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Infants Gas Relief

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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 2014
Label revision date
November 1, 2023
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 2014
Label revision date
November 1, 2023
Manufacturer
Geri-Care Pharmaceuticals, Corp
Registration number
M002
NDC root
57896-798
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

Simethicone Oral Suspension USP is a medication designed to provide relief from gas discomfort in infants. It is a dye-free solution that helps alleviate symptoms associated with gas, making it easier for your little one to feel comfortable. This product is often compared to the active ingredient found in Infants MYLICON®, and it comes with a plastic dropper for easy administration.

By acting as an antigas agent, simethicone works to break up gas bubbles in the stomach and intestines, helping to reduce bloating and discomfort. If your infant is experiencing gas-related issues, this product 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 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 safe option for many.

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 aged 2 years and older 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 dispensing the liquid slowly 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 your individual health needs.

Side Effects

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

While specific side effects are not detailed here, always be aware of how your body responds to any medication and consult your healthcare provider if you experience any unusual symptoms.

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 for your safety. Always keep emergency contact numbers handy and be aware of the signs to watch for. Your health is important, so take any concerns seriously.

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 best options for your health and the health of your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to talk to your healthcare professional before using this product. There is a possibility that the ingredients may pass into your breast milk, so caution is recommended to ensure the safety of both you and your baby. Always prioritize open communication with your healthcare provider to make informed decisions about your health and your child's well-being.

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 aged 2 years and older who weigh 24 pounds or more, the dose increases to 0.6 mL. You can administer the medication slowly into your child's mouth, aiming for the inner cheek, or mix it with 1 ounce of cool water, infant formula, or another suitable liquid.

You can repeat the dosage as needed after meals and at bedtime, but be sure not to exceed 12 doses in a single day. Always keep the medication out of reach of children, and if you suspect an overdose, seek medical help or contact a poison control center immediately.

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

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 medications and treatment plan. They can help ensure your safety and effectiveness of any treatments you may be receiving.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

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 all the medications and supplements you are using. This way, you can work together to ensure your treatment is safe and effective.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature. Avoid freezing, as this can damage the product. Before use, check the tamper-evident seal; do not use the product if the foil seal under the cap is broken or punctured, as this indicates it may not be safe. Additionally, make sure to look at the bottom panel for the lot number and expiration date to confirm that the product is still within its usable timeframe.

Additional Information

You can take this medication orally, and you may repeat the dosage as needed after meals and at bedtime, or as directed by your doctor. It's important to follow your physician's instructions regarding how often to take it. If you have any questions or concerns about your treatment, be sure to discuss them with your healthcare provider.

FAQ

What is Simethicone Oral Suspension USP used for?

Simethicone Oral Suspension USP is used to relieve symptoms referred to as gas.

What is the recommended dosage for infants under 2 years?

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

What is the recommended dosage for children 2 years and over?

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

How should I administer the dosage?

You can dispense the liquid slowly into the baby’s mouth toward the inner cheek or mix it with 1 oz. of cool water, infant formula, or other suitable liquids.

Are there any warnings I should be aware of?

Keep Simethicone out of reach of children. In case of overdose, seek medical help or contact a poison control center immediately.

Can nursing mothers use this product?

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 need to repeat the dosage?

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

How should I store Simethicone Oral Suspension?

Store at room temperature and do not freeze. Ensure the foil seal under the cap is intact before use.

Packaging Info

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

Packaging configurations for Infants Gas Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

NDC 57896-798-01. This product is an INFANTS' GAS RELIEF DROPS formulation containing Simethicone Oral Suspension USP, designed to relieve symptoms associated with gas. The product is dye-free and is provided in a 1 FL OZ (30 mL) dosage form. A plastic dropper is enclosed for accurate dosing. This formulation is comparable to the active ingredient of Infants MYLICON®.

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

Shake the bottle 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 not to exceed 12 doses in a 24-hour period.

For administration, fill the enclosed dropper to the recommended dosage level. 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. After each use, the dropper should be cleaned thoroughly, and the original cap must be replaced on the bottle.

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 not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence.

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 or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Packaging configurations for Infants 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 aged 2 years and older, the recommended dose is 0.6 mL for those weighing 24 lbs and over.

The administration of the dosage can be performed by dispensing it slowly into the baby’s mouth, directed toward the inner cheek, or by mixing it with 1 oz. of cool water, infant formula, or other suitable liquids. Dosages may be repeated as needed after meals and at bedtime, or as directed by a physician, with a maximum limit of 12 doses per day.

It is crucial to keep this 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.

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. 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 and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while using this medication.

Lactation

Lactating mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk; therefore, caution is advised when administering to nursing mothers.

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 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 aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

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 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 a configuration that includes a tamper-evident seal. It is essential to inspect the foil seal under the cap; the product should not be used if this seal is broken or punctured.

For optimal storage, the product must be kept at room temperature. It is critical to avoid freezing, as this may compromise the integrity of the product. Additionally, users should refer to the bottom panel of the container for the lot number and expiration date to ensure the product's validity and safety.

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 Infants 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 Infants 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.