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Infants Gas Relief Drops

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Active ingredient
Dimethicone, Unspecified 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 2020
Label revision date
August 22, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone, Unspecified 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 2020
Label revision date
August 22, 2025
Manufacturer
DOLGENCORP INC
Registration number
M002
NDC root
55910-790
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 Drops are a medication designed specifically for infants to relieve gas discomfort. This product works by addressing the discomfort caused by gas that can result from swallowing air or certain formulas and foods. With a fast and effective formula, Simethicone Drops provide relief from gas symptoms, helping to soothe your little one.

The drops are dye-free and have a non-staining formula, making them a convenient option for parents. Each 1 FL. OZ. (30 mL) bottle contains enough for 100 doses, ensuring you have plenty on hand when needed.

Uses

If your baby is experiencing discomfort from gas, this medication can help relieve that discomfort. Infant gas can often be caused by swallowing air or certain formulas and foods. This product is designed to ease that discomfort, making your little one feel more comfortable.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so you can use it with confidence.

Dosage and Administration

Before you give this medicine to your child, make sure to shake the bottle well. To find the right dose, refer to the dosage chart based on your child's weight or age. For infants under 2 years who weigh less than 24 pounds, the dose is 0.3 mL. For children over 2 years who weigh more than 24 pounds, the dose is 0.6 mL.

Use only the enclosed syringe to measure the dose—do not use any other type of syringe, dropper, or spoon. After removing the cap, insert the syringe into the liquid and pull it up to the prescribed level. If you accidentally pull too much, simply push the plunger back to the correct level. When giving the medicine, slowly dispense it into your child's mouth, aiming for the inner cheek. You can repeat the dosage as needed after meals and at bedtime, but do not exceed 12 doses in a single day. If preferred, you can mix the dosage with 1 ounce of cool water, infant formula, or another suitable liquid.

What to Avoid

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222 for guidance.

While there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication, always use it responsibly and as directed. Your safety is a priority, so please follow these precautions carefully.

Side Effects

If you experience an overdose, it’s important to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Quick medical attention is crucial, even if you don’t notice any signs or symptoms.

Please be aware that serious side effects can occur, and it’s essential to monitor your health closely. If you have any concerns about your symptoms or side effects, don’t hesitate to reach out to your healthcare provider for guidance.

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 at 1-800-222-1222. Quick medical attention is crucial, even if you don’t notice any signs or symptoms of an overdose.

Always follow your healthcare provider's instructions and be aware of any potential side effects. If you experience any unusual symptoms or have concerns about your health while using this medication, stop use and call your doctor right away. 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 important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance. Quick medical attention is crucial, even if you don’t notice any signs or symptoms of an overdose.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you experience any of these symptoms or have concerns about an overdose, don’t hesitate to reach out for help. Your safety is the top priority.

Pregnancy Use

While the provided information does not specify any particular safety concerns, dosage modifications, or special precautions for use during pregnancy, it is always important to consult with your healthcare provider if you are pregnant or planning to become pregnant. They can provide personalized advice based on your health needs and any medications you may be taking. Always prioritize open communication with your doctor to ensure the best outcomes for you and your baby.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation in the information provided. This means that if you are breastfeeding, you may want to consult with your healthcare provider for personalized advice and to discuss any medications or treatments you are considering. They can help ensure that both you and your baby remain healthy and safe during this time.

Pediatric Use

If your child is experiencing discomfort from gas, this medication can help relieve their symptoms, which may be caused by swallowing air or certain foods. For infants under 2 years old, the recommended dosage is 0.3 mL if they weigh less than 24 pounds. For children over 2 years old, the dosage increases to 0.6 mL for those who weigh more than 24 pounds. It's best to use your child's weight for dosing, but if that's not possible, you can use their age instead.

Make sure to use only the enclosed syringe for measuring the dose—other devices like droppers or spoons can lead to incorrect dosing. You can give the medication after meals and at bedtime, or as directed by your child's doctor, but do not exceed 12 doses in a day. If you prefer, 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.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Remember, even if there are no specific dosage adjustments or safety concerns mentioned, your healthcare provider may still recommend monitoring for any potential side effects or interactions with other medications you may be taking. Always prioritize open communication with your healthcare team to ensure the best care.

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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to 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 determine the best approach for you based on your individual health needs.

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 the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any new medications or tests with your healthcare provider to avoid potential issues and to get personalized advice tailored to your health needs.

Storage and Handling

To ensure the safety and effectiveness of your product, always check that the printed seal under the cap is intact before use; do not use it if the seal is broken or missing. 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

It's important to follow some guidelines when using this medication. First, make sure to check the product's seal; do not use it if the printed seal under the cap is broken or missing. Store the medication at room temperature and avoid freezing it. Additionally, you should look at the bottom panel of the packaging for the lot number and expiration date to ensure the product is still valid.

