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Infants Gas Relief Drops

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This product has been discontinued

Active ingredient
Dimethicone 20 mg/0.3 mL
Other brand names
Dosage form
Emulsion
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
December 9, 2019
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 20 mg/0.3 mL
Other brand names
Dosage form
Emulsion
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
December 9, 2019
Manufacturer
WinCo Foods, LLC
Registration number
part332
NDC root
67091-218
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 is a medication designed to provide relief from gas discomfort in infants. It works by alleviating symptoms such as pressure, bloating, and gas that can occur from swallowing air or due to certain formulas or foods. Each dose contains 20 mg of SIMETHICONE, and it is formulated to be alcohol-free and dye-free, making it a gentle option for your little one.

These drops are comparable to the active ingredient found in MYLICON® Non-Staining Infants Drops, offering soothing relief for common gas-related issues in infants.

Uses

You can use this medication to help relieve the discomfort caused by gas, which may occur from swallowing air or consuming certain formulas or foods. It’s designed to ease the symptoms associated with this common issue, making you feel more comfortable.

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) associated with this medication, so it is considered safe in that regard.

Dosage and Administration

Before using the medication, make sure to shake the bottle well. For infants under 2 years old (weighing less than 24 pounds), the recommended dosage is 0.3 mL, while for children over 2 years old (weighing more than 24 pounds), the dosage is 0.6 mL. You can fill the enclosed dropper to the recommended level and dispense the liquid slowly into your child's mouth, aiming for the inner cheek to make it easier for them to swallow.

You can give the medication after meals and at bedtime, and you may repeat the dosage as needed. If your child prefers, you can mix the medication with 1 ounce of cool water, infant formula, or another suitable liquid to help with administration. After each use, be sure to clean the dropper and securely close the bottle to keep it safe for your child.

What to Avoid

It's important to use this medication responsibly. You should not exceed 12 doses in a single day, as taking more than this can lead to potential health risks. While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, always follow the recommended guidelines to ensure your safety and well-being. If you have any questions or concerns about your treatment, please consult your healthcare provider.

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. This ensures that any potential risks are managed promptly and effectively.

Warnings and Precautions

It's important to use this medication safely. You should not take more than 12 doses in a single day. Always keep it out of reach of children to prevent accidental ingestion.

If you think you have taken too much, seek medical help immediately or contact a poison control center. Your safety is a priority, so please follow these guidelines carefully.

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 these symptoms, don’t wait. Getting prompt assistance can be vital for safety and recovery.

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 or planning to breastfeed, it's important to be aware that there is no specific information available regarding the effects of this medication on nursing mothers or lactation (the process of producing breast milk). Since there are no guidelines or data provided, it’s advisable to consult with your healthcare provider to discuss any potential risks or concerns related to your situation. They can help you make informed decisions about your health and your baby'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 over 2 years old and weighing more than 24 pounds, the recommended dose increases to 0.6 mL.

Make 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. Your child's safety is the top priority, so following these guidelines is essential.

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, which can affect how well they work and the potential for side effects.

If you or a loved one is considering this medication, it’s wise to discuss it with a healthcare provider. They can help determine if any special precautions or adjustments are needed based on individual health conditions and overall well-being. 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 the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific condition. They can help you understand any necessary precautions or adjustments based on your kidney health.

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 you understand any potential risks and monitor your condition effectively.

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 at room temperature. This helps maintain its effectiveness and safety. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep it in a clean environment to ensure it remains safe for use. If you have any questions about disposal or further handling, please refer to the guidelines provided with your product.

Additional Information

You should take this medication orally. It's important to keep it out of reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical help or contact a poison control center immediately.

FAQ

What is SIMETHICONE used for?

SIMETHICONE is used to relieve the symptoms of gas frequently caused by air swallowing or certain formulas or foods.

What is the recommended dosage for infants and children?

For infants under 2 years old and weighing under 24 lbs, the recommended dose is 0.3 mL. For children over 2 years old and weighing over 24 lbs, the recommended dose is 0.6 mL.

How often can I give SIMETHICONE?

You can repeat all dosages as needed, after meals and at bedtime, but do not exceed 12 doses per day.

Are there any warnings associated with SIMETHICONE?

Yes, keep SIMETHICONE out of reach of children. In case of overdose, get medical help or contact a poison control center right away.

Is SIMETHICONE safe during pregnancy or breastfeeding?

The insert does not provide specific information regarding the use of SIMETHICONE during pregnancy or breastfeeding.

What should I do before using SIMETHICONE?

Shake well before using and fill the enclosed dropper to the recommended dosage level. Dispense the liquid slowly into your baby's mouth, toward the inner cheek.

What are the ingredients in SIMETHICONE?

SIMETHICONE contains 20 mg of SIMETHICONE and is alcohol-free and dye-free.

How should I store SIMETHICONE?

Store SIMETHICONE at room temperature.

Packaging Info

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

Packaging configurations for Infants Gas Relief Drops.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Simethicone is an anti-gas agent formulated to provide soothing relief from pressure, bloating, and gas symptoms. Each dosage contains 20 mg of simethicone. The product is presented in a liquid dosage form, with a total volume of 1 fluid ounce (30 mL). It is free from alcohol and dyes, ensuring a formulation suitable for sensitive individuals.

Uses and Indications

This drug is indicated for the relief of symptoms associated with gas, which may frequently result from air swallowing or the consumption of certain formulas or foods.

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

Dosage and Administration

The medication should be shaken well before use. For infants under 2 years of age (weighing less than 24 lb), the recommended dosage is 0.3 mL. For children over 2 years of age (weighing more than 24 lb), the recommended dosage is 0.6 mL.

All dosages may be repeated as needed, with administration recommended after meals and at bedtime. To administer, fill the enclosed dropper to the appropriate dosage level. The liquid should be dispensed slowly into the child's mouth, directed toward the inner cheek.

For ease of administration, the medication may be mixed with 1 oz. of cool water, infant formula, or other suitable liquids. It is essential to clean the dropper after each use and securely close the bottle to maintain child resistance.

Contraindications

There are no contraindications listed for this product. However, it is advised that patients do not exceed 12 doses per day to avoid potential adverse effects associated with overuse.

Warnings and Precautions

It is imperative to adhere to the recommended dosage guidelines, as exceeding 12 doses per day may lead to serious adverse effects. Healthcare professionals should counsel patients on the importance of following the prescribed dosing regimen to mitigate the risk of overdose.

To ensure safety, this medication must be kept out of reach of children. It is crucial to educate caregivers about the potential dangers associated with accidental ingestion by pediatric patients.

In the event of an overdose, immediate medical assistance should be sought. Healthcare providers are advised to instruct patients and caregivers to contact a poison control center without delay to receive appropriate guidance 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

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Infants Gas Relief Drops.
Details

Pediatric Use

Pediatric patients under 2 years of age and weighing less than 24 lbs are recommended to receive a dose of 0.3 mL. For children over 2 years of age and weighing more than 24 lbs, the recommended dose is 0.6 mL. It is important to note that the total daily dosage should not exceed 12 doses.

Healthcare professionals should ensure that the product is kept 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

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 adverse effects or changes in therapeutic response, given the lack of targeted data for 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 lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 assess the patient for any signs of toxicity or distress.

Management of an overdose should be guided by established protocols, which may include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition is recommended to ensure appropriate interventions are implemented in a timely manner.

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 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 identification. It is essential to store the product at room temperature to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to keep the medication out of reach of children. In the event of an overdose, patients are instructed to seek medical assistance or contact a poison control center immediately.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Infants Gas Relief Drops, 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 Drops, 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.