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Infant Gas Relief

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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 2018
Label revision date
July 18, 2023
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 2018
Label revision date
July 18, 2023
Manufacturer
AMERISOURCEBERGEN DRUG CORPORATION
Registration number
M002
NDC root
46122-547
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

You may find that this medication is designed to relieve symptoms associated with gas, helping to alleviate discomfort you might experience. While the specific details about how it works are not provided, its primary purpose is to address the symptoms of gas, making it a helpful option for those seeking relief from this common issue.

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 use this treatment to find relief and feel more comfortable in your daily activities. Rest assured, there are no known risks of teratogenic effects (which can cause birth defects) associated with this medication, making it a safer option for those concerned about such 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. For children over 2 years old who weigh 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 slowly dispensing the liquid into your child's mouth, aiming for the inner cheek. Alternatively, 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 after meals and at bedtime, or as directed by your doctor, but be careful not to exceed 12 doses in a single day. After each use, remember to clean the dropper thoroughly and put the original cap back on the bottle to keep it safe and effective.

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 you.

Side Effects

It's important to keep this medication out of reach of children. If an overdose occurs, seek medical help or contact a poison control center immediately.

While specific side effects were not detailed, always be aware of how your body responds to any medication and report any unusual symptoms to your healthcare provider. Your safety is a priority, so don't hesitate to ask questions or express concerns about your treatment.

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 and monitor your health while using this medication. If you experience any unusual symptoms or side effects, stop using the medication and call your doctor for guidance. Your safety is a 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 drowsiness, confusion, or difficulty breathing.

Don’t wait for symptoms to worsen; getting prompt assistance can be vital. Always keep emergency contact information handy and be aware of the signs to ensure your safety and well-being.

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 are not clearly defined.

If you are pregnant or planning to become pregnant, it’s important to discuss any medications you are considering with your healthcare provider. They can help you understand the implications and make informed decisions that prioritize your health and the health of your baby.

Lactation Use

While the drug insert for Infant Gas Relief (simethicone suspension/drops) does not provide specific information about nursing mothers or considerations for breastfeeding, it's always best to consult with your healthcare provider before using any medication while breastfeeding. They can help you understand any potential effects on your milk production or your nursing infant.

If you have concerns about gas relief for your baby, discussing safe options with your doctor can ensure both you and your baby stay healthy and comfortable.

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 who weigh less than 24 pounds, the recommended dose is 0.3 mL. For children over 2 years old who weigh 24 pounds or more, the dose increases to 0.6 mL. You can repeat these dosages as needed after meals and at bedtime, but be sure not to exceed 12 doses in a single day.

To administer the medication, fill the enclosed dropper to the recommended level and dispense the liquid slowly into your child's mouth, aiming for the inner cheek. If your child prefers, you can also mix the dosage with 1 ounce of cool water, infant formula, or another suitable liquid to make it easier for them to take. Always consult with your physician if you have any questions or concerns about your child's dosage.

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. As you age, your body may process medications differently, and factors like kidney function (renal impairment) and changes in cognition can affect how well a drug works or how it may impact you.

If you are an older adult or a caregiver, it’s wise to discuss any concerns with your healthcare provider. They can help determine the best approach for your individual health needs and ensure that any medication is safe and effective for you. Always keep an open line of communication with your doctor about any changes in your health or any side effects you may experience.

Renal Impairment

There are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for patients with kidney problems in the provided information. If you have renal impairment (kidney issues), it's important to consult your healthcare provider for personalized advice regarding your treatment and any necessary adjustments. Always keep them informed about your kidney health to ensure safe and effective care.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines, dosage adjustments, or special monitoring requirements 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 ensure that any medications you take are safe and appropriate for your liver health.

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 this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. It's important to avoid freezing, as this can damage the device. Additionally, make sure to check the bottom panel for the lot number and expiration date, as this information is crucial for tracking the product's safety and effectiveness.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You can take this medication orally, and you may repeat the dosage as needed, either after meals or at bedtime, unless your doctor advises otherwise. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is the primary use of this drug?

This drug is used to relieve symptoms referred to as gas.

What is the recommended dosage for infants under 2 years?

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

What is the recommended dosage for children over 2 years?

For children 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.

Can the dosage be mixed with other liquids?

Yes, the dosage can be mixed with 1 oz. of cool water, infant formula, or other suitable liquids.

What precautions should be taken regarding dosage?

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

What should I do in case of an overdose?

In case of overdose, get medical help or contact a poison control center right away.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

Is this drug safe to use during pregnancy?

No specific information regarding safety concerns or precautions during pregnancy is provided.

How should the drug be stored?

Store at room temperature and do not freeze. Check the bottom panel for the lot number and expiration date.

What should I do after using the dropper?

Clean the dropper well after each use and replace the original cap on the bottle.

Packaging Info

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

Packaging configurations for Infant Gas Relief.
Details

Drug Information (PDF)

This file contains official product information for Infant 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 symptoms associated with gas.

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

Dosage and Administration

Healthcare professionals should instruct caregivers to shake the product well before use. The recommended dosages may be repeated as needed after meals and at bedtime, or as directed by a physician. It is important to note that the total daily dosage should not exceed 12 doses.

For administration, caregivers should fill the enclosed dropper to the recommended dosage level and dispense the liquid slowly into the infant's mouth, directing it 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. After each use, the dropper should be cleaned thoroughly, and the original cap should be replaced on the bottle to maintain product integrity.

Dosage by Age and Weight:

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

  • Children (over 2 years): 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 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 the 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 no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Infant Gas Relief.
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 over 2 years, the recommended dose is 0.6 mL for those weighing 24 lbs and above. All dosages may be repeated as needed, after meals and at bedtime, or as directed by a physician. It is important not to exceed 12 doses per day.

When administering the medication, the enclosed dropper should be filled to the recommended dosage level, and the liquid should be dispensed slowly into the child’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.

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 potential 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

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for INFANT GAS RELIEF (simethicone suspension/drops). Therefore, healthcare professionals should exercise caution when recommending this product to lactating mothers, as the effects on breastfed infants have not been established.

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

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 data necessitates careful evaluation of potential risks and benefits.

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 patient’s response.

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 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. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a poison control center. Patients should be made aware of the signs of overdose and the urgency of obtaining assistance to ensure their safety and well-being.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for reference. It is essential to store the product at room temperature, ensuring that it is not exposed to freezing conditions. For traceability, the lot number and expiration date can be found on the bottom panel of the packaging. Proper handling and storage are crucial to maintain the integrity of the product.

Additional Clinical Information

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

Drug Information (PDF)

This file contains official product information for Infant 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 Infant 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.