FAQ

What is Simethicone Drops used for?

Simethicone Drops are used for relieving the discomfort of infant gas, which is often caused by air swallowing or certain formulas or foods.

How should I administer Simethicone Drops to my child?

Use the enclosed syringe to measure the dose. Slowly dispense the liquid into your child's mouth towards the inner cheek.

What is the recommended dosage for infants under 2 years?

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

What is the recommended dosage for children over 2 years?

For children over 2 years who weigh over 24 lbs, the recommended dose is 0.6 mL.

Are there any warnings I should be aware of?

Keep Simethicone Drops out of reach of children. In case of overdose, seek medical help or contact a Poison Control Center immediately.

Can I mix Simethicone Drops with other liquids?

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

Is there a satisfaction guarantee for Simethicone Drops?

Yes, there is a 100% satisfaction guarantee for Simethicone Drops.

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

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

How should I store Simethicone Drops?

Store Simethicone Drops at room temperature and do not freeze.

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)

Uses and Indications

This drug is indicated for the relief of discomfort associated with infant gas, which may frequently result from air swallowing or specific formulas or foods.

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

Dosage and Administration

Shake the medication well before use. Healthcare professionals should refer to the dosage chart below to determine the appropriate dose based on the patient's weight; if weight is not available, age may be used as a guide.

Dosage Chart:

  • Infants under 2 years: For those weighing under 24 lb, the recommended dose is 0.3 mL.

  • Children over 2 years: For those weighing over 24 lb, the recommended dose is 0.6 mL.

Administration should be performed using the enclosed syringe only. Other syringes, droppers, spoons, or dosing devices are not recommended. To administer the dose, remove the cap and insert the syringe into the prescribed level. Pull the syringe plunger up until the liquid reaches the prescribed level. If the liquid exceeds the desired level, push the plunger back until the correct dose is achieved.

The liquid should be dispensed slowly into the child’s mouth, directing it towards the inner cheek. 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 in a 24-hour period. Additionally, the dosage may be mixed with 1 oz. of cool water, infant formula, or other suitable liquids to facilitate administration.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

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 is crucial. Healthcare professionals should advise patients to seek medical help or contact a Poison Control Center at 1-800-222-1222 without delay.

Quick medical attention is essential, even if the patient does not exhibit any signs or symptoms of overdose. Vigilance in monitoring for any adverse effects is recommended to ensure patient safety and effective management of any potential complications.

Side Effects

In the event of an overdose, patients are advised to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. It is crucial for patients to receive prompt medical attention, even if they do not exhibit any signs or symptoms of overdose.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

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 may experience discomfort from gas, often resulting from air swallowing or specific formulas and foods. For infants under 2 years of age, the recommended dosage is 0.3 mL for those weighing less than 24 lbs. For children over 2 years, the dosage increases to 0.6 mL for those weighing more than 24 lbs.

When determining the appropriate dosage, weight should be used whenever possible; if weight is not available, age may be utilized as a guide. It is essential to administer the medication using only the enclosed syringe, as other dosing devices such as droppers, spoons, or syringes are not recommended.

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. Additionally, the dosage can be mixed with 1 oz. of cool water, infant formula, or other suitable liquids to facilitate administration.

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

Pregnancy

Pregnant patients may use this medication as no specific safety concerns regarding pregnancy have been identified in the available data. There are no dosage modifications recommended for pregnant individuals, nor are there any special precautions noted for use during pregnancy. Healthcare professionals should continue to monitor emerging data and consider individual patient circumstances when prescribing this medication to women of childbearing potential.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or lactation. Therefore, healthcare professionals should exercise caution when prescribing this medication to lactating mothers, as the effects on breastfed infants and the excretion of the drug in breast milk are not established.

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 of these patients.

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 at 1-800-222-1222. Prompt intervention is crucial, as the absence of noticeable signs or symptoms does not preclude the potential for serious health consequences.

Healthcare professionals should be aware that quick medical attention is essential, regardless of whether the patient exhibits any overt symptoms. This proactive approach ensures that any potential complications arising from the overdose can be effectively managed.

Nonclinical Toxicology

No teratogenic effects were noted in animal studies. Additionally, there was no increase in fetal malformations observed in these studies.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to inform patients about the risks associated with overdose. In the event of an overdose, patients should seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Additionally, healthcare providers should emphasize the importance of quick medical attention, even if patients do not notice any signs or symptoms of overdose. This proactive approach can be crucial in ensuring patient safety and effective management of any potential adverse events.

Storage and Handling

The product is supplied in a tamper-evident container. Healthcare professionals are advised not to use the product if the printed seal under the cap is broken or missing. 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

Patients should be advised on the importance of tamper evidence; the product should not be used if the printed seal under the cap is broken or missing. It is recommended that the product be stored at room temperature and not frozen. Patients should also check the bottom panel for the lot number and expiration date to ensure product safety and efficacy.

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.