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Infants Gas Relief

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Active ingredient
Dimethicone 20 mg/0.3 mL
Other brand names
Dosage form
Solution/ 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 2021
Label revision date
December 20, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Dimethicone 20 mg/0.3 mL
Other brand names
Dosage form
Solution/ 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 2021
Label revision date
December 20, 2024
Manufacturer
UNITED NATURAL FOODS, INC. DBA UNFI
Registration number
M002
NDC root
41163-096
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

EQUALINE is a gentle gas relief drop designed specifically for infants. It contains simethicone (20 mg), an ingredient that helps break down gas bubbles in your baby's stomach, providing relief from discomfort caused by gas. This product is safe to use at every feeding and is particularly helpful for symptoms related to air swallowing or certain formulas and foods.

EQUALINE is dye-free and non-staining, making it a convenient option for parents looking to soothe their little ones without added colors or mess. If your baby is experiencing gas discomfort, EQUALINE may be a supportive choice to help ease their symptoms.

Uses

If you're dealing with a gassy baby, this product can help relieve those uncomfortable symptoms caused by swallowing air or certain foods and formulas. It works gently to break down gas bubbles, making it easier for your little one to feel better.

You can use this product safely at every feeding, ensuring your baby gets the relief they need without any worries. It's designed to be a helpful solution for those common gas issues that many infants experience.

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 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

There are no specific side effects or adverse reactions listed for this medication. It's important to stay informed and discuss any concerns with your healthcare provider, as they can provide personalized guidance based on your health history and current medications. If you experience any unusual symptoms while taking this medication, be sure to reach out to your doctor.

Warnings and Precautions

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a poison control center. This is important to ensure your safety and receive the appropriate care.

Currently, there are no specific warnings, general precautions, or laboratory tests associated with this medication mentioned. Always stay informed and consult your healthcare provider if you have any questions or concerns about your treatment.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are concerned about a possible overdose, seek medical help right away.

In case of an overdose, contacting your local emergency services or going to the nearest hospital is crucial. Always keep the medication packaging with you, as it can help healthcare professionals understand what you've taken. Remember, it's better to be safe and get checked out if you have any doubts.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the safety or use of this medication during pregnancy. This means that there are no established guidelines regarding dosage adjustments or special precautions for pregnant individuals.

Given the lack of information, it's crucial to discuss any medications you are considering with your healthcare provider to ensure the best care for you and your baby. Always prioritize open communication with your doctor about your health and any concerns you may have during your pregnancy.

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 (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always a good idea to consult with your healthcare provider. They can help you understand any potential risks and provide personalized advice based on your situation.

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 suggested 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. Remember, you should not give more than 12 doses in a single day.

Always keep this medication out of reach of children to prevent accidental ingestion. If you suspect an overdose, seek medical assistance or contact a poison control center immediately. Your child's safety is the top priority, so following these guidelines is essential.

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 considering this medication, it’s important to consult with a healthcare provider. 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

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. Your healthcare provider will likely assess your creatinine clearance (a test that measures how well your kidneys are filtering waste) to determine the right dose for you.

Additionally, you should have your renal function tested before starting treatment and regularly during your therapy. Close monitoring is essential to ensure your safety and the effectiveness of the medication. Always communicate with your healthcare team about any concerns you may have regarding 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 may affect you 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 monitor your condition and make any necessary adjustments to your treatment plan.

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 helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

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.

If you have any components that come with the product, make sure to keep them in a clean and safe environment. Proper storage and careful handling are key to ensuring that everything works as intended.

Additional Information

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

FAQ

What is EQUALINE?

EQUALINE is an infants' gas relief drop that contains simethicone 20 mg, which helps relieve gas symptoms in babies.

How does EQUALINE work?

EQUALINE gently breaks down baby's gas bubbles, providing relief from gas caused by air swallowing or certain formulas and foods.

Is EQUALINE safe for my baby?

Yes, EQUALINE is safe enough to use at every feeding when used as directed.

What is the recommended dosage for infants?

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

How should I administer EQUALINE?

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

Are there any side effects associated with EQUALINE?

No specific side effects or warnings are mentioned for EQUALINE.

What should I do in case of an overdose?

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

How should I store EQUALINE?

Store EQUALINE at room temperature and keep it out of the reach of children.

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

EQUALINE infants' gas relief drops contain simethicone as the active ingredient, providing 20 mg per 1 FL OZ (30 mL) dosage form. This formulation is designed to gently break down gas bubbles in infants, offering relief from discomfort associated with gas. The product is dye-free and non-staining, making it suitable for use at every feeding. The National Drug Code (NDC) for this product is 41163-096-09.

Uses and Indications

This drug is indicated for the relief of symptoms associated with gas, which may frequently occur due to air swallowing or specific formulas and foods. It gently breaks down gas bubbles in infants, providing comfort during feeding. The formulation is considered safe for use at every feeding.

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 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.

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

In the event of an overdose, it is imperative to seek emergency medical assistance or contact a poison control center immediately. Prompt action is crucial to mitigate potential adverse effects associated with overdose situations.

Healthcare professionals are advised to remain vigilant and ensure that patients are informed about the importance of recognizing overdose symptoms and the necessity of timely intervention.

Side Effects

There are no specific adverse reactions, warnings, or additional important notes listed for this product. As such, no detailed information regarding adverse reactions is available from clinical trials or postmarketing experiences. It is essential for healthcare professionals to monitor patients for any unexpected effects and report them as necessary.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring 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 and weighing less than 24 pounds are recommended to receive a dose of 0.3 mL. For children over 2 years of age and weighing more than 24 pounds, the recommended dose is 0.6 mL. It is important to note that the total daily dosage should not exceed 12 doses. Care should be taken to keep the medication out of the 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 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 are no specific statements regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced renal function. It is essential to assess creatinine clearance to determine the appropriate dosing regimen. Additionally, patients with reduced kidney function should be monitored closely throughout the treatment course. Renal function tests are recommended prior to initiation of therapy and should be conducted periodically during treatment to ensure patient safety and efficacy of the medication.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a poison control center in the event of an overdose. It is crucial for patients to understand the importance of adhering to the recommended dosage guidelines. Specifically, they should be informed not to exceed 12 doses per day to avoid potential adverse effects. Clear communication regarding these points can help ensure patient safety and effective use of the medication.

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. Proper handling should be observed to ensure optimal conditions are met throughout the storage period.

Additional Clinical Information

The medication is administered orally, with all dosages able to be repeated as needed, preferably after meals and at bedtime. 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.