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Simethicone Infant

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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
July 29, 2025
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
July 29, 2025
Manufacturer
AARNA USA Inc.
Registration number
M002
NDC root
82568-0017
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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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. It works by targeting the underlying causes of gas, providing you with relief from these uncomfortable sensations. If you're experiencing issues related to gas, this drug may be a helpful option for you.

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 medication, as there are no known teratogenic effects (which means it doesn't cause birth defects) associated with it. This makes it a safer option for those who may be concerned about potential risks.

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 careful not to exceed 12 doses in a single day. Always follow your physician's directions for the best results.

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, you can use it without concerns about these particular issues. However, 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 experience an overdose of this medication, it is crucial to seek medical help immediately or contact a Poison Control Center. This is important to ensure your safety and receive the appropriate care. Always be aware of the signs of overdose and act quickly if you suspect it.

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.

While there are no specific general precautions or laboratory tests mentioned, always be mindful of how you feel while taking any medication. If you experience any unusual symptoms or have concerns, don’t hesitate to reach out to your healthcare provider for guidance.

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 not typical for you.

Remember, acting quickly can make a significant difference in your health. Don’t hesitate to reach out for assistance if you think you or someone else may have taken too much of a medication. 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, 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 discuss your options with your healthcare provider. They can help you understand any potential risks and make informed decisions about your treatment. Always prioritize open communication with your doctor regarding any medications you are considering during this time.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk and your baby are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding. They can help you weigh the potential risks and benefits to ensure the safety 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 for those who 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 use the enclosed dropper to measure the dose and dispense the liquid slowly into your child's mouth, aiming for the inner cheek. If preferred, you can also mix the dosage with 1 ounce of cool water, infant formula, or another suitable liquid.

Always keep this medication out of reach of children. If you suspect an overdose, seek medical help immediately or contact a Poison Control Center.

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, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach, considering any unique health needs or conditions that may be present. Always keep an open line of communication with your doctor about how the medication is affecting you, especially if you notice any changes in your health or well-being.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no dosage adjustments, special monitoring, or safety considerations to discuss for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to consult your healthcare provider for personalized advice and guidance.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no detailed recommendations available for how your liver health might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and appropriate for your liver condition. They can help you understand how to manage your health effectively while considering your liver function.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share any other medications or supplements you may be using. This helps to create a comprehensive picture of your health and ensures your safety while receiving treatment.

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 should take this medication orally and follow the specific instructions provided. It's important to keep it out of reach of children. If you suspect an overdose, seek medical help or contact a Poison Control Center immediately. Before using, make sure to shake the bottle well. You can repeat dosages as needed, adjust them around meal times and bedtime, or follow your doctor's directions. However, do not exceed 12 doses in a single day.

When administering the medication, fill the enclosed dropper to the recommended dosage level and dispense the liquid slowly into your baby's mouth, aiming for the inner cheek. Alternatively, you can mix the dosage with 1 ounce of cool water, infant formula, or another suitable liquid to make it easier for your baby to take.

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 I administer the drug?

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 I should be aware of?

Keep the 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 seal under the cap is broken?

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

How should I store this drug?

Store the drug at room temperature and do not freeze.

Can I repeat the dosage?

Yes, all dosages may be repeated as needed, at meals and at bedtime, or as directed by a physician. However, do not exceed 12 doses per day.

Are there any teratogenic or nonteratogenic effects?

No teratogenic or nonteratogenic effects are mentioned.

Is there any information regarding use during pregnancy or nursing?

No specific information regarding use during pregnancy or nursing mothers is provided.

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 relevant information is available for SPL code 34089-3.

Uses and Indications

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

There are no teratogenic or nonteratogenic effects associated with this medication.

Dosage and Administration

The medication should be shaken well before use. 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 per day.

For administration, the enclosed dropper should be filled to the recommended dosage level. The liquid should be dispensed slowly into the baby's mouth, directed toward the inner cheek. Alternatively, the dosage can be mixed with 1 oz. 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 contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

It is imperative to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or the individual should contact a Poison Control Center without delay.

No specific general precautions or laboratory tests have been identified for this medication. However, healthcare professionals should remain vigilant and monitor for any adverse effects or unusual symptoms in patients.

Side Effects

Patients should be aware that in the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted without delay. This warning is critical to ensure prompt intervention and management of potential adverse effects associated with overdose.

No additional adverse reactions have been reported in clinical trials or postmarketing experiences. It is essential for patients to remain vigilant and report any unexpected symptoms or reactions to their healthcare provider.

Drug Interactions

There are no specific drug interactions identified for the product, nor are there any noted interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the available data.

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.

Administration should be performed by filling the enclosed dropper to the recommended dosage level and dispensing the liquid slowly into the child's mouth, directing it toward the inner cheek. Alternatively, the dosage may be mixed with 1 oz. of cool water, infant formula, or other suitable liquids to facilitate ingestion.

It is crucial to keep this product out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information 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. 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 advised to discuss their pregnancy status and any plans for pregnancy with their healthcare provider prior to initiating treatment.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. The effects on breastfed infants have not been established, and further data may be necessary to inform clinical decisions.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for 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, as the lack of data may impact the safety and efficacy of treatment in this population.

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 be aware that they can vary based on the substance involved and the individual’s health status.

Management of an overdose typically involves supportive care and symptomatic treatment. The healthcare provider should assess the patient's condition and implement appropriate measures based on the severity of the overdose and the symptoms presented. Continuous monitoring and evaluation are recommended to ensure patient safety and effective management of the situation.

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 potential effects in nonclinical settings.

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. Clinicians should advise patients to keep the product out of reach of children and to seek medical assistance or contact a Poison Control Center immediately in the event of an overdose. Patients are instructed to shake the bottle well before use and to follow the recommended dosage guidelines, which may be repeated as needed, adjusted around meal times, or as directed by a physician. It is important not to exceed 12 doses per day. The enclosed dropper should be filled to the recommended dosage level, and the liquid should be dispensed slowly into the baby's mouth, directed toward the inner cheek. Additionally, the dosage can be mixed with 1 oz. of cool water, infant formula, or other suitable liquids.

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.