Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Infants Gas Relief Drops

Last content change checked dailysee data sync status

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 2013
Label revision date
September 5, 2014
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 2013
Label revision date
September 5, 2014
Manufacturer
Select Brand
Registration number
part332
NDC root
15127-042
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

Infant's Gas Relief Drops are a medication designed to help relieve excess gas in infants. They contain simethicone, which is an anti-gas ingredient that works by breaking up gas bubbles in the stomach and intestines, making it easier for your baby to pass gas. This product is alcohol-free, saccharin-free, and does not contain any artificial flavors, ensuring a gentle option for your little one.

These drops are particularly useful for addressing gas symptoms that may arise from swallowing air or from certain formulas and foods. With a convenient 1 fl oz (30 mL) bottle, Infant's Gas Relief Drops provide a simple solution to help soothe your baby's discomfort caused by gas.

Uses

If you're experiencing discomfort from gas, this medication can help relieve those symptoms. Gas can often be caused by swallowing air or by certain foods and formulas you might consume.

It's important to note that this medication has not been associated with teratogenic effects (which means it does not cause birth defects) or any other non-teratogenic effects. This makes it a safer option for those concerned about potential risks.

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 appropriate level for your child's age and weight.

When giving the medication, dispense the liquid slowly into your baby's mouth, aiming for the inner cheek to make it easier for them to swallow. If you prefer, you can mix the medication with 1 ounce of cool water, infant formula, or another suitable liquid to help with administration. Remember, you can repeat the dosage as needed after meals and at bedtime. After each use, clean the dropper thoroughly 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 serious health issues. 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 right away. 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 this medication out of reach of children to prevent accidental ingestion.

If you think you have taken too much, seek medical help right away 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 right away 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 notice anything concerning, don’t hesitate to get help. Quick action can make a significant difference in ensuring your safety and well-being.

Pregnancy Use

When considering the use of Infants Gas Relief Drops (which contain simethicone) during pregnancy, it's important to note that there is no available information about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this medication on pregnancy have not been studied, and you should exercise caution.

If you are pregnant or planning to become pregnant, it's best to consult with your healthcare provider before using this product. They can provide guidance tailored to your specific situation and help you make informed decisions about your health and the health of your baby.

Lactation Use

If you are breastfeeding and considering using Infant's Gas Relief Drops, it's important to note that the drug insert does not provide specific information about nursing mothers or any considerations for lactation (the process of producing milk). This means there is no established guidance on how the drops may affect your milk production or your nursing infant.

As always, it's a good idea to consult with your healthcare provider before using any medication while breastfeeding to ensure it is safe for you and your baby.

Pediatric Use

When it comes to giving this medication to children, it's important to follow specific guidelines based on their age and weight. For infants who are under 2 years old and 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 dose increases to 0.6 mL.

Always keep this medication out of reach of children. If you suspect an overdose, seek medical help or contact a poison control center right away. Your child's safety is the top priority, so make sure to adhere to these dosing recommendations carefully.

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, it’s wise to discuss any potential risks or benefits with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 interactions with laboratory tests for the medication in question. However, always ensure that your healthcare provider is aware of all the medications you are using, as well as any tests you may undergo, to ensure your safety and the effectiveness of your treatment. This way, you can avoid any potential issues and receive the best care possible.

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, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use to ensure your safety and the product's reliability. If you have any questions about disposal or other safety measures, please refer to the guidelines provided with your product.

Additional Information

You can take this medication orally, and you may repeat the dosage as needed, preferably after meals and at bedtime. If you have any questions about how to take this medication or its effects, be sure to consult your healthcare provider for guidance.

FAQ

What is Infant's Gas Relief Drops used for?

Infant's Gas Relief Drops are used to relieve symptoms of gas frequently caused by air swallowing or certain formulas or foods.

What is the active ingredient in Infant's Gas Relief Drops?

The active ingredient in Infant's Gas Relief Drops is Simethicone, which is an anti-gas agent.

What is the recommended dosage for infants under 2 years?

For infants under 2 years old and weighing under 24 lbs, the recommended dosage is 0.3 mL.

What is the recommended dosage for children over 2 years?

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

How should I administer Infant's Gas Relief Drops?

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

Can I mix Infant's Gas Relief Drops with other liquids?

Yes, you may mix the drops with 1 oz. of cool water, infant formula, or other suitable liquids.

Are there any warnings associated with Infant's Gas Relief Drops?

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

Is there any information about using Infant's Gas Relief Drops during pregnancy?

There is no specific information regarding the use of Infant's Gas Relief Drops during pregnancy.

How should I store Infant's Gas Relief Drops?

Store Infant's Gas Relief Drops at room temperature.

Are there any contraindications for using Infant's Gas Relief Drops?

No contraindications are specified for Infant's Gas Relief Drops.

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

Select Brand is a formulation designed for the relief of excess gas in infants, containing simethicone as its active ingredient. This product is comparable to the active ingredient found in Infants Mylicon® Drops. It is presented in a liquid dosage form, specifically 1 fluid ounce (30 mL). The formulation is characterized as non-staining and is free from alcohol, saccharin, and artificial flavors, making it suitable for use in infants requiring anti-gas treatment.

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 effects associated with this drug, nor are there any nonteratogenic effects noted.

Dosage and Administration

The medication should be shaken well before each 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 advised after meals and at bedtime. To administer, fill the enclosed dropper to the recommended dosage level. The liquid should be dispensed slowly into the child's mouth, directed toward the inner cheek to facilitate swallowing.

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

Use of this product is contraindicated in patients who exceed 12 doses per day. Exceeding this dosage may lead to potential adverse effects. No other contraindications have been specified.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions when administering this medication.

It is imperative that the recommended dosage is strictly adhered to, with a maximum limit of 12 doses per day. Exceeding this dosage may lead to serious adverse effects.

This medication should be stored securely and kept out of reach of children to prevent accidental ingestion, which could result in severe health consequences.

In the event of an overdose, immediate medical assistance is crucial. Healthcare providers should instruct patients and caregivers to seek medical help or contact a poison control center without delay to ensure appropriate management of the situation.

Side Effects

Patients should be advised to keep this 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 reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

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 should 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 essential 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 currently no information available regarding the use of Infants Gas Relief Drops (simethicone emulsion) during pregnancy. This includes any safety concerns, dosage modifications, or special precautions that may be necessary for pregnant patients. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for Infant's Gas Relief Drops (simethicone emulsion). Therefore, healthcare professionals should exercise caution when recommending this product to lactating mothers. The effects on breastfed infants have not been established, and the excretion of simethicone in breast milk is not documented.

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 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 remain alert to any signs of toxicity or adverse reactions that may develop.

Management of an overdose should be guided by established protocols, which may include supportive care and symptomatic treatment as necessary. The healthcare provider should ensure that the patient receives appropriate evaluation and intervention based on the severity of the overdose and the clinical presentation.

In summary, immediate medical attention is essential in cases of overdose, and healthcare professionals should be prepared to implement appropriate management strategies to ensure patient safety and well-being.

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 or contact a poison control center immediately. 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 necessary beyond standard storage practices.

Additional Clinical Information

The medication is administered orally, with the option for patients to repeat all dosages as needed, preferably after meals and at bedtime. There are no additional details available regarding laboratory tests, abuse information, patient counseling, 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.