and promoting responsible use of the medication.

Storage and Handling

The product is supplied in a configuration that includes a printed seal under the cap, which must remain intact; do not use the product if this seal is broken or punctured. It should be stored at room temperature, ensuring that it is not exposed to freezing conditions. For reference, the lot number and expiration date can be found on the bottom panel of the container.

Additional Clinical Information

The medication is administered orally, with all dosages being repeatable as needed, during meals, at bedtime, or as directed by a physician. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Simethicone Infant, 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 Infant, 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.